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急性双相躁狂的药物干预:随机安慰剂对照试验的系统评价

Pharmacological interventions for acute bipolar mania: a systematic review of randomized placebo-controlled trials.

作者信息

Smith Lesley A, Cornelius Victoria, Warnock Adrian, Tacchi Mary Jane, Taylor David

机构信息

Medical Research Matters, Eynsham, UK.

出版信息

Bipolar Disord. 2007 Sep;9(6):551-60. doi: 10.1111/j.1399-5618.2007.00468.x.

DOI:10.1111/j.1399-5618.2007.00468.x
PMID:17845269
Abstract

OBJECTIVES

We conducted a systematic review and meta-analysis of randomized, placebo-controlled trials in acute bipolar mania to summarize available data on drug treatment of mania.

METHODS

We included trials of medications licensed in the USA or UK for the treatment of any phase of bipolar disorder. Outcomes investigated were changes in mania scores, attrition, extrapyramidal effects and weight change. Data were combined through meta-analyses.

RESULTS

We included 13 studies (involving 3,089 subjects) and identified 2 studies for each of the following medications: carbamazepine, haloperidol, lithium, olanzapine, quetiapine, risperidone, valproate semisodium and aripiprazole. All drugs showed significant benefit compared with placebo for reduction in mania scores. Compared with placebo, for all antipsychotics pooled, response to treatment (> or =50% reduction in Young Mania Rating Scale scores) was increased more than 1.7 times [relative risk (RR) = 1.74, 95% confidence interval (CI) = 1.54, 1.96]; for all mood stabilizers pooled, response to treatment was doubled (RR 2.01, 95% CI = 1.66, 2.43). Overall withdrawals were 34% fewer (24-43%) with antipsychotics, and 26% fewer (10-39%) with mood stabilizers. However, for carbamazepine, aripiprazole and lithium an increase in risk of withdrawal could not be excluded. Small but significant increases in extrapyramidal side effects occurred with risperidone and aripiprazole.

CONCLUSIONS

Antipsychotics and mood stabilizers are significantly more effective than placebo for the treatment of acute mania. Their effect sizes are similar. Small differences between effect sizes may be due to differences in the patients included in the studies or to chance. Carbamazepine and lithium may be more poorly tolerated, and antipsychotics cause more extrapyramidal side effects.

摘要

目的

我们对急性双相躁狂症的随机、安慰剂对照试验进行了系统评价和荟萃分析,以总结有关躁狂症药物治疗的现有数据。

方法

我们纳入了在美国或英国获批用于治疗双相情感障碍任何阶段的药物试验。所研究的结局包括躁狂评分的变化、损耗、锥体外系反应和体重变化。通过荟萃分析合并数据。

结果

我们纳入了13项研究(涉及3089名受试者),并为以下每种药物确定了2项研究:卡马西平、氟哌啶醇、锂盐、奥氮平、喹硫平、利培酮、丙戊半钠和阿立哌唑。与安慰剂相比,所有药物在降低躁狂评分方面均显示出显著益处。与安慰剂相比,所有汇总的抗精神病药物的治疗反应(杨氏躁狂评定量表评分降低≥50%)增加了1.7倍以上[相对危险度(RR)=1.74,95%置信区间(CI)=1.54,1.96];所有汇总的心境稳定剂的治疗反应增加了一倍(RR 2.01,95%CI=1.66,2.43)。总体而言,抗精神病药物导致的退出率减少34%(24%-43%),心境稳定剂导致的退出率减少26%(10%-39%)。然而,不能排除卡马西平、阿立哌唑和锂盐导致退出风险增加的可能性。利培酮和阿立哌唑导致锥体外系副作用有小幅但显著的增加。

结论

抗精神病药物和心境稳定剂在治疗急性躁狂症方面明显比安慰剂更有效。它们的效应大小相似。效应大小之间的微小差异可能是由于研究中纳入的患者不同或偶然因素所致。卡马西平和锂盐的耐受性可能较差,抗精神病药物会导致更多的锥体外系副作用。

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