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  

Efficacy and safety of iloperidone and risperidone tablets in the treatment of acute schizophrenic patients:a multi-center,randomized,double-blind,controlled clinical study

作　　者：双梅[1] 刘琦[1] 闫俊[1] 康岚[1] 刘粹[1] 杨甫德[2] 杜波[3] 石玉中 许秀峰[5] 王传跃[6] 徐广明[7] 张鸿燕[1] 

机构地区：[1]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),北京100191 [2]北京回龙观医院,北京100096 [3]河北省精神卫生中心,保定071000 [4]河南省精神病院,新乡453002 [5]昆明医学院第一附属医院,昆明650032 [6]首都医科大学附属北京安定医院,北京100088 [7]天津市安定医院,天津300222

出　　处：《中国新药杂志》2014年第23期2772-2776,共5页Chinese Journal of New Drugs

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（P〈0.05）。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（P〉0.05）。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（P〈0.05）。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。Objective： To evaluate the efficacy and safety of flexible doses of iloperidone tablets in comparison with risperidone in patients with acute schizophrenia. Methods： Two hundreds and sixty patients with DSM-IVschizophrenia were randomized into iloperidone （n = 130, 12 -24 rag·d^-1） or risperidone （n = 130, 3 -6 mg·d^-1） treatment in a 6-week, muhicenter, double-blinded, parallel-group study. The primary efficacy measure was changes in the total score of the Positive and Negative Syndrome Scale （PANSS） after the 6-week treatment. Results： Both iloperidone and risperidone groups demonstrated a significant improvement in total PANSS score （P 〈 0.05） after 6-week treatment. The reduction in total PANSS score was （33. 31±13. 94） in iloperidone group and （32.54 ±14.77） in risperidone group at the end point; there was no statistically significant difference between the two groups （P 〉 0.05）. The non-inferiority test showed that the iloperidone group was not inferior to the risperi- clone group （μA -μB, 95% CI〉 -7.0）. The common adverse events were Parkinson＇s syndrome, akathisia, transaminases increasing, blood lipids increasing, weight gain, and prolactin increasing. lloperidone group demonstrated fewer prolactin increasing and Parkinson＇s syndrome than risperidone group; the difference was statistically significant （P 〈 0.05）. Conclusion： Iloperidone and risperidone are similarly effective in the treatment of patient with acute schizophrenia, and iloperidone causes fewer prolactin increasing and Parkinson＇s syndrome.

关 键 词：伊潘立酮 利培酮 精神分裂症 疗效 安全性 

分 类 号：R969.4[医药卫生—药理学]