摘要
目的运用循证医学系统评价方法评价逍遥散治疗抑郁症的疗效和安全性。方法检索电子数据库MEDLINE、Cochrane图书馆、CNKI、VIP、CBM。纳入中药逍遥散与安慰剂或抗抑郁药物比较治疗抑郁症的随机对照试验和逍遥散联用抗抑郁药与单用抗抑郁药比较的试验。由两人独立提取资料,采用Cochrane协作网的质量评价标准并用其提供的软件RevMan5.017进行资料分析。结局的效应指标为相对危险度或均数差,均以95%可信区间表示。结果共计纳入32项随机对照试验涉及2253例抑郁症患者。所纳入的中文文献质量普遍偏低。在逍遥散与安慰剂比较的试验中,仅抑郁自评量表(SDS)得分降低水平显示无统计学意义。在临床总体改善率以及汉密顿抑郁量表(HAMD)和SDS分值降低水平方面,逍遥散联合抗抑郁药物与单纯抗抑郁药物治疗抑郁症差异有统计学意义,而逍遥散与抗抑郁药比较疗效相当。逍遥散制剂未发现有明显不良反应。结论逍遥散治疗抑郁症可能具有一定的疗效,确切的结论尚需要设计更为严谨的大样本临床试验进行验证。
Objectives To assess the efficacy and safety of Xiaoyao Powder （Carefree Powder） in the treatment of depression using the method of systematic review of evidence-based medicine.Method Data published before December 2009 were searched from MEDLINE,Cochrane library,CNKI,VIP,CBM.We included randomize-controlled trials （RCT） testing Xiaoyao Powder against placebo or antidepressants,and Xiaoyao Powder combined with antidepressants against antidepressants alone.Two researchers collected data independently.The assessment of methodological quality was based on Cochrane handbook and the materials were analyzed with software RevMan 5.017.The outcome measure index was relative risk or difference of mean value （95% confidence interval）.Results Thirty-two RCTs involving 2 253 patients were included.Involved trials published in Chinese were of low quality.In the trials of comparison between Xiaoyao Powder and placebo,only decrease of self-rating depression scale （SDS） score was not significantly different.For general clinical improvement and decrease of Hamilton rating scale for depression （HAMD） and SDS scores,Xiaoyao Powder combined with antidepressants was more effective than antidepressants alone,but the effect of Xiaoyao Powder was equal to antidepressants.No adverse effect was reported in the trials regarding Xiaoyao Powder.Conclusions Xiaoyao Powder appears to be effective for depression.However,the exact effect needs to be confirmed in well-designed large-sampled clinical trials.
出处
《中医杂志》
CSCD
北大核心
2010年第6期500-505,共6页
Journal of Traditional Chinese Medicine
基金
国家重点基础研究发展计划("973"计划)资助项目(2006CB504602)
关键词
逍遥散
抑郁症
系统评价
随机对照试验
Xiaoyao Powder （Carefree Powder）
Depression
Systematic review
Randomize-controlled clinical trials
