小剂量氨磺必利联合帕罗西汀治疗强迫症的临床随机对照双盲研究

Clinical Randomized Bouble-blind Observation on Small Dose of Amisulpiride Combined with Paroxetine in the Treatment of Obsessive-compulsive Disorder

目的:探讨小剂量氨磺必利联合帕罗西汀治疗强迫症的疗效与安全性。方法:120例强迫症患者随机分入观察组(n=60)和对照组(n=60),观察组予帕罗西汀+小剂量氨磺必利、对照组予帕罗西汀+安慰剂,治疗12周。采用耶鲁-布朗强迫量表(YBOCS)和副反应量表(TESS)分别评定临床疗效和不良反应。结果:在治疗后第4、8、12周末,观察组临床疗效均优于对照组(P<0.05)。两组治疗后YBOCS评分均较治疗前明显下降(P<0.01),且观察组评分值均明显低于对照组同期(P<0.01)。两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:小剂量氨磺必利联合帕罗西汀治疗强迫症可明显提高疗效,不增加不良反应。

Objective： To explore the efficacy and safety of small dose of amisulpiride combined with paroxetine in the treatment of obsessive-compulsive disorder. Methods ：120 patients with obsessive-compulsive disorder were randomly assigned to observation group and control group. Each group had 60 cases. The patients in the observation group were treated with paroxetine and small dose of amisupiride while the patients in the control group treated with paroxetine and placebo for 12 weeks. The Yale-Brown obsessive-compulsive scale （YBOCS）and Treatment Emergent Symptom Scale（TESS） were used to evaluate the efficacy and adverse drug reaction respectively. Results：In the end of the 4th, 8th,12th week after the treatment, the clinical efficacy in the observation group was significantly better than that in the control group （P 〈 0.05）. The scores of YBOCS after treatment were significantly lower than those before in the both groups （ P 〈 0.01 ）. And the score value of observation group were significantly lower than control group in the same period （P 〈 0.01 ）. There was no significant difference between both groups in the rate of adverse drug reaction （ P 〉 0.05 ）. Conclusion： Small doses of amisulpiride cooperating with paroxetine could significantly improve the efficacy in the treatment of the obsessive-compulsive disorder. It didn＇ t increase the adverse drug reactions.