利培酮胶囊与利培酮片剂治疗精神分裂症对照研究

Contrast Study of Treating Schizophrenia by Risperidone Capsule and Risperidone Tablet

目的:探讨利培酮胶囊治疗精神分裂症的疗效及不良反应。方法:将72例精神分裂症患者随机分为利培酮胶囊组(36例)作为研究组,利培酮片剂组(36例)作为对照组进行临床对照研究。二组药物平均治疗量分别为(5±1.82)mg/d,(4.2±1.29)mg/d,疗程8周。疗效指标包括阳性和阴性症状量表(PANSS),不良反应指标包括不良反应症状量表(TESS)及相关实验室检查。结果:治疗结束时,二组PANSS评分较入组时均明显减低(P<0.01),PANSS总减分率:利培酮胶囊组为(50.38±11.3)%,利培酮片剂组为(51.85±12.4)%;临床总有效率:利培酮胶囊组为86.11%,利培酮片剂组为88.88%,二组间疗效及不良反应无显著性差异(P>0.05)。结论:利培酮胶囊治疗精神分裂症是一种有效、安全的新型非典型抗精神病药剂型,但和利培酮片剂相比,在平均治疗剂量和起效时间上有统计学差异(P<0.05)。

Objective：To explore Risperidone Capsule treatment on schizophrenia and the side effects.Methods：Total 72 cases of patients with schizophrenia were randomly divided into Risperidone Capsule group（36 cases）,Risperidone Tablet（36 cases）,Carrying on the clinical check experiment,two groups of medicin average therapeutic dose respectively is 5±1.82 mg/d,4.2±1.29 mg/d,the treatment course is 8 weeks.Indicators include the effect of positive and negative symptom scale（PANSS）,adverse reactions indicators for adverse reactions Symptom Rating Scale（TESS） and the laboratory.Results： At the end of treatment,two groups PANSS score in the group,were significantly reduced（P〈0.01）.By PANSS total points： Risperidone Capsule group（50.38±（11.3））%,Risperidone Tablet group（51.85±12.4）%;The total efficiency： Risperidone Capsule 86.11%,Risperidone Tablet 88.88%.There is no significant difference in the two groups（P〉0.05）.Conclusions： Risperidone Capsule is an effective,safe drug type,as new atypical antipsychotic to treat schizophrenia.But there is significant difference in average therapeutic dose and time go into effect to compared with Risperidone Tablet（P〈0.05）.