国产利培酮治疗精神分裂症疗效与安全性的随机双盲对照研究  

Efficacy and Safety of the Domestic Risperidone in Patients with Schizophrenia:a Randomized,Double-blind,Controlled Trial

作　　者：杨甫德[1] 陈松[1] 王向群[2] 张新波[3] 李鸣[4] 周建初[5] 刘哲宁[6] 王华阳[7] 高树贵 

机构地区：[1]北京回龙观医院,北京100096 [2]北京大学精神卫生研究所,卫生部精神卫生学重点实验室(北京大学),北京100191 [3]南京脑科医院,南京210029 [4]苏州市广济医院,苏州215008 [5]重庆市精神卫生中心,重庆401147 [6]中南大学湘雅二医院精神卫生研究所,长沙410011 [7]上海市精神卫生中心,上海200030 [8]宁波康宁医院,浙江宁波315201

出　　处：《中国心理卫生杂志》2009年第7期498-503,共6页Chinese Mental Health Journal

摘　　要：目的:评价国产利培酮片治疗精神分裂症的疗效及安全性。方法:采用随机双盲多中心对照研究,214例符合中国精神障碍分类与诊断标准第3版的精神分裂症患者随机接受国产利培酮片或进口利培酮片治疗,每组均为107例,平均剂量分别为3.9mg/d和3.7mg/d,观察疗程为8周。于入组时(基线)、治疗后第2、4、6、8周,采用阳性与阴性症状量表(Positive and Negative Symptoms Scale,PANSS)和临床总体印象量表(Clinical Global Impression Scale,CGI-S)进行疗效评估。于治疗前和试验结束时,以不良反应症状量表(Treatment Emergent Symptom Scale,TESS)、血生化指标、心电图和体质量改变等进行安全性评估。结果:国产利培酮组患者的有效率为76%,进口利培酮组为68.6%,差异无统计学意义(P>0.05)。随着治疗时间的延长,两组的阳性症状分、阴性症状分、一般精神病理症状分以及PANSS总分均显著下降(P<0.01),并且每个访视点PANSS减分率在两组之间差异无统计学意义(P>0.05)。国产利培酮组与研究药物有关的不良事件发生率为40%,进口利培酮组为37.1%,差异无统计学意义(P>0.05)。两组在治疗后体质量均有显著增加(P均<0.01)。第8周末国产利培酮组TESS总分低于进口利培酮组,差异有统计学意义(P<0.01)。结论:国产利培酮治疗精神分裂症的疗效与进口利培酮相当,安全性良好。Objective： To evaluate the efficacy and safety of domestic risperidone in the treatment of schizophrenia. Methods： A randomized, double-blind, controlled multicenter clinical trial was conducted. All 214 outpatients or inpatients who met criteria for schizophrenia in the Chinese Classification and Diagnostic Criteria of Mental Disorders Third Edition were randomly assigned to domestic （ n = 107 ） or import risperidone （ n = 107 ） treatment for 8 weeks, and the averaged dosage was 3.9 mg/d and 3.7 mg/d respectively. The efficacy was evaluated with the Positive and Negative Symptoms Scale （ PANSS ） and Clinical Global Impression Scale （ CGI ） . The safety and tolerability were assessed with the Treatment Emergent Symptom Scale （ TESS ）, biochemical index, electrocardiogram and weight gain. Results： The response rates were 76% and 68. 6% in domestic risperidone and import risperidone group respectively. The positive, negative and general psychopathological symptoms were significantly improved （P 〈0. 05 ） after 8 week treatment in the two groups, there were no significant differences on reducing score rate of PANSS total scores between the two groups. Incidence of adverse events was 40% in domestic risperidone and 37. 1% in import risperidone group. Both medications caused substantial rapid weight gain （P 〈 0. 01 ）, and the TESS total score of domestic risperidone was significantly lower than that of import risperidone （P 〈0. 01 ） . Conclusion： The results show that domestic risperidone has similar therapeutic effect to import risperidone in treatment of schizophrenia, and is safe and generally well-tolerated.

关 键 词：精神分裂症 利培酮 国产 进口 疗效 安全性 随机对照研究 

分 类 号：R749.3[医药卫生—神经病学与精神病学] R749.053[医药卫生—临床医学]