国产奎硫平与氯丙嗪治疗精神分裂症的多中心双盲对照研究  

Multi-center, double blind control study of domestic manufactured quetiapine on schizophrenia

作　　者：陈晋东[1] 赵靖平[1] 李乐华[1] 陈远光[1] 陈晓岗[1] 黄继忠[2] 张鸿燕[3] 周沫[3] 谢世平[4] 文启琴[5] 张铁林[6] 宫玉祥[7] 秦英绂[8] 范洪玉 

机构地区：[1]中南大学湘雅二医院精神卫生研究所,长沙410011 [2]上海市精神卫生中心 [3]北京大学精神卫生研究所 [4]南京医科大学附属脑科医院 [5]广州市精神病医院 [6]天津市安定医院 [7]济宁市精神病防治院 [8]北京安定医院 [9]大连市第七人民医院

出　　处：《中华精神科杂志》2001年第4期193-196,共4页Chinese Journal of Psychiatry

摘　　要：目的　验证奎硫平治疗精神分裂症的疗效及安全性。方法　将 2 2 1例精神分裂症患者随机分为奎硫平组 ( 1 1 4例 )和氯丙嗪组 ( 1 0 7例 ) ,进行多中心双盲双模拟对照研究 ,两药治疗剂量均为 2 0 0～ 80 0mg d ,疗程 8周。疗效指标包括阳性和阴性症状量表 (PANSS)、简明精神病评定量表(BPRS)、临床总体印象量表 (CGI)。不良反应指标为不良反应量表 (TESS)及有关实验室检查。结果治疗结束时 ,两组PANSS和BPRS评分较入组时均显著减低 (P <0 0 1 ) ;PANSS减分率 :奎硫平组为( 65 9± 2 7 8) % ,氯丙嗪组为 ( 66 5± 2 6 4 ) % ;临床总有效率 :奎硫平组 68 1 % ,氯丙嗪组 69 6% ;两组疗效差异无显著性。奎硫平组的不良反应较氯丙嗪组少 ,其中活动减少、震颤、扭转痉挛、静坐不能、口干、视物模糊、便秘、头晕的发生率显著少于氯丙嗪组 (P <0 0 1或 0 0 5)。结论　国产奎硫平治疗精神分裂症的疗效与氯丙嗪相似 ,某些不良反应较氯丙嗪轻而少 ;是一种有效、耐受性好的抗精神病药。Objective To verify the efficacy and side effects of domestic manufactured quetiapine on schizophrenia Methods Patients who met CCMD 2 R criteria for schizophrenia were randomized into two groups: quetiapine group ( n =114) and chlorpromazine (CPZ) group ( n =107) in a double blind, double dummy study The range of dosage for the two experiment drugs was 200 800 mg/d, the treatment duration was 8 weeks The PANSS, BPRS, CGI, TESS and related lab tests were employed for assessing the treatment effectiveness and side effects Results At the end of treatments, the scores of PANSS and BPRS in both treatment groups decreased significantly compared with baseline ( P <0 01), and the decreasing rates on PANSS were (65 9±27 8)% in quetiapine group and (66 5±26 4)% in CPZ group Total clinical effective rates were 68 1% in quetiapine group and 69 6% in CPZ group, which was no significant difference between two groups However, patients in quetiapine group reported much fewer side effects than those in CPZ group, especially in the items of reduced activities, tremor, akathisia, acute dystonia, dry month, blur sight, constipation, and dizziness on TESS ( P <0 05) Conclusion Quetiapine has similar efficacy to CPZ, but has less side effects Quetiapine is an effective antipsychotic drug with fewer side effects

关 键 词：精神分裂症 氯丙嗪 奎硫平 药物治疗 双盲试验 

分 类 号：R749.3[医药卫生—神经病学与精神病学] R971.41[医药卫生—临床医学]