国产利培酮治疗精神分裂症的开放性临床研究

摘要

Objective The purpose of this study was to observe the safety andefficacy of domestic risperidone in treating of schizophrenia patients in a 6-week open trial.Methods Thirty-three inpatients schizophrenia diagnosed according to Chinese classification and diagnostic criteria of mental disorders, 2 nd edition-revise (CCMD-2-R) took the treatment of risperidon. Its dosage ranged 2～6!mg/day. The positive and negative symptoms scale(PANSS),the brief psychiatric rating scale (BPRS),clinical grobal impressions scale (CGI) were used for the efficacy. Treatment emergent symptom scale(TESS) and Simpson-Angns scales (SAS) were used to assess the unwanted effects.Results At the end of the study,87.9% of the patients were rated as marked improvement and 97% of them as improvement. The clinical effectiveness of risperidone show up at the end of second week of treatment. The optimal dose ranged from 2!mg to 4!mg. The common side effects of risperidone were mild myotonia, tremor,akathisia and drowsiness.Conclusion The domestic risperidone is effective and safe in the treating schizophrenia.%目的 验证国产利培酮治疗精神分裂症的疗效与安全性。方法 对33例住院精神分裂症病人给予口服国产利培酮片2～6!mg/d治疗，疗程为6周。采用阳性和阴性症状量表(PANSS)及简明精神病评定量表(BPRS)评定疗效，不良反应量表(TESS)及Simpson-Angns(SAS)量表评定药物不良反应。结果 治疗结束时显效率为87.9%，总有效率为97%；有效治疗剂量2～4!mg/d，起效时间为2周；主要副反应为轻度肌紧张、震颤、静坐不能、困倦等。结论 国产利培酮对精神分裂症阳性症状、阴性症状均有明显的治疗效果，且副反应轻，使用安全。