伊潘立酮片与利培酮片治疗急性精神分裂症疗效及安全性的双盲对照研究

发布时间：2018-04-18 21:29

本文选题：伊潘立酮 + 利培酮　；参考：《中国新药杂志》2014年23期

【摘要】：目的:评价可变剂量伊潘立酮片治疗精神分裂症患者的疗效与安全性,并与利培酮进行比较。方法:本研究为随机、双盲、平行对照多中心临床试验。将符合《精神障碍诊断统计手册第四版》(DSM-IV)精神分裂症临床诊断标准的260例患者随机分至伊潘立酮组(130例,12~24 mg·d-1)或利培酮组(130例,3~6 mg·d-1),观察疗程为6周。主要疗效指标为治疗6周末两组阳性和阴性症状量表(PANSS)总分减分值。安全性评价包括不良事件(AEs)发生率、生命体征、心电图、体重变化及实验室指标。结果:治疗6周末,两组PANSS总分均较基线明显降低(P0.05)。伊潘立酮组减分(33.31±13.94)分,利培酮组减分(32.54±14.77)分,两组差异无统计学意义(P0.05)。对治疗前后PANSS量表总评分减分值进行非劣效检验,结果显示伊潘立酮组非劣于利培酮组(μA-μB的双侧95%CI大于-7.0)。利培酮组和伊潘立酮组常见不良事件为帕金森综合征、静坐不能、转氨酶升高、血脂升高、体重增加、泌乳素增高等,其中伊潘立酮组帕金森综合征和泌乳素增高的发生率低于利培酮组,差异有统计学意义(P0.05)。结论:伊潘立酮片治疗急性精神分裂症的疗效与利培酮相当,较少引起帕金森综合征及泌乳素增高。
[Abstract]:Aim: to evaluate the efficacy and safety of variable dose of epridone tablets in the treatment of schizophrenia and to compare with risperidone.Methods: this study was a randomized, double blind, parallel controlled multicenter clinical trial.260 patients who met the criteria for clinical diagnosis of schizophrenia in the fourth edition of the Statistical Manual for the diagnosis of Mental Disorders (DSM-IV) were randomly divided into two groups: Ipperidone group (n = 130) or risperidone group (n = 130) or risperidone group (n = 130). The course of treatment was 6 weeks.The main outcome measure was the total score of PANSS at the end of 6 weeks.Safety assessment included incidence of adverse events, vital signs, electrocardiogram, weight changes and laboratory indicators.Results: at the end of 6 weeks, the total score of PANSS in both groups was significantly lower than that in baseline.There was no significant difference between the two groups (33.31 卤13.94) and risperidone (32.54 卤14.77). There was no significant difference between the two groups (P 0.05).The total score of PANSS before and after treatment was tested by non-inferior effect test. The results showed that the bilateral 95%CI of the epridone group was higher than that of risperidone group (渭 A- 渭 B > -7.0).The common adverse events in risperidone group and Ipperidone group were Parkinson's syndrome, no sit-down, elevated aminotransferase, elevated blood lipids, weight gain, prolactin, and so on.The incidence of Parkinson's syndrome and prolactin elevation in the group of epantilinione was lower than that in the group of risperidone, and the difference was statistically significant (P 0.05).Conclusion: the efficacy of epridone tablets in the treatment of acute schizophrenia is similar to that of risperidone, and it is less associated with Parkinson's syndrome and prolactin elevation.
【作者单位】：北京大学第六医院卫生部精神卫生学重点实验室(北京大学);北京回龙观医院;河北省精神卫生中心;河南省精神病院;昆明医学院第一附属医院;首都医科大学附属北京安定医院;天津市安定医院;
【分类号】：R749.3

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