自免方联合熊去氧胆酸治疗肝肾阴虚证原发性胆汁性胆管炎随机对照研究

Effect of Zimian Formula Combined with Ursodeoxycholic Acid in Treatment of Primary Biliary Cholangitis Patients with Gan-Shen Yin Deficiency Syndrome: a Randomized Controlled Trial

目的观察自免方联合熊去氧胆酸(UDCA)治疗肝肾阴虚证原发性胆汁性胆管炎(PBC)患者的临床疗效和安全性。方法73例符合纳入标准的肝肾阴虚证PBC患者,按照随机数字表法分为对照组37例和治疗组36例,对照组口服UDCA治疗,治疗组口服自免方联合UDCA治疗。比较两组治疗前、治疗后3、6个月的中医证候积分、中医证候疗效、碱性磷酸酶(ALP)、γ-谷氨酰转移酶(GGT)、总胆红素(TBIL)、总胆汁酸(TBA)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、凝血酶原时间(PT)、AST与血小板(PLT)比值指数(APRI)/基于4项因子的肝纤维化指数(FIB-4)、血常规、肌酐(Cr)、尿素氮(BUN)的变化,并观察不良反应。结果73例患者治疗过程中脱落8例,最终纳入分析65例,对照组32例,治疗组33例。对照组有效率为56.25%(18/32),治疗组有效率为96.97%(32/33),治疗组临床疗效优于对照组(χ2=27.375,P<0.05)。治疗3个月后,两组患者中医证候积分、ALP、GGT较治疗前明显下降(P<0.05),且治疗组优于对照组(P<0.05)。治疗6个月后,两组患者中医证候积分、ALP、GGT、TBA较治疗前明显下降(P<0.05),与对照组同期比较,治疗组ALP、GGT下降更显著(P<0.05)。治疗6个月后,ALT、AST、PT、APRI评分、FIB-4评分均较治疗前明显下降(P<0.05),但两组比较,差异无统计学意义(P>0.05)。治疗期间两组均未见明显不良反应。结论自免方联合UDCA能明显改善肝肾阴虚证PBC患者的中医证候积分、ALP、GGT,疗效优于单用UDCA治疗,且安全性良好。

Objective To observe the clinical efficacy and safety of Zimian Formula(ZMF) combined with ursodeoxycholic acid(UDCA) in treatment of primary biliary cholangitis(PBC) patients with Gan-Shen yin deficiency syndrome(GSYDS). Methods Totally 73 PBC patients with GSYDS in line with the inclusion criteria were assigned to the control group(37 cases) and the treatment group(36 cases) according to random number table. Patients in the control group took UDCA, while those in the treatment group took ZMF combined UDCA. The changes of Chinese medicine(CM) syndrome scores,CM syndrome efficacy, alkaline phosphatase(ALP), γ-glutamyltransferase(GGT), total bilirubin(TBIL), total bile acids(TBA), alanine aminotransferase(ALT), aspartate aminotransferase(AST), prothrombin time(PT),aspartate aminotransferase-to-platelet ratio index(APRI)/fibrosis index based on the 4 factors(FIB-4), blood routines, creatinine(Cr), urea nitrogen(BUN) were compared before treatment, 3 and 6 months after treatment. Adverse reactions were also observed.Results Of the 73 patients, 8 dropped off during the treatment course, and 65 cases were finally included in analysis, 32 patients in the control group and 33 patients in the treatment group. The effective rate of the control group was 56.25%(18/32 cases), and that of the treatment group was 96.97%(32/33 cases). The clinical efficacy of the treatment group was better than that of the control group (χ~2=27.375, P<0.05). After 3 months of treatment, CM syndrome scores, ALP, GGT of the two groups significantly decreased, as compared with those before treatment(P<0.05), and the treatment group was better than the control group(P<0.05). After 6months of treatment, the CM syndrome scores, ALP, GGT, and TBA of the two groups significantly decreased, as compared with those before treatment(P<0.05). Compared with the control group at the same time points, ALP and GGT decreased more significantly in the treatment group(P<0.05). After 6 months of treatment, ALT, AST, PT, APRI scores, and FIB-4 scores decreased more significantly, as compared with those before treatment(P<0.05), but there were no differences between the two groups(P>0.05). No obvious adverse reactions occurred during the treatment. Conclusion ZMF combined UDCA significantly improved CM syndrome score, ALP, GGT of PBC patients with GSYDS, and the curative effect was better than that of UDCA alone with favorable safety.