文拉法辛治疗广泛性焦虑症疗效与安全性的系统评价

Systematic Review on Efficacy and Safety of Venlafaxine in the Treatment of Generalized Anxiety Disorder

目的:系统评价文拉法辛治疗广泛性焦虑症的疗效与安全性。方法:计算机检索PubMed、EMBase、the Cochrane Library、中国生物医学文献数据库、万方数据库、中国知网和维普数据库等数据库,获取文拉法辛治疗广泛性焦虑症的随机对照试验(研究组的干预措施为文拉法辛或文拉法辛缓释剂单药治疗,对照组的干预措施为其他药物单药或安慰剂治疗),检索时限均为建库至2019年10月,并追溯纳入文献的参考文献,由2名研究人员按照纳入与排除标准筛选文献、提取资料、评价质量并交叉核对后,采用RevMan 5.20软件对各项指标进行荟萃分析(Meta分析)。结果:共纳入16篇文献,包括3662例广泛性焦虑症患者。Meta分析结果显示,有效率方面,文拉法辛治疗广泛性焦虑症的有效率明显高于安慰剂,差异有统计学意义(RR=1.26,95%CI=1.07~1.49,P=0.006);文拉法辛与阳性药物的有效率相当,差异无统计学意义(RR=0.97,95%CI=0.90~1.05,P=0.5)。降低汉密尔顿焦虑量表总分方面,文拉法辛的效果明显优于安慰剂,差异有统计学意义(MD=-1.44,95%CI=-2.52^-0.36,P=0.009);文拉法辛与阳性药物的效果相当,差异无统计学意义(MD=0.06,95%CI=-0.46~0.58,P=0.81)。常见不良反应方面,除头痛发生率与安慰剂相当外,文拉法辛致失眠、口干、便秘、恶心及头晕的发生率均明显高于安慰剂,差异有统计学意义(P<0.05);文拉法辛致恶心发生率明显高于阳性药物,头晕发生率明显低于阳性药物,差异有统计学意义(P<0.05),文拉法辛致失眠、口干、便秘、呕吐和头痛的发生率与阳性药物相当,差异无统计学意义(P>0.05)。结论:文拉法辛治疗广泛性焦虑症的疗效较好,安全性较高。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量研究予以验证。

OBJECTIVE:To systematically evaluate the efficacy and safety of venlafaxine in the treatment of generalized anxiety disorder(GAD).METHODS:Database of PubMed,EMBase,the Cochrane Library,CBM,Wanfang,CNKI and VIP were retrieved for randomized controlled trials(the intervening measure of research group was venlafaxine or venlafaxine sustained-release for single-drug therapy,the intervening measure of control group was other drugs or placebo for treatment)on venlafaxine in the treatment of GAD,the searching time limited from base-building to Oct.2019,and the references of involved studies were retrospected.After two researchers conducted literature screening,data extraction,quality evaluation and cross-check according to the inclusion and exclusion criteria,RevMan 5.20 was adopted to carry out Meta-analysis on various indicators.RESULTS:Totally 16 studies were involved,including 3662 patients with GAD.Results of Meta-analysis indicated in terms of effective rate,venlafaxine in the treatment of GAD was significantly higher than that of the placebo,with statistically significant difference(RR=1.26,95%CI=1.07-1.49,P=0.006);venlafaxine had same effective rate as positive drugs,and the difference had no statistical significance(RR=0.97,95%CI=0.90-1.05,P=0.5).In terms of reducing HAMA score,venlafaxine had significantly better effect than placebo,with statistically significant difference(MD=-1.44,95%CI=-2.52--0.36,P=0.009);venlafaxine had same effect as positive drugs,and the difference had no statistical significance(MD=0.06,95%CI=-0.46-0.58,P=0.81).In terms of common adverse drug reactions,except for same incidence of headache,the incidences of insomnia,thirsty,constipation,nausea and dizziness caused by venlafaxine were significantly higher than those of placebo,with statistically significant differences(P<0.05);the incidence of nausea caused by venlafaxine was significantly higher than that of positive drugs,and the incidence of dizziness was significantly lower than that of positive drugs,with statistically significant differences(P<0.05),the incidences of insomnia,thirsty,constipation,vomiting and headache caused by venlafaxine were equivalent to those of positive drugs,the differences had no statistical significance(P>0.05).CONCLUSIONS:The efficacy of venlafaxine in the treatment of GAD is remarkable,with high safety.Limited by the number and quality of involved studies,the above conclusions still need to be verified by more high-quality studies.