我国高血压药物临床试验文献的伦理状况研究  

Reporting of informed consent and ethics committee approval in clinical trials of antihypertensive drugs

作　　者：周宇子 张叶萍[2] 郭婷婷[1] 郭曦滢 王真[1] 娄莹[1] 华潞[1] 李一石[1] 

机构地区：[1]中国医学科学院北京协和医学院阜外心血管病医院卫生部心血管药物临床研究重点实验室,北京100037 [2]民航总医院,北京100123

出　　处：《中国新药杂志》2015年第10期1141-1144,共4页Chinese Journal of New Drugs

摘　　要：目的:对高血压药物临床试验文献的伦理问题进行调研,以了解我国杂志是否提高了报告临床试验伦理道德的情况。方法:在维普中文科技期刊数据库中检索2003年、2008年和2013年高血压患者口服降压药物临床研究文献,分析文献中是否有通过伦理委员会批准、是否患者签署知情同意书的描述,比较各阶段高血压口服降压药物临床试验文献的伦理状况。结果:共收集到相关文献2003年292篇、2008年603篇、2013年1 046篇,随机对照临床试验的各有76篇(26.03%)、364篇(60.36%)、828篇(79.15%)(P=0.000),其中描述通过伦理委员会审查的文献分别为为2(2.63%),4(1.10%),以及57(6.88%),(P=0.000),描述患者签署知情同意书的分别为7(9.21%),29(7.67%),和144(17.39%)(P=0.000)。结论:与2003、2008年相比,2013年我国降压药物临床试验文献对伦理的报告有明显改善,但与国外文献相比仍有差距,我国药物临床试验文献的伦理管理仍亟需加强。Objective： To determine whether journals have improved their disclosure of ethical protections in clinical trials of antihypertensive drugs. Methods： We searched VIP Chinese Biomedical Database for 2003, 2008, and 2013 articles of clinical trials of oral antihypertensive drugs. We analyzed and compared the reporting rates of ＇ethics review board＇ and ＇informed consent＇ in these articles among 2003, 2008, and 2013. Results： We totally collected 292 articles in 2003, 603 in 2008, and 1 046 in 2013, among which 76 （26.03%） , 364 （60.36%） , and 828 （79. 15% ） were randomized controlled trials, P = 0. 000. In these randomized controlled studies, the reporting rates of ethics committee approval were 2 （2.63%） , 4 （ 1.10% ）, and 57 （6.88%）, re- spectively, P = 0. 000; the reporting rates of informed consent were 7 （9. 21%）, 29 （7. 67%）, and 144 （17.39%）, respectively. Conclusion： Compared with 2003 and 2008, medical journals have improved their re- porting of informed consent and ethics committee approval in 2013. However, near 82% of studies still report nei-ther. There is an urgent need to strengthen the reporting of informed consent and ethics committee approval in clini- cal trials in China.

关 键 词：降压药物 临床试验 伦理委员会 知情同意书 

分 类 号：R969[医药卫生—药理学]