扶肝健脾方联合替比夫定对慢性乙型肝炎患者病毒学应答的临床疗效研究

Clinical Effects of Fugan Jianpi Prescription Plus Telbivudine on Viral Response in Patients with Chronic Hepatitis B

【目的】探讨扶肝健脾方联合替比夫定对慢性乙型肝炎(简称慢性乙肝)患者病毒学应答的影响。【方法】将115例慢性乙肝患者(HBV-DNA>1×105cps/mL)随机分为治疗组57例及对照组58例,治疗组采用扶肝健脾方联合替比夫定治疗,对照组单用替比夫定治疗。观察2组的中医症候疗效,并分别在治疗前及治疗12周、24周、36周时检测2组患者的谷丙转氨酶(ALT)、谷草转氨酶(AST),乙肝病毒DNA定量检测(HBV-DNA)等指标的变化情况。【结果】(1)2组中医症候疗效比较,差异无统计学意义(P﹥0.05)。(2)治疗12周、24周、36周后,2组血清ALT、AST水平均显著下降,与治疗前比较差异均有统计学意义(P<0.05);2组治疗后各时间点比较,差异均无统计学意义(P﹥0.05)。(3)治疗12周、24周后2组的HBV-DNA应答率比较,差异无统计学意义(P﹥0.05);治疗36周后,治疗组的HBV-DNA应答率显著高于对照组,差异有统计学意义(P<0.05)。【结论】扶肝健脾方联合替比夫定治疗能够明显缓解慢性乙型肝炎肝郁脾虚夹瘀型患者的症状、体征,较好地改善肝功能,提高抗病毒治疗的应答率。

Objective To observe the effect of Fugan Jianpi Prescription plus Telbivudine on viral response in patients with chronic hepatitis B. Methods One hundred and fifteen chronic hepatitis B patients with the titers of HBV-DNA over 1×1^5 cps/mL were randomly divided into treatment group （N= 57） and control group （N= 58） . The treatment group was given Fugan Jianpi Prescription （a compound recipe with the actions of soothing liver and strengthening spleen） plus Telbivudine, and the control group was given Telbivudine alone. The serum levels of alanine aminotransferase （ALT）, aspartate aminotransferase （AST） and HBV-DNA were detected before treatment, and 12, 24 and 36 after treatment. After treatment, the effect on traditional Chinese medical syndromes was evaluated. Results There was no significant difference of effect on traditional Chinese medical syndromes between the two groups （P 〉 0.05） . Serum ALT and AST levels were decreased in both groups 12, 24 and 36 after treatment （P〈0.05 compared with those before treatment）, the differences being insignificant between the two groups after treatment （P〉0.05） . In the two groups, HBV-DNA response rate remained steady in both groups 12 and 24 weeks after treatment, but was higher in the treatment group than that in the control group after treatment for 36 weeks （P〈0.05） . Conclusion Fugan Jianpi Prescription plus Telbivudine exerts certain effect on relieving symptoms and signs, improving hepatic function, and increasing viral response in patients with chronic hepatitis B.