异甘草酸镁注射液治疗抗结核药物所致急性肝损伤的临床研究

摘要

This study was designed to evaluate the efficacy and safety of Magnesium Isoglycyrrhizinate Injection to treat acute hepatic dysfunction caused by antituberculosis therapies .In this randomized double-blinded and active drug-controlled clinical study , new pulmonary tuberculosis patients with hepatic dysfunction associated with antituberculosis therapies were recruited and randomly divided into two groups and treated with Magnesium Isoglycyrrhizinate Injection and Tiopronin (another liver function protector ,as a controlled drug) ,respectively .The Magnesium Isoglycyrrhizinate Injection group showed more significant improvement in function parameters of liver than the control group . It was concluded that Magnesium Isoglycyrrhizinate Injection can improve acute hepatic dysfunction associated with antituberculosis therapies .%本文旨在研究用异甘草酸镁注射液治疗抗结核药物所致急性肝损伤的有效性和安全性。采用随机、双盲、阳性药平行对照设计，入选者为初治肺结核常规抗结核治疗中发生急性肝功能损伤的患者，试验组采用异甘草酸镁注射液治疗，与对照组（硫普罗宁注射液）进行比较。结果显示，异甘草酸镁注射液在降低主要疗效指标---肝功能综合疗效指标、丙氨酸氨基转移酶（ALT）等方面明显优于对照组（P＜0．01），在降低天冬氨酸氨基转移酶（AST）、碱性磷酸酶（AKP）等方面也优于对照组（P＜0．05），且未发生明显不良反应。本研究提示，异甘草酸镁注射液在治疗抗结核药物引发的急性肝损伤中安全、有效。