扶正益肝颗粒对HBeAg阴性慢性乙型肝炎病毒低水平复制的影响

The impact of Fuzheng Yigan granule on low level replication of HBV in patients with HBeAg negative

目的:观察扶正益肝颗粒对HBeAg阴性慢性乙型肝炎(CHB)病毒低水平复制患者的疗效及安全性。方法:选择HBeAg阴性CHB病毒低水平复制(5.0×102拷贝∕ml≤HBV DNA水平≤104拷贝/ml,ALT≤2×ULN)患者80例,随机分为两组,治疗组40例,对照组40例。对照组患者采用西医一般常规疗法,包括护肝、支持及对症治疗,使用药物如甘利欣、还原型谷胱甘肽、维生素C及肌苷等,不使用核苷类似物、干扰素等抗病毒药物。治疗组在对照组基础上加用扶正益肝颗粒,疗程52周。观察两组患者治疗后症状体征、肝功能、血清HBV DNA、B超变化情况及临床综合疗效。结果:治疗组与对照组综合有效率分别达70%及40%,两组比较差异有显著性意义,治疗组明显优于对照组(P<0.01)。对血清HBV DNA的影响,治疗组HBV DNA阴转率达37.5%,总有效率达70%,对照组分别为15%、40%,两组比较,差异均有显著性意义(P<0.05及P<0.01)。治疗组患者在症状体征及肝功能恢复、影像学改善等方面亦明显优于对照组。未发生与研究药物相关的严重不良反应。结论:扶正益肝颗粒治疗HBeAg阴性CHB病毒低水平复制疗效显著,对降低此类患者血清HBV DNA载量有满意疗效,并能促进HBV DNA阴转,临床安全性良好。

Objective： To observe the treatment efficiency and safety of Fuzheng Yigan granule on low level replication of HBV in patients with HBeAg negative. Methods ： Eighty patients with HBeAg negative and low level replication of HBV （5.0 × 102copy / ml≤HBV DNA level~〈104 eopy/ml, ALTo〈2 x ULN） were selected. They were randomly divided into two groups, 40 cases were in the treatment group and 40 cases were in the comparison group. The comparison group was adopted general regu- lar treatment method of western medicine, including liver protection, support and heteropathy such as diammonium glycyrrhiz- inate, reduced glutathione tablets, vitamin C and hypoxanthine ribonucleoside, etc, without using nucleoside analogue, interfer- on and other medicines for anti-virus. On the basis of the comparison group, the treatment group was been added self-made Fuzheng Yigan granule, and treatment period was 52 weeks. Symptom and liver function, serum HBV DNA after the treatment, and B ultrasound conversion situation and comprehensive clinical treatment efficiency was observed. Results： Comprehensive treatment efficiency of the treatment group and comparison group had reached respectively 70% and 40% , in comparison, these two groups were significantly different, the treatment group was obviously superior to the comparison group （ P 〈 0. 01 ） . As to the impact of serum HBV DNA, HBV DNA negative conversion rate of the treatment group reached 37. 5% , general effective rate reached 70% , and the comparison group had respectively reached 15% and 40%, in comparison, these two groups were greatly different （ P 〈 0. 05 and P 〈 0. 01 ） . In respects of symptom, liver function recovery and ieonography, the treatment group was much superior to the comparison group. No serious unfavorable reaction to relevant medicine under study had occurred. Conclusion ： The treatment efficiency of Fuzheng Yigan granule on patients with HBeAg negative and low level replication of HBV is remarkable, it has a satisfactory treatment efficiency on lowering serum HBV DNA bearing capacity, and it also shall boost HBV DNA to convert to negative, its clinical safety is excellent.