目的:了解喜炎平注射液上市后研究的现状与不足。方法:以“喜炎平”或“Xiyanping”为检索词,检索Cochrane图书馆、Medline、EMbase、CBMDisc、CNKI、VIP和万方数据库,由2位研究者独立筛选和提取资料,分析采用SPSS 20.0软件。结果:共纳入1 598篇文献,其中16.2%发表于中国科技核心期刊。用药领域以呼吸系统疾病、消化系统疾病、手足口病为主,分别约占50.4%、22.7%、20.5%,其余为部分外科疾病、皮肤科疾病或心血管疾病。用药方式以静脉注射为主(90.8%),雾化吸入占4.2%,但给药速度、单次给药时间和停药后随访时间的报告比例均未达3%。将喜炎平注射液作为核心干预并设对照(多为利巴韦林注射液或空白组)的研究有1 393项(90.5%),涉及患者105 703位。无研究提供样本量计算依据。1 431篇自报随机对照试验中,错误使用回顾性资料、未提及具体随机方法、未提及盲法和未提及分配隐藏的比例分别为20.5%、85.7%、99.2%和99.7%。其中,只设一个对照组且以有效率作效果指标的1 256篇研究中,样本量不满足者占85.8%。结论:喜炎平注射液上市后研究关注度很高,研究资源充足,但质量存有不足,主题有待调整。建议今后研究充分利用患者资源,从临床实践中凝练新的问题,结合高质量、大样本的设计回答药品在各种情况下的有效性和安全性。企业、政府、期刊等多方也应合力发挥必要的引导监督作用。 Objective: To understand the status quo and deficiency of Xiyanping injection after its market. METHODS: The Cochrane Library, Medline, EMbase, CBMDisc, CNKI, VIP and Wanfang databases were searched with the search term “Xiyanping” or “Xiyanping”. Two researchers independently screened and extracted data, Analysis using SPSS 20.0 software. Results: A total of 1 598 articles were included, of which 16.2% were published in China Science and Technology Core Journals. Respiratory diseases, digestive diseases and hand-foot-mouth disease were the major areas of medication, accounting for 50.4%, 22.7% and 20.5% respectively, with the rest being partial surgical diseases, dermatological diseases or cardiovascular diseases. Intravenous injection (90.8%) and nebulized inhalation (4.2%) were the main modes of administration. However, the rate of delivery, the single administration time and the follow-up time after discontinuation of drugs did not reach 3%. There were 1 393 (90.5%) studies of Xiyanping injection as the core intervention and control (mostly ribavirin injection or blank group), involving 105 703 patients. No research provided basis for calculation of sample size. Of the 4331 self-reported randomized controlled trials, the retrospective data was misused, no specific random method was mentioned, and no reference was made to the blindness and the unmentioned distribution hiding to 20.5%, 85.7%, 99.2% and 99.7% respectively. Of these, of the 1 256 studies that included only one control group and were effective indicators of effectiveness, 85.8% did not meet the sample size. Conclusion: Xiyanping injection after the listing of a high degree of research attention, sufficient research resources, but the quality of inadequate, the subject needs to be adjusted. It is suggested that in the future, research should make full use of patients’ resources, conclude new problems from clinical practice, and combine the design of high quality and large samples to answer the effectiveness and safety of drugs in various situations. Enterprises, governments, periodicals and other parties should also work together to play the necessary role in guiding and supervising.