中成药上市后临床安全性医院集中监测报告规范的建议
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摘要
本研究旨在通过制定中成药上市后临床安全性医院集中监测报告规范的建议,提高中成药上市后临床安全性医院集中监测的报告质量。按照国际卫生研究中报告规范的制定指南五大步骤(立项发起、会前准备、面对面共识会议、会后行动、发布后工作)开展研制,形成了中成药临床安全性监测报告规范建议以及相关条目清单。通过该研究所形成的报告规范建议,能够为如何撰写中成药上市后临床安全性医院集中监测报告提供参考和借鉴,但有待进一步广泛征集国内外相关专家反馈意见,并推广使用。
This study aims to draw up a proposed standard for reporting intensive hospital monitoring of traditional Chinese patent medicines,based on the laws and regulations of the drug administration in China and international research reporting standards. We developed the proposed reporting standard by summarizing items according to the five steps from the Guidance for Developers of Health Research Reporting Guidelines. This study had developed proposed reporting standards and related evaluating list for reporting study on postmarketing surveillance of traditional Chinese patent medicines. It will be a useful tool for reporting study on intensive hospital monitoring of traditional Chinese patent medicines. However,consensus is needed to be reached by domestic and overseas experts and scholars to improve the utility and practicability for such a reporting standard.
This study aims to draw up a proposed standard for reporting intensive hospital monitoring of traditional Chinese patent medicines,based on the laws and regulations of the drug administration in China and international research reporting standards. We developed the proposed reporting standard by summarizing items according to the five steps from the Guidance for Developers of Health Research Reporting Guidelines. This study had developed proposed reporting standards and related evaluating list for reporting study on postmarketing surveillance of traditional Chinese patent medicines. It will be a useful tool for reporting study on intensive hospital monitoring of traditional Chinese patent medicines. However,consensus is needed to be reached by domestic and overseas experts and scholars to improve the utility and practicability for such a reporting standard.
引文
[1]廖星,徐向阳,谢雁鸣,等.构建注射用丹参多酚酸盐再评价证据体的研究[J].中国中药杂志,2014,39(18):3645-3649.
[2]王连心,谢雁鸣,艾青华,等.医院集中监测嵌套巢式病例对照设计的30 026例参芪扶正注射液上市后临床安全性研究[J].中国中药杂志,2015,40(24):4739-4745.
[3]廖星,谢雁鸣,王永炎,等.药品安全性证据分级分类探索研究---构建中药上市后安全性证据体[J].中国中药杂志,2015,40(24):4723-4727.
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[6]詹思延.第三讲:如何报告观察性流行病学研究---国际报告规范STROBE解读[J].中国循证儿科杂志,2010,5(3):223-227.
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[8]姚亮,陈耀龙,王琪,等.病例报告的报告规范解读[J].中国循证儿科杂志,2014,9(3):216-219.
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[13]国家食品药品监督管理局安监司.关于征求《关于推动生产企业开展药品重点监测工作的通知(征求意见稿)》意见的函[EB/OL].http://samr.cfda.gov.cn/WS01/CL0778/79321.html,2013-03-19/2018-04-10.
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[15]Benchimol EI,Smeeth L,Guttmann A,et al.The Reporting of studies conducted using observational routinely-collected health data(RECORD)statement[J].Plo S Med,2015,12(10):e1001885.
[16]U.S.Department of Health and Human Services Food and Drug Administration,Center for Drug Evaluation and Research(CDER),Center for Biologics Evaluation and Research(CBER).Guidance for industry postmarketing studies and clinical trials-implementation of section 505(o)(3)of the federal food,drug,and cosmetic act[EB/OL].https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatory Information/Guidances/UCM172001.pdf,2011-04/2018-04-10.
[17]Gliklich R,Dreyer N,Leavy M.Registries for evaluating patient outcomes:A user's guide[M].Third edition.Rockville,MD:Agency for Healthcare Research and Quality,2014:1-591.
[18]U.S.Department of Health and Human Services Food and Drug Administration,Center for Drug Evaluation and Research(CDER),Center for Biologics Evaluation and Research(CBER).Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment[EB/OL].https://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM071696.pdf,2005-03/2018-04-10.
[19]European Medicines Agency.Guideline on good pharmacovigilance practices(GVP)ModuleⅧ-Post-authorisation safety studies(Rev 3)[EB/OL].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf,2017-10-09/2018-04-10.
[20]费宇彤,刘建平.国际草药CONSORT声明及中药临床试验报告规范化问题思考[J].中国中药杂志,2008,33(1):89-94.
[21]Dreyer NA,Velentgas P,Westrich K,et al.The GRACEchecklist for rating the quality of observational studies of comparative effectiveness:a tale of hope and caution[J].JManag Care Spec Pharm,2014,20(3):301-308.
[22]Brina L Strom,Stephen E Kimmel.曾繁典,石侣元,詹思延译.药物流行病学教程[M].New York:John Wiley&Sons(Asia)Pte Ltd,2008:28.
[23]Tubert-Bitter P,Bégaud B,Moride Y,et al.Sample size calculations for single group post-marketing cohort studies[J].J Clin Epdemiol,1994,47(4):435-439.
[24]Hurwitz N,Wade OL.Intensive hospital monitoring of adverse reactions to drugs[J].Br Med J,1969,1(5643):531-536.
[25]Wu YT,Makuch RW.Detecting rare adverse events in postmarketing studies:sample size considerations[J].Drug Inf J,2006,40(1):89-98.
[26]Pinnock H,Epiphaniou E,Sheikh A,et al.Developing standards for reporting implementation studies of complex interventions(StaRI):an e-Delphi[J].Implement Sci,2015,10:42.
[27]General Assembly of the World Medical Association,et al.World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects[J].J Am Coll Dent,2014,81(3):14-18.
[2]王连心,谢雁鸣,艾青华,等.医院集中监测嵌套巢式病例对照设计的30 026例参芪扶正注射液上市后临床安全性研究[J].中国中药杂志,2015,40(24):4739-4745.
[3]廖星,谢雁鸣,王永炎,等.药品安全性证据分级分类探索研究---构建中药上市后安全性证据体[J].中国中药杂志,2015,40(24):4723-4727.
[4]Li XL,Tang JF,Li WX,et al.Postmarketing safety surveillance and reevaluation of Danhong Injection:clinical study of 30 888 cases[J].Evid Based Complement Alternat Med,2015:610846.
[5]廖星,王桂倩,谢雁鸣.纵览循证医学证据质量评价标准[J].中国中药杂志,2015,40(13):2542-2547.
[6]詹思延.第三讲:如何报告观察性流行病学研究---国际报告规范STROBE解读[J].中国循证儿科杂志,2010,5(3):223-227.
[7]廖星,章轶立,谢雁鸣.真实世界研究标准:RECORD清单和GRACE清单的解读[J].中国中药杂志,2015,40(24):4734-4738.
[8]姚亮,陈耀龙,王琪,等.病例报告的报告规范解读[J].中国循证儿科杂志,2014,9(3):216-219.
[9]Moher D,Schulz KF,Simera I,et al.Guidance for developers of health research reporting guidelines[J].PLo SMed,2010,2(7):e1000217.
[10]Murphy MK,Black NA,Lamping DL,et al.Consensus development methods,and their use in clinical guideline development[J].Health Technol Assess,1998,2(3):Ⅰ-Ⅳ,1-88.
[11]谢雁鸣,廖星,赵玉斌,等.中药上市后安全性医院集中监测技术规范(征求意见稿)[J].中国中药杂志,2013,38(18):2919-2924.
[12]张雯.中药上市后安全性医院集中监测关键技术向技术规范转化路径研究[D].北京:中国中医科学院,2014.
[13]国家食品药品监督管理局安监司.关于征求《关于推动生产企业开展药品重点监测工作的通知(征求意见稿)》意见的函[EB/OL].http://samr.cfda.gov.cn/WS01/CL0778/79321.html,2013-03-19/2018-04-10.
[14]中华人民共和国卫生部.药品不良反应报告和监测管理办法(卫生部令第81号)[EB/OL].http://samr.cfda.gov.cn/WS01/CL1031/62621.html,2011-05-04/2018-04-10.
[15]Benchimol EI,Smeeth L,Guttmann A,et al.The Reporting of studies conducted using observational routinely-collected health data(RECORD)statement[J].Plo S Med,2015,12(10):e1001885.
[16]U.S.Department of Health and Human Services Food and Drug Administration,Center for Drug Evaluation and Research(CDER),Center for Biologics Evaluation and Research(CBER).Guidance for industry postmarketing studies and clinical trials-implementation of section 505(o)(3)of the federal food,drug,and cosmetic act[EB/OL].https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatory Information/Guidances/UCM172001.pdf,2011-04/2018-04-10.
[17]Gliklich R,Dreyer N,Leavy M.Registries for evaluating patient outcomes:A user's guide[M].Third edition.Rockville,MD:Agency for Healthcare Research and Quality,2014:1-591.
[18]U.S.Department of Health and Human Services Food and Drug Administration,Center for Drug Evaluation and Research(CDER),Center for Biologics Evaluation and Research(CBER).Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment[EB/OL].https://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM071696.pdf,2005-03/2018-04-10.
[19]European Medicines Agency.Guideline on good pharmacovigilance practices(GVP)ModuleⅧ-Post-authorisation safety studies(Rev 3)[EB/OL].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf,2017-10-09/2018-04-10.
[20]费宇彤,刘建平.国际草药CONSORT声明及中药临床试验报告规范化问题思考[J].中国中药杂志,2008,33(1):89-94.
[21]Dreyer NA,Velentgas P,Westrich K,et al.The GRACEchecklist for rating the quality of observational studies of comparative effectiveness:a tale of hope and caution[J].JManag Care Spec Pharm,2014,20(3):301-308.
[22]Brina L Strom,Stephen E Kimmel.曾繁典,石侣元,詹思延译.药物流行病学教程[M].New York:John Wiley&Sons(Asia)Pte Ltd,2008:28.
[23]Tubert-Bitter P,Bégaud B,Moride Y,et al.Sample size calculations for single group post-marketing cohort studies[J].J Clin Epdemiol,1994,47(4):435-439.
[24]Hurwitz N,Wade OL.Intensive hospital monitoring of adverse reactions to drugs[J].Br Med J,1969,1(5643):531-536.
[25]Wu YT,Makuch RW.Detecting rare adverse events in postmarketing studies:sample size considerations[J].Drug Inf J,2006,40(1):89-98.
[26]Pinnock H,Epiphaniou E,Sheikh A,et al.Developing standards for reporting implementation studies of complex interventions(StaRI):an e-Delphi[J].Implement Sci,2015,10:42.
[27]General Assembly of the World Medical Association,et al.World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects[J].J Am Coll Dent,2014,81(3):14-18.