棕榈酸帕利哌酮注射液治疗少年精神分裂症的疗效观察及社会功能的恢复

发布时间：2018-03-30 11:25

本文选题：棕榈酸帕利哌酮　切入点：利培酮　出处：《中国新药杂志》2014年08期

【摘要】：目的:研究棕榈酸帕利哌酮对少年精神分裂症的疗效、耐受性、安全性及对社会功能的影响。方法:入组147例患者,均符合《美国精神障碍诊断与统计手册》第4版中精神分裂症诊断标准,且年龄为16~18岁,按随机数字表法分为棕榈酸帕利哌酮组67例和利培酮组80例。棕榈酸帕利哌酮组治疗剂量100~150 mg·mL-1,利培酮组治疗剂量4~6 mg·d-1,观察期为12周。于基线、治疗2,4,8,12周末采用阳性与阴性症状量表(PANSS)和个人和社会功能量表(PSP)分别评价有效性和社会功能,并用临床总体印象量表改善项目(CGI-I)评价其疗效,比较治疗后与基线的差异,包括每组前后和组间差异。记录相关不良反应,对147例患者进行安全性分析。结果:共有102例患者完成研究,棕榈酸帕利哌酮组47例,利培酮组55例。两组在治疗第12周末的PANSS阳性症状、阴性症状分及总分较基线有显著降低,CGI-I评分较基线有明显改善,但两组组间相比差异无统计学意义。两组PSP总分改善随时间变化较基线有改善,棕榈酸帕利哌酮组在第2周[(40.68±5.58)vs(32.38±9.24),P0.01],第4周[(45.14±5.14)vs(40.24±9.37),P0.05],第12周[(66.73±10.38)vs(55.48±9.86),P0.01)]较利培酮组改善更为明显。棕榈酸帕利哌酮组不良反应发生率小于利培酮组(17.3%vs 42%,P=0.001)。结论:棕榈酸帕利哌酮能有效改善少年精神分裂症患者的精神症状和社会功能,减少药物不良反应,耐受性好。
[Abstract]:Objective: to study the efficacy, tolerance, safety and social function of palipiperidone palmitate in the treatment of juvenile schizophrenia. In accordance with the diagnostic criteria for schizophrenia in the 4th edition of the American Handbook for the diagnosis and Statistics of Mental Disorders, and aged 1618 years, According to the random number table method, 67 cases of palipiperidone palmitate group and 80 cases of risperidone group were divided into two groups: paliperidone palmitate group (100mg / ml), risperidone group (4mg / d) and risperidone group (4mg / d) for 12 weeks. The efficacy and social function were evaluated by using the positive and negative symptom scale (PANSS) and the personal and social function scale (PSPP) at the end of 12 weeks of treatment. The efficacy was evaluated with the clinical general impression improvement item (CGI-I), and the difference between the treatment and baseline was compared. Safety analysis was performed in 147 patients. Results: 102 patients completed the study, 47 in the palmitic acid group, 47 in the palmitate group. There were 55 cases in risperidone group. At the end of the 12th week of treatment, the scores of negative symptoms and total scores of PANSS in both groups were significantly lower than that of baseline, and the scores of CGI-I were significantly improved compared with baseline. However, there was no significant difference between the two groups. The improvement of the total score of PSP in the two groups over time was better than that in the baseline. In the second week [40.68 卤5.58)vs(32.38 卤9.24P0.01], in the 4th week [45.14 卤5.14)vs(40.24 卤9.37P0.01], in the 12th week [66.73 卤9.86P0.01], the improvement was more obvious in the palmitate group than in the risperidone group. The incidence of adverse reactions in the palipiperidone palmitate group was lower than that in the risperidone group. Conclusion: palmitic acid paliperidone can effectively correct P0.01.Conclusion: Pariperidone palmitate is effective. Mental symptoms and social functions of juvenile schizophrenic patients, Reduce adverse drug reactions, good tolerance.
【作者单位】：华中科技大学同济医学院附属精神卫生中心;武汉市精神卫生中心;
【分类号】：R749.3

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