国产与进口度洛西汀治疗抑郁症的临床疗效与安全性比较

目的:比较国产与进口度洛西汀治疗抑郁症的临床疗效和安全性。方法:入组门诊和住院抑郁症患者共81例,随机分为国产度洛西汀组(n=41)和进口度洛西汀组(n=40),两组的有效剂量均为60mg·d-1,疗程为6周。于基线及服药第1,24,和6周末,采用汉密尔顿抑郁量表(HAMD-17)、汉密尔顿焦虑量表(HAMA)和临床总体印象量表-病情严重程度(CGI-S)评定疗效,用副反应量表(TESS)评定不良反应。结果:治疗第6周末,国产与进口度洛西汀组HAMD-17总减分率分别为(67.4±11.8)%和(67.6±11.3)%;HAMA总减分率分别为(65.7±10.5)%和(65.6±10.4)%,两组间差异均无显著性。国产度洛西汀组减分率为74%,有效率为89%;进口度洛西汀组减分率为76%,有效率为89%,两组间疗效差异无显著性。国产与进口度洛西汀组不良反应发生率分别为31.5%和28.9%。两组的不良反应轻微,安全性好,常见不良反应有恶心、口干、便秘、食欲下降和头昏等。结论:国产度洛西汀的抗抑郁作用疗效肯定,使用安全,与进口度洛西汀疗效相当。

Comparison of the clinical efficacy and safety of domestic duloxetine with imported duloxetine in treating depression

Objective: To evaluate the efficacy and safety of domestic and imported duloxetine in the treatment of depression.Methods: In this 6-week randomized study,81 patients diagnosed with depression were divided randomly into domestic group(n=41) and imported group(n=40).The effective dose was 60 mg·d-1 for both groups.The efficacy and safety were assessed with Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity of Illness(CGI-S) and Treatment Emergent Symptom Score(TESS) at baseline and week 1,2,4,6 of treatment,respectively.Results: The decreasing rate on HAMD-17 in the domestic duloxetine group was(67.4±11.8)% and that of the imported duloxetine group was(67.6±11.3)%,the decreasing rate on HAMA in the domestic duloxetine group was(65.7±10.5)% and that of the imported duloxetine group was(65.6±10.4) %,and reduction rate and effective rate of domestic and imported group were 74% and 89%,76% and 89%,respectively.The clinical efficacy of the two groups showed no significant difference.No severe side-effects were observed.The incidences of adverse reactions in the domestic and imported duloxetine group were 31.5% and 28.9%,respectively.The common adverse reactions of duloxetine were nausea,thirsty,constipation,appetite decrease,etc.Conclusion: Domestic duloxetine is as effective and safe as imported duloxetine in the treatment of depression.