欢迎访问药物流行病学杂志网站！

设为首页加入收藏

国家科技部中国科技论文统计源期刊

中国科技核心期刊

WHO西太平洋地区医学索引(WPRIM)收录期刊

湖北优秀期刊

《药物流行病学杂志》官方网站与投审稿系统变更通知<点击查看详情>

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

DOI：

中文关键词: 喜炎平注射液文献计量上市后研究

英文关键词:Xiyanping injection Bibliometrics Post marketing study

基金项目:

作者	单位
陈茹^① 卓琳^② 潘昱廷^② 蔡婷^② 曹宇^② 王胜锋^②	①国家癌症中心/中国医学科学院北京协和医学院肿瘤医院(北京 100021)； ②北京大学公共卫生学院流行病与卫生统计学系

摘要点击次数: 1630

全文下载次数: 0

中文摘要:

摘要目的：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。

英文摘要:

ABSTRACT 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% and 99.7%, 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.

查看全文查看/发表评论下载PDF阅读器

关闭