Thornley B, Adams C
Cochrane Schizophrenia Group, Summertown Pavilion, Oxford OX2 7LG.
BMJ. 1998 Oct 31;317(7167):1181-4. doi: 10.1136/bmj.317.7167.1181.
To provide a comprehensive survey of the content and quality of intervention studies relevant to the treatment of schizophrenia.
Data were extracted from 2000 trials on the Cochrane Schizophrenia Group's register.
Type and date of publication, country of origin, language, size of study, treatment setting, participant group, interventions, outcomes, and quality of study.
Hospital based drug trials undertaken in the United States were dominant in the sample (54%). Generally, studies were short (54%<6 weeks), small (mean number of patients 65), and poorly reported (64% had a quality score of <=2 (maximum score 5)). Over 600 different interventions were studied in these trials, and 640 different rating scales were used to measure outcome.
Half a century of studies of limited quality, duration, and clinical utility leave much scope for well planned, conducted, and reported trials. The drug regulatory authorities should stipulate that the results of both explanatory and pragmatic trials are necessary before a compound is given a licence for everyday use.
全面调查与精神分裂症治疗相关的干预性研究的内容和质量。
从Cochrane精神分裂症研究组登记的2000项试验中提取数据。
发表类型和日期、原产国、语言、研究规模、治疗环境、参与者组、干预措施、结果及研究质量。
样本中以美国开展的基于医院的药物试验为主（54%）。总体而言，研究时间较短（54%<6周）、规模较小（患者平均数量为65名）且报告质量较差（64%的质量评分为≤2分（满分5分））。这些试验研究了600多种不同的干预措施，使用了640种不同的评定量表来衡量结果。
半个世纪以来质量、时长和临床实用性有限的研究，为精心规划、实施和报告的试验留下了很大空间。药品监管当局应规定，在一种药物获得日常使用许可之前，解释性试验和实用性试验的结果都必不可少。
