甘麦大枣汤治疗抑郁症疗效与安全性的系统评价

Efficacy and Safety of Ganmai Dazao Tang for Depression

目的:评价甘麦大枣汤与抗抑郁剂比较治疗抑郁症的临床疗效和安全性。方法:计算机检索EMBASE,Pub Med,The Cochrane Library,CNKI,Wan Fang Data,CBM,VIP数据库,全面收集甘麦大枣汤与抗抑郁剂比较治疗抑郁症随机对照试验,由两位研究者独立筛选文献、提取资料和质量评价后,采用Rev Man 5.2软件进行Meta分析。结果:共纳入14个随机对照试验,1 105例患者。Meta分析结果显示:甘麦大枣汤联合抗抑郁剂组较之单用抗抑郁剂组能显著降低HAMD评分[MD=-3.46,95%CI(-4.66,-2.26),P<0.000 01],单用甘麦大枣汤组降低HAMD评分与抗抑郁剂组相当[MD=-0.98,95%CI(-2.59,0.63),P=0.23];两组在总有效率方面疗效相当。所有纳入的研究中均无严重毒副作用报道,但7个研究的不良反应事件[RR=0.16,95%CI(0.09,0.30),P<0.000 01]与2个研究的TESS评分[MD=-8.2,95%CI(-9.69,-7.74),P<0.000 01]的Meta分析显示甘麦大枣汤较之抗抑郁剂毒副作用小。结论:目前证据表明甘麦大枣汤治疗抑郁症是有效而且安全的。因纳入研究质量普遍较低,尚需更多高质量的随机对照试验结果来验证。

Objective： To assess and compare the efficacy and safety of Ganmai Dazao Tang（ GMDZD）and antidepressants for depression. Method： The randomized controlled trials（ RCTs） about GMDZD for depression were searched in the databases of EMBASE, Pub Med, The Cochrane Library, China National Knowledge Infrastructure,Wanfang Data,Chinese Biomedical Literature Database,and VIP Information. Two reviewers independently screened the literatures,extracted the data,and evaluated the methodological quality.Meta-analyses were performed by using Rev Man 5. 2 software. Result： A total of 14 RCTs involving 1 105 cases were included. Meta-analyses suggested that compared with simple administration with antidepressants,GMDZD combined with antidepressants showed a significantly greater reduction in HAMD scores [MD =- 3. 46,95% CI（- 4. 66,- 2. 26）,P〈0. 000 01]. There was no significant difference in HAMD scores between the simple administration with GMDZD and antidepressants [MD =- 0. 98,95% CI（- 2. 59,0. 63）,P = 0. 23]. GMDZD group was comparable with antidepressants group in the total effective rate. No serious adverse events were reported in all of the included trials. Pooled analyses of adverse events in 7 trials [RR = 0. 16,95% CI（ 0. 09,0. 30）,P〈0. 000 01]and TESS scores of 2 trials [MD =- 8. 2,95% CI（- 9. 69,- 7. 74）,P〈0. 000 01]suggested that GMDZD group had less adverse effects compared with antidepressants group. Conclusion： The present evidence suggests that GMDZD was effective and safe for patients with depression. However,due to the low quality of trials included,more high-quality RCTs are required to verify the results.