Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Schizophr Bull. 2011 Jul;37(4):788-99. doi: 10.1093/schbul/sbp149. Epub 2009 Nov 27.
It remains unknown as to whether the antipsychotic dose needed for the acute-phase treatment of schizophrenia is also necessary for relapse prevention.
To compare the efficacy between standard dose [(World Health Organization daily defined dose (DDD)] vs low dose (≥50% to <1 DDD) or very low dose (<50% DDD) for relapse prevention in schizophrenia.
Double-blind, randomized, controlled trials with a follow-up duration of ≥24 weeks, including ≥2 dosage groups of the same antipsychotic drug for relapse prevention in schizophrenia, were searched using MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE (last search: August 2009).
Data on overall treatment failure, hospitalization, relapse, and dropouts due to side effects were extracted and combined in a meta-analysis.
Thirteen studies with 1395 subjects were included in this meta-analysis. Compared with the standard-dose treatment, the low-dose therapy did not show any statistically significant difference in overall treatment failure or hospitalization, while the standard dose showed a trend-level (P = .05) superiority in risk of relapse. The very low-dose group was inferior to the standard-dose group in all efficacy parameters. No significant difference was found in the rate of dropouts due to side effects between either standard dose vs low dose or very low dose.
Although antipsychotic treatment with ≥50% to <1 DDD may be as effective as standard-dose therapy, there are insufficient clinical trial data to draw firm conclusions on standard- vs low-dose maintenance antipsychotic therapy for schizophrenia.
抗精神病药物用于精神分裂症急性期治疗的剂量是否也需要用于预防复发尚不清楚。
比较标准剂量([世界卫生组织每日规定剂量(DDD)]与低剂量(≥50%至<1 DDD)或超低剂量(<50%DDD)预防精神分裂症复发的疗效。
使用 MEDLINE、Cochrane 对照试验中心注册库和 EMBASE(最近一次检索日期:2009 年 8 月)搜索了双盲、随机、对照试验,随访时间≥24 周,包括≥2 种相同抗精神病药物的剂量组用于预防精神分裂症复发。
提取并合并了关于总治疗失败、住院、复发和因副作用退出的资料进行荟萃分析。
共有 13 项研究,涉及 1395 例患者纳入荟萃分析。与标准剂量治疗相比,低剂量治疗在总治疗失败或住院方面无显著差异,而标准剂量在复发风险方面显示出趋势水平(P=0.05)的优势。超低剂量组在所有疗效参数方面均不如标准剂量组。标准剂量与低剂量或超低剂量之间因副作用导致的退出率无显著差异。
尽管≥50%至<1 DDD 的抗精神病药物治疗可能与标准剂量治疗同样有效,但对于精神分裂症的标准剂量与低剂量维持抗精神病治疗,临床试验资料不足以得出明确结论。