Suzuki Takefumi
Keio University, School of Medicine, Department of Neuropsychiatry, 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Psychopharmacol Bull. 2011;44(1):18-31.
This paper reviewed which rating scales past studies adopted as an outcome measure in clinical trials for schizophrenia, for which a consensus has been lacking.
A PubMed search was conducted using keywords 'outcome', 'rating scales' and 'schizophrenia'. Studies published in 1999, 2004 and 2009 were examined to globally see if a trend has changed over the last decade.
One-hundred fifty articles were inspected. As for psychopathology, the positive and negative syndrome scale (PANSS) has been by far the most frequently utilized scale (46%, 79%, and 78% in the respective years), followed by the brief psychiatric rating scale. Affective/anxiety symptoms have been only rarely recorded Extrapyramidal symptoms have been assessed mostly with the Simpson Angus scale (SAS), more frequently in combination with the abnormal involuntary movement scale (AIMS) and Barnes akathisia scale (BARS) recently. Non-motor adverse effects have been typically reported without a usage of formal rating scales. Depending on the interest of investigation, other critical domains of the illness including functioning, cognition and subjective perspectives have been sporadically reported through the rating scales. The assessment scales were similarly utilized across the years, except for a numerical rise in scale utilization to rate the latter three domains in 2009.
The PANSS and set of AIMS, BARS and SAS, which are expected to take about 60 minutes to complete, are frequently utilized and may be regarded as a 'standard' in clinical trials for schizophrenia. Clinical implication of the findings and practical challenges with the existing scales are discussed.
本文回顾了以往研究在精神分裂症临床试验中作为结局指标所采用的评定量表,对此一直缺乏共识。
使用关键词“结局”“评定量表”和“精神分裂症”在PubMed上进行检索。对1999年、2004年和2009年发表的研究进行审查,以全面了解过去十年中趋势是否发生了变化。
共检查了150篇文章。在精神病理学方面,阳性和阴性症状量表(PANSS)是迄今为止使用最频繁的量表(各年份分别为46%、79%和78%),其次是简明精神病评定量表。情感/焦虑症状很少被记录。锥体外系症状大多用辛普森·安格斯量表(SAS)进行评估,最近更多地与异常不自主运动量表(AIMS)和巴恩斯静坐不能量表(BARS)联合使用。非运动不良反应通常在未使用正式评定量表的情况下进行报告。根据研究兴趣,通过评定量表偶尔会报告该疾病的其他关键领域,包括功能、认知和主观观点。这些评定量表在各年份的使用情况相似,只是在2009年用于评定后三个领域的量表使用率在数值上有所上升。
预计大约需要60分钟完成的PANSS以及AIMS、BARS和SAS这一组量表经常被使用,可能被视为精神分裂症临床试验中的“标准”。本文讨论了研究结果的临床意义以及现有量表面临的实际挑战。