基于文献计量学的喜炎平注射液上市后研究现状分析

Bibliometric Analysis on Status of Post-marketing Study About Xiyanping Injection

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 current status of post-marketing study of Xiyanping Injection. Methods：The Cochrane library,Medline and Embase with four Chinese databases including CBMDisc,CNKI,VIP and Wanfang data were systematically searched with the keywords ＂ Xiyanping＂. The relevant information was extracted by two researchers independently and the data were bibliometrics analyzed using SPSS 20. 0. Results： A total of 1 598 studies were included,16. 2% of which were published in China Core Journals of Science and Technology. The majority of this medication was used to treat respiratory disease（50. 4%）,digestive diseases（22. 7%） and hand-foot-and-mouth disease（20. 5%）. The rest was used in surgical conditions,skin diseases or cardiovascular diseases. Most of the routes of administration were intravenous injection（90. 8%）,while 4. 2% were inhalation. The reported proportion of administration rate,administration time and follow-up time were all less than 3%. There were 1393 studies（90. 5%）,involved 105 703 patients,which took Xiyanping injection as core treatment with control group. None of the studies provided the rationale of the sample size.There were 1 431 self-reported randomized control trials,and the proportions for incorrect using retrospective data,non-reporting detail randomization methods,blind method and allocation concealment were 20. 5%,85. 7%,99. 2% and99. 7%,separately. Most of those used ribavirin or blank as control,and among those,1 256 studies were with only one control group and using general effective rate as evaluation index,85. 8% of which could not be satisfied the required sample size. Conclusion： The post-marketing study of Xiyanping injection was with numerous amount but poor design quality,as well as poor reporting quality. It was used in considerable patients with diverse diseases,even existed off-label drug use phenomenon. It＇s suggested that future studies should make best use of the patients＇ resources,and get idea from clinical practice,combined with high-quality and large sample design to provide evidence for its efficiency and safety in a variety of situations. Medication industry,government,and periodical association should work together to bring their influencing of supervision and guidance.