Objective: To examine the effects of ursodeoxycholic acid combined with Traditional Chinese Medicine on biochemical response in patients with primary biliary cholangitis. Methods: According to the method of receiving treatment, 197 patients with primary biliary cholangitis were divided into Traditional Chinese Medicine plus Western medicine group (93 cases, 47.2%) and Western medicine group (104 cases, 52.8%). From the baseline date, the combined group was treated with ursodeoxycholic acid plus traditional Chinese medicine decoction or Chinese patent medicine for at least one month and the Western medicine group simply took ursodeoxycholic acid . Additionally, Traditional Chinese medicine decoction prescriptions were mainly Xiaoyaosan and Yinchenhao. Chinese patent medicine were restricted to Biejia Ruangan tablets, Fuzheng Huayu capsules, Jiuweigantai capsules and Yinzhihuang capsules, which were used to treat liver fibrosis and cholestasis. The primary efficacy endpoint was defined as ALP level < 1.67 × ULN and ≥ 15% decrease in ALP with baseline level and TBIL≤ULN after 12 months of treatment. Results: The overall biochemical response rate of patients was 35.0% (69/197). The response rate of TCM+ Western medicine group was 43.0% (40/93), and that of Western medicine group was 27.9% (29/104). The difference between the two groups was statistically significant (χ(2) = 4.936, P < 0.05). Further analysis showed that the Chinese and Western medicine group was superior to the Western medicine group alone in reducing γ-glutamyltransferase (GGT) and TBiL [the median decline were GGT: 160.1 U/L and 111.3 U/L (Z = -2.474, P < 0.05), TBiL: 5.2 umol/l and 3.1 umol/l (Z = -2.125, P < 0.05)]. Conclusion: UDCA combined with TCM therapy can remarkably improve the biochemical response rate in patients with PBC and distinctly decrease the TBIL and GGT levels than UDCA monotherapy.
目的： 探讨熊去氧胆酸联合中药治疗对原发性胆汁性胆管炎患者1年后生物化学应答的影响。方法： 197例原发性胆汁性胆管炎患者根据接受治疗的方法，将其分为中西医结合组93例（47.2%）和西医组104例（52.8%）。中西医结合组为自基线日期起在熊去氧胆酸治疗的基础上联合中药汤剂或中成药治疗至少1个月，西医组单纯服用熊去氧胆酸。中西医结合组的中药汤剂处方主要是逍遥散合茵陈蒿汤加减，中成药种类限于用于抗肝纤维化和治疗胆汁淤积的复方鳖甲软肝片、扶正化瘀胶囊、九味肝泰胶囊、茵栀黄胶囊等。主要疗效终点为治疗12个月后，患者碱性磷酸酶（ALP）<1.67×正常值上限（ULN）且ALP较基线下降≥15%且总胆红素（TBil）≤ULN。组间数据比较采用t检验、非多数检验或χ(2)检验、Fisher精确概率法检验。结果： 患者总体生物化学应答率为35.0%（69/197），中西医结合组应答率为43.0%（40/93），西医组27.9%（29/104），两组比较差异有统计学意义（χ(2) = 4.936，P < 0.05）。进一步分析发现，中西医结合组在降低γ-谷氨酰转移酶(GGT)和TBil方面优于西医组[下降的中位数分别为：GGT：160.1 U/L 与111.3 U/L（Z = -2.474, P < 0.05)；TBil：5.2 μmol/l与3.1 μmol/l（Z = -2.125, P < 0.05）]。结论： 相比熊去氧胆酸单药治疗，熊去氧胆酸联合中药治疗能明显提高原发性胆汁性胆管炎患者1年后的生物化学应答率，并且能明显降低患者的TBil、GGT水平。.
Keywords: Biochemical response; Cholangitis, biliary; Drugs, Chinese herbal; Integrative medicine; Ursodeoxycholic acid.