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目的:分析硝基咪唑类抗菌药物所致肝损害的特点、危险因素和致病机制,为临床安全用药提供参考。方法:利用国内外医药数据库平台,检索与下载硝基咪唑类致肝损害的病例报告,分析硝基咪唑类抗菌药物致肝损害的危险因素及其致病机制。结果:共检索到硝基咪唑类抗菌药物致肝损害病例报告51例,其中甲硝唑为32例,奥硝唑为17例,替硝唑为2例,塞克硝唑尚未见报道;中青年、女性患者和大剂量用药、疗程过长、联合使用肝毒性药物及饮酒等是致肝损害的危险因素;肝损害机制主要涉及药物或代谢产物对肝脏的直接毒性和免疫介导的过敏反应;5例因服用大剂量的甲硝唑致肝衰竭病死。结论:慎重选择用药人群,严格按照药品说明书用药,加强临床用药监测和严格硝基咪唑类药物的监管是预防硝基咪唑类肝损害的重要措施。
OBJECTIVE: To analyze the characteristics, risk factors and pathogenesis of liver damage caused by nitroimidazole antibiotics and to provide reference for the clinical safety of drugs. Methods: The reports of nitroimidazole-induced liver damage were retrieved and downloaded from domestic and foreign medical database platforms. The risk factors of liver damage caused by nitroimidazole antibiotics and their pathogenesis were analyzed. Results: A total of 51 cases of liver damage caused by nitroimidazole antibiotics were reported, including 32 cases of metronidazole, 17 cases of ornidazole and 2 cases of tinidazole. Securoxazole has not been reported yet. Young, female patients and high-dose medication, long course of treatment, combined use of hepatotoxic drugs and alcohol consumption are risk factors for liver damage; liver damage mechanisms mainly involve the direct toxicity of drugs or metabolites on the liver and immune-mediated allergic reactions ; 5 patients died of liver failure due to taking large doses of metronidazole. Conclusion: It is an important measure to prevent nitroimidazole-induced liver damage by careful selection of drug users, administration of drugs in strict accordance with the drug instruction manual, strengthening of clinical drug monitoring and strict supervision of nitroimidazoles.