【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。更多还原

【Abstract】 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.更多还原