小剂量氨磺必利配合氯氮平治疗难治性精神分裂症

Amisulpiride at low Dosage Combined with Clozapine in the Treatment of Refractory Schizophrenia

目的:探讨小剂量氨磺必利配合氯氮平治疗难治性精神分裂症的疗效与安全性。方法:160例难治性精神分裂症患者随机分为观察组和对照组各80例。观察组予氯氮平+氨磺必利、对照组予氯氮平+安慰剂,治疗12周。用阳性和阴性症状量表(PANSS)和副反应量表(TESS)分别评定两组临床疗效和药品不良反应。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PANSS各因子积分和总分均较治疗前下降(P<0.01),但观察组减分幅度均大于对照组(P<0.05或P<0.01)。两组药品不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:小剂量氨磺必利配合氯氮平治疗难治性精神分裂症可显著提高疗效,且不增加不良反应。

Objective： To explore the efficacy and safety of amisulpiride at low dosage combined with clozapine in the treatment of refractory schizophrenia. Methods： Totally 160 patients with refractory schizophrenia were chosen from the psychiatric department of 4 hospitals during January to September in 2014 and randomly divided into the observation group and the control group with 80 cases in each. The patients were treated with clozapine plus amisupiride or clozapine plus placebo for 12 weeks. The positive and negative syndrome scale （PANSS） and treatment emergent side effect scale （TESS） was used to respectively evaluate the efficacy and the adverse effects. Results ： At the weekend of the 4th, 8th and 12th week after the treatment, the clinical efficacy in the observation group was sig- nificantly better than that in the control group （ all P 〈 0.05 ）. The total and every factors scores of PANSS after the treatment were sig- nificantly lower than those before the treatment in both groups （ P 〈 0.01 ） , and the decrease in the observation group was more significant than that in the control group （P 〈 0.05 or P 〈 0.01 ）. There was no significant difference in the incidence of adverse effects between the two groups （ P 〉 0.05 ）. Conclusion ： Amisulpiride at low dosage combined with clozapine can significantly improve the efficacy in the treatment of refractory schizophrenia without added adverse effects.