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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 被引量:56

Multi-center, double blind control study of domestic manufactured quetiapine on schizophrenia
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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
出处 《中华精神科杂志》 CAS CSCD 北大核心 2001年第4期193-196,共4页 Chinese Journal of Psychiatry
关键词 精神分裂症 氯丙嗪 奎硫平 药物治疗 双盲试验 Schizophrenia Chlorpromazine Quetiapine
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