Wu Haishan, Wang Xijin, Liu Xuejun, Sang Hong, Bo Qijing, Yang Xiaodong, Xun Zhiyuan, Li Keqing, Zhang Ruiling, Sun Meijuan, Cai Duanfang, Deng Huaili, Zhao Guijun, Li Juhong, Liu Xianglai, Zhan Guilai, Chen Jindong
National Clinical Research Center for Mental Disorders, Department of Psychiatry, China National Technology Institute on Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, China.
The First Psychiatric Hospital of Harbin, Harbin, China.
Front Psychiatry. 2022 Aug 18;13:935769. doi: 10.3389/fpsyt.2022.935769. eCollection 2022.
Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China. A multi-center, prospective, open-label, 12-week surveillance was carried out to evaluate the safety and effectiveness of BNS in patients with schizophrenia in China. Safety assessments included adverse drug reactions (ADRs), extrapyramidal symptoms (EPS), akathisia, concomitant medications for EPS by the end of treatment, and the changes in body weight from baseline by the end of treatment. The effectiveness was evaluated by the Brief Psychiatric Rating Scale (BPRS). From September 2018 to May 2020, of the 1,060 patients enrolled, 1,018 were included in the full analysis set (FAS) and safety set (SS), respectively. ADRs were developed in 205 patients among the included, the incidence being 20.1%. ADRs of EPS occurred in 169 patients, the incidence being 16.6%, ADRs of akathisia occurred in 90 patients, the incidence being 8.8%; concomitant therapeutic and prophylactic agents for EPS accounts for 19.2%; 4.0% of patients had a ≥7% increase in body weight from baseline at 12 weeks after initiating treatment. Using the last-observation-carried-forward (LOCF) method, the changes in total BPRS scores were -11.2 ± 10.17 ( = 1,018), -16.8 ± 12.69 ( = 1,018) and -20.6 ± 13.99 ( = 1,018) after 2/4, 6/8, or 12 weeks, respectively. 53.5% (545/1,018) patients showed response to blonanserin treatment in week 12. The post-marketing surveillance results of BNS demonstrates safety profile and effectiveness of the drug.
精神分裂症是一种病因不明、复杂且严重的精神疾病。布南色林（BNS）是一种广泛用于治疗精神分裂症的新型抗精神病药物。然而，中国尚未开展大规模临床研究。本研究开展了一项多中心、前瞻性、开放标签的12周监测，以评估BNS在中国精神分裂症患者中的安全性和有效性。安全性评估包括药物不良反应（ADR）、锥体外系症状（EPS）、静坐不能、治疗结束时用于治疗EPS的伴随用药以及治疗结束时相对于基线的体重变化。有效性通过简明精神病评定量表（BPRS）进行评估。2018年9月至2020年5月，在纳入的1060例患者中，分别有1018例纳入全分析集（FAS）和安全集（SS）。纳入患者中205例出现ADR，发生率为20.1%。169例出现EPS的ADR，发生率为16.6%；90例出现静坐不能的ADR，发生率为8.8%；治疗和预防性使用EPS药物的比例为19.2%；4.0%的患者在开始治疗12周后体重较基线增加≥7%。采用末次观察结转（LOCF）法，在2/4周、6/8周或12周后，BPRS总分变化分别为-11.2±10.17（n = 1018）、-16.8±12.69（n = 1018）和-20.6±13.99（n = 1018）。53.5%（545/1018）的患者在第12周对布南色林治疗有反应。BNS的上市后监测结果证实了该药物的安全性和有效性。
