1992-2006年我国与精神障碍治疗相关的临床研究文献质量的调查

目的 了解国内近15年公开发表的与精神障碍治疗相关的临床研究文献的进展及质量状况.方法 以临床治疗临床试验随机对照双盲单盲盲法为关键词,检索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、万方数据库于1992-2006年以中文公开发表的与精神障碍治疗相关的临床研究文献.对文献数量、治疗病种、治疗方法及若干研究质量指标进行综合分析.同时,根据文献中的随机对照盲法等研究方法的说明对所有论文进行质量评价.临床试验方法学质量的评估部分参照Jadad评分量表,结合研究中的对照组设置情况进行评分(0～5分).结果 共纳入分析文献3667篇.研究涉及的疾病主要为精神分裂症(34.0%)、抑郁障碍(22.4%)、痴呆(7.8%)、躯体疾病伴发精神障碍(6.6%)和焦虑障碍(6.4%).治疗方法以药物治疗为主,占82.2%.18.1%的研究未采用随机化;59.3%提到随机,但未说明具体随机方法;14.8%的随机方法为伪随机;7.9%的研究方法符合随机化的原则.尽管98.1%的研究设置了对照组,但仅16.6%采用了盲法,其中双盲占13.3%.根据文献的研究方法说明,评分为0,1,2,3,4,5分的文献分别占1.9%,28.1%,49.0%,9.4%,9.3%,2.3%,平均为2.03分.结论 近15年来,国内以中文发表的精神障碍治疗相关的研究报道数量有显著增加,但其中大部分临床研究报告的质量仍偏低.

Qualities of controlled clinical trials relevant to treatment of mental disorders published in China from 1992 to 2006

Objective The present study was to investigate the qualities of clinical trials related to treatment of mental disorders published in China in recent 15 years.Methods We searched the clinical trials related to mental disorders through several databases including the Chinese Biologic Medicine database disc (CBMdisc), Chinese Hospital Knowledge Database (CHKD), Chongqing VIP full-text Database (VIP), Wangfang Database.The keywords of clinical trial, clinical research, randomization,control, blind, double blind, and single blind were used and all references published from 1992 to 2006 were included in the analysis.Results We identified 3667 articles with full-text copies online.There was a significant increase of the number of controlled trials published over time.The common disorders in the above trials were schizophrenia (34.0%), depression (22.4%), dementia (7.8%), psychosis associated with physical diseases (6.6%), anxiety disorder (6.4%).The majority (82.2%) of trials was drug treatment intervention.The proportion of no randomization, quasi-randomization, randomization without description in details and randomization with description of appropriate method were 18.1% ,14.8% , 59.3% , and 7.9% , respectively.Using quality scale score (0worst to 5 best) to evaluate these clinical trials, the scores distribution from 0 to 5 were 1.9% ,28.1% ,49.0% ,9.4% ,9.3% ,and 2.3%,respectively, with the mean score of 2.03.Conclusion Though some progresses have been made in clinical trials of mental disorders in China during recent decades, there are still a lot of challenges on how to improve the overall quality.