沃替西汀治疗重度抑郁症的Meta分析

Vortioxetine for major depressive disorder: a systematic review and meta-analysis of randomized controlled trials

目的:通过Meta分析方法,系统评价沃替西汀治疗重度抑郁症(major depressive disorder,MDD)的有效性和安全性。方法:通过检索Pubmed、Clinical trials等数据库,筛选获得沃替西汀治疗MDD的随机对照临床试验(randomized controlled trials,RCTs),应用Rev Man 5.3软件进行统计分析。结果:与安慰剂相比,5 mg和10mg沃替西汀可显著增加治疗前后的蒙哥马利抑郁评价量表(Montgomery-sberg Depression Rating Scale,MADRS)平均改变量(WMD=-2.59,P=0.002;WMD=-3.47,P=0.000 3),提高治疗的有效率(OR=1.76,P=0.006;OR=2.18,P=0.005),增加总体不良反应率(OR=1.28,P=0.008;OR=1.33,P=0.01),提示沃替西汀的疗效明显优于安慰剂,但不良反应发生率亦增高。与阳性药度洛西汀相比,5 mg沃替西汀治疗后的MADRS平均改变量(P=0.43)和有效率(P=0.10)无统计学差异;但总体不良反应率显著降低(OR=0.52,P<0.000 1),提示5 mg沃替西汀的疗效与阳性药物度洛西汀相当,但不良反应发生率明显低于度洛西汀。结论:沃替西汀治疗MDD疗效确切,安全性较好。

AIM： To systematically review the therapeutic efficacy and safety of vortioxetine in trea- ting major depressive disorder（MDD） with an upda- ted meta-analysis. METHODS： The databases of Pubmed and Clinical trials were searched to obtain the randomized controlled trials （RCTs） of vortioxe- tine in treating MDD. Data were synthesized using RevMan 5.3 software provided by the Cochrane Col- laboration. RESULTS ： Compared with placebo, 5 mg and 10 mg vortioxetine could significantly in- crease the Montgomery-Asberg Depression Rating Scale （MADRS） mean changes （ WMD = - 2.59, P =0.002; WMD= -3.47, P=0.0003）, the responder rate （ OR = 1.76, P = 0. 006 ; OR = 2.18, P = 0. 005 ） and the rate of overall adverse events （OR=1.28, P =0.008; 0R=1.33, P=0.01）, suggesting better effectiveness but higher rate of ad- verse event of vortioxetine. There were no statistical- ly significant differences between vortioxetine （5 rag） and positive drug duloxetine （60 mg ） on MADRS mean changes （ P = 0.43 ） and responder rate （P = 0.10） , while the rate of overall adverse e- vents of 5 mg vortioxetine was much lower （ OR = 0.52, P 〈 0. 000 1 ）. CONCLUSION： Vortioxe- tine is effective and relatively safe for the treatment of MDD.