艾司氯胺酮治疗难治性抑郁症的有效性和安全性的系统综述及Meta分析

Systematic Review and Meta-analysis of Efficacy and Safety of Esketamine in Treatment-Resistant Depression Patients

目的评价艾司氯胺酮治疗难治性抑郁症的疗效与安全性。方法检索国内外数据库中有关艾司氯胺酮治疗难治性抑郁患者的随机对照试验(RCT),试验组给予艾司氯胺酮或艾司氯胺酮联合口服抗抑郁药物治疗,对照组为安慰剂或安慰剂联合口服抗抑郁药物治疗,运用统计软件RevMan 5.4.1进行Meta分析。结果根据入排标准最终纳入7项随机对照试验,共1067例患者。数据分析结果表明艾司氯胺酮显著降低难治性抑郁症患者蒙哥马利抑郁评定量表(MADRS)评分,治疗后7 d内及8~28 d试验组与对照组间差异具有统计学意义(P<0.05)。相比安慰剂组,艾司氯胺酮组显著增加治疗7 d内和8~28 d难治性抑郁患者临床有效率及缓解率(P<0.05)。艾司氯胺酮组比安慰剂组更容易发生头晕、感觉异常、分离、呕吐、眩晕、血压升高、恶心、嗜睡及头痛等不良反应。结论Meta分析结果显示艾司氯胺酮能够改善难治性抑郁患者抑郁症状,与安慰剂组相比,艾司氯胺酮组更易发生不良反应,多为轻至中度。

OBJECTIVE To evaluate the efficacy and safety of esketamine in the treatment of Treatment-Resistant Depression.METHODS The randomized controlled trials(RCTs)of esketamine in the treatment of treatment-resistant depression were collected from PubMed,CNKI,and other databases.The experimental group was treated with esketamine or esketamine combined with oral antidepressants,and the control group was treated with a placebo or placebo combined with oral antidepressants.Meta-analysis was performed using the statistical software RevMan 5.4.1.RESULTS According to the inclusion criteria,seven randomized controlled trials with 1067 patients were finally included.The results of the meta-analysis showed that the experimental group was more effective in reducing the scores of the Montgomery-Asberg Depression Rating Scale(MADRS),with significant dfferences between the experimentaland control groups both within 7 days and 8 to 28 days after treatment(P<0.05).Compared with the placebo group,esketamine significantly increased the rate of response and remission in treatment-resistant depression patients within 7 days and 8 to 28 days after treatment(P<0.05).Patients in the esketamine group were more likely to experience adverse effects such as vertigo,paresthesia,dissociation,vomiting,dizziness,increased blood pressure,nausea,somnolence,and headache.CONCLUSION The results of this meta-analysis support the efficacy and safety of esketamine as an augmentation option for patients with treatment-resistant depression,and the esketamine group was more likely to have adverse reactions than the placebo group,and most of the adverse reactions were mild to moderate.