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目的研究评价肝康颗粒抗乙肝病毒的疗效。方法 2000年7月～2003年7月进行多中心,随机,双盲实验,从280个携带乙型肝炎表面抗原、乙型肝炎e抗原和乙肝病毒的患者中随机抽取209人作为肝康颗粒组,该组患者服用肝康颗粒4g/d,tid,疗程为12周;另71人服用乙肝宁粉末制剂作为对照组,该组患者服用乙肝宁粉末制剂1包/d,tid。结果经过12周的治疗,在肝康颗粒组患者血清中的乙型肝炎病毒迅速减少。肝康颗粒组和对照组的病毒载量下降中位数在第12周时分别是4.3、2.1log_(10)copies/mL(P<0.001)。肝康颗粒组中45.93%的患者通过PCR实验已经检测不到乙型肝炎病毒,但是对照组中只为24%。肝康颗粒组和对照组中乙型肝炎e抗原分别减少33.49%和22.53%,病人丙氨酸转氨酶的水平达到正常化的比例分别为39%和29%。结论经过12周的治疗,肝康颗粒抗慢性乙肝病毒有效。
Objective To evaluate the curative effect of Gankang Granule against hepatitis B virus. Methods A multicenter, randomized, double-blind trial was conducted from July 2000 to July 2003. A total of 209 patients were randomly selected from 280 patients with hepatitis B surface antigen, hepatitis B e antigen and hepatitis B virus (HBV) , The patients taking Gan Kang particles 4g / d, tid, the course of treatment for 12 weeks; the other 71 people taking Hepatitis B powder as a control group, the patients taking Hepatitis B powder 1 package / d, tid. Results After 12 weeks of treatment, the hepatitis B virus in the serum of patients with liver-Kang granules rapidly decreased. The median decrease of viral load in Gankang granules group and control group was 4.3, 2.1 log_ (10) copies / mL at week 12 (P <0.001), respectively. 45.93% of patients in Hekang granule group had no detectable hepatitis B virus by PCR experiment, but only 24% of control group. Hekang granule group and control group hepatitis B e antigen decreased by 33.49% and 22.53%, the level of alanine aminotransferase normalized patients were 39% and 29%. Conclusion After 12 weeks of treatment, Gan Kang Granules is effective against chronic hepatitis B virus.