目的 系统评价帕罗西汀联合奥氮平与单用帕罗西汀对我国抑郁症合并睡眠障碍患者临床疗效的影响.方法 计算机检索PubMed、Embase、Cochrane Library、CINAHL、SinoMed、CNKI、VIP、WanFang Data 数据库、SUMsearch 和 Google 搜索引擎,搜集关于帕罗西汀联合奥氮平对比单用帕罗西汀治疗我国抑郁症合并睡眠障碍患者的随机对照试验(RCT),检索时限均从建库至2023年4月3日.由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.3软件进行Meta分析.结果 共纳入70个RCT,包含5 683例患者.Meta分析结果显示,①试验组患者的总有效率显著高于对照组[OR=5.98,95%CI(4.51,7.94),P<0.001];②试验组患者的匹兹堡睡眠质量指数评分在治疗后1个月[MD=-2.81,95%CI(-3.24,-2.38),P<0.001]、2个月[MD=-2.41,95%CI(-3.13,-1.70),P<0.001]、3 个月[MD=-2.80,95%CI(-3.18,-2.42),P<0.001]和 6 个月[MD=-1.65,95%CI(-1.83,-1.48),P<0.001]均显著低于对照组;③试验组患者的汉密尔顿抑郁量表评分在治疗后1个月[MD=-5.79,95%CI(-6.63,-4.95),P<0.001]、2 个月[MD=-4.33,95%CI(-5.45,-3.21),P<0.001]、3 个月[MD=-3.76,95%CI(-4.17,-3.34),P<0.001]和 6 个月[MD=-3.38,95%CI(-3.60,-3.15),P<0.001]均显著低于对照组;④试验组患者的汉密尔顿焦虑量表评分显著低于对照组[MD=-3.47,95%CI(-3.78,-3.16),P<0.001].结论 当前证据显示,与单用帕罗西汀相比,帕罗西汀联合奥氮平能提高我国抑郁症合并睡眠障碍患者临床治疗的总有效率,改善治疗后1个月、2个月、3个月、6个月的睡眠质量和抑郁症状,且降低焦虑情绪.受纳入研究数量和质量限制,上述结论尚需更多高质量研究予以验证.
Clinical efficacy of paroxetine combined with olanzapine among Chinese patients with depression complicated with sleep disorders:a Meta-analysis
Objective To systematically review the clinical efficacy of paroxetine plus olanzapine versus paroxetine alone among depression complicated with sleep disorder patients in China.Methods PubMed,Embase,Cochrane Library,CINAHL,SinoMed,CNKI,VIP,WanFang Data databases,SUMsearch and Google search engine were electronically searched to collect randomized controlled trials(RCTs)of paroxetine plus olanzapine versus paroxetine in the treatment of depression complicated with sleep disorder Chinese patients from inception to April 3,2023.Two researchers independently screened the literature,extracted data and evaluated the risk of bias of the included studies,and the Meta-analysis was then performed by using RevMan 5.3 software.Results A total of 70 RCTs involving 5 683 patients were included.The results of Meta-analysis showed that:(1)the total effective rate in experimental group was significantly higher than that of the control group(OR=5.98,95%CI 4.51 to 7.94,P<0.001);(2)Pittsburgh sleep quality index scores after treatment in the first month(MD=-2.81,95%CI-3.24 to-2.38,P<0.001),in 2 months(MD=-2.41,95%CI-3.13 to-1.70,P<0.001),in 3 months(MD=-2.80,95%CI-3.18 to-2.42,P<0.001)and in 6 months(MD=-1.65,95%CI-1.83 to-1.48,P<0.001)in experimental group were significantly lower than the control group;(3)Hamilton depression scale scores after treatment in the first month(MD=-5.79,95%CI-6.63 to-4.95,P<0.001),in 2 months(MD=-4.33,95%CI-5.45 to-3.21,P<0.001),in 3 months(MD=-3.76,95%CI-4.17 to-3.34,P<0.001)and in 6 months(MD=-3.38,95%CI-3.60 to-3.15,P<0.001)in experimental group were significantly lower than the control group;(4)Hamilton anxiety scale scores in experimental group were significantly lower than the control group(MD=-3.47,95%CI-3.78 to-3.16,P<0.001).Conclusion Current evidence shows that,compared with the paroxetine alone in the treatment of depression complicated with sleep disorder patients in China,paroxetine plus olanzapine can effectively increase patients'total effective rate of clinical treatment,improve the sleep quality and depression symptoms in 1 month,2 months,3 months and 6 months after treatment,and also reduce patients'anxiety.Due to limited quality and quantity of the included studies,more high-quality studies are required to verify above conclusions.