中国临床药学杂志

目的 探讨住院人群中注射用顺铂相关急性肾损伤的临床特征及影响因素，为临床安全合理用药提供参考。方法 基于“医疗机构药物不良事件主动监测与智能评估警示系统”，回顾性监测2012年1月1日至2019年12月31日期间我院使用注射用顺铂（冻干型，10 mg）的住院病例，分析其相关急性肾衰竭（AKI）的发生特征，采用倾向性评分匹配的方法选取对照组以探究相关影响因素。结果 14 287例使用注射用顺铂的住院患者中290例发生AKI，发生率为2.03%;logistic回归模型分析结果显示注射用顺铂相关AKI的影响因素主要包括体质量指数（OR=0.944,95%CI:0.895～0.997）、既往糖尿病史（OR=1.956,95%CI:1.111～3.446）、既往顺铂用药史（OR=1.718,95%CI:1.145～2.577）、联用利尿剂（OR=4.505,95%CI:2.624～7.733）、贫血（OR=3.273,95%CI:2.114～5.068）、尿蛋白异常（OR=1.906,95%CI:1.188～3.056）。结论 “医疗机构药物不良事件主动监测与智能评估警示系统”可精准高效地获取大样本目标用药人群的真实世界数据；注射用顺铂相关AKI属常见的药品不良反应；临床使用注射用顺铂应关注体质量指数高、有糖尿病史和顺铂用药史的患者，加强血红蛋白及尿蛋白水平的监测。

AIM To investigate the clinical characteristics and influencing factors of acute kidney injury(AKI) associated with cisplatin for injection in hospitalized patients and provide reference for clinical safe and rational drug use. METHODS Based on the “adverse drug event active surveillance and assessment system(ADE-ASAS)”, a retrospective study was conducted for hospitalized patients who received cisplatin for injection(lyophilized, 10 mg) from January 1, 2012 to December 31, 2019. The incidence and characteristics of AKI were analyzed. Propensity score matching(PSM) method was used to select the control group to explore the relevant influencing factors. RESULTS Among 14 287 hospitalized patients receiving cisplatin for injection, 290 patients were finally identified as AKI with an incidence rate of 2.03%. Logistic regression model analysis showed that the main influencing factors of cisplatin for injection induced AKI included body mass index(BMI)(OR = 0.944, 95% CI 0.895-0.997), previous diabetes history(OR = 1.956, 95% CI 1.111-3.446), previous cisplatin using history(OR = 1.718, 95% CI 1.145-2.577), combined use of diuretics(OR = 4.505, 95% CI 2.624-7.733), anemia(OR = 3.273, 95% CI 2.114-5.068) and abnormal urinary protein(OR = 1.906, 95% CI 1.188-3.056). CONCLUSION ADE-ASAS can accurately and efficiently obtain the real world data for a large sample of target drug users. AKI associated with cisplatin for injection is a common adverse drug reaction. In clinical use of cisplatin for injection, attention should be paid to patients' higher BMI, previous diabetes history and cisplatin using history. The monitoring of hemoglobin and urinary protein levels should also be strengthened.