[1] Pitts P J, Louet H L, Moride Y, et al.21st century pharmacovigilance: Efforts, roles, and responsibilities[J]. Lancet Oncol, 2016, 17(11): e486-e492.
[2] 许景峰. 药物相关基因多态型与药品不良反应[J]. 中国临床医师杂志(电子版), 2010, 4(2): 188-192.
[3] 杨焕. 国内外药物不良反应监测发展概况[J]. 中国临床药理学杂志, 2009, 25(1): 75-78.
[4] Bates D W, Larizgoitia I, Prasopa-Plaizier N, et al.Global priorities for patient safety research[J]. BMJ, 2009, 338(7705):b1775.
[5] Kessler C, Ward M J, McNaughton C D. Reducing adverse drug events: The need to rethink outpatient prescribing[J]. JAMA, 2016, 316(20): 2092-2093.
[6] 国务院. 国务院关于印发“十三五”国家食品安全规划和“十三五”国家药品安全规划的通知[EB/OL]. (2017-02-21) [2018-06-20]. http://www.gov.cn/zhengce/content/2017-02/21/content_5169755.htm.
[7] 王丹. 药品不良反应主动监测及其发展趋势[J]. 中国药物警戒, 2015, 12(10): 600-602.
[8] 侯永芳, 沈璐, 刘巍, 等. 美国医疗产品安全主动监测系统概述及启示[J]. 中国药物警戒, 2017, 14(1):32-35.
[9] Xin Sun, Jing Tan, Li Tang, et al.Real world evidence: Experience and lessons from China[J]. BMJ, 2018,360:j5262.
[10] Agoritsas T, Merglen A, Shah N D, et al.Adjusted analyses in studies addressing therapy and harm: Users' guides to the medical literature[J]. JAMA, 2017, 317(7): 748-759.
[11] Novikov I, Kalter-Leibovici O.Analytic approaches to observational studies with treatment selection bias[J]. JAMA, 2007, 297(19): 2077.
[12] Armstrong K.Methods in comparative effectiveness research[J]. J Clin Oncol, 2012, 30(34): 4208-4214.
[13] 赵厚宇, 詹思延. 疾病风险评分在药物流行病学研究中的应用[J]. 中华流行病学杂志, 2017, 38(2): 261-266.
[14] FDA. Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data [EB/OL]. (2013-05-01) [2018-06-20]. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ ucm243537.pdf.
[15] 赵璐,叶小飞, 王超, 等. 分层分析在药品不良反应信号检测中的应用[J]. 中国药物警戒, 2011, 8(3):158-160.
[16] Wang J, Donnan P T.Propensity score methods in drug safety studies: Practice, strengths and limitations[J]. Pharmacoepidemiol Drug Saf, 2001, 10(4): 341-344.
[17] 田峰, 廖星, 谢雁鸣. 欧盟《药物流行病学研究方法学标准指导手册》译介[J]. 中国中药杂志, 2013, 38(18):2949-2957.
[18] Solomon D H, Shadick N A, Weinblatt M E, et al.Drug safety analyses in a rheumatoid arthritis registry: Application of different approaches regarding timing of exposure and confounder measurement[J]. Arthritis Res Ther, 2017, 19(1): 130.
[19] Hernandez-Diaz S, Huybrechts K F, Desai R J, et al.Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study[J]. Neurology, 2018, 90(4): e342-e351.
[20] Wyss R, Ellis A R, Brookhart M A, et al.Matching on the disease risk score in comparative effectiveness research of new treatments[J]. Pharmacoepidemiol Drug Saf, 2015, 24(9): 951-961.
[21] Baiocchi M, Cheng J, Small D S.Instrumental variable methods for causal inference[J]. Stat Med, 2014, 33(13): 2297-2340.
[22] Uddin M J, Groenwold R H, Ali M S, et al.Methods to control for unmeasured confounding in pharmacoepidemiology:An overview[J]. Int J Clin Pharm, 2016, 38(3): 714-723.
[23] Uddin M J, Groenwold R H, De Boer A, et al.Application of instrumental variables method in pharmacoepidemiology: An example of beta2-agonist use and myocardial infarction[J]. Pharmacoepi-demiol Drug Saf, 2013, 22(S1): 32-33.
[24] Uddin M J, Groenwold R H, De Boer A, et al.Instrumental variables analysis using multiple databases: An example of antidepre-ssant use and risk of hip fracture[J]. Pharmacoepidemiol Drug Saf, 2016, 25(S1): 122-131.
[25] Cain L E, Cole S R, Greenland S, et al.Effect of highly active antiretroviral therapy on incident aids using calendar period as an instrumental variable[J]. Am J Epidemiol, 2009, 169(9): 1124-1132.
[26] Ionescu-Ittu R, Abrahamowicz M, Pilote L.Treatment effect estimates varied depending on the definition of the provider prescribing preference-based instrumental variables[J]. J Clin Epidemiol, 2012, 65(2): 155-162.
[27] Swanson S A.Instrumental variable analyses in pharmacoepidemiology: What target trials do we emulate?[J]. Curr Epidemiol Rep, 2017, 4(4): 281-287.
[28] Cai B, Small D S, Have T R.Two-stage instrumental variable methods for estimating the causal odds ratio: Analysis of bias[J]. Stat Med, 2011, 30(15): 1809-1824.
[29] 国家药品不良反应监测中心. 国家中心举办国家药品不良反应监测哨点授牌仪式[EB/OL]. (2017-12-14) [2018-06-20]. http://www.cdr-adr.org.cn/xwdt/201712/ t20171214_19834. html.
[30] 河南省药品不良反应监测中心. 稳步推进药品不良反应监测系统保障民生健康发展 [EB/OL]. (2018-05-24) [2018-06-20]. http://www.hnadr.org/view/1674.
[31] Zhang X, Faries D E, Li H, et al.Addressing unmeasured confounding in comparative observational research[J]. Pharmacoepi-
demiol Drug Saf, 2018, 27(4):373-382.
[32] Ertefaie A, Small D S, Flory J H, et al.A tutorial on the use of instrumental variables in pharmacoepidemiology[J]. Pharmacoepi-demiol Drug Saf, 2017, 26(4): 357-367. |