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

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...

Monitoring results and analysis of adverse drug reactions caused by N-acetylcysteine injection in 1 857 patients with non-acetaminophen-induced liver injury

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 1 857 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.