基于中国医院电子病历数据的药品安全性评价模式探索
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摘要
医院电子病历数据可为药品安全性评价提供重要数据资源,日益受到广泛关注。但在我国的实际环境下,如何基于医院电子病历记录(EMR)开展药品安全性评价仍缺乏清晰的技术框架和模式。本文基于已有的实证研究,探讨了基于我国EMR开展上市后药品安全性评价的可行性及研究模式,以期为研究者及监管部门正确生产和解读基于EMR的药物安全性研究证据提供参考。
Electronic medical records(EMRs) may represent an important data source for drug safety evaluation, and have received wide attention. However, the framework and approaches to use EMRs for drug safety evaluation have not been well established in Chinese setting. On the basis of empirical studies, we explored framework and methods for drug safety evaluation by using EMRs. Hopefully, this paper may offer a general guidance for rigorous production and appropriate use of real-world drug safety evidences based on the data from EMRs.
Electronic medical records(EMRs) may represent an important data source for drug safety evaluation, and have received wide attention. However, the framework and approaches to use EMRs for drug safety evaluation have not been well established in Chinese setting. On the basis of empirical studies, we explored framework and methods for drug safety evaluation by using EMRs. Hopefully, this paper may offer a general guidance for rigorous production and appropriate use of real-world drug safety evidences based on the data from EMRs.
引文
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[24] Kyriacou D N, Lewis R J. Confounding by Indication in Clinical Research[J]. JAMA, 2016, 316(17):1818-1819.
[25] Wilchesky M, Tamblyn R M, Huang A. Validation of diagnostic codes within medical services claims[J]. Journal of Clinical Epidemiology, 2004, 57(2):131-141.
[26] Garg R, Chen W, Pendergrass M. Acute pancreatitis in type 2diabetes treated with exenatide or sitagliptin:a retrospective observational pharmacy claims analysis[J]. Diabetes Care, 2010,33(11):2349-2354.
[27]王海洋,谢雁鸣,姜俊杰,等.真实世界中注射用丹参多酚酸盐对肾功能影响的安全性分析[J].中国药物警戒, 2015, 13(8):452-455.
[28] Mayo C S, Kessler M L, Eisbruch A,et al. The big data effort in radiation oncology:Data mining or data farming?[J]. Advances in Radiation Oncology, 2016, 1(4):260-271.
[29]王玲.基于医院信息系统开展药品不良反应监测研究[J].中国药物警戒, 2015, 12(4):229-240.
[2] Jolivot P A, Hindlet P, Pichereau C,et al. A systematic review of adult admissions to ICUs related to adverse drug events[J]. Crit Care, 2014, 18(6):643.
[3] Shepherd G, Mohom P, Yacoub K,et al. Adverse Drug Reaction Deaths Reported in United States Vital Statistics, 1999-2006[J].The Annals of Pharmacotherapy, 2012, 46(2):169-175.
[4]孙鑫,谭婧,唐立,等.重新认识真实世界研究[J].中国循证医学杂志, 2017, 17(2):126-130.
[5] Sherman R E, Anderson S A, Dal Pan G J,et al. Real-World Evidence-What Is It and What Can It Tell Us?[J]. N Engl J Med,2016, 375(23):2293-2297.
[6] FDA. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices[EB/OL].(2017-10-10)[2018-08-01].https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm574232.htm.
[7] Yu O H, Filion K B, Azoulay L,et al. Incretin-based drugs and the risk ofcongestiveheart failure[J].DiabetesCare,2015,38(2):277-284.
[8] Faillie J L, Azoulay L, Patenaude V,et al. Incretin based drugs and risk of acute pancreatitis in patients with type 2 diabetes:cohort study[J]. BMJ, 2014, 348:g2780.
[9] FDA. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data[EB/OL].(2013-05-14)[2018-08-01]. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm243537pdf.
[10] Alagozlu H, Cindoruk M, Unal S. Severe INR elevation in a patient with choledocholithiasis receiving cefoperazone[J]. Clin Drug Investig, 2006, 26(8):481-484.
[11] Berger M L, Mamdani M, Atkins D,et al. Good research practices for comparative effectiveness research:defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources:the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report-Part I[J]. Value Health, 2009, 12(8):1044-1052.
[12] Cox E, Martin B C, Van Staa T,et al. Good research practices for comparative effectiveness research:Approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources:The international society for pharmacoeconomics and outcomes research good research practices for retrospective database analysis task force report-Part II[J]. Value in health, 2009, 12(8):1053-1061.
[13] Johnson M L, Crown W, Martin B C,et al. Good research practices for comparative effectiveness research:Analytic methods to improve causal inference from nonrandomized studies of treatment effects using secondary data sources:The ISPOR good research practices for retrospective database analysis task force report-Part III[J]. Value in health, 2009, 12(8):1062-1073.
[14] Shu T, Liu H, Goss F R,et al. EHR adoption across China's tertiary hospitals:a cross-sectional observational study[J]. Int J Med Inform, 2014, 83(2):113-121.
[15]王雯,刘艳梅,谭婧,等.回顾性数据库研究的概念、策划与研究数据库构建[J].中国循证医学杂志, 2018, 18(2):230-237.
[16] Sun X, Tan J, Tang L,et al. Real world evidence:experience and lessons from China[J]. BMJ, 2018, 360:j5262.
[17] Singh S, Chang H Y, Richards T M,et al. Glucagonlike peptide1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus:a population-based matched case-control study[J]. JAMA Intern Med, 2013, 173(7):534-539.
[18] Dodson J A, Petrone A, Gagnon D R,et al. Incidence and Determinants of Traumatic Intracranial Bleeding Among Older Veterans Receiving Warfarin for Atrial Fibrillation[J]. JAMA Cardiol,2016, 1(1):65-72.
[19]毕凤兰,张力.中药注射剂安全性问题探讨[J].中国药物警戒,2012, 9(2):89-92.
[20] Rossi-Semerano L, Fautrel B, Wendling D,et al. Tolerance and efficacy of off-label anti-interleukin-1 treatments in France:a nationwide survey[J]. Orphanet Journal of Rare Diseases, 2015, 10:19.
[21] Peduzzi P, Concato J, Kemper E,et al. A simulation study of the number of events per variable in logistic regression analysis[J].Journal of Clinical Epidemiology, 1996, 49(12):1373-1379.
[22] Azoulay L, Yin H, Filion K B,et al. The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes:nested case-control study[J]. BMJ, 2012, 344:e3645.
[23] Schneeweiss S. Developments in post-marketing comparative effectiveness research[J]. Clin Pharmacol Ther, 2007, 82(2):143-156.
[24] Kyriacou D N, Lewis R J. Confounding by Indication in Clinical Research[J]. JAMA, 2016, 316(17):1818-1819.
[25] Wilchesky M, Tamblyn R M, Huang A. Validation of diagnostic codes within medical services claims[J]. Journal of Clinical Epidemiology, 2004, 57(2):131-141.
[26] Garg R, Chen W, Pendergrass M. Acute pancreatitis in type 2diabetes treated with exenatide or sitagliptin:a retrospective observational pharmacy claims analysis[J]. Diabetes Care, 2010,33(11):2349-2354.
[27]王海洋,谢雁鸣,姜俊杰,等.真实世界中注射用丹参多酚酸盐对肾功能影响的安全性分析[J].中国药物警戒, 2015, 13(8):452-455.
[28] Mayo C S, Kessler M L, Eisbruch A,et al. The big data effort in radiation oncology:Data mining or data farming?[J]. Advances in Radiation Oncology, 2016, 1(4):260-271.
[29]王玲.基于医院信息系统开展药品不良反应监测研究[J].中国药物警戒, 2015, 12(4):229-240.
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