Lewis Shôn W, Barnes Thomas R E, Davies Linda, Murray Robin M, Dunn Graham, Hayhurst Karen P, Markwick Alison, Lloyd Helen, Jones Peter B
University of Manchester, London.
Schizophr Bull. 2006 Oct;32(4):715-23. doi: 10.1093/schbul/sbj067. Epub 2006 Mar 15.
There is good evidence that clozapine is more efficacious than first-generation antipsychotic drugs in resistant schizophrenia. It is less clear if clozapine is more effective than the other second-generation antipsychotic (SGA) drugs. A noncommercially funded, pragmatic, open, multisite, randomized controlled trial was conducted in the United Kingdom National Health Service (NHS). Participants were 136 people aged 18-65 with DSM-IV schizophrenia and related disorders whose medication was being changed because of poor clinical response to 2 or more previous antipsychotic drugs. Participants were randomly allocated to clozapine or to one of the class of other SGA drugs (risperidone, olanzapine, quetiapine, amisulpride) as selected by the managing clinician. Outcomes were assessed blind to treatment allocation. One-year assessments were carried out in 87% of the sample. The intent to treat comparison showed no statistically significant advantage for commencing clozapine in Quality of Life score (3.63 points; CI: 0.46-7.71; p = .08) but did show an advantage in Positive and Negative Syndrome Scale (PANSS) total score that was statistically significant (-4.93 points; CI: -8.82 to -1.05; p = .013) during follow-up. Clozapine showed a trend toward having fewer total extrapyramidal side effects. At 12 weeks participants who were receiving clozapine reported that their mental health was significantly better compared with those receiving other SGA drugs. In conclusion, in people with schizophrenia with poor treatment response to 2 or more antipsychotic drugs, there is an advantage to commencing clozapine rather than other SGA drugs in terms of symptom improvement over 1 year.
有充分证据表明，在难治性精神分裂症中，氯氮平比第一代抗精神病药物更有效。氯氮平是否比其他第二代抗精神病药物（SGA）更有效则不太明确。在英国国家医疗服务体系（NHS）中进行了一项非商业资助、务实、开放、多中心的随机对照试验。参与者为136名年龄在18至65岁之间、患有DSM-IV精神分裂症及相关障碍的患者，他们因对之前两种或更多种抗精神病药物临床反应不佳而正在更换药物。参与者被随机分配至氯氮平组或由主治医生选择的其他SGA药物类别（利培酮、奥氮平、喹硫平、氨磺必利）之一。对治疗分配情况进行盲法评估结果。87%的样本进行了一年的评估。意向性治疗比较显示，在生活质量评分方面开始使用氯氮平没有统计学上的显著优势（3.63分；CI：0.46 - 7.71；p = 0.08），但在随访期间阳性和阴性症状量表（PANSS）总分上确实显示出显著优势（-4.93分；CI：-8.82至-1.05；p = 0.013）。氯氮平显示出锥体外系副作用总数较少的趋势。在12周时，接受氯氮平治疗的参与者报告称，与接受其他SGA药物的参与者相比，他们的心理健康状况明显更好。总之，对于对两种或更多种抗精神病药物治疗反应不佳的精神分裂症患者，在症状改善方面，开始使用氯氮平而非其他SGA药物有优势。
