布瑞哌唑片治疗成人急性期精神分裂症患者的临床研究  

Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia

作　　者：周书喆 李良[2] 杨栋[3] 翟金国 姜涛[5] 石玉中[6] 吴斌[7] 吴向平 栗克清[9] 刘铁榜[10] 李洁[11] 唐仕友 王丽莉[13] 王学义[14] 谭云龙[15] 刘琦[1] 宇木元道 咸明姬 张鸿燕[1] ZHOU Shu-zhe;LI Liang;YANG Dong;ZHAI Jin-guo;JIANG Tao;SHI Yu-zhong;WU Bin;WU Xiang-ping;LI Ke-qing;LIU Tie-bang;LI Jie;TANG Shi-you;WANG Li-li;WANG Xue-yi;TAN Yun-long;LIU Qi;MOTOMICHI Uki;XIAN Ming-ji;ZHANG Hong-yan(Office of Good Clinical Practice,Peking University Sixth Hospital,Peking University Institute of Mental Health,NHC Key Laboratory of Mental Health(Peking University),National Clinical Research Center for Mental Disorders(Peking University Sixth Hospital),Beijing 100191,China;Medical Affairs Section,Huzhou Third People’s Hospital,Huzhou,Huzhou 313000,Zhejiang Province,China;Department of Psychosomatic Medicine,Brain Hospital of Hunan Province,Changsha 410021,Hunan Province,China;Department of Psychiatry,Shandong Daizhuang Hospital,Jining 272051,Shandong Province,China;Psychiatry Dept.10,Beijing Anding Hospital,Capital Medical University,Beijing 100120,China;Psychiatry Dept.3,Henan Psychiatric Hospital,Zhengzhou 452370,Henan Province,China;Clinical Trail Institution,Xi’an Mental Health Center,Xi’an 710061,Shanxi Province,China;Department of Psychiatry,Ningbo Kangning Hospital,Ningbo 315201,Zhejiang Province,China;Dept.of Adult Psychiatry,Hebei Mental Health Center,Baoding 071030,Hebei Province,China;Dept.of Adult Psychiatry,Shenzhen Kangning Hospital,Shenzhen 518020,China;Department of Community Psychiatry,The Affiliated Brain Hospital of Guangzhou Medical University,Guangzhou 510370,Guangdong Province,China;Department of Psychiatry,Chongqing University Affiliated Three Gorges Hospital,Chongqing 404031,China;Clinical Dept.8,Tianjin Anding Hospital,Tianjin 300222,China;Mental Health Center,The First Hospital of Hebei Medical University,Shijiazhuang 050030,Hebei Province,China;Department of Psychiatry,Beijing Huilongguan Hospital,Beijing 102208,China;Otsuka Pharmaceutical Co.,Ltd.,Japan;Otsuka Beijing Research Institute,Beijing 100010,China)

机构地区：[1]北京大学第六医院,北京大学精神卫生研究所,国家卫生健康委员会精神卫生学重点实验室(北京大学),国家精神心理疾病临床医学研究中心(北京大学第六医院)国家药物临床试验机构办公室,北京100191 [2]湖州市第三人民医院医务科,浙江湖州313000 [3]湖南省脑科医院心身医学科,湖南长沙410021 [4]山东省戴庄医院精神科,山东济宁272051 [5]首都医科大学附属北京安定医院十病区,北京100120 [6]河南省精神病医院精神三科,河南郑州452370 [7]西安市精神卫生中心临床试验机构,陕西西安710061 [8]宁波市康宁医院精神科,浙江宁波315201 [9]河北省精神卫生中心成人精神科,河北保定071030 [10]深圳市康宁医院成人精神科,广东深圳518020 [11]广州医科大学附属脑科医院社区精神科,广东广州510370 [12]重庆大学附属三峡医院精神科,重庆404031 [13]天津市安定医院临床八科,天津300222 [14]河北医科大学第一医院精神卫生中心,河北石家庄050030 [15]北京回龙观医院精神科,北京102208 [16]大冢制药株式会社,日本 [17]大冢制药研发(北京)有限公司,北京100010

出　　处：《中国临床药理学杂志》2024年第5期654-658,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 观察布瑞哌唑对成人急性期精神分裂症患者的疗效和安全性。方法 将成人急性期精神分裂症患者随机分为试验组与对照组,试验组给予口服布瑞哌唑每日2~4 mg,对照组给予口服阿立哌唑每日10~20 mg,2组均治疗6周。比较2组治疗后有效率,比较2组阳性和阴性症状量表(PANSS)总评分、临床总体印象-严重程度(CGI-S)评分、个人和社会功能量表(PSP)评分、PANSS阳性症状分量表评分和PANSS阴性症状分量表评分治疗前后的变化,观察2组患者治疗相关不良事件的发生情况。结果 试验组184例、对照组186例。治疗6周末,试验组和对照组的治疗有效率分别为79.50%(140例/184例)和82.40%(150例/186例),临床总体印象-改善量表(CGI-I)评分分别为(2.00±1.20)和(1.90±1.01)分,在统计学上差异均无统计学意义(均P>0.05)。治疗6周后试验组和对照组的PANSS总分较基线变化分别为(-30.70±16.96)和(-32.20±17.00)分,2组间差异无统计学意义(P>0.05)。治疗前后,试验组和对照组的CGI-S评分变化分别为(-2.00±1.27)和(-1.90±1.22)分,PSP评分变化分别为(18.80±14.77)和(19.20±14.55)分,PANSS阳性症状评分变化分别为(-10.30±5.93)和(-10.80±5.81)分,PANSS阴性症状评分变化分别为(-6.80±5.98)和(-7.30±5.15)分,在统计学上差异均无统计学意义(P>0.05)。试验组治疗相关不良事件发生率与对照组相比差异无统计学意义(69.00%vs.64.50%,P>0.05)。结论 布瑞哌唑相比于阿立哌唑治疗精神分裂症的非劣效性成立,疗效及安全性相当。Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d~(-1) orally and the control group was given aripiprazole 10-20 mg·d~(-1) orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases) and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20) and(1.90±1.01),with no significant difference(allP> 0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96) points in treatment group and(-32.20±17.00) points in control group,with no significant difference(P> 0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27) and(-1.90±1.22) points,PSP scores were(18.80±14.77) and(19.20±14.55) points,PANSS positive syndrome scores were(-10.30±5.93) and(-10.80±5.81) points,PANSS negative syndrome scores were(-6.80±5.98) and(-7.30±5.15) points,with no significant difference(P> 0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P> 0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.

关 键 词：布瑞哌唑 阿立哌唑 精神分裂症 疗效 安全性 

分 类 号：R97[医药卫生—药品]