调肝化纤丸联合恩替卡韦治疗乙肝肝硬化代偿期疗效分析

Effect of Tiaogan Huaxian Pill and entecavir on compensation period of hepatitis B cirrhosis

[目的]观察调肝化纤丸联合恩替卡韦治疗乙肝(HBV)肝硬化代偿期的临床疗效。[方法]本研究基于随机性、双盲性、对照性对照方法,纳入乙肝肝硬化代偿期且符合六经辨证属小柴胡汤合当归芍药散方证的患者84例,随机分成对照组及治疗组,对照组(42例)服用恩替卡韦分散片0.5 mg/次,1次/日;治疗组(42例)服用恩替卡韦分散片0.5 mg/次,1次/日;联合调肝化纤丸10 g/次,3次/日,疗程为36周。分析比较治疗前及治疗36周后肝功能改善情况、肝脏瞬时弹性成像(FibroScan)测定硬度值(LSM)、HBV-DNA载量及中医证候积分变化等。[结果]治疗前,谷氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、血清白蛋白(ALB)、HBV-DNA、LSM、中医症候积分均无统计学差异(P>0.05);治疗后,经36周两组患者治疗后,两组患者的ALT、AST、TBIL均较基线下降(P<0.05),治疗组下降更为显著(P<0.05),ALB均较基线升高,治疗组升高较为明显(P<0.05)。两组患者治疗后HBV-DNA转阴率(<200 IU/mL)无统计学差异(P>0.05),两组患者治疗后LSM及中医症候积分均较治疗前显著降低(P<0.05)。[结论]调肝化纤丸联合恩替卡韦可显著改善乙肝肝硬化代偿期患者的中医证候积分、肝功能,降低肝脏硬度及DNA载量,延缓肝硬化进展,提高患者生活质量。

[Objective]To observe the clinical efficacy of Tiaogan Huaxian Pill combined with entecavir in the treatment of compensatory hepatitis B virus(HBV)cirrhosis.[Methods]Based on prospective,randomized and controlled clinical study,the 84 patients with hepatitis B cirrhosis in compensatory phase were randomly divided into control group and treatment group.The 42 patients in control group took entecavir dispersible tablets 0.5 mg/d;the 42 patients in treatment group took entecavir dispersible tablets 0.5 mg/d;combined Tiaogan Huaxian Pill 10 g,3 times one day for 36 weeks.The improvement of liver function before treatment and 36 weeks after treatment,the changes of LSM,HBV-DNA load and TCM syndrome integral were analyzed and compared.[Results]Before treatment,there was no significant difference in the scores of ALT,AST,TBIL,ALB,HBV-DNA,LSM and TCM symptoms(P>0.05).After 36 weeks of treatment,the ALT,AST and TBIL of the two groups were lower than those of the baseline(P<0.05),the treatment group was more significant(P<0.05),and that of the treatment group was lower than that of the baseline(P<0.05).ALB were higher than baseline,the treatment group increased more significantly(P<0.05).There was no significant difference in HBV-DNA negative conversion rate(<200 IU/mL)between the two groups after treatment(P>0.05).LSM and TCM symptom scores of the two groups after treatment were significantly lower than those before treatment(P<0.05).[Conclusion]Tiaogan Huaxian Pill combined with entecavir can significantly improve the TCM syndrome score and liver function of patients with compensatory hepatitis B cirrhosis,reduce liver hardness and DNA load,delay the progress of liver cirrhosis and improve the quality of life of patients.