喹硫平治疗精神分裂症随机双盲双模拟对照临床试验

A double-blind and double-dummy comparative study of quetiapine and chlorpromazine in the treatment of schizophrenia

目的 :评价二类新药喹硫平片治疗精神分裂症的有效性及安全性 ,与阳性药氯丙嗪进行比较。方法 :采用随机双盲双模拟对照试验 ,2 2 1例患者随机分为喹硫平组 114例与氯丙嗪组 10 7例。剂量均为 2 0 0～ 80 0mg·d-1,疗程 8周。用阳性和阴性症状量表 (PANSS)评定疗效。结果 :有效率喹硫平组 6 8.1% ,氯丙嗪组 6 9.5 % ;2组疗效无显著性差异。活动减少、震颤、扭转痉挛、静坐不能、口干、视物模糊、便秘、头晕等不良反应的发生率喹硫平组显著少于氯丙嗪组 (P <0 .0 5 )。结论 :国产喹硫平治疗精神分裂症有效且较安全。

Objective:To evaluate the efficacy and safety of quetiapine for treatment of schizophrenia.Methods:221 cases of schizophrenic patients were randomly divided into quetiapine group( n =114) and chlorpromazine group( n =107), and treated for eight weeks.The PANSS was adopted for evaluating therapeutic effects.Results:The total effective rates in quetiapine and chlorpromazine group were simillar,with no significant difference.Less adverse reactions were found in quetiapine group.Conclusion:The domestic quetiapine is an effective and safe agent for treatment of schizophrenia.