1857名非对乙酰氨基酚肝损患者应用乙酰半胱氨酸注射液的不良反应监测结果及分析  

Monitoring results and analysis of adverse drug reactions caused by N-acetylcysteine injection in 1857 patients with non-acetaminophen-induced liver injury

作　　者：陈大宇 卞晓洁[1,2] 刘金春[1,2] 刘淑君 任昊桢[3] 施晓雷[3] 张海霞[1,2] CHEN Da-yu;BIAN Xiao-jie;LIU Jin-chun;LIU Shu-jun;REN Hao-zhen;SHI Xiaolei;ZHANG Hai-xia(Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University,Department of Pharmacy,Jiangsu Nanjing 210000,China;Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University,Nanjing Medical Center of Clinical Pharmacy,Jiangsu Nanjing 210000,China;Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University,Department of Hepatobiliary&Pancreatic Surgery,Jiangsu Nanjing 210000,China;Nanjing Drum Tower Clinical College of Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Jiangsu Nanjing 210000,China)

机构地区：[1]南京大学医学院附属鼓楼医院药学部,江苏南京210000 [2]南京大学医学院附属鼓楼医院南京临床药学中心,江苏南京210000 [3]南京大学医学院附属鼓楼医院肝胆胰中心,江苏南京210000 [4]南京中医药大学中西医结合鼓楼临床医学院,江苏南京210000

出　　处：《中国医院药学杂志》2022年第3期308-312,共5页Chinese Journal of Hospital Pharmacy

基　　金：中国毒理学会临床毒理专项研究课题(编号:CST2019CT305);南京大学医院管理研究所课题项目和南京鼓楼医院医学发展医疗救助基金会资助项目(编号:NDYG2020052)。

摘　　要：目的:监测乙酰半胱氨酸注射液的不良反应,寻找影响乙酰半胱氨酸注射液发生无法耐受治疗的严重不良反应的危险因素。方法:针对接受乙酰半胱氨酸注射液治疗的非对乙酰氨基酚肝损伤患者进行了回顾性分析。共收集1857名患者的乙酰半胱氨酸注射液的药物治疗方案,结合相关临床数据进行多因素分析。结果:纳入研究的1857名患者中,共有537名患者(28.92%)发生不良反应,而无法耐受乙酰半胱氨酸注射液治疗的严重不良反应患者共141名(7.59%),导致患者无法耐受治疗的高危因素有:日剂量大于137 mg·kg^(-1)·d^(-1),(OR=8.74,95%CI:4.11~18.56,P<0.001);初始谷草转氨酶(AST)≤261.40 U·L^(-1),(OR=2.56,95%CI:1.25~5.26,P=0.01);初始终末期肝病评分(MELD评分)≤5.96,(OR=2.08,95%CI:1.08~4.00,P=0.03)。结论:乙酰半胱氨酸注射液的整体不良反应发生率为28.92%,经处理仍不能耐受的不良反应发生率为7.59%,乙酰半胱氨酸注射液日剂量大于137 mg·kg^(-1)、较低的初始谷草转氨酶(AST≤261.40 U·L^(-1))和初始MELD评分较低(≤5.96)是发生无法耐受治疗的严重不良反应的高危因素。OBJECTIVE To analyze and monitor the adverse drug reactions(ADRs)and to find the risk factors in intolerable severe ADRs caused by N-acetylcysteine(NAC)injection.METHODS A retrospective study was performed on patients with non-acetaminophen-induced liver injury.The NAC injection therapy plans and clinical data of 1857 patients were reviewed for multivariable analysis.RESULTS ADRs were identified in 537 patients(28.92%),and among them,141 patients(7.59%)suffered from severe ADRs.Three independent risk factors were identified:dosage over 137 mg·kg^(-1)·d^(-1)(OR=8.74,95%CI:4.11-18.56,P<0.001),initial AST≤261.40 U·L^(-1)(OR=2.56,95%CI:1.25-5.26,P=0.01)and initial MELD score≤5.96(OR=2.08,95%CI:1.08-4.00,P=0.03).CONCLUSION The overall incidence of ADRs is 28.92%,and the incidence of severe ADRs is 7.59%.High dosage of NAC injection,low initial AST and low initial MELD score increase the risks of severe ADRs during the therapy.

关 键 词：肝损伤 药物不良反应 乙酰半胱氨酸注射液 

分 类 号：R975.5[医药卫生—药品]