氨磺必利与氟哌啶醇治疗精神分裂症对照研究

A control study of amisulpride vs haloperidol in the treatment of schizophrenia

目的 探讨氨磺必利与氟哌啶醇治疗精神分裂症的临床疗效和安全性.方法 将78例精神分裂症患者随机分为两组,研究组38例,口服氨磺必利治疗,对照组40例,口服氟哌啶醇治疗.观察8周.于治疗前及治疗第2周、4周、8周末,采用阳性与阴性症状量表评定临床疗效,副反应量表评定不良反应.结果 治疗后两组阳性与阴性症状量表总分及各因子分均较治疗前显著下降（P＜0.05或0.01）;治疗8周末,研究组显效率76.3%、有效率89.5%,对照组分别为72.5%、85.0%,两组差异无显著性（χ2=0.15、0.35,P＞0.05）.研究组不良反应发生率为47.4%,对照组为52.5%,两组比较差异无显著性（χ2=0.21,P＞0.05）,但研究组失眠、恶心呕吐、内分泌改变发生率均显著高于对照组（P＜0.05或0.01）,锥体外系反应发生率显著低于对照组（P＜0.01）,且未出现嗜睡、心动过速、体质量增加不良反应（P＜0.05）.结论 氨磺必利治疗精神分裂症疗效显著,总体疗效与氟哌啶醇相当,但不良反应表现有所不同.

Objective To explore the efficacy and safety of amisulpride vs haloperidol in the treatment of schizophrenia. Methods Seventy-eight schizophrenics were randomly assigned to research group（n= 38） taking orally amisulpride control group （n=40） did haloperidol for 8 weeks. Efficacies were assessed with the Positive and Negative Syndrome Scale （ PANSS ） and adverse reactions with the Treatment Emergent Symptom Scale （TESS） at baseline and at the end of the 2nd, 4th and 8th week. Results After treatment the total and each factor scores of both groups lowered more significantly compared with pretreatment （P〈0.05 or 0.01）; at the end of the 8th week, obvious effective and effective rate were respectively 76.3% and 89.5% in research and 72.5~ and 85.0% in control group, which showed no significant differ- ences （Z2 =0.15,0.35 ,P〈0.05）. Incidences of adverse reactions were respectively 47.40,/00 in research and 52.5~/00 in control group, which showed no significant differences （X2 =0.21,P〈0.05）, but incidences of insomnia, nausea and vomiting and endocrine alteration were significantly higher （P〈0.05 or 0.01） and those of extrapyramidal symptoms lower （P〈0.01） in research than control group, the former had no such adverse reactions as hypersomnia, tachycardia, weight gain （P〈0.05）. Conclusion Amisulpride has an evident effect on schizophrenia, its total efficacy is equivalent to haloperidol, but its adverse reactions are different from the latter somewhat.