摘要
目的:了解我国近14年以中文发表的与焦虑障碍治疗相关的临床研究文献进展及质量状况。方法:以“临床治疗”、 “临床试验”、 “随机”、 “对照”、 “双盲”、 “单盲”、 “盲法”、 “焦虑障碍”为关键词,在中国生物医学文献数据库、中国医院知识数据库、维普中文电子期刊数据库、万方数据库中检索1993-2006年间公开发表的与焦虑障碍治疗相关的中文临床研究文献,排除由器质性疾病导致焦虑的治疗。根据文献中对“随机”、“对照”、“盲法”等研究方法的说明,部分参照Jadad评分量表并结合文献中对照组设置的情况对所有文献进行质量评价(总分为0~5分)。结果:共纳入分析文献232篇。其中研究方法符合随机化原则的文献有15篇,占所有纳入文献数量的6.5%。研究提到随机但未说明具体随机方法的有124篇(53.4%),使用了伪随机方法的文献有62篇(26.7%);另外有31篇(13.4%)未采用随机化。尽管98.7%的研究设置了对照组,但是仅37篇(16.0%)使用了盲法,有方法说明的双盲设计为29篇(12.5%)。根据文献的研究方法说明,评分为0、1、2、3、4、5分的文献为3篇(1.3%)、85篇(36.6%)、98篇(42.2%)、18篇(7.8%)、23篇(9.9%)、5篇(2.2%),平均为1.95分。结论:国内发表的与焦虑障碍治疗相关的中文临床研究文献近14年来数量显著增加,但研究和报告的方法学质量亟待进一步提高。
Objective:To investigate the qualities of clinical trials related to treatment of anxiety disorder published in China in recent 14 years.Methods:The clinical trials related to anxiety disorder were searched through several databases,including the Chinese Biologic Medicine database disc(CBMdisc),Chinese Hospital Knowledge Database(CHKD),Chongqing VIP full-text Database(VIP),and Wanfang Database.The key words of "clinical trials","clinical research","randomization","control","blind","single blind" and "double blind" were used and all references published from 1993-2006 were included in the analysis.Results:Totally 232 articles were identified with full-text copies online.The proportion of "randomization with description of appropriate method","randomization without description in details","quasi-randomization" and "no randomization" were 6.5%,53.4%,26.7% and 13.4%,respectively.Using quality scale score(0 worst to 5 best)to evaluate these clinical trials,the scores distribution from 0 to 5 were 1.3%,36.6%,42.2%,7.8%,9.9% and 2.2%,respectively,with the mean score of 1.95.Conclusion:Though some progresses have been made in clinical trials of anxiety disorder in China during recent 14 years,there are urgent further needs on how to improve the overall quality of conduction and reporting of clinical intervention studies.
出处
《中国心理卫生杂志》
CSSCI
CSCD
北大核心
2011年第3期191-195,共5页
Chinese Mental Health Journal
基金
国家高技术研究发展计划(863计划)(2007AA02Z420)
上海市科委重点科技攻关项目(074119520)
上海市市级医院新兴前沿技术联合攻关项目(SHDC12006105)
重大新药创制科技重大专项(2008ZX09312-003)
关键词
临床试验
文献计量学
焦虑障碍
治疗
结果评价
clinical trials
bibliometrics
anxiety disorder
treatment
assessment