摘要
目的 观察畲药地稔滋肾方联合针刺辅助治疗原发性胆汁性胆管炎肝肾阴虚证的临床疗效及安全性.方法 将70例原发性胆汁性胆管炎肝肾阴虚证患者随机分为对照组和治疗组各35例.对照组给予口服熊去氧胆酸胶囊(每次250 mg、每日3次);治疗组在对照组治疗的基础上给予口服畲药地稔滋肾方汤剂(每日1剂,分早晚两次各200ml温服)联合针刺治疗(选穴取双侧三阴交、太冲、肝俞、足三里、丰隆,每日1次,每周连续5日),疗程均为3个月.比较两组治疗前后皮肤瘙痒、乏力、黄疸、胁痛4种中医症状评分及中医证候积分,肝功能指标[门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、碱性磷酸酶(ALP)、γ-谷氨酰转移酶(GGT)、总胆红素(TBiL)],肝纤维化指标[血清层粘连蛋白(LN)、血清透明质酸酶(HA)、血清Ⅳ型胶原(Ⅳ-C)、血清Ⅲ型前胶原(PC-Ⅲ)]以及炎症因子指标[血清白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)],治疗后统计中医证候疗效,并进行安全性评价.结果 最终纳入疗效分析治疗组32例,对照组31例.治疗组中医证候总有效率(87.50％,28例/32例)高于对照组(67.74％,20例/31例)(P＜0.05).治疗后两组中医各项症状评分及证候积分、肝功能及肝纤维化各项指标均较治疗前明显降低,治疗组炎症因子指标较治疗前降低,且治疗组上述各项指标改善效果均优于对照组(P＜0.05或P＜0.01).两组安全性良好,未出现不良反应.结论 畲药地稔滋肾方联合针刺辅助治疗能显著提高原发性胆汁性胆管炎患者的临床疗效,改善肝功能,减轻炎症反应,缓解肝纤维化,且安全性好.
Abstract
Objective To observe the clinical effectiveness and safety of She medicine(畲药)Diren Zishen Formula(地稔滋肾方)combined with acupuncture as adjunctive treatment for primary biliary cholangitis with liver and kidney yin deficiency syndrome.Methods Seventy patients of primary biliary cholangitis with liver and kidney yin deficien-cy syndrome were randomly divided into a control group and a treatment group,with 35 patients in each group.The control group received oral ursodeoxycholic acid capsules(250 mg per dose,three times daily).The treatment group received She medicine Diren Zishen Formula oral decoction(one dose daily,200 ml per dose in the morning and evening,served warm)and acupuncture[bilateral Sanyingjiao(SP6),Taichong(LR3),Ganshu(BL18),Zusanli(ST36),Fenglong(ST17),once daily,5 consecutive days per week]in addition to the same treatment as the control group.The treatment duration was three months for both groups.Comparisons were made between the two groups before and after treatment for the following parameters,which were four traditional Chinese medicine(TCM)symptoms scores(skin itching,fatigue,jaundice,and flank pain),TCM syndrome scores,liver function indicators including aspartate aminotransferase(AST),alanine aminotransferase(ALT),alkaline phosphatase(ALP),gamma-glutamyl transferase(GGT)and total bilirubin(TBiL),liver fibrosis markers including serum laminin(LN),serum hyaluronic acid(HA),serum type Ⅳ collagen(Ⅳ-C)and serum type Ⅲ procollagen(PC-Ⅲ),and inflammatory factor indicators including serum interleukin-6(IL-6)and tumor necrosis factor-alpha(TNF-α).The effectiveness of TCM syndrome between the two groups was compared and safety evaluations were also conducted after treatment.Results A total of 32 cases were finally analyzed in the treatment group,while the control group had 31 cases.The total effective rate of TCM syndrome in the treatment group(87.50％,28/32)was higher than that in the control group(67.74％,20/31)(P＜0.05).After treatment,the TCM symptom scores,syndrome scores,liver function,and liver fibrosis markers in both groups signi-ficantly decreased,while in the treatment group,the inflammatory factor indicators decreased after treatment,and more decreases were found than those in the control group(P＜0.05 or P＜0.01).Both groups had good safety,and no adverse reactions were observed.Conclusion The combination of She medicine Diren Zishen Formula and acupuncture as an adjunctive treatment for primary biliary cholangitis can significantly improve the clinical effectiveness,improve liver function,reduce inflammatory response,and alleviate liver fibrosis,with good safety.
基金项目
国家中医药管理局全国中医药创新骨干人才培训项目(国中医药人教函[2019]128号)
浙江省中青年临床名中医培养项目(浙中医药[2021]22号)
维普
万方数据