Purgato Marianna, Adams Clive E
Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Verona, Italy.
Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001719. doi: 10.1002/14651858.CD001719.pub4.
Antipsychotic drugs are the mainstay treatment for schizophrenia. Long-acting depot injections of drugs such as bromperidol decanoate are extensively used as a means of long-term maintenance treatment.
To assess the effects of depot bromperidol versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes.
For this 2012 update we searched the Cochrane Schizophrenia Group's Register (February 2012).
We sought all randomised trials focusing on people with schizophrenia where depot bromperidol, oral antipsychotics or other depot preparations. Primary outcomes were clinically significant change in global function, service utilisation outcomes (hospital admission, days in hospital), relapse.
For the 2011 update MP independently extracted data, CEA carried out the reliability check. We calculated fixed-effect risk ratios (RR) and 95% confidence intervals (CI) for dichotomous data, and calculated weighted or standardised means for continuous data. Where possible, we calculated the number needed to treat statistic (NNT). Analysis was by intention-to-treat.For the 2012 update, data collection and analysis was not carried out as no new studies were found.
The 2012 search found no new studies, we have therefore included no new trials in this 2012 update. The number of included trials remain 4 RCTs, total n = 117. A single, small study of six months' duration compared bromperidol decanoate with placebo injection. Similar numbers left the study before completion (n = 20, 1 RCT, RR 0.4 CI 0.1 to 1.6) and there were no clear differences between bromperidol decanoate and placebo for a list of adverse effects (n = 20, 1 RCT, RR akathisia 2.0 CI 0.21 to 18.69, RR increased weight 3.0 CI 0.14 to 65.9, RR tremor 0.33 CI 0.04 to 2.69). When bromperidol decanoate was compared with fluphenazine depot, we found no important change on global outcome (n = 30, RR no clinical important improvement 1.50 CI 0.29 to 7.73). People allocated to fluphenazine decanoate and haloperidol decanoate had fewer relapses than those given bromperidol decanoate (n = 77, RR 3.92 Cl 1.05 to 14.60, NNH 6 CI 2 to 341). People allocated bromperidol decanoate required additional antipsychotic medication somewhat more frequently than those taking fluphenazine decanoate and haloperidol decanoate, but the results did not reach conventional levels of statistical significance (n = 77, 2 RCTs, RR 1.72 CI 0.7 to 4.2). The use of benzodiazepine drugs was very similar in both groups (n = 77, 2 RCTs, RR 1.08 CI 0.68 to 1.70). People left the bromperidol decanoate group more frequent than those taking other depot preparation due to any cause (n = 97, 3 RCTs, RR 2.17 CI 1.00 to 4.73). Anticholinergic adverse effects were equally common between bromperidol and other depots (n = 47, RR 3.13 CI 0.7 to 14.0) and additional anticholinergic medication was needed with equal frequency in both depot groups, although results did tend to favour the bromperidol decanoate group (n = 97, 3 RCTs, RR 0.80 CI 0.64 to 1.01). The incidence of movement disorders was similar in both depot groups (n = 77, 2 RCTs, RR 0.74 CI 0.47 to 1.17).
AUTHORS' CONCLUSIONS: Minimal poorly reported trial data suggests that bromperidol decanoate may be better than placebo injection but less valuable than fluphenazine or haloperidol decanoate. If bromperidol decanoate is available it may be a viable choice, especially when there are reasons not to use fluphenazine or haloperidol decanoate. Well-conducted and reported randomised trials are needed to inform practice.
抗精神病药物是治疗精神分裂症的主要手段。癸酸溴哌利多等药物的长效注射剂被广泛用作长期维持治疗的一种方式。
从临床、社会和经济结果方面评估长效癸酸溴哌利多与安慰剂、口服抗精神病药物及其他长效抗精神病制剂对精神分裂症患者的影响。
对于本2012年更新版,我们检索了Cochrane精神分裂症研究组注册库(2012年2月)。
我们查找了所有针对精神分裂症患者的随机试验,这些试验涉及长效癸酸溴哌利多、口服抗精神病药物或其他长效制剂。主要结局包括整体功能的临床显著变化、服务利用结局(住院、住院天数)、复发情况。
对于2011年更新版,MP独立提取数据,CEA进行可靠性检查。我们计算二分数据的固定效应风险比(RR)和95%置信区间(CI),并计算连续数据的加权或标准化均值。在可能的情况下,我们计算需治疗人数统计量(NNT)。分析采用意向性分析。对于2012年更新版,由于未发现新的研究,未进行数据收集和分析。
2012年的检索未发现新的研究,因此在本2012年更新版中未纳入新的试验。纳入试验数量仍为4项随机对照试验,总计n = 117。一项为期6个月的小型研究将癸酸溴哌利多与安慰剂注射进行了比较。在研究完成前退出的人数相似(n = 20,1项随机对照试验,RR 0.4,CI 0.1至1.6),在一系列不良反应方面,癸酸溴哌利多与安慰剂之间无明显差异(n = 20,1项随机对照试验,RR静坐不能2.0,CI 0.21至18.69,RR体重增加3.0,CI 0.14至65.9,RR震颤0.33,CI 0.04至2.69)。当将癸酸溴哌利多与氟奋乃静长效注射剂比较时,我们发现整体结局无重要变化(n = 30,RR无临床重要改善1.50,CI 0.29至7.73)。分配至氟奋乃静癸酸酯和氟哌啶醇癸酸酯组的患者复发次数少于给予癸酸溴哌利多组的患者(n = 77,RR 3.92,Cl 1.05至14.60,NNH 6,CI 2至341)。分配至癸酸溴哌利多组的患者比服用氟奋乃静癸酸酯和氟哌啶醇癸酸酯组的患者更频繁地需要额外的抗精神病药物,但结果未达到传统统计学意义水平(n = 77,2项随机对照试验,RR 1.72,CI 0.7至4.2)。两组中苯二氮䓬类药物的使用非常相似(n = 77,2项随机对照试验,RR 1.08,CI 0.68至1.70)。由于任何原因,癸酸溴哌利多组患者比服用其他长效制剂组的患者更频繁地退出(n = 97,3项随机对照试验,RR 2.17,CI 1.00至4.73)。溴哌利多与其他长效制剂的抗胆碱能不良反应同样常见(n = 47,RR 3.13,CI 0.7至14.0),两个长效制剂组中需要额外抗胆碱能药物的频率相同,尽管结果确实倾向于癸酸溴哌利多组(n = 97,3项随机对照试验,RR 0.80,CI 0.64至1.01)。两个长效制剂组运动障碍的发生率相似(n = 77,2项随机对照试验,RR 0.74,CI 0.47至1.17)。
极少且报告不佳的试验数据表明,癸酸溴哌利多可能优于安慰剂注射,但比氟奋乃静或氟哌啶醇癸酸酯价值更低。如果有癸酸溴哌利多可用,它可能是一个可行的选择,特别是在有理由不使用氟奋乃静或氟哌啶醇癸酸酯的情况下。需要开展设计良好且报告规范的随机试验为临床实践提供依据。