疏肝利胆颗粒治疗原发性胆汁性胆管炎72例的疗效观察

Observation of the Therapeutic Efficacy of Shugan Lidan Granule on 72 Cases of Primary Biliary Cholangitis

目的:探讨疏肝利胆颗粒治疗原发性胆汁性胆管炎(PBC)胆腑郁热证患者效果。方法:纳入兰州大学第一医院普外科就诊的72例胆腑郁热证PBC患者,根据数字奇偶法分为对照组和治疗组,每组36例。对照组服用熊去氧胆酸胶囊治疗,治疗组服用熊去氧胆酸胶囊+疏肝利胆颗粒治疗。比较两组临床症状、微炎症指标[白细胞介素6(IL-6)、白细胞介素17(IL-17)、肿瘤坏死因子-α(TNF-α)]、肝功能[谷草转氨酶(AST)、总胆红素(TBIL)、谷丙转氨酶(ALT)]、氧化应激指标[丙二醛(MDA)、谷胱甘肽过氧化物酶(GSH-Px)、超氧化物歧化酶(SOD)]、肝纤维化[血清透明质酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原、Ⅳ型胶原]、免疫球蛋白M(IgM)变化及疗效情况。结果:两组治疗后身热不退、身目发黄、胁肋胀痛、大便秘结、呕吐呃逆、口苦咽干中医证候积分对比,治疗组均低于对照组(P<0.05)。两组治疗后IL-17、IL-6、TNF-α水平均下降(P<0.05),治疗组比对照组更低(P<0.05)。两组TBIL、AST、ALT水平治疗后均下降(P<0.05),治疗组比对照组更低(P<0.05)。两组治疗后MDA水平均降低(P<0.05),治疗组更低(P<0.05),两组治疗后GSH-Px、SOD水平均升高(P<0.05),治疗组更高(P<0.05)。两组治疗后肝纤维化、免疫指标HA、LN、III型前胶原、IV型胶原、IgM水平均下降(P<0.05),治疗组比对照组更低(P<0.05)。治疗后治疗组总有效率显著高于对照组(91.67%vs 72.22%)。结论:疏肝利胆颗粒治疗胆腑郁热证PBC临床疗效显著,能有效促进临床症状及肝功能改善,减轻机体炎症反应及氧化应激反应,改善机体免疫功能、肝纤维化程度,具有较高的临床推广价值。

Objective:To explore the efficacy of Shugan Lidan Granule in treating primary biliary cholangitis(PBC)with liver and gallbladder heat syndrome.Methods:Seventy-two PBC patients with liver and gallbladder heat syndrome were included from the Department of General Surgery at The First Hospital of Lanzhou University.They were randomly divided into a control group and a treatment group,with 36 cases in each group.The control group was treated with ursodeoxycholic acid capsule,while the treatment group received ursodeoxycholic acid capsule combined with Shugan Lidan Granule.Clinical symptoms,microinflammatory markers[interleukin-6(IL-6),interleukin-17(IL-17),tumor necrosis factor-alpha(TNF-α)],liver function[aspartate aminotransferase(AST),total bilirubin(TBIL),alanine aminotransferase(ALT)],oxidative stress markers[malondialdehyde(MDA),glutathione peroxidase(GSH-Px),superoxide dismutase(SOD)],liver fibrosis indicators[serum hyaluronic acid(HA),laminin(LN),type III procollagen,type IV collagen],changes in immunoglobulin M(IgM),and overall treatment efficacy were compared between the two groups.Results:After treatment,Traditional Chinese Medicine(TCM)syndrome scores for persistent fever,jaundice,hypochondriac distention and pain,constipation,vomiting,and bitter taste and dry throat were lower in the treatment group compared to the control group(P<0.05).Levels of IL-17,IL-6,and TNF-αdecreased in both groups after treatment(P<0.05),with lower levels in the treatment group(P<0.05).TBIL,AST,and ALT levels also decreased in both groups(P<0.05),with lower levels in the treatment group(P<0.05).MDA levels decreased in both groups(P<0.05),with lower levels in the treatment group(P<0.05),while GSH-Px and SOD levels increased,with higher levels in the treatment group(P<0.05).Liver fibrosis and immunological indicators HA,LN,type III procollagen,type IV collagen,and IgM all decreased after treatment in both groups,with lower levels in the treatment group(P<0.05).The total effective rate in the treatment group was significantly higher than in the control group(91.67%vs.72.22%).Conclusion:Shugan Lidan Granule demonstrate significant clinical efficacy in treating PBC with liver and gallbladder heat syndrome.The treatment effectively improves clinical symptoms and liver function,reduces inflammation and oxidative stress,and improves immune function and liver fibrosis,making it highly valuable for clinical promotion.