奥氮平联合氟西汀治疗难治性抑郁症有效性和安全性的系统评价

Effectiveness and Safety of Olanzapine Combined with Fluoxetine for Refractory Depression:A Systematic Review

目的评价奥氮平+氟西汀与单纯氟西汀比较治疗难治性抑郁症的有效性与安全性。方法计算机检索PubMed(1966～2009.9)、Cochrane Library(2009年第3期)、EMbase(1974～2009.9)、SCI(1974～2009.9)、中国期刊全文数据库(1994～2009.9)、中国生物医学文献数据库(1978～2009.9)、中文科技期刊全文数据库(1989～2009.9)和万方数字化期刊全文数据库(1997～2009.9),同时手检相关期刊和会议论文集,纳入有关奥氮平联合氟西汀(试验组)与单用氟西汀(对照组)比较治疗难治性抑郁症的随机对照试验,参照Jadad评分标准对纳入文献的方法学质量进行评估,提取有效数据,采用RevMan5.0软件进行Meta分析。结果共纳入7个研究,包括1230例患者。Meta分析结果显示:两组治疗后第1周汉密尔顿焦虑量表评分改善差异无统计学意义,治疗后第2、4、8、12周评分改善试验组优于对照组;治疗后第1、2、4、8周的汉密尔顿抑郁量表评分改善试验药比对照组有明显优势;在临床总体印象量表评分上,治疗后第2、4周的评分改善差异无统计学意义,第8、12周的变化差异有统计学意义;治疗后第1、2、4、12周的蒙哥马利和阿斯伯格抑郁症等级量表评分改善试验组较对照组有优势。合并分析结果显示,试验组临床效果优于对照组。两组不良反应差异无统计学意义[RR=1.10,95%CI(0.99,1.23)]。结论现有证据表明,奥氮平+氟西汀治疗难治性抑郁症的临床有效性和安全性显著优于单用氟西汀。

Objective To evaluate the effectiveness and safety of both olanzapine combined with fluoxetine （combination therapy） and fluoxetine （monotherapy） for refractory depression.Methods According to the computer retrieval from PubMed （1966 to September 2009）,Cochrane Library （Issue 3,2009）,EMbase （1974 to September 2009）,SCI （1974 to September 2009）,CNKI （1994 to September 2009）,CBM （1978 to September 2009）,CSJD （1989 to September 2009） and Wanfang Database （1997 to September 2009）,and the manual retrieval from related journals and conference proceedings were conducted,to include randomized controlled trials of comparison in between olanzapine combined with fluoxetine and fluoxetine in treating refractory depression.We collected the valid data after assessing the methodology quality of included studies on the basis of Jadad scoring standard,and conducted meta-analysis with RevMan 5.0 software.Results A total of 7 studies with 1 230 patients were included.The meta-analysis showed that,there was no significant difference between two groups about the scores of HAMA （Hamilton Anxiety Scale） at the end of the 1st week,but the olanzapine combined with fluoxetine in trial group was much better for relieving anxiety situation compared to fluoxetine in control group at the end of the 2nd,4th,8th and 12th week.In accordance with the scores of CGI （Clinical Global Impression Scale）,there was no significant difference at the end of 2nd and 4th week after treatment,but there was a significant difference at the end of 8th and 12th week.As to the changes of MADRS （Montgomery and Asberg Depression Rating Scale）,the trial group was much distinct than control group at the end of the 1st,2nd,4th and 8th week.In summary,the clinical effect of trial group was superior to that of control group,and there was no significant difference in adverse reactions between two groups （RR=1.10,95%CI 0.99 to 1.23）.Conclusion Current evidence shows that,the clinical effect and safety of olanzapine combined with fluoxetine in treating refractory depression is obviously superior to that of fluoxetine.