Objective:The clinical and biological characteristics of colorectal cancer have been found to differ depending on the anatomic site of the cancer.However,for Chinese patients,there is limited information on the propor...Objective:The clinical and biological characteristics of colorectal cancer have been found to differ depending on the anatomic site of the cancer.However,for Chinese patients,there is limited information on the proportion of cases at each site and the related features.In this study,we explored the location,distribution and other features of colorectal cancers at each anatomic site in Chinese patients.Methods:We conducted a hospital-based study using hospitalization summary reports from 10 Peking University-affiliated hospitals from 2014 to 2018;the reports covered a total of 2,097,347 hospitalizations.Incident cases were chosen as the study population,and their epidemiological features were further analyzed.Results:A total of 20,739 colorectal cancer patients were identified.Rectum was the most common location(48.3%)of the cancer,whereas the proportions of patients with distal and proximal colon cancer were 24.5%and18.6%,respectively.Patients with rectal cancer were predominantly male and were the youngest for all anatomical sites(each P<0.001).The highest proportion of emergency admissions,the longest hospital stays and the highest hospitalization costs were found in patients with proximal colon cancer(each P<0.001).The proximal colon cancer subgroup included the highest proportions of patients with medical histories of cholecystectomy,cholecystolithiasis and/or gallbladder polyps and appendectomy(P=0.009,P<0.001 and P<0.001,respectively).The distal colon cancer subgroup included the highest proportions of patients with medical histories of diabetes and hypertension(P<0.001,respectively).Conclusions:The patterns of colorectal cancer observed in this study differ from those reported for Western patients and show a significantly higher proportion of patients with rectal cancer.Different epidemiological features were also found based on anatomic sites.Further studies based on tumor location should be conducted to facilitate more accurate screening and treatment.展开更多
Objective: To describe patterns of utilization of traditional Chinese medicine(TCM) in the treatment of patients with coronavirus disease 2019(COVID-19).Methods: Adult patients with COVID-19 who received TCM treatment...Objective: To describe patterns of utilization of traditional Chinese medicine(TCM) in the treatment of patients with coronavirus disease 2019(COVID-19).Methods: Adult patients with COVID-19 who received TCM treatment were divided into a non-serious group(mild and moderate types) and a serious group(severe and critical types) according to their admission conditions. The medical records and prescriptions of these patients were investigated to determine their TCM utilization patterns.Results: In all, 3,872 COVID-19 patients were included. Oral Chinese traditional patent medicine(CPM) was the most commonly used type of TCM(83.2%), fol owed by decoction(64.4%). As for medication pattern, the proportion of multi-drug combinations was higher than single drug use(55.0% vs. 45.0%). Decoction combined with oral CPM was the most common combination(39.1%,1,514/3,872). Oral y administered, injected, and external y applied CPM were significantly more common in the serious group than in the non-serious, while decoction and non-drug TCM treatments were more common in the non-serious than in the serious group.Multi-drug combinations were used for the majority of patients in both groups, mainly in the form of decoction combined with oral CPM.Serious patients were analysed by three groups of different prognoses and outcomes, including discharged after improvement,discharged after relapse and improvement, died final y. The two most common medication patterns were decoction combined with oral CPM and oral CPM alone in the two final y discharged groups. Oral CPM alone or used in combination with injected CPM were seen most commonly in the death group. Significant differences were established in medication patterns among patients in these three groups.Conclusions: Oral CPM was the mainly used TCM for COVID-19 patients, followed by decoction. More common medication pattern was multi-drug combination, especially decoction combined with oral CPM. The treatment measures and medication patterns of TCM commonly used in COVID-19 patients with the range of conditions found in this study should be further explored in the future to provide a more complete reference for COVID-19 treatment.展开更多
To the Editor:Assessment of data appropriateness is a process to answer whether electronic health records(EHRs)from routine healthcare practices couldt intended study purposes,for example,available to be proceeded,wit...To the Editor:Assessment of data appropriateness is a process to answer whether electronic health records(EHRs)from routine healthcare practices couldt intended study purposes,for example,available to be proceeded,with enough individual records,with relevant information able to be extracted from records,etc.[1-3]This has been increasingly underscored as a prerequisite when using EHRs(one important type of real-world data[RWD])for scientic purposes.[4-6]Although controversies remain on the denitions,types and assessment methods of the dimensions of RWD appropriateness,the latest ofcial guidelines(i.e.,from the U.S.Food and Drug Administration[FDA][4]and China National Medical Products Administration[NMPA][6])suggest that the assessment start from a preliminary stage on variable existence,and subsequently deepen into the issue of data value(such as missing value,outliers,etc.),as the preliminary assessment is the foundation of the overall RWD appropriateness.[7]Little is known about the appropriateness of EHRs in developing regions,which feature high visit volumes and a great number of hospitals.Therefore,this study aimed to preliminarily investigate RWD appropriateness from hospitals in developing regions from the perspective of core variables’comparison.展开更多
Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules...Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune response.However,the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.Registration:PROSPERO;https://www.crd.york.ac.uk/PROSPERO/;No.CRD42021278149.展开更多
To the Editor:Nonalcoholic fatty liver disease(NAFLD)is one of the most common chronic liver diseases globally,and this systemic disease carries a substantial economic burden and will result in a greater disease burde...To the Editor:Nonalcoholic fatty liver disease(NAFLD)is one of the most common chronic liver diseases globally,and this systemic disease carries a substantial economic burden and will result in a greater disease burden in the future.[1]Mass screening of asymptomatic individuals using ultrasonography is not cost-effective.Therefore,simple,noninvasive tests are required to identify patients with NAFLD.The fatty liver index(FLI)and hepatic steatosis index(HSI)are accurate and easy to obtain.展开更多
Background:The coronavirus disease 2019(COVID-19)pandemic is ravaging the world.Many therapies have been explored to treat COVID-19.This report aimed to assess the global research trends for the development of COVID-1...Background:The coronavirus disease 2019(COVID-19)pandemic is ravaging the world.Many therapies have been explored to treat COVID-19.This report aimed to assess the global research trends for the development of COVID-19 therapies.Methods:We searched the relevant articles on COVID-19 therapies published from January 1,2020,to May 25,2022,in the Web of Science Core Collection Database(WOSCC).VOSviewer 1.6.18 software was used to assess data on the countries,institutions,authors,collaborations,keywords,and journals that were most implicated in COVID-19 pharmacological research.The latest research and changing trends in COVID-19-relevant pharmacological research were analyzed.Results:After manually eliminating articles that do not meet the requirements,a total of 5,289 studies authored by 32,932 researchers were eventually included in the analyses,which comprised 95 randomized controlled trials.3,044(57.6%)studies were published in 2021.The USA conducted the greatest number of studies,followed by China and India.The primary USA collaborators were China and England.The topics covered in the publications included:the general characteristics,the impact on pharmacists’work,the pharmacological research,broad-spectrum antiviral drug therapy and research,and promising targets or preventive measures,such as vaccine.The temporal diagram revealed that the current research hotspots focused on the vaccine,molecular docking,Mpro,and drug delivery keywords.Conclusion:Comprehensive bibliometric analysis could aid the rapid identification of the principal research topics,potential collaborators,and the direction of future research.Pharmacological research is critical for the development of therapeutic and preventive COVID-19-associated measures.This study may therefore provide valuable information for eradicating COVID-19.展开更多
Background and objective Moyamoya disease(MMD)is an increasingly recognised cause of stroke,mainly described in East Asia.China is the largest nation in Asia,but few studies reported the epidemiology of MMD,especially...Background and objective Moyamoya disease(MMD)is an increasingly recognised cause of stroke,mainly described in East Asia.China is the largest nation in Asia,but few studies reported the epidemiology of MMD,especially at a national level.We aimed to estimate the incidence and prevalence of MMD in China.Methods We performed a population-based study using data from the national databases of Urban Basic Medical Insurance between 2013 and 2016,covering approximately 0.50 billion individuals.MMD cases were identified by diagnostic code(International Classification of Diseases,10th Revision I67.5)or related diagnostic text.Results A total of 1987 MMD patients(mean age 44.45±14.30 years,female-to male ratio 1.12)were identified,representing a national crude incidence of 0.59(95%CI:0.49 to 0.68)and a prevalence of 1.01(95%CI:0.81 to 1.21)per 100000 person-years in 2016.Rates were higher in females than in males for the incidence(0.66 vs 0.52)and prevalence(1.05 vs 0.90).And the age-specific rates showed a bimodal distribution,with the highest peak in middle-aged group and the second peak in child group.Conclusions Our results confirm that MMD is relatively common in East Asians,but the rates in China were lower than those in other East Asian countries such as Japan and Korea.The unique epidemiological features,including a relatively weak female predominance and a shift in the highest peak of incidence from children to adults,revealed new sight into MMD.Further research is expected to explore the potential pathogenesis of MMD.展开更多
Vaccination is one of the most cost-effective interventions for saving lives and promoting public health.The coronavirus disease 2019(COVID-19)pandemic is providing a stark reminder of the importance and power of vacc...Vaccination is one of the most cost-effective interventions for saving lives and promoting public health.The coronavirus disease 2019(COVID-19)pandemic is providing a stark reminder of the importance and power of vaccines(1).However,vaccines can cause harm,and their rare safety concerns have increased in relative visibility as successful control and prevention of vaccine preventable diseases has diminished awareness of these diseases.展开更多
Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understandi...Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance.It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights.In the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns.Then,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active surveillance.With these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical considerations.Conclusion.In the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and feasible.This process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners.展开更多
Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and i...Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.展开更多
基金supported by grants from the National Natural Science Foundation of China(No.81972702 and No.91959110)national multidisciplinary cooperative diagnosis and treatment capacity building project for major diseases:comprehensive diagnosis and treatment of gastrointestinal tumors,National Health and Family Planning Commission Foundation of China(No.2020YB57)“Clinical Medicine+X”Foundation of Peking University(No.PKU2021LCXQ001)。
文摘Objective:The clinical and biological characteristics of colorectal cancer have been found to differ depending on the anatomic site of the cancer.However,for Chinese patients,there is limited information on the proportion of cases at each site and the related features.In this study,we explored the location,distribution and other features of colorectal cancers at each anatomic site in Chinese patients.Methods:We conducted a hospital-based study using hospitalization summary reports from 10 Peking University-affiliated hospitals from 2014 to 2018;the reports covered a total of 2,097,347 hospitalizations.Incident cases were chosen as the study population,and their epidemiological features were further analyzed.Results:A total of 20,739 colorectal cancer patients were identified.Rectum was the most common location(48.3%)of the cancer,whereas the proportions of patients with distal and proximal colon cancer were 24.5%and18.6%,respectively.Patients with rectal cancer were predominantly male and were the youngest for all anatomical sites(each P<0.001).The highest proportion of emergency admissions,the longest hospital stays and the highest hospitalization costs were found in patients with proximal colon cancer(each P<0.001).The proximal colon cancer subgroup included the highest proportions of patients with medical histories of cholecystectomy,cholecystolithiasis and/or gallbladder polyps and appendectomy(P=0.009,P<0.001 and P<0.001,respectively).The distal colon cancer subgroup included the highest proportions of patients with medical histories of diabetes and hypertension(P<0.001,respectively).Conclusions:The patterns of colorectal cancer observed in this study differ from those reported for Western patients and show a significantly higher proportion of patients with rectal cancer.Different epidemiological features were also found based on anatomic sites.Further studies based on tumor location should be conducted to facilitate more accurate screening and treatment.
基金Special Project of Clinical Toxicology,Chinese Society of Toxicology(CST2020CT605,CST2021CT102)The second batch of Key Projects of Scientific Act for Drug Regulation of China,Grant/Award Number:[2021]3710+2 种基金Traditional Chinese Medicine Research Project,Health Commission of Hubei Province(ZY2021Z021)Special Project for Director,China Center for Evidence Based Traditional Chinese Medicine(2020YJSZX-2)National Science and Technology Major Project(2021YFC0863200)。
文摘Objective: To describe patterns of utilization of traditional Chinese medicine(TCM) in the treatment of patients with coronavirus disease 2019(COVID-19).Methods: Adult patients with COVID-19 who received TCM treatment were divided into a non-serious group(mild and moderate types) and a serious group(severe and critical types) according to their admission conditions. The medical records and prescriptions of these patients were investigated to determine their TCM utilization patterns.Results: In all, 3,872 COVID-19 patients were included. Oral Chinese traditional patent medicine(CPM) was the most commonly used type of TCM(83.2%), fol owed by decoction(64.4%). As for medication pattern, the proportion of multi-drug combinations was higher than single drug use(55.0% vs. 45.0%). Decoction combined with oral CPM was the most common combination(39.1%,1,514/3,872). Oral y administered, injected, and external y applied CPM were significantly more common in the serious group than in the non-serious, while decoction and non-drug TCM treatments were more common in the non-serious than in the serious group.Multi-drug combinations were used for the majority of patients in both groups, mainly in the form of decoction combined with oral CPM.Serious patients were analysed by three groups of different prognoses and outcomes, including discharged after improvement,discharged after relapse and improvement, died final y. The two most common medication patterns were decoction combined with oral CPM and oral CPM alone in the two final y discharged groups. Oral CPM alone or used in combination with injected CPM were seen most commonly in the death group. Significant differences were established in medication patterns among patients in these three groups.Conclusions: Oral CPM was the mainly used TCM for COVID-19 patients, followed by decoction. More common medication pattern was multi-drug combination, especially decoction combined with oral CPM. The treatment measures and medication patterns of TCM commonly used in COVID-19 patients with the range of conditions found in this study should be further explored in the future to provide a more complete reference for COVID-19 treatment.
基金supported by grants from the National Natural Science Foundation of China(Nos.82173616 and 82003536)Peking University Medicine Fund of Fostering Young Scholars’Scientific&Technological Innovation(No.BMU2022PYB035)+1 种基金Fundamental Research Funds for the Central University,Key Clinical Projects of Peking University Third Hospital(No.BYSYZD2021030)Institute of Cultural Heritage and Innovation,Fuzhou Branch,Peking University(No.FZICIPKU20200010)
文摘To the Editor:Assessment of data appropriateness is a process to answer whether electronic health records(EHRs)from routine healthcare practices couldt intended study purposes,for example,available to be proceeded,with enough individual records,with relevant information able to be extracted from records,etc.[1-3]This has been increasingly underscored as a prerequisite when using EHRs(one important type of real-world data[RWD])for scientic purposes.[4-6]Although controversies remain on the denitions,types and assessment methods of the dimensions of RWD appropriateness,the latest ofcial guidelines(i.e.,from the U.S.Food and Drug Administration[FDA][4]and China National Medical Products Administration[NMPA][6])suggest that the assessment start from a preliminary stage on variable existence,and subsequently deepen into the issue of data value(such as missing value,outliers,etc.),as the preliminary assessment is the foundation of the overall RWD appropriateness.[7]Little is known about the appropriateness of EHRs in developing regions,which feature high visit volumes and a great number of hospitals.Therefore,this study aimed to preliminarily investigate RWD appropriateness from hospitals in developing regions from the perspective of core variables’comparison.
基金National Key R&D Program of China(No.2021YFC2301601)
文摘Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune response.However,the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.Registration:PROSPERO;https://www.crd.york.ac.uk/PROSPERO/;No.CRD42021278149.
文摘To the Editor:Nonalcoholic fatty liver disease(NAFLD)is one of the most common chronic liver diseases globally,and this systemic disease carries a substantial economic burden and will result in a greater disease burden in the future.[1]Mass screening of asymptomatic individuals using ultrasonography is not cost-effective.Therefore,simple,noninvasive tests are required to identify patients with NAFLD.The fatty liver index(FLI)and hepatic steatosis index(HSI)are accurate and easy to obtain.
基金the special fund of Beijing Key Clinical Specialty Construction Project,and the Hospital Library Committee of Library Society of China(Grant No.YX2021Y05).
文摘Background:The coronavirus disease 2019(COVID-19)pandemic is ravaging the world.Many therapies have been explored to treat COVID-19.This report aimed to assess the global research trends for the development of COVID-19 therapies.Methods:We searched the relevant articles on COVID-19 therapies published from January 1,2020,to May 25,2022,in the Web of Science Core Collection Database(WOSCC).VOSviewer 1.6.18 software was used to assess data on the countries,institutions,authors,collaborations,keywords,and journals that were most implicated in COVID-19 pharmacological research.The latest research and changing trends in COVID-19-relevant pharmacological research were analyzed.Results:After manually eliminating articles that do not meet the requirements,a total of 5,289 studies authored by 32,932 researchers were eventually included in the analyses,which comprised 95 randomized controlled trials.3,044(57.6%)studies were published in 2021.The USA conducted the greatest number of studies,followed by China and India.The primary USA collaborators were China and England.The topics covered in the publications included:the general characteristics,the impact on pharmacists’work,the pharmacological research,broad-spectrum antiviral drug therapy and research,and promising targets or preventive measures,such as vaccine.The temporal diagram revealed that the current research hotspots focused on the vaccine,molecular docking,Mpro,and drug delivery keywords.Conclusion:Comprehensive bibliometric analysis could aid the rapid identification of the principal research topics,potential collaborators,and the direction of future research.Pharmacological research is critical for the development of therapeutic and preventive COVID-19-associated measures.This study may therefore provide valuable information for eradicating COVID-19.
基金This work was supported by the National Natural Science Foundation of China(grants 91646107,81973146 and 81502884)Peking University Medicine Seed Fund for Interdisciplinary Research:The Fundamental Research Funds for the Central Universities(BMU2020MX017).
文摘Background and objective Moyamoya disease(MMD)is an increasingly recognised cause of stroke,mainly described in East Asia.China is the largest nation in Asia,but few studies reported the epidemiology of MMD,especially at a national level.We aimed to estimate the incidence and prevalence of MMD in China.Methods We performed a population-based study using data from the national databases of Urban Basic Medical Insurance between 2013 and 2016,covering approximately 0.50 billion individuals.MMD cases were identified by diagnostic code(International Classification of Diseases,10th Revision I67.5)or related diagnostic text.Results A total of 1987 MMD patients(mean age 44.45±14.30 years,female-to male ratio 1.12)were identified,representing a national crude incidence of 0.59(95%CI:0.49 to 0.68)and a prevalence of 1.01(95%CI:0.81 to 1.21)per 100000 person-years in 2016.Rates were higher in females than in males for the incidence(0.66 vs 0.52)and prevalence(1.05 vs 0.90).And the age-specific rates showed a bimodal distribution,with the highest peak in middle-aged group and the second peak in child group.Conclusions Our results confirm that MMD is relatively common in East Asians,but the rates in China were lower than those in other East Asian countries such as Japan and Korea.The unique epidemiological features,including a relatively weak female predominance and a shift in the highest peak of incidence from children to adults,revealed new sight into MMD.Further research is expected to explore the potential pathogenesis of MMD.
基金The National Natural Science Foundation of China(Grant No.81973146)the Advanced Project of Beijing Natural Science Foundation(Grant No.BMU2019GJJXK003).
文摘Vaccination is one of the most cost-effective interventions for saving lives and promoting public health.The coronavirus disease 2019(COVID-19)pandemic is providing a stark reminder of the importance and power of vaccines(1).However,vaccines can cause harm,and their rare safety concerns have increased in relative visibility as successful control and prevention of vaccine preventable diseases has diminished awareness of these diseases.
基金This work was supported by the National Natural Science Foundation of China(Grant no.81973146)the advanced project of the Beijing Natural Science Foundation(Grant no.BMU2019GJJXK003).
文摘Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance.It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights.In the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns.Then,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active surveillance.With these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical considerations.Conclusion.In the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and feasible.This process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners.
文摘Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.
