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首页> 外文期刊>Clinical Psychopharmacology and Neuroscience >A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia
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A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia

机译:一种随机对照试验,可比较aseanapine对精神分裂症管理中的蛋白曲线与奥氮平的疗效,安全性和耐受性

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Objective Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease. Methods It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann?Whitney U test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher’s exact test, as appropriate. Results The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant ( p 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients. Conclusion Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.
机译:客观精神分裂症是一种严重的疾病,其特征在于现实的感知或表达的损害,导致职业和社会功能障碍。在精神分裂症的一线治疗中,抗精神病药的使用现在是普遍的。本研究旨在比较aseanapine与标准的非典型抗精神病药,奥氮平治疗这种疾病的疗效。方法设计为单一盲,随机,受控,并联组,单中心期IV试验,较新的非典型抗精神病药,aseanapine与现有标准的非典型抗精神病药,奥兰扎丁。每次有资格标准注册80个受试者。移居的受试者每天接受试用药物治疗(奥沙齐滨10毫克或茶碱10毫克每日10毫克)12周。评估和分析BPRS,CGI-S,CGI-I,实验室参数和合规性。通过T测试和非参数数据进行比较连续变量,由MANN分析惠特尼U测试和WILCOXON签名等级测试。根据Chi-Square测试或Fisher的确切测试,分析了可能的分类变量。结果呈现的精神分裂症的持续时间在治疗组中具有可比性。在每种治疗组的任何两次访问之间的BPRS得分显着减少了BPRS得分。在任何两个治疗臂的访问之间比较时,CGI-S和CGI-I分数的下降均显着(P <0.001)。所有患者都适合治疗。结论较新的非典型抗精神病药类aseNapine比标准奥拉滨在降低这项研究中的精神分裂症症状的情况下更有效,并进行进一步的研究。

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