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

Duloxetine hydrochloride enteric tablets in the treatment of major depressive disorder:a multicenter,randomized,double-blind,and positive drug parallel controlled clinical trial

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(P<0.05),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(P>0.05)。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(P<0.05)。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。

Objective： To evaluate the efficacy and safety of duloxetine hydrochloride enteric tablets in the treatment of major depressive disorder. Methods： A total of 281 patients with major depressive disorder were randomly divided into 2 groups, and treated with duloxetine hydrochloride enteric tablets （n = 140） or paroxetine hydrochloride tablets （n = 141） in a 6 weeks, multicenter, double-blind, parallel-group study. The primary effica-Chinese Journal of New Drugs 2014,23（23） cy measure was the total score changes of the 17-item Hamiltons Depression Scale （HAMD）. Clinical response rate, clinical remission rate, Clinical Global Impression （CGI） and Hamilton anxiety scale （HAMA） were adopted as secondary efficacy measures. Results： Both groups demonstrated a significant improvement in HAMD score （P 〈 0. 001 ）. The mean decrease of total HAMD score was 13.79 at end point in duloxetine group, and 12.02 in paroxetine group. There was statistically significant difference between the two groups （P 〈 0.05） after 6-week treatment, with a change of - 1.87 points （95% CI - 3.37, - 0.37）. The clinical remission rate and HAMA showed no significant difference, but the clinical response rate and CGI showed statistical differences （P 〈 0.05） between two groups. Most adverse events were mild to moderate, including nausea, dry mouth, vomiting, loss of appetite and dizziness. Conclusion：① Duloxetine hydrochloride enteric tablets are efficacious for the six-week treatment of major depressive disorder. ② The efficacy of duloxetine hydrochloride enteric tablets in major depressive disorder is not inferior to the control drug paroxetine hydrochloride tablets. ③During the treatment of major depressive disorder, duloxetine hydrochloride enteric tablets are well tolerated and safe.