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可变剂量帕利哌酮缓释剂治疗急性期精神分裂症的疗效、耐受性及安全性
引用本文:余一旻,李华芳,杨甫德,胡建,赵振环,董继承,陈红辉,许秀峰,李鸣,王刚,王晓萍,谢世平,唐济生,张晋碚,关念红,丁瑛,谭庆荣,李惠春,钟华,张鸿燕,谢光荣,孙学礼,顾牛范.可变剂量帕利哌酮缓释剂治疗急性期精神分裂症的疗效、耐受性及安全性[J].上海精神医学,2010,22(6):349-353.
作者姓名:余一旻  李华芳  杨甫德  胡建  赵振环  董继承  陈红辉  许秀峰  李鸣  王刚  王晓萍  谢世平  唐济生  张晋碚  关念红  丁瑛  谭庆荣  李惠春  钟华  张鸿燕  谢光荣  孙学礼  顾牛范
作者单位:[1]上海交通大学医学院附属精神卫生中心,200030 [2]北京回龙观医院,100096 [3]哈尔滨医科大学第一临床医学院,150036 [4]广州脑科医院,510370 [5]青岛市精神卫生中心,266042 [6]武汉市精神卫生中心,430022 [7]昆明医学院第一附属医院,650032 [8]苏州市广济医院,215008 [9]首都医科大学附属北京安定医院,100088 [10]武汉大学人民医院,430060 [11]南京脑科医院,210029 [12]山东省精神卫生中心,250014 [13]中山大学附属第三医院,510630 [14]杭州市第七人民医院,310013 [15]第四军医大学西京医院,710032 [16]浙江大学医学院附属第二医院,310009 [17]湖州市第三人民医院,313000 [18]北京大学第六医院,100083 [19]中南大学湘雅二院,410013 [20]四川大学华西医院,610041
基金项目:国家"重大新药创制"科技重大专项
摘    要:目的研究可变剂量的帕利哌酮缓释剂治疗急性期精神分裂症患者的有效性、耐受性与安全性。方法采用开放性、单组、多中心研究,使用可变剂量的帕利哌酮缓释剂(3~12mg/d)治疗急性期精神分裂症患者608例,观察期8周,通过阳性和阴性综合征量表(PANSS)评价有效性。通过体检、实验室检查、心电图检查及其他不良事件的报告评价安全性。结果治疗有效率(PANSS减分率≥30%)随治疗时间而增加,治疗8周末有效率为82.6%。研究终点PANSS总分与基线相比,差异具有统计学意义(P〈0.01)。终点平均剂量为(7.9±2.2)mg/d。治疗8周时40.11%患者的治疗剂量保持6mg/d的水平,4.44%患者的治疗剂量下调至3mg/d。常见的不良事件为锥体外系反应、便秘、肝功能异常、睡眠障碍、嗜睡、疲乏及恶心。结论可变剂量帕利哌酮缓释剂(3~12mg/d)治疗急性期精神分裂症有效,且耐受性、安全性良好。

关 键 词:帕利哌酮缓释剂  精神分裂症  有效性  耐受性  安全性

Effectiveness, tolerability and safety of flexible-dose treatment with oral extended release paliperidone in acute schizophrenia
Institution:Yu Yimin1, Li Huafang1, Yang Pude2, et al. 1. Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai 200030; 2. Beijing HuiLongGuan Hospital, Beijing 100096
Abstract:Objective:Evaluate flexible-dose treatment with paliperidone extended release tablets in acute schizophrenia. Methods: Patients with acute schizophrenia (N = 608) participated in an open label, 8-week, one-arm, multicenter trial of flexible dose treatment with paliperidone extended release tablets (3-12 mg/d). The Positive and Negative Syndrome Scale (PANSS) was used to evaluate effectiveness. Safety was assessed. The results of a physical examination, lab tests, an electrocardiogram and an adverse events scale were used to evaluate safety. Results:The response rate (that is, the proportion of subjects with at least 30% drop from the baseline PANSS total score) increased with the duration of treatment and was 82.6% at week 8. The baseline and 8-week PANSS total scores were significantly different (P0.01). The average dosage was (7.9±2.2) mg/d at week 8. The dose of paliperidone in 40.11% patients remained 6 mg/d and 4.44% down to 3 mg/d at endpoint. Common adverse events included extrapyramidal symptoms, constipation, hepatic dysfunction, sleeping disorder, drowsiness, fatigue, and nausea. Conclusion:Flexible dosing (3~12 mg/d) treatment with paliperidone extended release tablets is safe, well-tolerated and effective for patients with acute schizophrenia.
Keywords:Extended release paliperidone Schizophrenia Effectiveness Tolerability Safety
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