摘要
目的:了解应用贝伐珠单抗的住院患者药源性尿蛋白阳性的情况,计算其真实世界发生率并探究风险因素。方法:借助医疗机构药物不良事件主动监测与智能评估警示系统-Ⅱ(ADE-ASAS-Ⅱ),回顾性监测某三甲医院2018年1月1日–2019年12月31日所有使用贝伐珠单抗的住院患者电子病历信息,确定阳性病例后,应用个案控制匹配1∶1匹配对照组,通过条件逻辑回归识别相关风险因素。结果:1932例用药患者中,出现贝伐珠单抗相关尿蛋白阳性353例,发生率为18.27%,其中三级及以上尿蛋白阳性的发生率为4.04%。相关风险因素有合并肾脏疾病(OR=7.238,95%CI:1.512~34.655),单次使用剂量>5 mg·kg^(-1)(OR=2.055,95%CI:1.359~3.108),使用贝伐珠单抗周期数>10(OR=2.950,95%CI:1.136~7.692),用药前尿糖阳性(OR=2.458,95%CI:1.112~5.434)和收缩压基值偏高(OR=1.714,95%CI:1.073~2.738)。结论:临床使用贝伐珠单抗时,对合并肾脏疾病、患高血压、糖尿病及高剂量、多疗程化疗的住院患者应加强监测,出现蛋白尿后及时干预以避免更严重后果。
Objective:To learn about the real-world incidence of drug-induced proteinuria associated with bevacizumab in hospitalized patients and its risk factors.Methods:The medical records of all inpatients using bevacizumab in our hospital from January 1st,2018 to December 31st,2019 was retrospectively monitored by active adverse events active surveillance and assessment system-Ⅱ(ADE-ASAS-Ⅱ).The individual matching 1∶1 was applied to match the control group after the positive cases were determined.And the relevant risk factors were identified by conditional Logistic regression.Results:Among 1932 patients,353 patients developed proteinuria associated with bevacizumab with an incidence of 18.27%.The incidence of gradeⅢand above proteinuria was 4.04%.The related risk factors included renal disease(OR=7.238,95%CI:1.512-34.655),single dose>5 mg·kg^(-1)(OR=2.055,95%CI:1.359-3.108),the number of cycles of bevacizumab>10(OR=2.950,95%CI:1.136-7.692),positive urine glucose before medication(OR=2.458,95%CI:1.112-5.434),and high baseline of systolic blood pressure(OR=1.714,95%CI:1.073-2.738).Conclusion:During the clinical use of bevacizumab,close monitoring should be taken for inpatients with kidney disease,hypertension,diabetes,high dose and multi-cycle of chemotherapy.Timely intervention should be made in case of proteinuria in order to avoid serious outcomes.
作者
李伯妍
郭代红
王嘉熙
郭海丽
张博
LI Bo-yan;GUO Dai-hong;WANG Jia-xi;GUO Hai-li;ZHANG Bo(Medical School of Chinese PLA,Beijing 100853,China;Department of Pharmacy,Medical Supplies Center of Chinese PLA General Hospital,Beijing 100853,China;School of Pharmacy,Chongqing Medical University,Chongqing 400016,China)
出处
《中国药物应用与监测》
CAS
2022年第2期101-105,共5页
Chinese Journal of Drug Application and Monitoring
基金
2017年军事医学创新工程重点项目(17CXZ010)
中国研究型医院学会委托项目(Y2021FH-YWPJ01)。
关键词
贝伐珠单抗
药品不良反应
自动监测
药物警戒
风险因素
Bevacizumab
Adverse drug reaction
Automatic monitoring
Pharmacovigilance
Risk factor
