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

doi:10.3969/j.issn.1672-5069.2022.01.016

实用肝脏病杂志 ›› 2022, Vol. 25 ›› Issue (1): 62-65.doi: 10.3969/j.issn.1672-5069.2022.01.016

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

姜晓颖, 杨恒, 李明武, 袁保东, 田明, 徐金田, 梅早仙, 潘洪秋, 刘向, 陈晓红, 于德美, 李成俊, 高绪胜, 刘旭晖, 刘建峰, 金龙, 王均琴, 李亮

101149 北京市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(姜晓颖,李亮);复旦大学附属上海市公共卫生临床中心(杨恒,刘旭辉);昆明第三人民医院(李明武);武汉市结核病防治所(袁保东);四川成都市传染病医院(田明);杭州师范大学附属医院(徐金田);天津海河医院(梅早仙);镇江第三人民医院(潘洪秋);新疆维吾尔自治区胸科医院(刘向);福州市肺科医院(陈晓红);西安市结核病胸部肿瘤医院(于德美);沈阳市胸科医院(李成俊);山东省胸科医院(高绪胜);江西省胸科医院(刘建峰);黑龙江省传染病防治院(金龙);南京中医药大学(王均琴)

收稿日期:2020-12-29 发布日期:2022-01-12
通讯作者: 李亮,E-mail:liliang69@hotmail.com
作者简介:姜晓颖,女,硕士研究生。E-mail:Ying060606@163.com;共同第一作者:杨恒,女,25岁,硕士研究生。E-mail:1831213235@qq.com

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

Jiang Xiaoying, Yang Heng, Li Mingwu, et al

Beijing Institute of Tuberculosis and Thoracic Tumor, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China

Received:2020-12-29 Published:2022-01-12

摘要/Abstract

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。

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

Abstract: Objective The aim of this study was to investigate the prevention of drug-induced liver injury(DILI) by orally diammonium glycyrrhetate in naïve 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 2HREZ/4HR regimen. The patients in the observation received diammonium glycyrrhetate enteric-coated capsules during anti-tuberculosis chemotherapy, whilethose in the control group didn't receive any hepatoprotectants. Results During the anti－tuberculosis 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 than36.8%(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 anti-tuberculosis treatment, which might keep the regimen going smoothly.

Key words: Drug-induced liver injury, Pulmonary tuberculosis, Anti-tuberculosis treatment, Diammonium glycyrrhetate, Prevention

姜晓颖, 杨恒, 李明武, 袁保东, 田明, 徐金田, 梅早仙, 潘洪秋, 刘向, 陈晓红, 于德美, 李成俊, 高绪胜, 刘旭晖, 刘建峰, 金龙, 王均琴, 李亮. 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[J]. 实用肝脏病杂志, 2022, 25(1): 62-65.

Jiang Xiaoying, Yang Heng, Li Mingwu, et al. Prevention of drug-induced liver injury by orally diammonium glycyrrhetate in naïve patients with pulmonary tuberculosis[J]. Journal of Practical Hepatology, 2022, 25(1): 62-65.

参考文献

[1] World Health Organization (WHO). Global tuberculosis report 2018. WHO Press, Geneva, WHO/CDS/TB/2018.20.
[2] Zhou Y, Yang L, Liao Z, et al. Epidemiology of drug-induced liver injury in China:a systematic analysis of the Chinese literature including 21,789 patients. Eur J Gastroenterol Hepatol, 2013,25(7):825-829.
[3] Shen T, Liu Y, Shang J, et al. Incidence and etiology of drug-induced liver injury in mainland China. Gastroenterology,2019,156(8):2230-2241.
[4] Yew WW, Chang KC, Chan DP. Oxidative stress and first-line antituberculosis drug-induced hepatotoxicity. Antimicrob Agents and Chemother,2018,62(8):e02637-2717.
[5] Abbara A, Chitty S, Roe JK, et al. Drug-induced liver injury from antituberculous treatment: a retrospective study from a large TB centre in the UK. BMC Infect Dis, 2017,17(1):231.
[6] Jaydeokar AV, Bandawane DD, Bibave KH, et al. Hepatoprotective potential of cassia auriculata roots on ethanol and antitubercular drug-induced hepatotoxicity in experimental models. Pharm Biol, 2014,52(3):344-355.
[7] Xu L, Zhang F, Xu C, et al. Is the prophylactic use of hepatoprotectants necessary in anti-tuberculosis treatment? Chemotherapy, 2017,62(5):269-278.
[8] Wu S, Xia Y, Lv X, et al. Preventive use of hepatoprotectors yields limited efficacy on the liver toxicity of anti-tuberculosis agents in a large cohort of Chinese patients. Gastroenterol Hepatol, 2015,30(3):540-545.
[9] Ghosh N, Ghosh R, Mandal V, et al. Recent advances in herbal medicine for treatment of liver diseases. Pharm Biol, 2011,49(9):970-988.
[10] 中华人民共和国卫生部.WS288--2008,肺结核诊断标准.北京:人民卫生出版社,2008.
[11] 中华医学会结核病学分会.抗结核药所致药物性肝损伤诊断与处理专家建议.中华结核和呼吸杂志,2013,36(10):732-736.
[12] 肖东楼,马玙,朱莉贞,等.抗结核药品不良反应诊疗手册. 2010:14-62.
[13] Baskaran UL, Sabina EP. Clinical and experimental research in antituberculosis drug-induced hepatotoxicity: a review. J Integr Med, 2017,15(1):27-36.
[14] Sun QQ, Zhang J, Gu WW, et al. Prevalence, risk factors, management, and treatment outcomes of first-line antituberculous drug-induced liver injury: a prospective cohort study. Pharmacoepidemiol Drug Saf, 2016,25(8):908-917.
[15] Chang TE, Huang YS, Chang CH, et al. The susceptibility of anti-tuberculosis drug-induced liver injury and chronic hepatitis C infection: A systematic review and meta-analysis. Chin Med Assoc, 2018,81(2):111-118.
[16] Teleman MD, Chee CB, Earnest A, et al. Hepatotoxicity of tuberculosis chemotherapy under general programme conditions in Singapore. Int J Tuberc Lung Dis, 2002,6(8):699-705.
[17] Lee SS, Lee CM, Kim TH, et al. Frequency and risk factors of drug-induced liver injury during treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis, 2016,20(6):800-805.
[18] Wong WM, Wu PC,Yuen MF, et al. Antituberculosis drug-related live dysfunction in chronic hepatitis B infection. Hepatology, 2000,31(1):201-206.
[19] Liu YM, Cheng YJ, Li YL, et al. Antituberculosis treatment and hepatotoxicity in patients with chronic viral hepatitis. Lung, 2014,192(1):205-210.
[20] Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc, 2014,89(1):95-106.
[21] Lee CM, Lee SS, Lee JM, et al. Early monitoring for detection of antituberculous drug-induced hepatotoxicity. Korean J Intern Med, 2016,31(1):65-72.

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 naïve patients with pulmonary tuberculosis

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