丙戊酸钠与安慰剂治疗急性双相抑郁症的疗效比较：系统评价和荟萃分析。
Divalproex sodium versus placebo in the treatment of acute bipolar depression: a systematic review and meta-analysis.
机构信息
Mood Disorders Centre, University of British Columbia, Room 2C7 - 2255 Wesbrook Mall, Vancouver, BC Canada V6T 2A1.
出版信息
J Affect Disord. 2010 Aug;124(3):228-34. doi: 10.1016/j.jad.2009.11.008. Epub 2009 Dec 30.
BACKGROUND
Bipolar disorders (BDs) are defined by mania and hypomania, but depressions occur more frequently, last longer, and lead to significant disability. Divalproex is the most frequently prescribed anticonvulsant medication for BD. While some evidence suggests that divalproex prevents depressive episodes during maintenance treatment, it is not commonly used in the treatment of acute depression, and there is a perception that there is little evidence to support its efficacy.
METHODS
We conducted a meta-analysis of randomized placebo-controlled trials assessing the efficacy of divalproex in acute BD depression. We searched MEDLINE and the Cochrane Database of Systematic Reviews using the search terms "divalproex AND bipolar depression", "valproate AND bipolar depression", and "valproic acid AND bipolar depression". We also accessed the databases of clinical trial registries, including www.ClinicalTrials.gov, www.who.int/ictrp, http://isrctn.org, http://www.mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articles_fs.html, and www.ClinicalStudyResults.org. All English-language, randomized, double-blind, placebo-controlled trials assessing the efficacy of divalproex monotherapy in the treatment of BD depression were included in the analysis. Data were subjected to meta-analysis to determine the relative risks of response and remission, and combined to estimate average response and remission rates.
RESULTS
We identified four trials, with a total sample size of 142 patients. The relative risks of response (RR=2.10, p=0.02) and remission (RR=1.61, p=0.04) were significantly greater for divalproex than placebo. Mean response rates were 39.3% for divalproex and 17.5% for placebo, and mean remission rates were 40.6% and 24.3%, respectively.
LIMITATIONS
The total sample size in the four trials was small.
CONCLUSIONS
These results provide preliminary evidence that divalproex is efficacious in the treatment of BD depression.
背景
双相障碍（BD）的定义是躁狂和轻躁狂，但抑郁症更为常见，持续时间更长，导致显著的残疾。丙戊酸钠是 BD 最常开的抗惊厥药物。虽然有一些证据表明丙戊酸钠在维持治疗期间预防抑郁发作，但它在急性抑郁症治疗中并不常用，而且人们认为几乎没有证据支持其疗效。
方法
我们对评估丙戊酸钠治疗急性 BD 抑郁症疗效的随机安慰剂对照试验进行了荟萃分析。我们使用搜索词“丙戊酸钠和双相抑郁”、“丙戊酸盐和双相抑郁”和“丙戊酸和双相抑郁”搜索了 MEDLINE 和 Cochrane 系统评价数据库。我们还访问了临床试验注册数据库，包括 www.ClinicalTrials.gov、www.who.int/ictrp、http://isrctn.org、http://www.mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articles_fs.html 和 www.ClinicalStudyResults.org。所有评估丙戊酸钠单药治疗 BD 抑郁症疗效的英文、随机、双盲、安慰剂对照试验均纳入分析。对数据进行荟萃分析以确定反应和缓解的相对风险，并结合起来估计平均反应和缓解率。
结果
我们确定了四项试验，总样本量为 142 例患者。丙戊酸钠的反应（RR=2.10，p=0.02）和缓解（RR=1.61，p=0.04）的相对风险显著高于安慰剂。丙戊酸钠的平均反应率为 39.3%，安慰剂为 17.5%，平均缓解率分别为 40.6%和 24.3%。
局限性
四项试验的总样本量较小。
结论
这些结果初步表明丙戊酸钠在治疗 BD 抑郁症方面有效。
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