盐酸度洛西汀肠溶片与帕罗西汀治疗重性抑郁障碍的多中心、随机、双盲、平行对照研究

发布时间：2018-06-30 01:20

本文选题：盐酸度洛西汀肠溶片 + 盐酸帕罗西汀　；参考：《中国新药杂志》2014年23期

【摘要】：目的:评价盐酸度洛西汀肠溶片治疗重性抑郁障碍的临床有效性和安全性。方法:采用为期6周的多中心、随机、双盲、阳性药平行对照临床试验。按1∶1的比例将281例重性抑郁障碍患者随机分入盐酸度洛西汀肠溶片(140例,60 mg·d-1),盐酸帕罗西汀片(141例,20 mg·d-1),观察疗程均为6周。主要疗效指标为治疗第6周末汉密尔顿抑郁量表总分的变化。以临床有效率、临床缓解率、临床总体印象量表、汉密尔顿焦虑量表为次要疗效指标。结果:经药物治疗6周后两组的汉密尔顿抑郁量表总评分均明显下降,盐酸度洛西汀肠溶片组相对基线平均降低了13.79;盐酸帕罗西汀片组相对基线平均降低了12.02。两组治疗后相对基线变化有统计学意义(P0.05),且两组相对基线变化的差值及其95%可信区间为-1.87(-3.37,-0.37)。治疗6周后两组的临床缓解率和汉密尔顿焦虑量表评分的差异均无统计学意义(P0.05)。试验组、对照组的临床有效率和临床总体印象量表评分差异有统计学意义(P0.05)。试验组发生不良事件多为轻中度,常见的不良反应有:恶心、口干、呕吐、食欲下降、头晕。结论:1盐酸度洛西汀肠溶片对重性抑郁障碍治疗6周的疗效显著。2试验药物盐酸度洛西汀肠溶片治疗重性抑郁障碍的疗效非劣于对照药物盐酸帕罗西汀片。3治疗重性抑郁障碍中,盐酸度洛西汀肠溶片的安全性和耐受性良好。
[Abstract]:Objective: to evaluate the efficacy and safety of doxetine hydrochloride enteric-coated tablets in the treatment of severe depressive disorder. Methods: a 6-week multicenter, randomized, double-blind, positive drug parallel controlled clinical trial was conducted. At 1:1, 281 patients with severe depressive disorder were randomly divided into doxetine hydrochloride enteric-coated tablets (140 cases) and paroxetine hydrochloride tablets (141 cases) 20 mg d ~ (-1). The course of treatment was 6 weeks. The main outcome measure was the change of the total score of Hamilton Depression scale at the end of 6 th week. The clinical effective rate, clinical remission rate, clinical overall impression scale and Hamilton anxiety scale were taken as the secondary therapeutic indicators. Results: after 6 weeks of drug therapy, the total scores of Hamilton depression scale in both groups were significantly decreased, the relative baseline of doxetine hydrochloride enteric-coated tablets group was 13.79, and the relative baseline of paroxetine hydrochloride group was 12.02. There was statistical significance in the changes of relative baseline between the two groups after treatment (P0.05), and the difference between the two groups and its 95% confidence interval was -1.87 (-3.37 卤0.37). There was no significant difference in clinical remission rate and Hamilton anxiety scale score between the two groups after 6 weeks of treatment (P0.05). In the experimental group and control group, there were significant differences in the clinical effective rate and the clinical overall impression scale (P0.05). The adverse events in the trial group were mostly mild and moderate. The common adverse reactions were nausea, dry mouth, vomiting, decreased appetite and dizziness. Conclusion the therapeutic effect of Duloxetine hydrochloride enteric-coated tablet on major depressive disorder is significant in 6 weeks. 2 the therapeutic effect of doxetine hydrochloride enteric-coated tablet is not inferior to that of paroxetine hydrochloride tablet in treatment of severe depressive disorder in 6 weeks. 2 the therapeutic effect of doloxetine hydrochloride enteric-coated tablet is not inferior to that of paroxetine hydrochloride tablet. In major depressive disorders, Doloxetine hydrochloride enteric-coated tablets are safe and well tolerated.
【作者单位】：卫生部精神卫生学重点实验室(北京大学);北京市回龙观医院;四川大学华西医院;西安市精神卫生中心;河北省精神卫生中心;山西医科大学第一医院;
【分类号】：R749.4

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