肝康颗粒抗乙型肝炎的临床研究(英文)

Clinical study of Gankang granule for treatment of chronic hepatitis B

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 antiviral efficacy of Gankang granule against HBV. [ Methods ] The multi-center, randomized, double-blind trial began from July 2000 and lasted to July 2003. A total of 280 patients with positive serum HBsAg, HBeAg and HBV DNA were randomized to receive Gankang granule 4 grams every time and three times a day for 12 weeks as Gankang group （209 patients）, while Yiganning powder preparation was given one bag every time and tree times a day as control group （71 patients）. [kesults] After 12-weeks＇ therapy, the level of serum HBV DNA decreased rapidly in Gankang group. Median serum HBV DNA reductions from baseline at week 12 were 4.3 and 2.1 logt0 eopies/mL in the Gankang group and control group respectively （P 〈0.001）. In the Gankang group 45.93% of patients had undetectable serum HBV DNA level by real-time quantitative PCR assay （less than 300 eopies/mL） but in control group the proportion was only 24% （P 〈0.001）. The loss of HBeAg was 33.49% in Gankang group whereas only 22.53% in control group after therapy. The proportion of patients who achieved normalization of alanine aminotransferase （ALT） level was 39% in the Gankang group and 29% in the control group. [ Conclusions ] Gankang granule shows well potent antiviral effect on CHB after 12-week treatment.