[1] WETTERMARK B, ELSEVIERS M, ALMARSDÓTTIR AB, et al. Introduction to drug utilization research. In: Elseviers [M]. Chichester, UK: John Wiley & Sons, Ltd; 2016:1-12.
[2] 杜春霖, 李晓松, 刘元元. 真实世界研究及国内文献综述[J]. 中国卫生信息管理杂志, 2018, 15(5):597-601.
[3] 张晓雨, 陈静, 赵晨, 等. 真实世界理念下观察性与实验性临床研究协同应用[J]. 中国循证医学杂志, 2018, 18(4):284-288. doi:  10.7507/1672-2531.201710034
[4] 黄卓山, 罗艳婷, 刘金来. 真实世界研究的方法与实践[J]. 循证医学, 2014, 14(6):364-368.
[5] 田磊, 岳彩宾, 管欣, 等. 真实世界研究与随机对照试验在临床实践及卫生决策中应用的比较[J]. 中国医院药学杂志, 2019, 39(3):274-277.
[6] 吴一龙, 陈晓媛, 杨志敏. 真实世界研究指南[M].2018版. 北京:人民卫生出版社,2019:1-28.
[7]

FRANKLIN J M, SCHNEEWEISS S. When and how can real world data analyses substitute for randomized controlled trials?[J]. Clin Pharmacol Ther, 2017, 102(6):924-933. doi:  10.1002/cpt.857
[8] 方碧陶. 国家药品监督管理局印发《真实世界证据支持药物研发与审评的指导原则(试行)》[J]. 中医药管理杂志, 2020, 28(2):107.
[9]

OHTSU H, SHIMOMURA A, SASE K. Real-world evidence in cardio-oncology: what is it and what can it tell us?[J]. JACC CardioOncol, 2022, 4(1):95-97. doi:  10.1016/j.jaccao.2022.02.002
[10] 李雪迎, 沙若琪, 姚晨, 等. 面向真实世界数据的临床研究数据治理模式选择[J]. 中国循证医学杂志, 2020, 20(10):1150-1156. doi:  10.7507/1672-2531.202003122
[11] 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. doi:  10.7507/1672-2531.201701088
[12]

MONTILLA S, MARCHESINI G, SAMMARCO A, et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry[J]. Nutr Metab Cardiovasc Dis, 2014, 24(12):1346-1353. doi:  10.1016/j.numecd.2014.07.014
[13]

SHANG N, WENG C H, HRIPCSAK G. A conceptual framework for evaluating data suitability for observational studies[J]. J Am Med Inform Assoc, 2018, 25(3):248-258. doi:  10.1093/jamia/ocx095
[14]

WEISKOPF N G, WENG C H. Methods and dimensions of electronic health record data quality assessment: enabling reuse for clinical research[J]. J Am Med Inform Assoc, 2013, 20(1):144-151. doi:  10.1136/amiajnl-2011-000681
[15] 国家药品监督管理局. 国家药监局药审中心关于发布《真实世界研究支持儿童药物研发与审评的技术指导原则(试行)》的通告(2020年第22号)[EB/OL]. (2020-09-01) [2024-01-01]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200901104448101.html.
[16] 赵亮, 张婷, 孔文妹, 等. 基于医院信息系统的真实世界研究主题分析[J]. 医药导报, 2022, 41(1):63-72.
[17] 王俊月, 何泽慧, 邓浩, 等. 基于真实世界数据的芍苓方治疗寻常型银屑病的疗效与安全性分析[J]. 中药新药与临床药理, 2021, 32(5):739-743.
[18]

LIU F X, OU W M, DIEDE S J, et al. Real-world experience with pembrolizumab in patients with advanced melanoma: a large retrospective observational study[J]. Medicine, 2019, 98(30):e16542. doi:  10.1097/MD.0000000000016542
[19] 刁一凡. 我国新型抗肿瘤药物公共保障政策与药物可及性评估研究[D]. 北京: 北京协和医学院, 2021. DOI: 10.27648/d.cnki.gzxhu.2020.000907.
[20] 贾玉龙, 姚明宏, 刘艳梅, 等. 特许医疗政策下真实世界数据治理的模式探索[J]. 中国循证医学杂志, 2021, 21(12):1373-1380. doi:  10.7507/1672-2531.202108147
[21] 周雪莹, 张策, 方丽萍, 等. 基于真实世界的3种止吐方案预防含顺铂多日化疗相关恶心呕吐的成本-效用分析[J]. 中国药房, 2021, 32(20):2509-2513. doi:  10.6039/j.issn.1001-0408.2021.20.12
[22] 张若梅, 吴斌. 3种促排卵药物在IVF-ET/ICSI中的临床疗效与经济学分析: 1项基于真实世界的回顾性分析[J]. 中国现代应用药学, 2021, 38(17):2128-2133.
[23]

ARMSTRONG A W, FOSTER S A, COMER B S, et al. Real-world health outcomes in adults with moderate-to-severe psoriasis in the United States: a population study using electronic health records to examine patient-perceived treatment effectiveness, medication use, and healthcare resource utilization[J]. BMC Dermatol, 2018, 18(1):4. doi:  10.1186/s12895-018-0072-2
[24] 乔佳慧, 杨浦, 董丽, 等. 真实世界研究方法在中成药上市后安全性评价中的应用[J]. 中国新药杂志, 2021, 30(9):769-772. doi:  10.3969/j.issn.1003-3734.2021.09.001
[25] 孙鑫, 张俊华, 王雯, 等. 制定中国中成药真实世界研究技术指导原则, 促进中成药临床研究向决策证据转化[J]. 中国循证医学杂志, 2020, 20(9):993-999.
[26] 王明霞, 王淑梅, 刘明, 等. 真实世界中30 012例参麦注射液使用情况与安全性评价[J]. 中国循证医学杂志, 2021, 21(2):133-138.
[27] 胡文, 侯政昆, 刘凤斌, 等. 关于大数据时代的中医药临床研究的思考[J]. 世界科学技术-中医药现代化, 2019, 21(8):1656-1661.
[28] 邹冲, 蒋萌, 蒋卫民, 等. 构建基于临床大数据真实世界的中医药临床科研模式[J]. 中华中医药杂志, 2016, 31(10):4113-4116.
[29] 陈秋平, 邵明义, 毕倩, 等. 基于叙事循证医学对中医临床疗效评价问题的解决策略[J]. 中国中药杂志, 2022, 47(2):557-561.
[30]

KLONOFF D C. The new FDA real-world evidence program to support development of drugs and biologics[J]. J Diabetes Sci Technol, 2020, 14(2):345-349. doi:  10.1177/1932296819832661
[31]

U.S.FOOD AND DRUG ADMINISTRATION. Statement from FDA Commissioner Scott Gottlieb, M. D. , on FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics[EB/OL]. (2018-01-01) [2024-01-01]. https://www.regulatoryaffairsnews.com/post/ ema-guidance-good-practice-guide-for-the-use-of-the-metadata- catalogue-of-real-world-data-sources.
[32]

EUROPEAN MEDICINES AGENCY. Good practice guide for the use of the Metadata Catalogue of Real-World Data Sources[EB/OL].(2022-09-01) [2023-12-31]. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf.
[33] 田磊, 徐赫, 孟蕊, 等. 不同类型临床证据在卫生决策中的应用进展: 以英国NICE为例[J]. 中国循证医学杂志, 2020, 20(1):112-118.
[34]

KRASENBAUM L J, PEDARLA V L, THOMPSON S F, et al. A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States[J]. J Headache Pain, 2022, 23(1):54. doi:  10.1186/s10194-022-01413-z
[35]

SULTANA J, TRIFIRÒ G, IENTILE V, et al. Traceability of pediatric antibiotic purchasing pathways in Italy: a nationwide real-world drug utilization analysis[J]. Front Pharmacol, 2020, 11:1232. doi:  10.3389/fphar.2020.01232
[36]

POULIN Y, BEAUCHEMIN C, ROYER C, et al. Real-world experience with apremilast in the treatment of adults with moderate to severe plaque psoriasis in québec: a claims-based analysis of drug utilization and healthcare resource utilization[J]. J Cutan Med Surg, 2020, 24(6):573-587. doi:  10.1177/1203475420936652
[37] 董晓丽, 宫建. 真实世界药物评价的伦理价值与伦理问题[J]. 医药导报, 2022, 41(1):44-47.
[38] 张海洪, 熊保权, 丛亚丽. 伦理审查质量: 以真实世界研究的伦理审查质量改进为例[J]. 医学与哲学, 2021, 42(21):11-14,18. doi:  10.12014/j.issn.1002-0772.2021.21.03
[39] 于茜, 王卯, 赵晓倩, 等. 真实世界研究的知情同意方式探讨[J]. 中药新药与临床药理, 2021, 32(7):1055-1058.
[40] 李洪, 魏来, 郭晓蕙, 等. 真实世界研究伦理审查初探[J]. 中国循证医学杂志, 2018, 18(11):1198-1202.
[41] 王思成, 刘保延, 熊宁宁, 等. 真实世界临床研究伦理问题及策略探讨[J]. 中国中西医结合杂志, 2013, 33(4):437-442.
[42]

HOLLINGWORTH S, KAIRUZ T. Measuring medicine use: applying ATC/DDD methodology to real-world data[J]. Pharmacy, 2021, 9(1):60. doi:  10.3390/pharmacy9010060
[43]

SOLÀ-MORALES O, SIGURÐARDÓTTIR K, AKEHURST R, et al. Data governance for real-world data management: a proposal for a checklist to support decision making[J]. Value Health, 2023, 26(4S):32-42.
[44] 王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究: 更新与展望[J]. 中国循证医学杂志, 2020, 20(11):1241-1246.
[45]

WINTZELL V, SVANSTRÖM H, PASTERNAK B. Selection of Comparator Group in Observational Drug Safety Studies: Alternatives to the Active Comparator New User Design [J]. Epidemiology, 2022, 33(5): 707-714.
[46]

VELENTGAS P, DREYER NA, NOURJAH P, et al. Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide[M]. Rockville(MD): Agency for Healthcare Research and Quality(US), 2013.
[47]

TALBOT J, STUCKEY R, CRAWFORD L, et al. Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment - real world outcomes[J]. J Headache Pain, 2021, 22(1):5-10. doi:  10.1186/s10194-020-01214-2
[48]

PAJECKI D, KAWAMOTO F, DANTAS A C B, et al. Real-world evidence of health outcomes and medication use 24 months after bariatric surgery in the public healthcare system in Brazil: a retrospective, single-center study[J]. Clinics, 2020, 75:e1588. doi:  10.6061/clinics/2020/e1588
[49] 张学成, 刘岩, 张晶晶, 等. 急性心力衰竭患者30天再住院率: 基于真实世界研究与随机对照试验比较的Meta分析[J]. 中国循证医学杂志, 2021, 21(10):1203-1210.
[50]

AL-MADFAA R O, ALALAWI M A, BASUDAN L O, et al. Dual versus triple therapy for uncomplicated brucellosis: a retrospective cohort study[J]. J Infect Dev Ctries, 2020, 14(12):1380-1386. doi:  10.3855/jidc.12741
[51]

TAKEUCHI Y, SANO H, ASAI Y, et al. Real-world evidence of the safety and efficacy profile of suvorexant in elderly patients with insomnia: a sub-analysis of the post-marketing drug-use results survey in Japan[J]. Curr Med Res Opin, 2020, 36(3):465-471. doi:  10.1080/03007995.2019.1700361
[52] 宣建伟, 李幼平. 真实世界研究与创新药物价值[J]. 中国循证医学杂志, 2018, 18(4):273-276. doi:  10.7507/1672-2531.201801090
[53] 刘雪丽, 韩晟, 官海静, 等. 基于真实世界数据开展药物经济学评价[J]. 中国研究型医院, 2017, 4(3):24-27.
[54]

HUANG J F, MENG Z, ZHENG X Q, et al. Real-world evidence in prescription medication use among U. S. adults with neck pain[J]. Pain Ther, 2020, 9(2):637-655. doi:  10.1007/s40122-020-00193-1
[55] 柏柳安宁, 夏结来, 王陵, 等. 真实世界研究中的常见偏倚及其控制[J]. 中国临床药理学与治疗学, 2020, 25(12):1422-1428. doi:  10.12092/j.issn.1009-2501.2020.12.015