Chen Li-He, Guo Qian, Hu Yao, Liu Xiao-Hua, Hu Hao, Chen Hai-Ying, Liu Cai-Ping, Li Hua-Fang, Chen Jin-Dong, Li Guan-Jun
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China.
Department of Psychiatry, National Clinical Research Center for Mental Disorders, National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China.
World J Psychiatry. 2025 May 19;15(5):103701. doi: 10.5498/wjp.v15.i5.103701.
Blonanserin, a novel antipsychotic, has demonstrated efficacy in treating both positive and negative symptoms. However, limited research exists on its dose-dependent effectiveness and safety in patients with and without prominent negative symptoms (PNS).
To evaluate the effectiveness and safety of blonanserin monotherapy for first-episode schizophrenia in real-world clinical settings and to explore the efficacy and safety of different doses of blonanserin for patients with PNS and without PNS.
A 12-week, multicenter, prospective post-marketing surveillance was conducted. In this study, we included patients with first-episode schizophrenia who received blonanserin monotherapy. Patients were divided into those with PNS and without PNS, based on the Brief Psychiatric Rating Scale (BPRS) negative symptoms subscale scores. Additionally, patients were labeled as high-dose and low-dose groups according to the maximum daily dose they received. Effectiveness was assessed using the BPRS, and safety was evaluated through the incidence of adverse drug reactions (ADRs).
A total of 653 patients were included in the analysis, with 613 completing the study. The BPRS total score decreased significantly from 47.94 ± 16.31 at baseline to 26.88 ± 9.47 at 12 weeks ( < 0.001). A significant interaction of PNS × dose × time was observed for BPRS total scores ( = 3.47, = 0.040) and negative symptom subscale scores ( = 6.76, = 0.002). In the PNS group, the high-dose group showed greater reductions in BPRS total scores ( = 0.001) and negative symptom subscale scores ( = 0.003) than the low-dose group in week 12. In the without PNS group, no significant difference was observed between the high-dose and low-dose groups at any visit. Most adverse reactions were mild or moderate, with extrapyramidal symptoms (9.3%) being most common; 1.5% of patients gained ≥ 7% body weight at 12 weeks.
Blonanserin effectively alleviated the clinical symptoms of first-episode schizophrenia with an acceptable safety profile. High-dose blonanserin is particularly beneficial for patients with PNS in the acute phase of first-episode schizophrenia. However, due to the limitation of ADR reporting the real world, the ADR incidence observed in this study may be underestimated.
布南色林是一种新型抗精神病药物，已证明对治疗阳性和阴性症状均有效。然而，关于其在有或无明显阴性症状（PNS）患者中的剂量依赖性有效性和安全性的研究有限。
评估布南色林单药治疗首发精神分裂症在实际临床环境中的有效性和安全性，并探讨不同剂量布南色林对有PNS和无PNS患者的疗效和安全性。
进行了一项为期12周的多中心前瞻性上市后监测。在本研究中，我们纳入了接受布南色林单药治疗的首发精神分裂症患者。根据简明精神病评定量表（BPRS）阴性症状分量表评分，将患者分为有PNS和无PNS两组。此外，根据患者接受的最大日剂量将其分为高剂量组和低剂量组。使用BPRS评估有效性，通过药物不良反应（ADR）发生率评估安全性。
共有653例患者纳入分析，613例完成研究。BPRS总分从基线时的47.94±16.31显著降至12周时的26.88±9.47（<0.001）。观察到BPRS总分（=3.47，=0.040）和阴性症状分量表评分（=6.76，=0.002）存在PNS×剂量×时间的显著交互作用。在PNS组中，第12周时高剂量组的BPRS总分（=0.001）和阴性症状分量表评分（=0.003）较之于低剂量组下降更为明显。在无PNS组中，高剂量组和低剂量组在任何访视时均未观察到显著差异。大多数不良反应为轻度或中度，锥体外系症状（9.3%）最为常见；1.5%的患者在12周时体重增加≥7%。
布南色林有效缓解了首发精神分裂症的临床症状，安全性可接受。高剂量布南色林对首发精神分裂症急性期有PNS的患者特别有益。然而，由于现实世界中ADR报告的局限性，本研究中观察到的ADR发生率可能被低估。
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