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精神分裂症新试验的证据与现有证据如何契合:这是一个“皇帝的新衣”的案例吗?

Where Does Evidence from New Trials for Schizophrenia Fit with the Existing Evidence: A Case of the Emperor's New Clothes?

作者信息

Jayaram Mahesh, Rattehalli Ranganath D, Adams Clive E

机构信息

Leeds and York Partnerships NHS Foundation Trust, Aire Court Community Unit, Lingwell Grove, Leeds LS10 4BS, UK.

出版信息

Schizophr Res Treatment. 2012;2012:625738. doi: 10.1155/2012/625738. Epub 2012 Apr 8.

Abstract

Advent of "atypical" antipsychotics has spawned new trials in the recent years and the number of such trial reports has been increasing exponentially. As clinicians we have been led to believe that "atypicals" are better than "typicals" despite the odd dissenting voice in academic and clinical circles. This has been largely ignored until the publication of two landmark, independent, pragmatic trials, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS), which proved that thoughtfully chosen "typical" antipsychotics were as good as the newer "atypicals." We pooled "leaving the study early data" from Cochrane Reviews that existed before CATIE and CUtLASS and added data from CATIE and CUtLASS to the pool for a "before and after" comparison. Addition of CATIE and CUtLASS data only led to narrowing of the already existing confidence intervals, merely increasing precision, and decreasing the risk of Type II error. Perhaps surprisingly, CATIE and CUtLASS when pooled with the already existing data showed us that we had chosen to turn a blind eye to findings that already existed. This leads clinicians to question as to whether, in future, we need to feel less guilty about crying out early on that the emperor has no clothes on.

摘要

近年来,“非典型”抗精神病药物的出现催生了新的试验,此类试验报告的数量呈指数级增长。作为临床医生,尽管学术界和临床界有一些不同的声音,但我们一直被引导着相信“非典型”药物比“典型”药物更好。在两项具有里程碑意义的、独立的、务实的试验——《干预有效性临床抗精神病药物试验》(CATIE)和《精神分裂症最新抗精神病药物的成本效益研究》(CUtLASS)发表之前,这一情况在很大程度上被忽视了,而这两项试验证明,精心挑选的“典型”抗精神病药物与新型“非典型”药物效果相当。我们汇总了CATIE和CUtLASS之前Cochrane系统评价中的“提前退出研究数据”,并将CATIE和CUtLASS的数据加入其中进行“前后”对比。加入CATIE和CUtLASS的数据仅导致已有的置信区间变窄,只是提高了精确度,并降低了II类错误的风险。也许令人惊讶的是,当将CATIE和CUtLASS与已有数据汇总时,我们发现我们之前选择对已有的研究结果视而不见。这使得临床医生质疑,未来我们是否不必再为过早指出皇帝没穿衣服而感到那么内疚了。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde2/3420610/e308f560cf7b/SPRT2012-625738.001.jpg

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