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利培酮治疗躁狂症的随机双盲对照临床试验

A randomized and double-blind controlled clinical trial of risperidone for treatment of mania
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摘要 目的:评价利培酮治疗躁狂症的有效性和安全性。方法:采用随机双盲双模拟、阳性药平行对照,剂量可调整的研究。受试者分别口服利培酮1~6mg/d或氟哌啶醇片2~12mg/d。疗程4周。结果:共收集符合入组条件的躁狂病人32例,其中利培酮组16例,氟哌啶醇组16例。主要疗效指标Young氏躁狂评定量表(YMRS)评分在治疗结束时较基线显著减少(P【0.01)。有效率利培酮组为87.5%,氟哌啶醇为81.25%,无显著性差异。两组常见不良反应有锥体外系反应、便秘及心电图异常,两组间无显著性差异。结论:试验药利培酮与对照药氟哌啶醇具有类似的疗效与不良反应。为治疗躁狂症的安全而有效的新药。 Objective:To evaluate the efficiency and safety of risperidone in the treatment of mania patients.Methods:A randomized, double-blind,double-dummy,haloperidol-controlled and multicenter clinical trial was conducted.Thirty two patients with mania were enrolled in this study,in which 16 patient received resperidone (trial) and 16 patients received haloperidol(control), for four weeks. Results:Compared with the baseline, the grades in Young Mania Rating Scale(YMRS)in two groups were significantly reduced at the end of treatment.The efficacy rate were 87.5% respectively in risperidone group, and 81.25% respectively in haloperidol group. There was no significant difference between the two groups. The incidence of adverse effects including extra-pyramidal symptoms,constipation and abnormal electrocardiogram in two groups was similar.Conclusion:Risperidone is an efficient and safety new drug in the treatment of mania.
出处 《临床医药实践》 2009年第5Z期1635-1637,共3页 Proceeding of Clinical Medicine
关键词 利培酮 躁狂症 临床试验 Risperidone Mania Clinical trial
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参考文献4

  • 1Ghaemi SN,Sachs GS,Baldassano CF,et al.Management of bioilar disorder with adjunctive risperidone:response to open treatment[].New research program of and abstracts of theth annual meeting of the American Psychiatric Associa-tion.1995
  • 2Legsen J E,Gommorenn W,Eens A,et al.The biochemical profile of risperidone, a new antipsychotic[].Journal of Pharmacology and Experimental Therapeutics.1988
  • 3Janssen PAL,Niemegeers CJE,Awouters F,et al.Pharmacology risperidone(R64766),a new antipsychotic with serotonin-S2and dopamine-D2antagonistic properties[].Journal of Pharmacology and Experimental Therapeutics.1988
  • 4Jacobsen FM.Risperidone in the treatment of affective illness and obsessive - compulsive disorder[].Journal of Clinical Psychopharmacology.1995

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