Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical s...Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.展开更多
This study aimed to investigate the protective effect of oral steroid premedication in terms of adverse reactions to non-ionic contrast media. We investigated the incidence of adverse reactions among patients who unde...This study aimed to investigate the protective effect of oral steroid premedication in terms of adverse reactions to non-ionic contrast media. We investigated the incidence of adverse reactions among patients who underwent contrast-enhanced computed tomography. Patients in the premedication group took 30 mg of prednisolone orally the night before and on the morning of the scheduled computed tomography. Sixty-five patients received the same contrast media. Among them, 56 took prednisolone orally prior to the procedure (premedication without change of contrast media group) and nine without premedication (no premedication and no change of contrast media group). In total, 379 patients received different contrast media. Among them, 340 took prednisolone orally (premedication with change of contrast media group), while 39 did not take the premedication (no premedication with change of contrast media group). The adverse reaction rates in the premedication with change of contrast media and no premedication with change of contrast media groups were 1.8% (6/340 cases) and 2.6% (1/39 cases) (P = 0.54), respectively. The incidence of adverse reaction after the administration of non-ionic iodinated contrast media did not differ significantly based on whether an oral steroid was administered prior to compute tomography. Our evaluation is limited due to the small sample size of the contrast media-changed group. However, even if premedication with steroids is effective, it may only result in an adverse reaction reduction rate of ≤3%.展开更多
Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFan...Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.展开更多
Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational u...Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.展开更多
The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor ...The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor and pre-cancer skin disease admitted to our hospital from January 20,2018 to September 18,2018 were selected,and all of them adopted photodynamic therapy.The 100 patients included 40 cases of basal cell carcinoma,14 cases of squamous cell carcinoma,7 cases of proliferative erythema,9 cases of Bowen’s disease and 39 cases of solar keratosis.Among the 100 patients,77 cases had excellent curative effect,18 cases had good effect and 5 cases had poor effect,and the overall effective rate was 95%(95/100).After 6 months of follow-up,5 cases of basal cell carcinoma,2 cases of squamous cell carcinoma,0 cases of proliferative erythra,1 case of Bowen’s disease and 3 cases of solar keratosis recurred,with an overall recurrence rate of 14%(14/100).The adverse reactions of pruritus were 90%(90/100),81%(81/100),90%(90/100)and 3%(3/100).Therefore,the application of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases is not only effective,but also safe and not easy to relapse.展开更多
Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gas...Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gastrodin-related preparations in clinical practice,and gastrodin injections are the most widely used.This article will summarize pharmacology and adverse reactions of gastrodin to evaluate its safety,effectiveness and quality control.Gastrodin has pharmacological effects on central nervous system(vertigo,headache,insomnia,neurasthenia,convulsions and epilepsy,etc.),cardiovascular system and other diseases(osteoporosis,osteoarthritis and bone injury,etc.),but we still need to pay attention to its clinical adverse reactions(some patients may have dry mouth and nose,dizziness and stomach discomfort).In addition,further research is needed in other fields,such as health products,food,cosmetics,etc.We also need to further develop and explore the new pharmacological effects of gastrodin and expand its medicinal value.展开更多
Objective:In general hospitals,pharmaceutical care was carried out to reduce the incidence of adverse drug reactions(ADR),and this effect was significant.It can significantly reduce the incidence of adverse drug react...Objective:In general hospitals,pharmaceutical care was carried out to reduce the incidence of adverse drug reactions(ADR),and this effect was significant.It can significantly reduce the incidence of adverse drug reactions and improve the safety of drug therapy.The Joint Surgery Department and the Department of Neurology of Changle County People's Hospital in Shandong province were investigated for the effect of pharmaceutical care on reducing adverse drug reactions.Methods:120 patients were selected from the Department of Joint Surgery and Neurology,Changle County People's Hospital,Shandong Province from May 2015 to May 2020.According to the random table method,the patients were divided into experimental group(60 cases)and control group(60 cases).Control group:routine drug therapy.Experimental group:pharmaceutical care treatment was carried out jointly,and the incidence of adverse reactions was compared between the two groups.Results:The incidence of adverse reactions in experimental group was lower than that in control group.Conclusion:In general hospitals,pharmaceutical care is effective in reducing adverse drug reactions,which can significantly reduce the incidence of adverse drug reactions.At the same time,this improves the safety of drug treatment,which is worthy of clinical promotion.展开更多
Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hi...Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hirudin derivatives such as lepirudin,desirudin and bivalirudin,and the third is new hirudin preparations such as hirudin-bovine serum albumin(BSA)nanoparticles,polydopamine fitted titanium dioxide nanoparticles systems and recombinant hirudins-2(rhv2)-loaded picmice.The pharmacological effects and adverse reactions of hirudin were reviewed to evaluate its safety,efficacy and quality control.Hirudin has obvious pharmacological effects on cardio-cerebrovascular diseases(coronary atherosclerotic heart disease,myocardial infarction,hyperlipidemia,cerebral infarction,arteriosclerosis obliterans of lower extremities),angiogenesis(fracture,skinflaptransplantation),tissue fibrosis,tumor,ophthalmopathy,hyperuricemia and female infertility.However,attention should be paid to clinical adverse reactions(bleeding,allergic reaction,infection,cutaneous pseudolymphoma).展开更多
Adverse drug reaction is defined by the World Health Organization as any response to a drug that is noxious and unintended and occurs at a dose normally used in man.Older people are at elevated risk of adverse drug re...Adverse drug reaction is defined by the World Health Organization as any response to a drug that is noxious and unintended and occurs at a dose normally used in man.Older people are at elevated risk of adverse drug reactions—because of changes in pharmacodynamics,concurrent use of multiple medications and the related drug interactions.However,adverse drug reactions are significantly underestimated in the elderly population that is also exposed to inappropriate drugs.Amiodarone is an antiarrhythmic drug used commonly for the treatment of atrial fibrillation and is increasingly prescribed in older people.While amiodarone is an efficient drug for rhythm control,it’s a carrier of different adverse reactions,and pro and cons must be carefully evaluated before its use especially in older people.展开更多
Purpose: To evaluate the rate of any type of anticoagulant drug use in urological inpatients and patients awareness of their effect on coagulation. Material and methods: This observational study was conducted prospect...Purpose: To evaluate the rate of any type of anticoagulant drug use in urological inpatients and patients awareness of their effect on coagulation. Material and methods: This observational study was conducted prospectively in a cohort of 193 consecutive urological inpatients who were asked to state the medications they were taking and following that, were specifically asked whether they were taking aspirin or other antiplatelet/anticoagulant agents. In case they did so, they were further asked why they were taking them, whether they knew their effect on coagulation and who had informed them on the matter. Results: Forty-seven patients received some kind of antithrombotic treatment. Twenty-nine per cent of aspirin users had to be specifically prompted in order to state its use, in comparison to 35.7% and 25% of other antiplatelets and warfarin users, respectively. Half of patients receiving warfarin were not aware of its effect on coagulation in comparison to 32.3% and 21.4% of those taking aspirin and other antiplatelets, respectively. Conclusion: Urologists should be aware of the high use of such agents by their patients and that not all patients are aware of their effect on coagulation, while some, even fail to report their use and have to be specifically prompted.展开更多
AIM: To analyze the clinical features and risk factors of adverse reactions associated with telbivudine. METHODS: Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. W...AIM: To analyze the clinical features and risk factors of adverse reactions associated with telbivudine. METHODS: Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. We analyzed general information and medicine status, clinical features, results of examination, and misdiagnosis. RESULTS: Out of 105 patients who were treated with telbivudine for hepatitis B in an outpatient department from January, 2007 to January, 2008, five presented with serious adverse drug reactions. Most of these five patients had used other nucleoside analogues in the past. Four were treated with a combination of telbivudine and interferon or another nucleoside analogue, while the other received an increased dose of telbivudine. The main adverse reactions were myalgia and general weakness. This was accompanied by cardiac arrhythmia in one patient, and nervous symptoms in three. Serum creatine kinase was elevated. The rate of misdiagnosis was high. CONCLUSION: The adverse reactions were related to telbivudine, but the biological mechanism of the reactions is not yet clear. Combination therapy with interferon or another nucleoside analogue and a high dose may increase the risk of adverse reactions.展开更多
Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (...Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (CT) in patients with cervical cancer and endometrial adenocarcinoma impact quality of life and, therefore, outcomes of these therapies. Objective: To identify Oncoxin-Viusid’s efficacy in reducing acute toxicity produced by onco-specific treatments in patients with cervical cancer and endometrial adenocarcinoma. Materials and Methods: A controlled, randomised double-blind phase II clinical trial was performed with a sample size of 63 patients distributed into 2 groups: one receiving the standard treatment plus the Oncoxin-Viusid nutritional supplement (OV group) and another receiving the standard treatment and placebo (P group). The primary efficacy variable is the proportion of secondary disruptions to acute adverse reactions produced by RT and CT. Results: The number of patients suffering adverse events from chemotherapy was 20.6% less in the OV group (70.0%) than in the placebo group (90.6%) (p = 0.04). We recorded consistently normal values of haemoglobin (-6.2 OV group vs -8.3 P group, p = 0.009), platelet count (-17.4 OV group vs -27.6 P group, p = 0.009) and leukocytes (-31.8 OV group vs -41.4 P group, p = 0.025) in the OV group, tolerating 4 more cytostatic doses on average than the placebo group. Significant increase in quality of life (QLQ-30) was registered in the OV group with a large effect size on such issues as emotional and social function (Cohen’s d = 0.9), as well as in the reduction of symptoms like dyspnea 60%, insomnia 15% and anorexia 30% (item CX-2), (Cohen’s d = 0.98), which were higher than the placebo group. Conclusions: OV administration reduces onco-specific adverse events and improves quality of life in patients diagnosed with cervical cancer and endometrial adenocarcinoma undergoing radiation therapy and chemotherapy.展开更多
Objective This cross-sectional study aimed to investigate the current attention and intervention of oncologists on oxaliplatin(OXA)-induced adverse reactions(ADRs).Methods In 31 provinces or administrative regions acr...Objective This cross-sectional study aimed to investigate the current attention and intervention of oncologists on oxaliplatin(OXA)-induced adverse reactions(ADRs).Methods In 31 provinces or administrative regions across China,401 oncologists were surveyed through a self-designed questionnaire.The survey queried the basic information of respondents,clinical use of OXA,OXA-induced ADRs,and relative interventions.Chi-square tests and multiple logistic regression were used to explore the sociodemographic factors influencing the safety perception of OXA and the relevant interventions.Results The survey showed that the age of respondents was mainly distributed between 30 and 40 years and the working period for most oncologists was no more than 5 years.Oncologists with long working years were more willing to conduct patient education and inquire about ADRs than those with short working years.The rate of ADRs reported by oncologists with intermediate professional titles was significantly higher than that reported by oncologists with junior and senior professional titles.Conclusion Our findings indicate that oncologists in China's Mainland are concerned about OXA-induced ADRs,but the reporting of ADRs still needs to be strengthened.Therefore,training and educational programs are urgently needed to improve the risk management of OXA-induced ADRs among oncologists.展开更多
Objective:To describe the perceptions of community members and programme partners regarding severity,management and impact of adverse reactions on mass drug administration (MDA) compliance.Methods:Based on various qua...Objective:To describe the perceptions of community members and programme partners regarding severity,management and impact of adverse reactions on mass drug administration (MDA) compliance.Methods:Based on various qualitative data collected from five districts of Orissa,India,where MDA had been implemented during 2002 and 2004.The qualitative surveys included focus group discussions with community members and health workers,and semi-structured interviews with key informants in the community,medical officers at primary health centres,district level health officers and private practitioners.Results:It showed that many people suffered from adverse reactions,though the reactions were not serious.The paper reported different ways of management of adverse reactions at the community level.The impact of adverse reactions on MDA compliance was serious,as many people did not consume the drug due to fear of adverse reactions.The rumours of adverse reactions and news in media deterred people from consuming the tablets.Conclusion:All categories of respondents indicates the need of more information to address the problem of adverse reactions during MDA.The present paper warrants incorporating the messages on adverse reactions during health communication and social mobilization campaigns of MDA.展开更多
Background:To explore the difference between the outcomes of correlations between a series of variables and adverse reactions(ARs)to fluorescein from univariate and multivariate analysis and to evaluate the nausea eff...Background:To explore the difference between the outcomes of correlations between a series of variables and adverse reactions(ARs)to fluorescein from univariate and multivariate analysis and to evaluate the nausea effects in different age groups.Methods:A retrospective study of patients undergoing consecutive fluorescein angiography between March2010 and February 2012 was conducted.No patients were excluded on the ground of age,presence of atopy,allergy history,previous procedures without severe allergic ARs,asymptomatic hypertension and kidney failure with serum creatinine levels lower than 250μmol/L or with renal dialysis.Results:A total of 829 patients were enrolled and 22.2%of them had ARs.The majority of reactions were nausea(12.1%)which occurred less when age became old(P<0.0001).When the correlations between a series of variables and ARs were assessed separately,age(P<0.0001),prior reactions(P<0.0001)and motion sickness(P=0.0062)were highly and cardio/cerebrovascular disease(P=0.0015),diabetes(P=0.0001)and renal disease(P=0.0219)were lowly related to ARs.However,when the correlations were assessed simultaneously,only age[odd ratio(OR)0.974;95%confidence interval(CI),0.962–0.986],prior reactions(OR 5.596;95%CI,2.083–15.029)and motion sickness(OR 4.849;95%CI,1.583–14.856)were statistically correlated with ARs.Conclusions:Fluorescein angiography is a safe procedure for patients who are relatively healthy but with a history of any systemic disease.Young age,prior reactions and motion sickness which are highly related to emetic events should be considered in the evaluation of ARs to fluorescein.展开更多
Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical...Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.展开更多
Objective:To explore the effect of bevacizumab combined with neoadjuvant chemotherapy in advanced ovarian cancer and the occurrence of adverse reactions.Methods:A total of 80 patients with advanced ovarian cancer,trea...Objective:To explore the effect of bevacizumab combined with neoadjuvant chemotherapy in advanced ovarian cancer and the occurrence of adverse reactions.Methods:A total of 80 patients with advanced ovarian cancer,treated in Affiliated People's Hospital of Inner Mongolia Medical University from June 2019 to December 2020,were randomly divided into two groups.In the chemotherapy group,40 patients were treated with neoadjuvant chemotherapy,while in the combined group,another 40 patients were treated with bevacizumab combined with neoadjuvant chemotherapy.The therapeutic effects were compared at the end of the treatment cycle.Results:There was no significant difference in the levels of CA125,CEA,and VEGF between the two groups before treatment.However,after the treatment cycle,the levels of CA125,CEA,and VEGF in the combined group were significantly better than those in the chemotherapy group(P<0.05).At the same time,the incidence of adverse reactions of the chemotherapy group was 67.50%,which was significantly higher than that of the combined group(35.00%;P<0.05).Conclusion:Bevacizumab combined with neoadjuvant chemotherapy for patients with advanced ovarian cancer has significant curative effect.The combined therapy reduces the levels of tumor markers and inflammatory factors,improves patients'quality of life,as well as reduces adverse reactions.It has high clinical promotion value.展开更多
Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conduc...Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.展开更多
Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and preven...Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.展开更多
The child patient, male, 4 months and 16 days old, was vaccinated orally by Type I Type III Live Attenuated Oral Poliomyelitis Vaccine (human diploid cells) at 10:45 a.m. on June 1st of 2016 in Shaoxian Community Heal...The child patient, male, 4 months and 16 days old, was vaccinated orally by Type I Type III Live Attenuated Oral Poliomyelitis Vaccine (human diploid cells) at 10:45 a.m. on June 1st of 2016 in Shaoxian Community Health Service Center of our hospital. Two hours after vaccination, the child patient showed erythema scattered on the upper of the left knee, on the right calf and on the abdomen. The forearm of the left upper limb was scattered with punctate rashes. He was admitted to Department of Pediatrics of our hospital at 12:32 on June 1st of 2016. The diagnosis was 'immune thrombocytopenic purpura'. After admission, the child patient received expert consultation and systematic treatment, consequently getting better.展开更多
文摘Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.
文摘This study aimed to investigate the protective effect of oral steroid premedication in terms of adverse reactions to non-ionic contrast media. We investigated the incidence of adverse reactions among patients who underwent contrast-enhanced computed tomography. Patients in the premedication group took 30 mg of prednisolone orally the night before and on the morning of the scheduled computed tomography. Sixty-five patients received the same contrast media. Among them, 56 took prednisolone orally prior to the procedure (premedication without change of contrast media group) and nine without premedication (no premedication and no change of contrast media group). In total, 379 patients received different contrast media. Among them, 340 took prednisolone orally (premedication with change of contrast media group), while 39 did not take the premedication (no premedication with change of contrast media group). The adverse reaction rates in the premedication with change of contrast media and no premedication with change of contrast media groups were 1.8% (6/340 cases) and 2.6% (1/39 cases) (P = 0.54), respectively. The incidence of adverse reaction after the administration of non-ionic iodinated contrast media did not differ significantly based on whether an oral steroid was administered prior to compute tomography. Our evaluation is limited due to the small sample size of the contrast media-changed group. However, even if premedication with steroids is effective, it may only result in an adverse reaction reduction rate of ≤3%.
基金funded the Province Natural Science key Foundation of Hainan(No:ZDYFXGFY2020004 and No:ZDYF 2019125)the National Natural Science Foundation of China(No:81960351)Hainan Province Clinical Medical Center.
文摘Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.
文摘Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.
文摘The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor and pre-cancer skin disease admitted to our hospital from January 20,2018 to September 18,2018 were selected,and all of them adopted photodynamic therapy.The 100 patients included 40 cases of basal cell carcinoma,14 cases of squamous cell carcinoma,7 cases of proliferative erythema,9 cases of Bowen’s disease and 39 cases of solar keratosis.Among the 100 patients,77 cases had excellent curative effect,18 cases had good effect and 5 cases had poor effect,and the overall effective rate was 95%(95/100).After 6 months of follow-up,5 cases of basal cell carcinoma,2 cases of squamous cell carcinoma,0 cases of proliferative erythra,1 case of Bowen’s disease and 3 cases of solar keratosis recurred,with an overall recurrence rate of 14%(14/100).The adverse reactions of pruritus were 90%(90/100),81%(81/100),90%(90/100)and 3%(3/100).Therefore,the application of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases is not only effective,but also safe and not easy to relapse.
文摘Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gastrodin-related preparations in clinical practice,and gastrodin injections are the most widely used.This article will summarize pharmacology and adverse reactions of gastrodin to evaluate its safety,effectiveness and quality control.Gastrodin has pharmacological effects on central nervous system(vertigo,headache,insomnia,neurasthenia,convulsions and epilepsy,etc.),cardiovascular system and other diseases(osteoporosis,osteoarthritis and bone injury,etc.),but we still need to pay attention to its clinical adverse reactions(some patients may have dry mouth and nose,dizziness and stomach discomfort).In addition,further research is needed in other fields,such as health products,food,cosmetics,etc.We also need to further develop and explore the new pharmacological effects of gastrodin and expand its medicinal value.
基金Key Research Project of Scientific and Educational Innovation in the Institute of Educational Science,Chinese Academy of Management Sciences(Grant No:KJCX5406).
文摘Objective:In general hospitals,pharmaceutical care was carried out to reduce the incidence of adverse drug reactions(ADR),and this effect was significant.It can significantly reduce the incidence of adverse drug reactions and improve the safety of drug therapy.The Joint Surgery Department and the Department of Neurology of Changle County People's Hospital in Shandong province were investigated for the effect of pharmaceutical care on reducing adverse drug reactions.Methods:120 patients were selected from the Department of Joint Surgery and Neurology,Changle County People's Hospital,Shandong Province from May 2015 to May 2020.According to the random table method,the patients were divided into experimental group(60 cases)and control group(60 cases).Control group:routine drug therapy.Experimental group:pharmaceutical care treatment was carried out jointly,and the incidence of adverse reactions was compared between the two groups.Results:The incidence of adverse reactions in experimental group was lower than that in control group.Conclusion:In general hospitals,pharmaceutical care is effective in reducing adverse drug reactions,which can significantly reduce the incidence of adverse drug reactions.At the same time,this improves the safety of drug treatment,which is worthy of clinical promotion.
文摘Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hirudin derivatives such as lepirudin,desirudin and bivalirudin,and the third is new hirudin preparations such as hirudin-bovine serum albumin(BSA)nanoparticles,polydopamine fitted titanium dioxide nanoparticles systems and recombinant hirudins-2(rhv2)-loaded picmice.The pharmacological effects and adverse reactions of hirudin were reviewed to evaluate its safety,efficacy and quality control.Hirudin has obvious pharmacological effects on cardio-cerebrovascular diseases(coronary atherosclerotic heart disease,myocardial infarction,hyperlipidemia,cerebral infarction,arteriosclerosis obliterans of lower extremities),angiogenesis(fracture,skinflaptransplantation),tissue fibrosis,tumor,ophthalmopathy,hyperuricemia and female infertility.However,attention should be paid to clinical adverse reactions(bleeding,allergic reaction,infection,cutaneous pseudolymphoma).
基金supported in part by Sapienza University grant#C26A15M78W(to IL)
文摘Adverse drug reaction is defined by the World Health Organization as any response to a drug that is noxious and unintended and occurs at a dose normally used in man.Older people are at elevated risk of adverse drug reactions—because of changes in pharmacodynamics,concurrent use of multiple medications and the related drug interactions.However,adverse drug reactions are significantly underestimated in the elderly population that is also exposed to inappropriate drugs.Amiodarone is an antiarrhythmic drug used commonly for the treatment of atrial fibrillation and is increasingly prescribed in older people.While amiodarone is an efficient drug for rhythm control,it’s a carrier of different adverse reactions,and pro and cons must be carefully evaluated before its use especially in older people.
文摘Purpose: To evaluate the rate of any type of anticoagulant drug use in urological inpatients and patients awareness of their effect on coagulation. Material and methods: This observational study was conducted prospectively in a cohort of 193 consecutive urological inpatients who were asked to state the medications they were taking and following that, were specifically asked whether they were taking aspirin or other antiplatelet/anticoagulant agents. In case they did so, they were further asked why they were taking them, whether they knew their effect on coagulation and who had informed them on the matter. Results: Forty-seven patients received some kind of antithrombotic treatment. Twenty-nine per cent of aspirin users had to be specifically prompted in order to state its use, in comparison to 35.7% and 25% of other antiplatelets and warfarin users, respectively. Half of patients receiving warfarin were not aware of its effect on coagulation in comparison to 32.3% and 21.4% of those taking aspirin and other antiplatelets, respectively. Conclusion: Urologists should be aware of the high use of such agents by their patients and that not all patients are aware of their effect on coagulation, while some, even fail to report their use and have to be specifically prompted.
文摘AIM: To analyze the clinical features and risk factors of adverse reactions associated with telbivudine. METHODS: Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. We analyzed general information and medicine status, clinical features, results of examination, and misdiagnosis. RESULTS: Out of 105 patients who were treated with telbivudine for hepatitis B in an outpatient department from January, 2007 to January, 2008, five presented with serious adverse drug reactions. Most of these five patients had used other nucleoside analogues in the past. Four were treated with a combination of telbivudine and interferon or another nucleoside analogue, while the other received an increased dose of telbivudine. The main adverse reactions were myalgia and general weakness. This was accompanied by cardiac arrhythmia in one patient, and nervous symptoms in three. Serum creatine kinase was elevated. The rate of misdiagnosis was high. CONCLUSION: The adverse reactions were related to telbivudine, but the biological mechanism of the reactions is not yet clear. Combination therapy with interferon or another nucleoside analogue and a high dose may increase the risk of adverse reactions.
文摘Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (CT) in patients with cervical cancer and endometrial adenocarcinoma impact quality of life and, therefore, outcomes of these therapies. Objective: To identify Oncoxin-Viusid’s efficacy in reducing acute toxicity produced by onco-specific treatments in patients with cervical cancer and endometrial adenocarcinoma. Materials and Methods: A controlled, randomised double-blind phase II clinical trial was performed with a sample size of 63 patients distributed into 2 groups: one receiving the standard treatment plus the Oncoxin-Viusid nutritional supplement (OV group) and another receiving the standard treatment and placebo (P group). The primary efficacy variable is the proportion of secondary disruptions to acute adverse reactions produced by RT and CT. Results: The number of patients suffering adverse events from chemotherapy was 20.6% less in the OV group (70.0%) than in the placebo group (90.6%) (p = 0.04). We recorded consistently normal values of haemoglobin (-6.2 OV group vs -8.3 P group, p = 0.009), platelet count (-17.4 OV group vs -27.6 P group, p = 0.009) and leukocytes (-31.8 OV group vs -41.4 P group, p = 0.025) in the OV group, tolerating 4 more cytostatic doses on average than the placebo group. Significant increase in quality of life (QLQ-30) was registered in the OV group with a large effect size on such issues as emotional and social function (Cohen’s d = 0.9), as well as in the reduction of symptoms like dyspnea 60%, insomnia 15% and anorexia 30% (item CX-2), (Cohen’s d = 0.98), which were higher than the placebo group. Conclusions: OV administration reduces onco-specific adverse events and improves quality of life in patients diagnosed with cervical cancer and endometrial adenocarcinoma undergoing radiation therapy and chemotherapy.
基金supported by the Clinical Toxicology Foundation of the Chinese Society of Toxicology(No.CST2020CT107)the Research Project of the Drug Clinical Evaluation Professional Committee of the China Pharmaceutical Association(No.CPA-Z06-ZC-2021-004).
文摘Objective This cross-sectional study aimed to investigate the current attention and intervention of oncologists on oxaliplatin(OXA)-induced adverse reactions(ADRs).Methods In 31 provinces or administrative regions across China,401 oncologists were surveyed through a self-designed questionnaire.The survey queried the basic information of respondents,clinical use of OXA,OXA-induced ADRs,and relative interventions.Chi-square tests and multiple logistic regression were used to explore the sociodemographic factors influencing the safety perception of OXA and the relevant interventions.Results The survey showed that the age of respondents was mainly distributed between 30 and 40 years and the working period for most oncologists was no more than 5 years.Oncologists with long working years were more willing to conduct patient education and inquire about ADRs than those with short working years.The rate of ADRs reported by oncologists with intermediate professional titles was significantly higher than that reported by oncologists with junior and senior professional titles.Conclusion Our findings indicate that oncologists in China's Mainland are concerned about OXA-induced ADRs,but the reporting of ADRs still needs to be strengthened.Therefore,training and educational programs are urgently needed to improve the risk management of OXA-induced ADRs among oncologists.
基金funded by UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases(TDR),World Health Organization,Geneva, Switzerland
文摘Objective:To describe the perceptions of community members and programme partners regarding severity,management and impact of adverse reactions on mass drug administration (MDA) compliance.Methods:Based on various qualitative data collected from five districts of Orissa,India,where MDA had been implemented during 2002 and 2004.The qualitative surveys included focus group discussions with community members and health workers,and semi-structured interviews with key informants in the community,medical officers at primary health centres,district level health officers and private practitioners.Results:It showed that many people suffered from adverse reactions,though the reactions were not serious.The paper reported different ways of management of adverse reactions at the community level.The impact of adverse reactions on MDA compliance was serious,as many people did not consume the drug due to fear of adverse reactions.The rumours of adverse reactions and news in media deterred people from consuming the tablets.Conclusion:All categories of respondents indicates the need of more information to address the problem of adverse reactions during MDA.The present paper warrants incorporating the messages on adverse reactions during health communication and social mobilization campaigns of MDA.
文摘Background:To explore the difference between the outcomes of correlations between a series of variables and adverse reactions(ARs)to fluorescein from univariate and multivariate analysis and to evaluate the nausea effects in different age groups.Methods:A retrospective study of patients undergoing consecutive fluorescein angiography between March2010 and February 2012 was conducted.No patients were excluded on the ground of age,presence of atopy,allergy history,previous procedures without severe allergic ARs,asymptomatic hypertension and kidney failure with serum creatinine levels lower than 250μmol/L or with renal dialysis.Results:A total of 829 patients were enrolled and 22.2%of them had ARs.The majority of reactions were nausea(12.1%)which occurred less when age became old(P<0.0001).When the correlations between a series of variables and ARs were assessed separately,age(P<0.0001),prior reactions(P<0.0001)and motion sickness(P=0.0062)were highly and cardio/cerebrovascular disease(P=0.0015),diabetes(P=0.0001)and renal disease(P=0.0219)were lowly related to ARs.However,when the correlations were assessed simultaneously,only age[odd ratio(OR)0.974;95%confidence interval(CI),0.962–0.986],prior reactions(OR 5.596;95%CI,2.083–15.029)and motion sickness(OR 4.849;95%CI,1.583–14.856)were statistically correlated with ARs.Conclusions:Fluorescein angiography is a safe procedure for patients who are relatively healthy but with a history of any systemic disease.Young age,prior reactions and motion sickness which are highly related to emetic events should be considered in the evaluation of ARs to fluorescein.
基金This research was financially supported by The National Key R&D Program of China(Grant No.2019YFC1709802).
文摘Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.
文摘Objective:To explore the effect of bevacizumab combined with neoadjuvant chemotherapy in advanced ovarian cancer and the occurrence of adverse reactions.Methods:A total of 80 patients with advanced ovarian cancer,treated in Affiliated People's Hospital of Inner Mongolia Medical University from June 2019 to December 2020,were randomly divided into two groups.In the chemotherapy group,40 patients were treated with neoadjuvant chemotherapy,while in the combined group,another 40 patients were treated with bevacizumab combined with neoadjuvant chemotherapy.The therapeutic effects were compared at the end of the treatment cycle.Results:There was no significant difference in the levels of CA125,CEA,and VEGF between the two groups before treatment.However,after the treatment cycle,the levels of CA125,CEA,and VEGF in the combined group were significantly better than those in the chemotherapy group(P<0.05).At the same time,the incidence of adverse reactions of the chemotherapy group was 67.50%,which was significantly higher than that of the combined group(35.00%;P<0.05).Conclusion:Bevacizumab combined with neoadjuvant chemotherapy for patients with advanced ovarian cancer has significant curative effect.The combined therapy reduces the levels of tumor markers and inflammatory factors,improves patients'quality of life,as well as reduces adverse reactions.It has high clinical promotion value.
文摘Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.
基金funded by National Science and Technology Major Project of New Important Drug Creation (2015ZX09501004-001-002)The National Natural Science Foundation of China (81473798):Study on allergic reaction mechanism of Chinese medicine injections with active monitoring and network target monitoring+1 种基金Project of "One Belt, One Road" for Traditional Chinese Medicine of China Academy of Chinese Medical Sciences (GH2017-04)Construction of China-US Major Disease Clinical Research Center (GH2017-04-01)
文摘Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.
文摘The child patient, male, 4 months and 16 days old, was vaccinated orally by Type I Type III Live Attenuated Oral Poliomyelitis Vaccine (human diploid cells) at 10:45 a.m. on June 1st of 2016 in Shaoxian Community Health Service Center of our hospital. Two hours after vaccination, the child patient showed erythema scattered on the upper of the left knee, on the right calf and on the abdomen. The forearm of the left upper limb was scattered with punctate rashes. He was admitted to Department of Pediatrics of our hospital at 12:32 on June 1st of 2016. The diagnosis was 'immune thrombocytopenic purpura'. After admission, the child patient received expert consultation and systematic treatment, consequently getting better.
