[Early efficacy and safety of sotatercept in the treatment of pulmonary arterial hypertension in a Chinese population: a single-center case series analysis].
📚 期刊: Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and📅 发表: 0000-00-00🔬 PMID: 42557069🔗 DOI:10.3760/cma.j.cn112147-20260401-00176👁️ 浏览: 2
👤 作者: Xiao QX, Li JJ, Ding YJ, Li QY, Ni YM
高血压
📑 引用格式
APAVancouver国标 GB/T 7714BibTeXRIS
Xiao QX, Li JJ, Ding YJ, Li QY, Ni YM (0000). [Early efficacy and safety of sotatercept in the treatment of pulmonary arterial hypertension in a Chinese population: a single-center case series analysis].. Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and. https://doi.org/10.3760/cma.j.cn112147-20260401-00176
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📝 摘要
Objective: To preliminarily evaluate the efficacy and safety of sotatercept in patients with pulmonary arterial hypertension (PAH) in China. Methods: This single-center, retrospective case series analysis included seven consecutive PAH patients treated at Ruijin Hainan Hospital, Shanghai Jiao Tong University School of Medicine, who received sotatercept in addition to stable background therapy from May to December 2025. Key efficacy indicators included 6-minute walk distance (6MWD), World Health Organization functional class (WHO FC), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and systolic pulmonary artery pressure (PASP). The core safety indicators were the dynamic changes in hemoglobin (Hgb) and platelet count (PLT). Results: Of the seven patients treated with sotatercept, one received only a single dose and discontinued for personal reasons, and was therefore excluded from subsequent analysis. The remaining six patients completed one-month follow-up, with three completing both one-and three-month follow-ups. At one month, 6MWD significantly improved in five of six patients (5/6), with further improvement in two of three patients (2/3) at three months. At the one-month follow-up, NT-proBNP significantly decreased in five of six patients (5/6) compared to baseline, with further reduction in one of three patients (1/3) at the three-month follow-up. At the three-month follow-up, echocardiographic estimates of pulmonary artery pressure decreased in two of three patients (2/3), and WHO FC improved in two of three patients (2/3). Among the six patients, one (1/6) had a delayed sotatercept dose due to an excessive increase in hemoglobin, and one developed a decrease in platelet count; no other adverse reactions occurred. Conclusions: Sotatercept demonstrated significant short-term improvements in cardiac function and exercise capacity in Chinese PAH patients, with a manageable safety profile. However, due to the small sample size and short follow-up period, these findings require further validation through large-scale, long-term prospective studies. 目的: 初步评估索特西普在我国动脉性肺动脉高压(PAH)患者中的疗效和安全性。 方法: 本研究为一项单中心、回顾性病例系列分析。连续纳入上海交通大学医学院附属瑞金医院海南医院2025年5月至12月接受稳定常规治疗并加用索特西普的7例PAH患者。主要疗效指标包括6 min步行距离、世界卫生组织心功能分级(WHO FC)、N末端B型利钠肽前体(NT-proBNP)和收缩期肺动脉压力(PASP)。安全性核心指标为血红蛋白与血小板计数的动态变化。 结果: 7例接受了索特西普治疗的患者中1例仅接受1次治疗,因个人原因中断治疗,因此没有纳入后续的数据统计;其余6例患者均完成了1个月随访,3例完成了3个月随访。5例患者在1个月随访节点6 min步行距离显著提高,2例患者在3个月随访节点6 min步行距离进一步提高;5例患者在1个月随访节点NT-proBNP较基线明显下降,1例在3个月随访节点NT-proBNP进一步下降;2例在3个月随访节点心脏超声估测肺动脉压力较基线下降,2例患者WHO FC改善。不良反应方面:1例(1/6)因血红蛋白升高幅度过大,延期使用索特西普;1例(1/6)出现血小板下降;无其他不良反应发生。 结论: 索特西普对我国PAH患者的心功能及运动能力在治疗后短期内显示出显著的改善作用,且安全性可控。但本研究样本量较小、随访时间较短,有待大样本、长期随访的前瞻性研究进一步验证。.