甘草酸二铵肠溶胶囊预防初治的肺结核患者药物性肝损害有效性研究  

Prevention of drug-induced liver injury by orally diammonium glycyrrhetate in na ve patients with pulmonary tuberculosis

作　　者：姜晓颖[1] 杨恒 李明武 袁保东 田明[5] 徐金田 梅早仙[7] 潘洪秋 刘向 陈晓红 于德美 李成俊[12] 高绪胜 刘旭晖 刘建峰 金龙 王均琴[16] 李亮[1] Jiang Xiaoying;Yang Heng;Li Mingwu(Beijing Institute of Tuberculosis and Thoracic Tumor,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院北京市结核病胸部肿瘤研究所/中国疾病预防控制中心结核病防治临床中心,北京市101149 [2]复旦大学附属上海市公共卫生临床中心 [3]昆明第三人民医院 [4]武汉市结核病防治所 [5]四川成都市传染病医院 [6]杭州师范大学附属医院 [7]天津海河医院 [8]镇江第三人民医院 [9]新疆维吾尔自治区胸科医院 [10]福州市肺科医院 [11]西安市结核病胸部肿瘤医院 [12]沈阳市胸科医院 [13]山东省胸科医院 [14]江西省胸科医院 [15]黑龙江省传染病防治院 [16]南京中医药大学

出　　处：《实用肝脏病杂志》2022年第1期62-65,共4页Journal of Practical Hepatology

摘　　要：目的评估给予预防性护肝治疗在抗结核治疗过程对降低药物性肝损伤(DILI)发生的作用。方法采用多中心、开放、随机、平行对照试验设计,在全国14家结核病专科医院纳入初治涂片细菌阳性肺结核患者933例,随机分为试验组495例和对照组438例,两组均采用2HREZ/4HR抗结核方案,治疗6个月。抗结核治疗的同时给予试验组甘草酸二铵肠溶胶囊治疗,不给予对照组任何护肝药物。结果在933例患者中,DILI总发生率为31.9%,其中试验组为27.7%,显著低于对照组的36.8%(P<0.05);试验组因DILI导致改变抗结核治疗方案发生率为3.2%,显著低于对照组的7.8%(P<0.05);在治疗6月末,两组痰菌转阴率分别为91.8%和92.2%(P>0.05);两组在肝损伤以外不良事件发生率分别为25.4%和30.7%(P=0.054)。结论应用甘草酸二铵肠溶胶囊预防性护肝治疗可减少抗结核治疗过程中肝损伤的发生,且不增加其他不良反应,对维持抗结核方案有益。Objective The aim of this study was to investigate the prevention of drug-induced liver injury(DILI) by orally diammonium glycyrrhetate in naive patients with pulmonary tuberculosis(PT).Methods A multi-centered,open,randomized,parallel controlled clinical trial was conducted in 14 specialized tuberculosis hospitals in China,and 933 patients with PT were recruited and randomly divided into observation(n=495) and control(n=438),receiving six month 2 HREZ/4 HR regimen.The patients in the observation received diammonium glycyrrhetate enteric-coated capsules during anti-tuber-culosis chemotherapy,whilethose in the control group didn’t receive any hepatoprotectants.Results During the anti-tuber-culosis therapy,the incidence of DILI in our series of 933 patients was 31.9%,and of which,that was 27.7% in the observation,significantly lower than 36.8%(P<0.05) in the control;the incidence of regimen change owing to DILI in the observation was 3.2%,significantly lower than 7.8%(P<0.05) in the control;at the end of six month therapy,thesputum smear negative rates were 91.8% and 92.2%(P>0.05) in the two groups;the incidences of side effects other than DILI were 25.4% and 30.7%(P=0.054) in the two groups.Conclusion Our findings suggest that the preventive administration ofdiammonium glycyrrhetate could reduce the incidence of DILI during antituber-culosis treatment,which might keep the regimen going smoothly.

关 键 词：药物性肝损伤 肺结核 抗结核药物治疗 甘草酸二铵 预防 

分 类 号：R521[医药卫生—内科学]