苦黄注射液预防抗结核药物导致的药物性肝损伤患者疗效研究

Administration of Kuhuang,a herbal injection compound,in preventing anti-tuberculosis drug-induced liver injury in patients with naïve pulmonary tuberculosis

目的本研究观察了应用苦黄注射液预防抗结核药物诱发药物性肝损伤(DILI)的作用,以避免不合理的抗痨中断治疗。方法2022年3月~2022年11月我院收治的97例肺结核患者,被随机分为试验组50例和对照组47例。所有患者均接受标准的2HREZ/4HR抗结核治疗,试验组在此治疗的基础上加用苦黄注射液治疗8周。采用ELISA法检测血清白介素6(IL-6)和肿瘤坏死因子-α(TNF-α),采用放射免疫法检测血清血红素加氧酶(HO-1)和超氧化物歧化酶(SOD)水平。结果在治疗4周末,试验适应性肝损伤和DILI发生率分别为6.0%和2.0%,显著低于对照组的17.0%和8.5%(P<0.05),在治疗8周末,试验组适应性肝损伤和DILI发生率分别为6.0%和4.0%,显著低于对照组的21.3%和17.0%(P<0.05);在治疗8周末,试验组血清ALT、AST和TBIL水平分别为(28.4±23.4)U/L、(30.8±18.7)U/L和(12.9±7.3)μmol/L,显著低于对照组【分别为(53.1±33.1)U/L、(52.5±37.7)U/L和(20.1±10.9)μmol/L,P<0.05】;试验组血清HO-1和SOD水平分别为(200.3±14.0)U/L和(418.0±18.7)U/L,显著高于对照组【分别为(128.8±21.4)U/L和(318.0±15.1)U/L,P<0.05】,而血清IL-6和TNF-α水平分别为(11.4±1.9)ng/L和(9.3±1.8)ng/L,显著低于对照组【分别为(17.5±4.0)ng/L和(14.5±3.0)ng/L,P<0.05】。结论在抗痨开始时应用苦黄能够显著降低DILI的发生,尽可能地维持标准化抗结核治疗,且安全性良好。

Objective This study was to observe the Kuhuang,a herbal injection compound,in preventing anti-tuberculosis drugs(ATD)-induced liver injury(DILI)for avoiding unreasonable anti-tuberculosis treatment interruption.Methods A total of 97 patients with naïve pulmonary tuberculosis were encountered in our hospital between March 2022 and November 2022,and were randomly divided into control(n=47)and observation(n=50)groups,receiving standardized 2HREZ/4HR anti-tuberculosis therapy,or intravenous injection of Kuhuang compound at base of anti-tuberculosis for 8 weeks.Serum interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)levels were detected by ELISA,and serum heme oxygenase(HO-1)and superoxide dismutase(SOD)levels were detected by radioimmunoassay.Results At the end of 4 week anti-tuberculosis treatment,the incidences of adaptive liver injury(ALI)and DILI in the observation group were 6.0%and 2.0%,much lower than 17.0%and 8.5%(P<0.05)in the control,and at the end of 8 week treatment,the incidences of ALI and DILI were 6.0%and 4.0%,much lower than 21.3%and 17.0%(P<0.05)in the control group;at the end of 8 week treatment,serum ALT,AST and total bilirubin levels in the observation group were(28.4±23.4)U/L,(30.8±18.7)U/L and(12.9±7.3)μmol/L,all significantly lower than[(53.1±33.1)U/L,(52.5±37.7)U/L and(20.1±10.9)μmol/L,respectively,P<0.05]in the control;serum HO-1 and SOD levels were(200.3±14.0)U/L and(418.0±18.7)U/L,both significantly higher than[(128.8±21.4)U/L and(318.0±15.1)U/L,P<0.05],while serum IL-6 and TNF-αlevels were(11.4±1.9)ng/L and(9.3±1.8)ng/L,both significantly lower than[(17.5±4.0)ng/L and(14.5±3.0)ng/L,respectively,P<0.05]in the control.Conclusion The administration of Kuhuang injection compound could prevent the occurrence of anti-tuberculosis DILI,and guarantee the standardized anti-tuberculosis treatment completing.