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
Editorial Note:On January 1,2020,we published an online comment,titled“Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice”,w...Editorial Note:On January 1,2020,we published an online comment,titled“Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice”,which focuses on the evaluation of traditional Chinese medicine.After the article was published,it attracted the attention of some scholars,who discussed with the editorial department by letters.The relevant letters are organized as follows for further communication and discussion by readers.展开更多
OBJECTIVE： To evaluate the medium- to long-term efficacy of ligustrazine plus conventional medicine treating ischemic stroke. METHODS： Randomized controlled trials （RCTs） testing ligustrazine in the treatment of a...OBJECTIVE： To evaluate the medium- to long-term efficacy of ligustrazine plus conventional medicine treating ischemic stroke. METHODS： Randomized controlled trials （RCTs） testing ligustrazine in the treatment of acute isch- emic stroke were retrieved from Cochrane Library, PubMed, Excerpta Medica Database, Chinese Medi- cal Journal Database, Chinese Biomedical Data- base, China National Knowledge Infrastructure Da- tabase, and Chinese Clinical Trial Register, and then identified by the inclusive and exclusive criteria. The quality of trials was assessed with the Co- chrane Handbook 5.1, a risk of bias assessment toot. RevMan 5.1 was used for meta-analysis.RESULTS： Three RCTs involving 643 patients were included. Compared to conventional medicine treatment alone, ligustrazine plus conventional medicine treatment showed significant difference in reduction of stroke recurrence either at the end of 1-year follow-up [RR=0.42, 95% CI （0.18, 0.94）, P〈 0.05] or 3-years observation [RR=0.48, 95% C/（0.27, 0.83）, P〈0.05]. The ligustrazine group also showed higher survival rate [RR=1.67, 95% CI （1.02, 0.2.71）, P〈0.05] and significantly better effective rate [RR= 1.28, 95% CI（1.10, 1.50）, P〈0.05] than that of the control group at the end of 1 year visit. Only one tri- al conducted safety assessment and no adverse events were reported. The methodological quality of all the trials included was generally poor. CONCLUSION： The findings provided evidence that the combination of ligustrazine and conven- tional medication was medium- and long-term ben- eficial to the patients suffering ischemic stroke. But more RCTs of high quality are needed to further prove the efficacy and safety of using ligustrazine for ischemic stroke.展开更多
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Editorial Note:On January 1,2020,we published an online comment,titled“Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice”,which focuses on the evaluation of traditional Chinese medicine.After the article was published,it attracted the attention of some scholars,who discussed with the editorial department by letters.The relevant letters are organized as follows for further communication and discussion by readers.
基金Supported by Joint Special Project of Guangdong Provincial Department of Science and Technology-Guangdong Provincial Academy of Chinese Medical Sciences:Construction and Application of Evidence-Based Knowledge Management System for Traditional Chinese Medicine(No.2012A032500009)
文摘OBJECTIVE： To evaluate the medium- to long-term efficacy of ligustrazine plus conventional medicine treating ischemic stroke. METHODS： Randomized controlled trials （RCTs） testing ligustrazine in the treatment of acute isch- emic stroke were retrieved from Cochrane Library, PubMed, Excerpta Medica Database, Chinese Medi- cal Journal Database, Chinese Biomedical Data- base, China National Knowledge Infrastructure Da- tabase, and Chinese Clinical Trial Register, and then identified by the inclusive and exclusive criteria. The quality of trials was assessed with the Co- chrane Handbook 5.1, a risk of bias assessment toot. RevMan 5.1 was used for meta-analysis.RESULTS： Three RCTs involving 643 patients were included. Compared to conventional medicine treatment alone, ligustrazine plus conventional medicine treatment showed significant difference in reduction of stroke recurrence either at the end of 1-year follow-up [RR=0.42, 95% CI （0.18, 0.94）, P〈 0.05] or 3-years observation [RR=0.48, 95% C/（0.27, 0.83）, P〈0.05]. The ligustrazine group also showed higher survival rate [RR=1.67, 95% CI （1.02, 0.2.71）, P〈0.05] and significantly better effective rate [RR= 1.28, 95% CI（1.10, 1.50）, P〈0.05] than that of the control group at the end of 1 year visit. Only one tri- al conducted safety assessment and no adverse events were reported. The methodological quality of all the trials included was generally poor. CONCLUSION： The findings provided evidence that the combination of ligustrazine and conven- tional medication was medium- and long-term ben- eficial to the patients suffering ischemic stroke. But more RCTs of high quality are needed to further prove the efficacy and safety of using ligustrazine for ischemic stroke.
