风口浪尖的羟乙基淀粉被引量：2

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摘要 2013年6月11日和24日，美国食品和药品管理局（FDA）在分析近期发表的有关人工胶体代血浆羟乙基淀粉注射液（ hydroxyethyl starch injection，HES-i）的多个随机对照试验、观察性研究及Meta分析h挖’后，先后2次发布警告，指出HES-i有增加死亡并导致严重肾损伤及过度出血的风险，要求企业修改说明书，添加黑框警告。FDA强调：（1）对脓毒症和重症监护室患者不应使用含有HES-i的治疗方案；（2）HES-i禁用于既往存在肾功能不全的患者；（3）一旦出现肾功能损伤的指征，应立即停药；（4）对所有使用HES-i超过90d的患者，需要开始进行肾脏替代治疗（如肾脏透析）并继续监测肾功能至少90d；（5）HES-i禁用于正在施行体外循环心脏直视手术的患者；（6）患者出现凝血功能障碍时应立即停用HES-i。

作者孙忠实

机构地区海军总医院药剂科

出处《药物不良反应杂志》 CSCD 2013年第4期181-182,共2页 Adverse Drug Reactions Journal

关键词羟乙基淀粉注射液美国食品和药品管理局体外循环心脏直视手术 INJECTION 肾功能不全随机对照试验 Meta分析肾脏替代治疗

分类号 R595.3 [医药卫生—内科学]

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