盐酸哌罗匹隆片治疗精神分裂症的Ⅱ期临床研究  

The second phase clinical trials for perospirone to treat schizophrenia

作　　者：白燕[1] 刘芳[1] 姜红燕[1] 许秀峰[1] 

机构地区：[1]昆明医学院第一附属医院精神科,云南昆明650032

出　　处：《云南医药》2010年第3期282-285,共4页Medicine and Pharmacy of Yunnan

基　　金：深圳市清华源兴药业有限公司提供资助

摘　　要：目的评价国产盐酸哌罗匹隆片治疗精神分裂症的疗效和安全性。方法对符合《CCMD-Ⅲ》精神分裂症和分裂样精神障碍诊断标准的48例精神分裂症和分裂样精神障碍患者进行哌罗匹隆,利培酮的对照研究。其中哌罗匹隆组24例,利培酮24例,共治疗6周,采用PANSS和CGI评定临床疗效,TESS评定不良反应。结果通过对PANSS量表总分和因子分进行疗效分析,两组疗效相当;两组副反应的发生率无显著差异,常见副反应为失眠,震颤,肌强直,静坐不能。结论哌罗匹隆与利培酮治疗精神分裂症安全有效,不良反应轻,适合临床应用。Objective To evaluate the efficacy and safety of perospirone to treat schizophrenia. Methods A double-blind controlled study was carried out in 48 patients who meet the CCMD-III diagnostic criteria of schizophrenia and schizophreniform disorder. 24 cases were treated with perospirone and the others were treated with risperidone for 6 weeks.The clinical efficacy was assessed with Positive and Negative Syndrome Scale（PANSS） and Clinical Global Impression （CGI）,the safety was assessed with Treatment Emergent Symptom Scale（TESS）. Results After 6 weeks treatment, the improvement rates between perospirone group and risperidone group had no significant difference. The total scores and factor scores of PANSS had no significant difference between perospirone group and risperidone group.The main adverse events of two group were insomnia, tremor, muscle rigidity and akathisia. There was no significant difference in incidence of adverse events between perospirone group and risperidone group. Conclusion Perospirone is an effective antipsychotic drug. It fits in clinical use.

关 键 词：精神分裂症 分裂样精神障碍 哌罗匹隆 利培酮 双盲对照研究 

分 类 号：R749.3[医药卫生—神经病学与精神病学]