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卡里卡叶提取物改善化疗诱导的血小板缺血症:一个III期三盲,随机,安慰剂控制的多中心试验

Vikas Ostwal¹, Manali Parulekar¹, Deepali Naughane¹

¹Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.

JCO global oncology

|March 11, 2026

概括

卡里卡叶提取物 (CPLE) 在化疗诱导的血小板缺血症 (CIT) 患者中有效增加了血小板计数. 这项研究发现,CPLE是一种安全且潜在的有益的干预措施,用于在癌症治疗期间管理低血小板数量.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
血液学血液学血液学

背景情况:

卡里卡叶提取物 (CPLE) 以其提高血小板计数 (PCs) 的潜力而闻名.
化疗诱导的血小板缺血 (CIT) 是一个重大的临床挑战,往往需要修改治疗.
现有的CIT治疗方法可能存在局限性,因此需要新的治疗策略.

研究的目的:

为了评估Carica叶提取物 (CPLE) 在加速血小板数恢复方面的疗效.
为了比较CPLE与安慰剂在经历化疗诱导的血小板缺血症 (CIT) 的患者中的有效性.
评估CPLE作为CIT治疗干预措施的安全性.

主要方法:

进行了一项III期随机试验,涉及219名患者.
患者被随机分配在2:1的比例接受CPLE或安慰剂.
治疗继续,直到血小板计数达到≥75,000 × 10⁹/L,需要输血,或高达D+10,修改治疗意图分析.

主要成果:

与安慰剂相比,在CPLE手臂中,在统计学上显著的比例上,患者的血小板计数达到D+4时≥75,000 × 10⁹/L (59%对44%,P = .042).
每项协议分析显示,CPLE显著改善了血小板计数,在D+4时达到>75,000 × 10⁹/L (64%对48%,P = .034).
没有3级或4级与治疗相关的不良事件与CPLE相关;CPLE组中较少的患者需要由于血小板减少而减少化疗剂量.

结论:

卡里卡叶提取物 (CPLE) 显示出作为治疗干预措施的潜力,可以比安慰剂更快更有效地改善化疗诱导的血小板缺血症 (CIT).
CPLE具有良好的安全性概况,没有观察到与治疗相关的重大不良事件.
提取物可能作为二次预防,以帮助维持CIT患者的化疗强度.

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