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喹硫平治疗精神分裂症的随机、平行对照和多中心临床研究
引用本文:李华芳,顾牛范,谢斌,李鸣,张磊,程毅,王美娟.喹硫平治疗精神分裂症的随机、平行对照和多中心临床研究[J].中国新药与临床杂志,2001,20(4):260-263.
作者姓名:李华芳  顾牛范  谢斌  李鸣  张磊  程毅  王美娟
作者单位:1. 上海市精神卫生中心上海 200030
2. 苏州市广济医院江苏苏州 215008
3. 沈阳市精神卫生中心辽宁沈阳 110168
摘    要:目的 :评价喹硫平治疗精神分裂症的疗效及安全性。方法 :精神分裂症病人 12 5例 ,其中喹硫平组 6 5例 ,给喹硫平 30 0~ 6 0 0mg·d- 1治疗 ;利培酮组 6 0例 ,给利培酮 3~ 6mg·d- 1治疗。观察时间6wk。疗效评定用PANSS ,BPRS ,CGI。安全性评价用TESS等。结果 :经 6wk治疗后 ,喹硫平组总有效率为 80 % ,利培酮组为 88% ,2组相比P >0 .0 5;喹硫平组血清催乳素浓度为 399IU±s 4 50IU ,利培酮组为 1351IU± 76 3IU ,P <0 .0 1。喹硫平组不良反应有失眠 (9% )、ECG轻度异常 (8% )、兴奋或激越 (8% )等。喹硫平组静坐不能的发生率 (0 )显著低于利培酮组 (10 % )。结论 :喹硫平治疗精神分裂症疗效与利培酮相当 ,但对血清催乳素的影响小 ,锥体外系症状少

关 键 词:喹硫平  精神分裂症  催乳素  利培酮  IV期临床试验  随机对照试验  多中心研究
文章编号:1007-7669(2001)04-0260-04

Quetiapine in treatment of schizophrenia: a randomized, controlled, multicentre study
LI Hua Fang ,GU Niu Fan ,XIE Bing ,LI Ming ,ZHANG Lei ,CHENG Yi ,WANG Mei Juan.Quetiapine in treatment of schizophrenia: a randomized, controlled, multicentre study[J].Chinese Journal of New Drugs and Clinical Remedies,2001,20(4):260-263.
Authors:LI Hua Fang  GU Niu Fan  XIE Bing  LI Ming  ZHANG Lei  CHENG Yi  WANG Mei Juan
Institution:LI Hua Fang 1,GU Niu Fan 1,XIE Bing 1,LI Ming 2,ZHANG Lei 2,CHENG Yi 3,WANG Mei Juan 3
Abstract:AIM: To evaluate the efficacy and safety of quetiapine in the treatment of schizophrenia. METHODS: One hundred and twenty five schizo phrenia patients were enrolled. Sixty five patients in the quetiapine group were treated with quetiapine 300-600 mg·d -1 . Sixty patients in the risperidone group were treated with risperidone 4-6 mg·d -1 . The treatment duration was 6 wk.PANSS, BPRS and CGI were adopted to evaluate the efficacy. TESS, Simpson scale, physical and laboratory examinations were used to evaluate the safety. RESULTS: The total effective rates for the quetiapine and risperidone groups were 80 %and 88 % respectively after 6 wk. There was no significant difference between the two groups. The plasma prolactin in the quetiapine group and risperidone group were 399 IU±450 IU and 1351 IU±763 IU, respectively ( P <0.01) after 6 wk. The common adverse reactions of quetiapine were insomnia (9 %), mild abnormal ECG (8 %),agitation (8 %). The rate of akinesia was significantly lower in the quetiapine group (0) than that in the risperidone group (10 %). CONCLUSION: Quetiapine is an effective and safe novel antipsychotic, but EPS is less.
Keywords:quetiapine  schizophrenia  prolactin  risperidone  phase IV clinical trials  randomized controlled trials  multicenter studies    [
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