摘要
目的:探讨复方丹黄方治疗肝胆湿热型胆汁淤积性肝病的疗效,且基于胆汁酸合成、转运及代谢、纤维化、炎症反应及氧化应激方面进一步分析其潜在作用机制。方法:纳入2020年3月至2022年10月该院肝病科收治的肝胆湿热型胆汁淤积性肝病患者128例进行研究,按随机数字表法分为对照组和观察组,各64例。对照组患者给予西医对症治疗;在对照组基础上,观察组患者辅以复方丹黄方治疗,均治疗4周。比较两组患者的证候积分、肝功能和不良反应状况,且对胆汁酸合成、转运及代谢相关参数、纤维化指标、炎症因子及氧化应激水平的影响进行进一步分析。结果:研究期间,对照组脱落或失访2例,观察组脱落或失访1例。治疗后,两组患者胁肋疼痛、脘腹闷胀、倦怠乏力及皮肤瘙痒证候积分较治疗前降低,且观察组患者低于对照组;两组患者碱性磷酸酶、γ-谷氨酰转肽酶水平较治疗前降低,且观察组患者低于对照组,差异均有统计学意义(P<0.05)。对照组、观察组患者的不良反应发生率分别为8.06%(5/62)、4.76%(3/63),差异无统计学意义(P>0.05)。治疗后,两组患者总胆汁酸、成纤维细胞生长因子-19水平较治疗前降低,且观察组患者低于对照组;两组患者Ⅲ型前胶原、透明质酸、层粘连蛋白及Ⅳ型胶原水平较治疗前降低,且观察组患者低于对照组,差异均有统计学意义(P<0.05)。治疗后,两组患者白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)水平较治疗前降低,超氧化物歧化酶(SOD)水平则有所升高;相比于对照组,观察组患者IL-6、TNF-α水平更低,SOD水平更高,差异均有统计学意义(P<0.05)。结论:肝胆湿热型胆汁淤积性肝病患者在西医对症治疗的基础上应用复方丹黄片可获得确切临床疗效,肝功能得到改善,且不良反应较少。复方丹黄方可在胆汁酸合成、转运及代谢、抗纤维化、抗炎症反应及氧化应激等方面发挥积极作用。
OBJECTIVE:To probe into the efficacy of compound Danhuang formula in the treatment of cholestatic liver disease of liver-gallbladder dampness-heat pattern,and to further analyze its potential mechanism based on the synthesis,transport and metabolism,fibrosis,inflammation and oxidative stress of bile acid.METHODS:Totally 128 patients with cholestatic liver disease of liver-gallbladder dampness-heat pattern admitted into the hepatology department of the hospital from Mar.2020 to Oct.2022 were enrolled for study,the patients were divided into control group and observation group via random number table method,with 64 cases in each group.The control group was given Western expectant treatment,the observation group was given compound Danhuang formula based on the control group,both groups were treated for 4 weeks.The syndrome integrals,liver function and incidences of adverse drug reactions were compared between two groups,its effects on related parameters of the synthesis,transport and metabolism,fibrosis,inflammation and oxidative stress of bile acid were further analyzed.RESULTS:During research,2 cases in the control group and 1 case in the observation group were loss to follow-up.After treatment,the syndrome integrals of lateral thorax pain,abdominal distension,fatigue and cutaneous pruritus of both groups were lower than those before treatment,and those of the observation group were lower than the control group;the alkaline phosphatase and glutamyl transpeptidase of both groups were lower than those before treatment,and those of the observation group were lower than the control group,with statistically significant differences(P<0.05).The incidences of adverse drug reactions of control group and observation group were respectively 8.06%(5/62)and 4.76%(3/63),the difference had no statistical significance(P>0.05).After treatment,the total bile acid and fibroblast growth factor-19 of both groups were lower than those before treatment,and those of the observation group were lower than the control group;theⅢ-type procollagen,hyaluronic acid,laminin andⅣ-type collagen of both groups were lower than those before treatment,and those of the observation group were lower than the control group,with statistically significant differences(P<0.05).After treatment,the interleukin-6(IL-6)and tumor necrosis factorα(TNF-α)were lower and the superoxide dismutase(SOD)was higher in both groups than those before treatment,the IL-6 and TNF-αwere lower and the SOD was higher in the observation group than those in the control group,with statistically significant differences(P<0.05).CONCLUSIONS:Patients with cholestatic liver disease of liver-gallbladder dampness-heat pattern can obtain definite efficacy by receiving compound Danhuang formula based on Western expectant treatment,which can improve lover function,with few adverse drug reactions.The compound Danhuang formula can play a positive role in the synthesis,transport and metabolism,anti-fibrosis,anti-inflammatory reaction and oxidative stress of bile acid.
作者
朱晓迪
苏春芝
孟宪鑫
周盼盼
张云风
苏飞
张金丽
ZHU Xiaodi;SU Chunzhi;MENG Xianxin;ZHOU Panpan;ZHANG Yunfeng;SU Fei;ZHANG Jinli(Dept.of Hepatology,Hebei Hospital of Traditional Chinese Medicine,Shijiazhuang 050000,China)
出处
《中国医院用药评价与分析》
2023年第10期1195-1199,1205,共6页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
河北省中医药管理局项目(No.2020066)。
关键词
胆汁淤积性肝病
肝胆湿热型
复方丹黄方
纤维化
氧化应激
Cholestatic liver disease
Liver-gallbladder dampness-heat pattern
Compound Danhuang formula
Fibrosis
Oxidative stress
