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.
出处
《实用肝脏病杂志》
CAS
2022年第1期62-65,共4页
Journal of Practical Hepatology
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
Drug-induced liver injury
Pulmonary tuberculosis
Anti-tuberculosis treatment
Diammonium glycyrrhetate
Prevention
