国产布南色林片与利培酮片治疗精神分裂症的多中心随机双盲双模拟平行对照临床试验

Efficacy and tolerability of domestic blonanserin tablets in acute schizophrenic: a randomized,double-blind,risperidone-controlled trial

目的：评价国产布南色林治疗急性精神分裂症的疗效及安全性。方法：采用随机双盲多中心活性药对照研究方法。将298例18~65岁急性精神分裂症患者随机分为布南色林组（n=148,8~24 mg·d-1）和利培酮组（n=150,2~6 mg·d-1）,疗程8周。以阳性和阴性症状量表（PANSS）总分变化为疗效指标。结果：布南色林组PANSS总分从基线的93.99分降至62.24分,利培酮组从基线的92.09分降至58.67分,平均减分分别为31.74和33.43分。布南色林组和利培酮组的有效率分别为58.11%和64.67%,不良事件发生率分别为78.38%和86.67%。布南色林组对体质量和血清泌乳素的影响较小。结论：国产布南色林治疗急性精神分裂症的疗效非劣于利培酮,不良反应相似。但是,布南色林较少引起患者体质量增加,对血清泌乳素水平影响较小。

Objective： To evaluate the efficacy and tolerability of domestic blonanserin tablets for the treatment of Chinese patients with acute schizophrenia. Methods： A randomized,double-blind,multi-center,non-inferiority,risperidone-controlled design was adopted. 298 patients aged 18 to 65 years with schizophrenia were ran-domly assigned to domestic blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale（ PANSS） total scores from baseline to week 8. The dosage was 8 ~ 24 mg·d- 1and 2 ~ 6 mg·d- 1,respectively. Safety assessments included monitoring of vital signs,physical examination,laboratory tests,and adverse events. Results： Among 298 enrolled patients,148 received blonanserin and 150 received risperidone. The mean change in the PANSS total score at the final evaluation time point was31. 74 ± 19. 70 for the blonanserin group and 33. 43 ± 20. 01 for the risperidone group. The clinical response rates were 58. 11% for blonanserin and 64. 67% for risperidone,respectively（ χ2= 1. 437,P = 0. 230 5）. The incidences of adverse events in the two groups were similar. Blonanserin showed smaller weight gain and smaller effect on prolactin level compared with risperidone（ F = 4. 535,P = 0. 034 3）（ F = 33. 576,P = 0. 000）. Conclusion：Blonanserin is non-inferior to risperidone in the treatment of Chinese schizophrenic patients and is more tolerable with a better safety profile,particularly with respect to prolactin elevation and weight gain. These findings suggest that domestic blonanserin is useful in the treatment of acute schizophrenia.