布南色林短期治疗精神分裂症的疗效和耐受性: 随机对照试验荟萃分析

doi:10.5246/jcps.2025.12.084

中国药学(英文版) ›› 2025, Vol. 34 ›› Issue (12): 1114-1125.DOI: 10.5246/jcps.2025.12.084

布南色林短期治疗精神分裂症的疗效和耐受性: 随机对照试验荟萃分析

陈玉清¹^,², 王占璋¹^,², 杨欣湖¹^,², 杨烨¹^,², 卢浩扬¹^,², 戴丽静¹^,², 宋娥美³, 温预关¹^,²^,^*()

^1. 广州医科大学附属脑科医院 I期临床研究实验室, 广东广州 510370
^2. 广东省神经科学疾病研究重点实验室、神经致病基因和离子通道病教育部重点实验室, 广东广州 510370
^3. 粤北第三人民医院药剂科, 广东韶关 512200

收稿日期:2025-08-28 修回日期:2025-09-15 接受日期:2025-09-28 出版日期:2025-12-31 发布日期:2025-12-31
通讯作者: 温预关

Efficacy and tolerability of blonanserin in the short-term treatment of schizophrenia: A meta-analysis of randomized controlled trials

Yuqing Chen¹^,², Zhanzhang Wang¹^,², Xinhu Yang¹^,², Ye Yang¹^,², Haoyang Lu¹^,², Lijing Dai¹^,², Emei Song³, Yuguan Wen¹^,²^,^*()

¹ Phase I Clinical Research Laboratory, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou 510370, Guangdong, China
² Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou 510370, Guangdong, China
³ Department of Pharmacy, The Third People’s Hospital of Yuebei, Shaoguan 512200, Guangdong, China

Received:2025-08-28 Revised:2025-09-15 Accepted:2025-09-28 Online:2025-12-31 Published:2025-12-31
Contact: Yuguan Wen
Supported by:
The Guangdong Provincial Hospital Pharmacy Research Fund (Grant No. 2024A34), the Guangdong Provincial Medical Research Fund (Grant Nos. A2024493, A2024771), the International Medical Exchange Foundation of China (Grant No. Z-2014-08-2309-5), the Science and Technology Program of Guangzhou (Grant Nos. 20251A011047, 20252A011018), and the Guangzhou Municipal Key Discipline in Medicine (Suiwei Letter [2024] No. 2184).

摘要/Abstract

摘要：

本研究采用系统评价和荟萃分析的方法, 评价短期使用布南色林与其他对照措施(安慰剂、利培酮和氟哌啶醇)治疗精神分裂症的疗效和安全性, 为其临床治疗精神分裂症提供可靠的药理学依据。本文系统地检索了PubMed、Web of Science、Scopus、中国知网和万方数据库中比较布南色林与其他治疗精神分裂症措施的随机对照试验, 并且提取了以下数据: 作者、年份、国家、诊断标准、样本量、疗程、剂量和结果。使用RevMan 5.3软件对纳入的数据进行了Meta分析。结果发现, 最初共有718项研究, 其中11项符合条件并纳入了我们的分析。就疗效而言, 短期使用布洛南色林并不比利培酮差。使用阳性与阴性综合征量表(PANSS), 布南色林的疗效并不比利培酮差。就PANSS应答而言, 短期服用布南色林明显优于安慰剂。在安全性方面, 短期服用布南色林与安慰剂、利培酮和氟哌啶醇相比, 在发生总体不良事件或导致严重不良事件的风险方面没有统计学差异。此外, 布南色林与其他抗精神病药物之间的不良事件发生率存在明显差异(两组中均≥ 5%)。

关键词: 荟萃分析, 布南色林, 精神分裂症, 随机对照试验

Abstract:

In the present study, a comprehensive systematic review and meta-analysis were conducted to assess the short-term efficacy and safety of blonanserin compared with control interventions, including placebo, risperidone, and haloperidol, in the treatment of schizophrenia. The goal was to provide a robust pharmacological foundation to inform clinical decision-making regarding the therapeutic use of blonanserin. We systematically searched five major databases-PubMed, Web of Science, Scopus, CNKI, and the WanFang Database-for randomized controlled trials (RCTs) evaluating blonanserin against standard comparators in patients with schizophrenia. Key data extracted included study authorship, publication year, geographic location, diagnostic criteria, sample size, treatment duration, dosing regimen, and clinical outcomes. Meta-analytic synthesis was performed using RevMan 5.3 software. Out of an initial pool of 718 articles, 11 trials met the inclusion criteria and were incorporated into the final analysis. In terms of clinical efficacy, short-term administration of blonanserin demonstrated non-inferiority to risperidone, with no indication of inferior performance across Positive and Negative Syndrome Scale (PANSS) subscales. Moreover, blonanserin significantly outperformed the placebo in terms of PANSS response rates, underscoring its therapeutic potential in managing acute symptoms. Regarding safety, the incidence of overall and serious adverse events did not differ significantly between blonanserin and the comparator agents. However, noteworthy distinctions were observed in the adverse event profiles (≥ 5% incidence in either group), underscoring differences in tolerability among the antipsychotics examined. These findings collectively supported the short-term use of blonanserin as a viable and well-tolerated alternative in the pharmacological management of schizophrenia.

Key words: Meta-analysis, Blonanserin, Schizophrenia, Randomized controlled trial

Supporting:

陈玉清, 王占璋, 杨欣湖, 杨烨, 卢浩扬, 戴丽静, 宋娥美, 温预关. 布南色林短期治疗精神分裂症的疗效和耐受性: 随机对照试验荟萃分析[J]. 中国药学(英文版), 2025, 34(12): 1114-1125.

Yuqing Chen, Zhanzhang Wang, Xinhu Yang, Ye Yang, Haoyang Lu, Lijing Dai, Emei Song, Yuguan Wen. Efficacy and tolerability of blonanserin in the short-term treatment of schizophrenia: A meta-analysis of randomized controlled trials[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(12): 1114-1125.

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布南色林短期治疗精神分裂症的疗效和耐受性: 随机对照试验荟萃分析

Efficacy and tolerability of blonanserin in the short-term treatment of schizophrenia: A meta-analysis of randomized controlled trials

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