白芍总苷联合双环醇治疗轻症自身免疫性肝炎临床观察

Clinical observation of total glucosides of paeony combined with bicyclol in the treatment of mild autoimmune hepatitis

目的:探讨白芍总苷联合双环醇治疗轻症自身免疫性肝炎(autoimmnue hepatitis,AIH)的临床疗效及安全性。方法:选取2020年4月-2023年4月收治的56例轻症AIH患者,随机分为治疗组与对照组,每组患者28例。治疗组给予白芍总苷(0.6 g/次,3次/天)联合双环醇(50 mg/次,3次/天)口服治疗,对照组仅给予双环醇(50 mg/次,3次/天)口服治疗,测定两组患者治疗基线,治疗12、24周的肝脏炎症学指标、免疫学相关指标、肝纤维化指标并记录药物相关不良反应。结果:24周后治疗组、对照组总有效率分别为89.29%、60.71%,差异具有统计学意义(P=0.037);两组患者ALT、AST、CD4^(+)T(%)、CD8^(+)T(%)、总球蛋白、IgG水平差异具有统计学意义(P<0.001),而ALP及肝硬度值(liver stiffness measurement,LSM)差异无统计学意义(P=0.570,0.671)。与对照组相比,24周后治疗组患者具有更低的ALT、AST、CD8^(+)T(%)、总球蛋白、IgG水平及更高的CD4^(+)T水平(P<0.001)。与基线相比,24周后两组患者LSM值均下降。两组患者不良反应发生率差异无明显统计学意义(P=1.0)。结论:白芍总苷联合双环醇治疗轻症AIH可以更好地改善肝脏炎症水平、调节机体免疫状态、控制肝纤维化进展且不增加药物不良反应发生率。

Objective:To observe the clinical effect and safety of total glucoside of paeony combined with bicyclol in the treatment of mild autoimmnue hepatitis.Methods:A total of 56 patients with mild AIH admitted from April 2020 to April 2023 were randomly divided into treatment group and control group,with 28 patients in each group.The treatment group was given total glucosides of paeony(0.6 g/time,3 times/d)combined with bicyclol(50 mg/time,3 times/d)oral treatment,while the control group was only given bicyclol(50 mg/time,3 times/d)oral treatment.The liver inflammation indexes,immunological related indexes and liver fibrosis indexes of the two groups were measured at baseline,12 weeks and 24 weeks of treatment,and the drug-related adverse reactions were recorded.Results:After 24 weeks,the total effective rates of the treatment group and the control group were 89.29%and 60.71%,respectively,and the difference was statistically significant(P=0.037).There were significant differences in ALT,AST,CD4^(+)T(%),CD8^(+)T(%),total globulin and IgG levels between the two groups(P<0.001),but there was no significant difference in ALP and liver stiffness measurement(LSM)between the two groups(P=0.72).Compared with the control group,the levels of ALT,AST,CD8^(+)T(%),total globulin and IgG in the treatment group decreased,and the level of CD4^(+)T(%)increased after 24 weeks.Compared with the baseline,the LSM values of the two groups decreased after 24 weeks.There was no significant difference in the incidence of adverse reactions between the two groups(P=1.0).Conclusion:Total glucosides of paeony combined with bicyclol can better improve the level of liver inflammation in patients with mild AIH,regulate the immune status of the body,control the progression of liver fibrosis and do not increase the incidence of adverse drug reactions.