Lan Zheng, Long Zhiguang, Jiang Haiyan, Huang Cuishan, Huang Wei
Department of Psychiatry, Xinshi Hospital, Foshan, Guangdong, China.
Department of Psychiatry, The Third People's Hospital of Foshan, Foshan, Guangdong, China.
Front Psychiatry. 2025 May 30;16:1606320. doi: 10.3389/fpsyt.2025.1606320. eCollection 2025.
Gender differences in antipsychotic efficacy for schizophrenia (SCZ) remain understudied despite evidence of sex-dependent pharmacokinetic, neurobiological, and social factors influencing outcomes. This trial compared 9 - month efficacy and tolerability of paliperidone palmitate injection 1-monthly (PP1M) versus extended-release tablets in male and female patients with SCZ, with a focus on gender-stratified results.
This randomized, open-label study enrolled 118 adult patients (61 males, 57 females) diagnosed with SCZ. Participants were randomized (1:1) to receive either paliperidone extended-release (ER) tablets (titrated 3-12 mg/day) or PP1M (3-9 mg monthly). Efficacy was assessed via PANSS total scores and CGI-S severity ratings at 3, 6, and 9 months. Safety was evaluated using the TESS scale.
Gender-stratified analysis revealed superior long-term efficacy for males treated with paliperidone palmitate injection. Males treated with PP1M demonstrated significantly greater reductions in PANSS scores (mean difference at 9 months: -7.44; p < 0.05) and CGI-S severity compared to ER therapy. Females showed no statistically significant differences between formulations at any time point, with overlapping confidence intervals (e.g., PANSS mean difference at 9 months: +3.16; p > 0.05). Both groups exhibited comparable tolerability, with minimal adverse events.
Gender-informed treatment strategies are critical in SCZ management. PP1M appears advantageous for males seeking long-term symptom stabilization, while treatment selection for females may prioritize lifestyle factors. These findings underscore the need for sex-stratified analysis in antipsychotic trials and the importance of tailored interventions to address sex-based disparities in psychiatric care.
尽管有证据表明药代动力学、神经生物学和社会因素存在性别差异会影响精神分裂症（SCZ）的治疗结果，但抗精神病药物对精神分裂症疗效的性别差异仍未得到充分研究。本试验比较了每月注射一次棕榈酸帕利哌酮（PP1M）与缓释片对男性和女性SCZ患者的9个月疗效和耐受性，重点关注性别分层结果。
这项随机、开放标签研究纳入了118名被诊断为SCZ的成年患者（61名男性，57名女性）。参与者被随机分配（1:1）接受帕利哌酮缓释（ER）片（滴定至3 - 12毫克/天）或PP1M（每月3 - 9毫克）。在3、6和9个月时通过阳性和阴性症状量表（PANSS）总分及临床总体印象量表（CGI-S）严重程度评分评估疗效。使用不良反应量表（TESS）评估安全性。
性别分层分析显示，接受棕榈酸帕利哌酮注射治疗的男性具有更好的长期疗效。与ER治疗相比，接受PP1M治疗的男性在PANSS评分（9个月时平均差异：-7.44；p < 0.05）和CGI-S严重程度方面的降低更为显著。女性在任何时间点的两种剂型之间均未显示出统计学上的显著差异，置信区间重叠（例如，9个月时PANSS平均差异：+3.16；p > 0.05）。两组的耐受性相当，不良事件极少。
基于性别的治疗策略在SCZ管理中至关重要。PP1M对寻求长期症状稳定的男性似乎具有优势，而女性的治疗选择可能优先考虑生活方式因素。这些发现强调了在抗精神病药物试验中进行性别分层分析的必要性，以及针对精神科护理中基于性别的差异进行量身定制干预的重要性。
