我国蛇毒类血凝酶随机对照临床试验现状的初步分析  

Preliminary Analysis of Randomized Controlled Trials on h rombin Like Enzyme in China

作　　者：胡文婷[1] 秦凤琴[1] 陈宁[1] 郭建[1] 方靖环 郭江[1] 周东[1] 何俐[1] 

机构地区：[1]四川大学华西医院神经内科,成都610041

出　　处：《华西医学》2014年第3期488-492,共5页West China Medical Journal

摘　　要：目的探讨我国蛇毒类血凝酶随机对照临床试验(RCT)的现状及能否向出血性疾病及围手术期出血的防治等临床实践提供可靠的研究依据。方法对我国可能刊登上述RCT的4种中文常用数据库进行检索,包括中国生物医学文献数据库(1978年-2012年)、中国知网(1979年-2012年)、万方数据知识服务平台(1986年-2012年)、维普全文数据库(1989年-2012年)。检索时间为各数据库建库至2012年,并根据国际标准,由两名评价者共同评价纳入研究质量,并对其RCT报告进行分析。结果查阅国内4种相关数据库,共检索出蛇毒类凝血酶文章2 358篇,含临床试验文章101篇,检索出并分析符合纳入标准的RCT报告53篇,其质量目前还不能满足临床实践的需要。结论应加强蛇毒类血凝酶领域的RCT的设计和实施等临床研究方法学的学习和培训,更多地开展高质量RCT研究,为临床提供更为可靠的研究依据。Objective To investigate the current situation of randomized controlled trials （RCTs） of thrombin like enzyme research and the ability to provide a reliable basis for the clinical practice. Methods RCTs identified from four Chinese databases up to the year 2012 were assessed according to international standard, including SinoMed （1978-2012）, CNKI （1979-2012）, Wanfang Data （1986-2012）, and VIP （1989-2012）. Results A total of 2358 articles were searched and 53 RCTs were identified. The results showed that the quality of these articles was not high enough to meet the needs of clinical practice in China. Condusions In China, current quantity and quality of RCTs of thrombin like enzyme can not meet the need of clinical practice. In order to improve the prevention and treatment of hemorrhagic diseases, and surgical bleeding, especially for patients lacking clotting factor, more high-quality RCTs are required.

关 键 词：蛇毒凝血酶 尖吻蝮蛇 白眉蛇毒 出血 随机对照试验 

分 类 号：R285[医药卫生—中药学]