帕罗西汀与氯米帕明治疗强迫症的多中心、随机、双盲、平行对照研究

Comparison study of paroxetine and clomipramine in treatment of obsessive-compulsive disorder:a multicentre parallel randomized double-blind study

目的 比较帕罗西汀和氯米帕明治疗强迫症的疗效和安全性。方法 14 1例符合美国精神障碍诊断与统计手册第 4版强迫症诊断标准的患者完成了研究 ,其中帕罗西汀治疗 72例 (帕罗西汀组 ) ,氯米帕明治疗 6 9例 (氯米帕明组 ) ,疗程均为 10周。所有患者在入组前均服用安慰剂 1周。帕罗西汀组第 1周 2 0mg/d ;第 2周 30mg/d ;第 3周 4 0mg/d ;第 4～ 10周低剂量组 4 0mg/d ,高剂量组5 0mg/d。氯米帕明组第 1周 5 0mg/d ;第 2周 10 0mg/d ;第 3周 15 0mg/d ,第 4～ 10周低剂量组 15 0mg/d ,高剂量组 2 0 0mg/d。结果 帕罗西汀组痊愈率为 2 1% ,显效率为 6 0 % ,总有效率为 93%。氯米帕明组痊愈率为 2 8% ,显效率为 5 7% ,总有效率为 90 %。两组患者疗效的差异无显著性。帕罗西汀组不良反应发生率为 18% ,氯米帕明组不良反应发生率为 4 3% ,两组的差异有显著性 (χ2 =10 .5 4 ,P =0 .0 0 )。结论 帕罗西汀治疗强迫症的疗效与氯米帕明相当 ,但不良反应比帕罗西汀少而轻。

Objective To compare the efficacy and tolerability of paroxetine and clomipramine in treating patients with obsessive-compulsive disorder (OCD). Methods The study was a multicentre parallel randomized double-blind clinical trial. Three centers participated in this trial,with 73 patients receiving paroxetine and 73 receiving clomipramine treatment for 10 weeks. The diagnosis of OCD was made according to the 4 th edition of Diagnostic statistical Manual of Mental Disorder criteria. Results Five of the 146 cases dropped out,with 1 in paroxetine group,4 in clomipramine group. The patients in both groups showed significant improvement of obsessive-compulsive symptomatology according to the Yale-Brown Obsessive-Compulsive Scale score. The clinical recovery rates were 21% and 28% with total improved rates of 93% and 90%,respectively. Concerning tolerability,there were significantly higher adverse reactions in the clomipramine group,with adverse event incidence of 43% in comparison with 18% in paroxetine. Conclusions The results show that paroxetine and clomipramine have similar efficacy in treatment of patients with OCD,but paroxetine has better toleration.