
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
郭新枝,陈裕,程俊伟,陈永芳,张晓慧,王志刚,刘宝琴
微生物与感染 ›› 2013, Vol. 8 ›› Issue (3) : 157-162.
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
Randomized double blinded and active drug-controlled clinical study of Magnesium Isoglycyrrhizinate Injection in the treatment of antituberculosis drug-induced acute hepatic dysfunction
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<0.001),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。
This study was designed to evaluate the efficacy and safety of Magnesium Isoglycyrrhizinate Injection to treat acute hepatic dysfunction caused by anti-tubercular therapies. In this randomized double blinded and active drug controlled clinical study, new pulmonary tuberculosis patients with hepatic dysfunctiondeterioration associated with anti-tubercular therapies were recruited and randomly divided into two groups and treated with Magnesium Isoglycyrrhizinate Injection and Tiopronin (another liver function protector, as an 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 anti-tubercular therapies.
Magnesium isoglycyrrhizinate / Pulmonary tuberculosis / Drug-induced liver injury / Anti-tuberculosis drug
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