多虑平治疗原发性失眠有效性及安全性的系统评价

Effectiveness and Safety of Doxepin for Primary Insomnia:A Systematic Review

目的系统评价多虑平治疗原发性失眠的有效性及安全性。方法计算机检索Cochrane图书馆(2009年第4期)、PubMed(1966～2009.12)、EMbase(1974～2009.12)、ISI(1961～2009.12)、CBM(1978～2009.12)、CNKI(1979～2009.12)、VIP(1989～2009.12)和万方(1998～2009.12)数据库,并补充查找相关会议文献及在研文献,由2名评价者独立选择研究、评价质量、提取资料并交叉核对,而后采用RevMan 5.0软件对数据进行统计分析。结果共纳入4篇文献,共171例患者。Meta分析结果表明:与安慰剂相比,中低剂量多虑平(1～25 mg)对原发性失眠患者的总睡眠时间、睡眠后觉醒时间、睡眠期间觉醒时间、睡眠有效率等睡眠质量指标的改善作用明显,其差异有统计学意义。相反,高剂量多虑平(50 mg)对绝大多数睡眠质量指标的改善与安慰剂相比并无统计学意义。而中高剂量多虑平(25～50 mg)对原发性患者的快速眼动睡眠、二期睡眠、快速眼动睡眠潜伏时间等睡眠结构指标的改善与安慰剂相比,其差异有统计学意义。结论中低剂量多虑平(1～25 mg)可有效改善原发性失眠患者的睡眠质量,但使用中等剂量多虑平治疗原发性失眠时需关注副作用及对睡眠结构的影响;尚不推荐使用高剂量多虑平(50 mg)治疗原发性失眠。由于纳入研究质量与例数有限,上述结论尚需开展更多高质量大样本的研究加以验证。

Objective To evaluate the effectiveness and safety of doxepin in the treatment of primary insomnia.Methods We searched The Cochrane Library（Issue 4,2009）,PubMed（1966 to December 2009）,EMbase（1974 to De-cember 2009）,ISI（1961 to December 2009）,CNKI（1979 to December 2009）,VIP（1989 to December 2008）,CBM（1978 to December 2009）,and WANFANG Data（1998 to December 2009）.We also searched the correlated grey literature and conference literature for complement.Data were extracted,methodologically evaluated,and cross-checked by two review-ers independently.RevMan 5.0 was used for statistical analysis.Results One randomized controlled trial and three cross trials involving 171 patients were included.The results of meta-analyses showed that total sleep time（TST）,wake time during sleep（WTDS）,wake time after sleep（WTAS）,and sleep effciency（SE） were improved by low and medium dosage of doxepin（1-25 mg） with statistically signi cant difference compared with placebo.On the contrary,most indicators of sleep quality had no statistically signi cant difference between high dose doxepin（50 mg） and placebo.While the sleep-ing structural indicators of rapid eye movement sleep（REM）,rapid-eyemovement latency（REM-L）,and sleep stage II（St.II） were changed by high and medium dosage of doxepin（25-50 mg） with statistically signi cant difference.Conclu-sions Low and medium dosage of doxepin（1-25 mg） is effective in improvement of the sleep quality in patients with primary insomnia,but it is necessary to concern the side effects and the effects on sleep structure when treating primary insomnia with medium dosage of doxepin（25 mg）.High dosage of doxepin（50 mg） is not recommended to treat primary insomnia.However,this conclusion still needs clinical trials to be further validated.