盐酸帕罗西汀肠溶缓释片治疗重性抑郁障碍的临床疗效和安全性

Efficacy and safety of enteric-coted sustained release tablets in the treatment of major depression

目的评价帕罗西汀肠溶缓释片(抗重性抑郁障碍药)治疗重性抑郁障碍的疗效和安全性。方法用随机双盲对照多中心临床研究方法,帕罗西汀肠溶缓释片组(n=209)25～62.5mg.d-1;帕罗西汀速释片组(n=209)20～50mg.d-1,疗程8周。结果帕罗西汀肠溶缓释片组和速释片组研究终点的HAMD-17评分相对基线分别下降了14.8(7.0)分和15.1(6.7)分,HAMD-17评分相对基线变化的最小二乘方均数(LSmeans)分别为-14.9分和-15.2分,组间差异(0.3分)无统计学意义(P>0.05),组间差异的95%CI(-1.0,1.6)上限小于方案所设定的非劣效界值(2.5),表明帕罗西汀肠溶缓释片治疗重性抑郁障碍非劣效于帕罗西汀速释片。因胃肠道不良事件而暂停试验或提前退出研究的比例,肠溶缓释片组患者低于速释片组(3.4%vs7.3%)。结论治疗中国重性抑郁障碍患者,帕罗西汀肠溶缓释片非劣效于帕罗西汀速释片,安全性相似,肠溶缓释片可能有更好的胃肠道耐受性。

Objective To evaluate the efficacy and safety of enteric - coted sustained release tablets paroxetine in the treatment of majors depression. Methods A randomized, double - blind, immediate - release paroxetine controlled and multicentre clinical trial was conducted. All subjects （n = 418） were randomized to receive either enteric -coted sustained release tablets paroxetine （ n = 209） or immediate - release paroxetine （n = 209） for 8 weeks. The dosage are 25 -62.5 mg · d^- 1 and 20 -50 mg · d^- 1, respectively. Results At the end point, the scores of HAMD - 17 decreased from the baseline were （ 14.8 ± 7.0） and （ 15.1 ±6. 7）, and the least square means of HAMD - 17 changes were - 14. 9 and - 15.2, respectively. There were no significance between two groups. Upper limit of 95 % CI of differences between two groups was under non - inferiority test with the criterion of 2.5 （ P = 0. 64）. The result showed non - inferiority of enteric - coted sustained release tablets paroxetine. The total adverse effects incidence rate of the two groups were not significant. Withdrawal/suspend rate due to gastrointestinal adverse effects were 3.4% and 7.3%. The enteric - coted sustained release tablets paroxetine group had lower gastrointestinal side effects. Conclusion The enteric - coted sustained release tabletsd paroxetine had similar therapeutic effects with immediaterelease paroxetine in the treatment of major depression. The enteric - coted sustained release tablets paroxetine had less gastrointestinal side effects.