纳曲酮联合腺苷蛋氨酸治疗酒精性肝病合并胆汁淤积的临床研究

Clinical study on naltrexone combined with ademetionine in treatment of alcoholic liver disease complicated with cholestasis

目的探讨纳曲酮联合腺苷蛋氨酸治疗酒精性肝病合并胆汁淤积的临床疗效。方法选取2014年3月—2015年5月第四军医大学唐都医院收治的酒精性肝病合并胆汁淤积患者96例,随机分为对照组和治疗组,每组各48例。对照组在基础治疗上静脉滴注注射用丁二磺酸腺苷蛋氨酸1.0 g加入到5%葡萄糖溶液500 m L,1次/d,6周后改为口服丁二磺酸腺苷蛋氨酸肠溶片,0.5 g/次,2次/d。治疗组在对照组基础上口服盐酸纳曲酮片,25 mg/次,1次/d。两组均连续治疗10周。观察两组患者的临床疗效,同时比较两组治疗前后丙氨酸氨基转移酶(ALT)、γ-谷氨酰转肽酶(GGT)、血清胆红素(SB)、天冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、总胆汁酸(TBA)、白蛋白(Alb)、透明质酸酶(HA)、层黏连蛋白(LN)、III型前胶原(PC-III)、IV型胶原蛋白(IV-C)的变化。结果治疗后,对照组和治疗组的总有效率分别为77.1%、91.7%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者Alb均显著升高、TBA、ALT、AST、TBIL、SB、GGT、HA、PC-III、IV-C、LN均显著降低,同组治疗前后差异具有统计学意义(P<0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。结论纳曲酮联合腺苷蛋氨酸治疗酒精性肝病合并胆汁淤积具有较好的临床疗效,可改善患者肝功能和肝纤维化指标,具体一定的临床推广应用价值。

Objective To observe the clinical efficacy of naltrexone combined with ademetionine in treatment of alcoholic liver disease complicated with cholestasis. Methods Patients（96 cases） with alcoholic liver disease complicated with cholestasis in Tangdu Hospital of the Fourth Military Medical University from March 2014 to May 2015 were randomly divided into control and treatment groups, and each group had 48 cases. The patients in the control group were iv administered with Ademetionine 1,4-Butanedisulfonate for injection on the basis of foundation treatment, 1.0 g added into 5% glucose solution 500 m L, once daily. After 6 weeks, they were po administered with Ademetionine 1,4-butanedisulfonate Enteric-coated Tablets, 0.5 g/time, twice daily. The patients in treatment group were po administered with Naltrexone Hydrochloride Tablets, 25 mg/time, once daily. Two groups were treated for 10 weeks. After treatment, the efficacy was evaluated, and the changes of ALT, GGT, SB, AST, TBIL, TBA, Alb, HA, LN, PC-III, and IV-C in the two groups before and after treatment were compared. Results After treatment, the efficacies in the control and treatment groups were 77.1% and 91.7%, respectively, and there were differences between two groups（P 〈 0.05）. After treatment, Alb were significantly increased, TBA, ALT, AST, TBIL, SB, GGT, HA, PC-III, IV-C, and LN were significantly decreased, and the difference was statistically significant in the same group（P 〈 0.05）. These observational indexes in the treatment group were better than those in the control group, with significant difference between two groups（P 〈 0.05）. Conclusion Naltrexone combined with ademetionine has curative effect in treatment of alcoholic liver disease complicated with cholestasis, and can improve liver function and liver fibrosis indexes, which has a certain clinical application value.