阿立哌唑与利培酮治疗麻谷丸所致精神障碍的疗效及安全性

Study on clinical efficacy and safety of aripiprazole versus risperidal in the treatment of Ma-gu pill induced psychiatric disorder

目的:评价阿立哌唑治疗麻谷丸所致精神障碍的疗效以及安全性。方法:采用随机、平行对照方法将107例麻谷丸所致精神障碍患者分别以阿立哌唑(n=54)和利培酮治疗(n=53),疗程4周,分别于治疗前和治疗后第1、2、4周末以简明精神病评定量表(BPRS)、临床疗效总评量表(CGI)评价疗效,治疗中出现的症状量表(TESS)评定其不良反应。结果:阿立哌唑治疗组总有效率为90.7%(49/54),利培酮组总有效率为90.6%(48/53),两组疗效差异无统计学意义(χ2=0.975,P>0.05)。治疗后阿立哌唑组中焦虑抑郁和缺乏活力因子分均显著低于利培酮组(P<0.05),而思维障碍和敌对猜疑因子分显著高于利培酮组(t=2.30,P=0.023;t=1.98,P=0.050)。阿立哌唑组不良事件发生率为55.6%(30/54),利培酮组为79.2%(42/53),两组差异有统计学意义(χ2=6.820,P=0.009)。结论:阿立哌唑和利培酮治疗麻谷丸所致精神障碍均有效,但阿立哌唑组能明显改善焦虑抑郁情绪,并提高内动力,且不良反应较少,安全性好。

Objective： To evaluate the efficacy and safety of aripiprazole in the treatment of patients who met CCMD-Ⅲ Ma-gu pill induced psychiatric disorder. Method：A randomized, controlled clinical trial was conducted. All 107 patients received 4 weeks treatment with either aripiprazole （ n = 54 ） or risperidal （ n = 53 ）. At baseline and the end of weeks 1,2, and 4, the main efficacy measures were the changes in total scores of Brief Psychiatric Rating Scale （BPRS） , Clinical Global Impressions scale （ CGI）, while the adverse reactions were appraised with the Treatment Emergent Side Effect Scale （TESS）. Results：The clincial response rates were 90.7% and 90.6% respectively in aripiprazole and risperidal group,with no significant differences. There were more adverse effects in risperidal group than in aripiprazole group. Conclusion：The results showed that aripi- prazole and risperidal of orally disintegrating tabletsin have similar therapeutic effect in the treatment of Ma-gu pill induced psychiatric disorder, but aripiprazole has better tolerability.