度洛西汀联合碳酸锂缓释片治疗疗效不佳的抑郁症患者疗效

Clinical study of duloxetine combined with lithium carbonate sustained-release tablets in treating depression with poor efficacy

目的:评估度洛西汀联合碳酸锂缓释片治疗疗效不佳抑郁症患者的疗效和安全性。方法:根据DSM-5抑郁症诊断标准,本研究纳入了80例度洛西汀单药治疗4周后疗效不佳的门诊抑郁症患者,随机分为两组,度洛西汀单药治疗为对照组,度洛西汀联合碳酸锂缓释片治疗为研究组,继续治疗4周,使用汉密尔顿抑郁量表17项(HAMD-17)、汉密尔顿焦虑量表(HAMA)、临床疗效总评量表(CGI-S)、健康状况调查问卷(SF-36)及蒙特利尔认知评估量表(MOCA)分别于分组后的基线及第4周末评估临床疗效;通过药物不良反应、实验室检查、心电图等评估治疗的安全性。结果:共75例完成了分组后的临床研究,脱落5例,分组治疗4周后,研究组有效率明显优于对照组(χ^2=6.04,P<0.05);两组汉密尔顿抑郁量表17项(t=4.63,P<0.01)、汉密尔顿焦虑量表(t=3.32,P<0.01)、临床疗效总评量表(t=2.95,P<0.01)、蒙特利尔认知评估量表(t=-3.50,P<0.01)评分具有统计学差异,健康状况调查问卷(SF-36)量表中的躯体职能(PF)(t=-22.72,P<0.01)、躯体健康问题导致的角色受限(RP)(t=-12.28,P<0.01)生命活力(VT)(t=-5.26,P<0.01)、社交功能(SF)(t=-3.28,P<0.01)及情感问题所致的角色受限(RE)(t=-2.63,P<0.05)的评分,两组间具有统计学差异;研究组体重增加高于对照组(χ^2=4.08,P<0.05)。结论:度洛西汀联合碳酸锂缓释片治疗疗效不佳的抑郁症,效果优于单用度洛西汀,安全可靠,但需要注意对体重的影响。

Objective:To evaluate the efficacy and safety of duloxetine combined with lithium carbonate sustained-release tablets in the treatment of depression patients with poor efficacy.Methods:According to the DSM-5 Diagnostic criteria for depression,this study included 80 outpatients with depression with poor efficacy after 4 weeks of duloxetine monotherapy,who were randomly divided into two groups:The control group with duloxetine monotherapy and the study group treated with duloxetine combined with lithium carbonate sustained-release tablets,continue treatment for 4 weeks.To evaluate the clinical efficacy by using the 17 items of Hamilton Depression Scale(HAMD-17),Hamilton Anxiety Scale(HAMA),The Clinical Global Impression Scale-Severity(CGI-S),36-Item short-form health survey(SF-36)and Montreal cognitive assessment(MOCA)at the baseline and 4 th weekend after grouping;the safety of treatment was evaluated by adverse drug reactions,laboratory tests,electrocardiogram,etc.Results:In total,75 cases completed the clinical study after grouping,and 5 cases dropped out.The response rate in study group was significantly higher than that in the control group(χ^2=6.04,P<0.05)after 4-week treatment.The scores of 17 items of Hamilton Depression Scale(t=4.63,P<0.01),Hamilton Anxiety Scale(t=3.32,P<0.01),The clinical global impression scale-severity(t=2.95,P<0.01)and Montreal cognitive assessment(t=-3.50,P<0.01)between two groups was statistically different.The subscales of 36-item short-form health survey(SF-36)included physical functioning(PF)(t=-22.72,P<0.01),role limitations due to physical health(RP)(t=-12.28,P<0.01),vitality(VT)(t=-5.26,P<0.01),social function(SF)(t=-3.28,P<0.01),and role limitations due to emotional problems(RE)(t=-2.63,P<0.05),and the score differences between two groups were of statistical significance;the weight gain in the study group was higher than that in the control group(χ^2=4.08,P<0.05).Conclusion:Duloxetine combined with lithium carbonate sustained-release tablets in the treatment of depression with poor efficacy is better than duloxetine monotherapy,safe and reliable,but attention should be paid to weight gain.