中国药物流行病学研究方法学指南
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摘要
<正>1背景药物流行病学是指采用流行病学的研究方法研究药物在人群中的使用情况和使用效果~([1])。药物流行病学研究能够为医疗产品的安全性和有效性提供有益的信息,并被越来越多地应用于卫生保健系统、干预措施及健康相关行为的评价中~([2])。为了保证药物流行病学的研究质量,激励有益于患者和公众医疗健康的创新,世界各国医药卫生管理部门和学会组织分别基于本国国情颁布了相关的药物流行病学研究指南。而在我国,药物流行病学尚处于起
引文
1 International Society for Pharmacoepidemiology(ISPE).About pharmacoepidemiology[EB/OL].(2016)[2016-07 -01]https:∥www. pharmacoepi. org/about/about. cfm
2 Strom BL,Kimmel SE,Hennessy S. Textbook of pharmacoepidemiology[M]. John Wiley&Sons Ltd,2016
3 European Medicines Agency. Guideline on good pharmacovigilance practices[EB/OL].(2014-12-28)[2016-07-08]http:∥www. ema. europa. eu/ema/index. jsp? curl=pages/regulation/document_listing/document_listing_000345.jsp
4 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Guide on Methodological Standards in Pharmacoepidemiology(Revision 5)[EB/OL].(2016)[2016-07-08]http:∥www. encepp. eu/standards_and_guidances/methodological Guide. shtml
5 International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices(GPP)(Revision3)[EB/OL].(2015-06)[2016-07-10]https:∥www.pharmacoepi. org/resources/guidelines_08027. cfm
6 European Medicines Agency. Guideline on conduct of pharmacovigilance for medicines used by the paediatric population[EB/OL].(2006-07-28)[2016-07-22]http:∥www.ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003764. pdf
7 U. S. Food and Drug Administration. Guidance for industry and FDA staff. Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data[EB/OL].(2013-05)[2016-08-06]http:∥www. fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm243537. pdf
8 Hall GC,Sauer B,Bourke A,et al. Guidelines for good database selection and use in pharmacoepidemiology research[J]. Pharmacoepidemiology and Drug Safety,2012,21(1):1-10
9 (AGENS)WGft Sa Uo SD. GPS-good practice in secondary data analysis:revision after fundamental reworking[EB/OL].(2008)[2016-06-26]http:∥dgepi. de/fileadmin/pdf/leitlinien/gps-version2-final_ENG. pdf
10 Mini-Sentinel Collaborating Centers. Mini-sentinel statement of principles and policies[EB/OL].(2014-05-01)[2016-07 -12]http:∥www. mini-sentinel. org/about_us/principles_and_policies. aspx
11 Verstraeten T,De Stefano F,Chen RT,et al. Vaccine safety surveillance using large linked databases:opportunities,hazards and proposed guidelines[J]. Expert Review of Vaccines,2003,2(1):21-29
12 Coloma PM,Schuemie MJ,Trifiro G,et al. Combining electronic healthcare databases in Europe to allow for largescale drug safety monitoring:the EU-ADR Project[J].Pharmacoepidemiology and Drug Safety,2011,20(1):1-11
2 Strom BL,Kimmel SE,Hennessy S. Textbook of pharmacoepidemiology[M]. John Wiley&Sons Ltd,2016
3 European Medicines Agency. Guideline on good pharmacovigilance practices[EB/OL].(2014-12-28)[2016-07-08]http:∥www. ema. europa. eu/ema/index. jsp? curl=pages/regulation/document_listing/document_listing_000345.jsp
4 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Guide on Methodological Standards in Pharmacoepidemiology(Revision 5)[EB/OL].(2016)[2016-07-08]http:∥www. encepp. eu/standards_and_guidances/methodological Guide. shtml
5 International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices(GPP)(Revision3)[EB/OL].(2015-06)[2016-07-10]https:∥www.pharmacoepi. org/resources/guidelines_08027. cfm
6 European Medicines Agency. Guideline on conduct of pharmacovigilance for medicines used by the paediatric population[EB/OL].(2006-07-28)[2016-07-22]http:∥www.ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003764. pdf
7 U. S. Food and Drug Administration. Guidance for industry and FDA staff. Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data[EB/OL].(2013-05)[2016-08-06]http:∥www. fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm243537. pdf
8 Hall GC,Sauer B,Bourke A,et al. Guidelines for good database selection and use in pharmacoepidemiology research[J]. Pharmacoepidemiology and Drug Safety,2012,21(1):1-10
9 (AGENS)WGft Sa Uo SD. GPS-good practice in secondary data analysis:revision after fundamental reworking[EB/OL].(2008)[2016-06-26]http:∥dgepi. de/fileadmin/pdf/leitlinien/gps-version2-final_ENG. pdf
10 Mini-Sentinel Collaborating Centers. Mini-sentinel statement of principles and policies[EB/OL].(2014-05-01)[2016-07 -12]http:∥www. mini-sentinel. org/about_us/principles_and_policies. aspx
11 Verstraeten T,De Stefano F,Chen RT,et al. Vaccine safety surveillance using large linked databases:opportunities,hazards and proposed guidelines[J]. Expert Review of Vaccines,2003,2(1):21-29
12 Coloma PM,Schuemie MJ,Trifiro G,et al. Combining electronic healthcare databases in Europe to allow for largescale drug safety monitoring:the EU-ADR Project[J].Pharmacoepidemiology and Drug Safety,2011,20(1):1-11