单用或联合应用泛昔洛韦和肝炎灵对乙型肝炎血清标志物的影响

Effects of administration of famciclovir and ganyanling injection alone or in combination on serum marker in patients with chronic hepatitis B

目的观察单用或联合应用泛昔洛韦和肝炎灵对乙型肝炎血清标志物的影响,探讨泛昔洛韦及泛昔洛韦和肝炎灵联合应用抗HBV的疗效。方法112例初治的慢性乙肝患者,采用分层随机化法分为3组。泛昔洛韦组39例,泛昔洛韦500mg,tid;肝炎灵组33例,肝炎灵4ml,肌注,qod;联合用药组40例,泛昔洛韦+肝炎灵。每组治疗24周,随访24周。治疗前与治疗后1、3、6、12个月时复查肝功能、乙肝血清标志物和HBVDNA,并观察药物不良反应。结果治疗结束后3组HBVDNA阴转率分别为43.6%、18.2%、72.5%,ALT复常率分别为69.2%、48.5%、90.0%,联合用药但与肝炎灵组、泛昔洛韦组比较有统计学差异(P<0.05);HBeAg阴转率分别为17.9%、9.1%、25.0%;HBeAg抗HBe血清转换率分别为10.3%、9.1%、17.5%,3组之间比较均无统计学差异。随访24周3组HBVDNA阴转率分别为28.2%、15.2%、50.0%;HBeAg阴转率分别为12.8%、9.1%、27.5%。治疗中未发现明显的不良反应。结论泛昔洛韦抑制HBVDNA优于肝炎灵,联合用药能提高HBVDNA阴转率,泛昔洛韦对促进HBeAg阴转、HBeAg抗HBe血清转换的作用不明显,联合用药也未能提高此作用;但联合用药增加HBeAg阴转的持续应答率。

AIM: To evaluate HBV marks after administration of famciclovir and ganyanling injection alone or in combination in the patients with chronic hepatitis B. METHODS: 112 patients with CHB were randomly assigned to three groups: 39 patients were alone administration of famciclovir 0.5 mg, tid, po (famciclovir group), 33 patients were alone administration of ganyanling injection 4 ml,im,qod (ganyanling group), 40 patients were combination administration of famciclovir 0.5 mg, tid,po and ganyanling injection 4 ml,im,qod (combination group). All the three groups were investigated for 24 weeks and 24 weeks after therapy. The levels of serum ALT, HBV marks and HBV DNA were detected before and after the treatment of 1, 3, 6, and 12 month. In addition, the conversion of HBeAg into HBeAb and the curative effect were observed. RESULTS: The normalization rates of serum ALT and HBV DNA in combination group were higher than those in famciclovir group and ganyanling group (P< 0.05 ).There was no significant difference of the normalization rate of HBeAg among three groups. Few side effects were found in the course of treatment. CONCULSION: Famciclovir can inhibit the replication of HBVDNA more effectively than ganyanling injection. The combination administration of famciclovir and ganyanling injection is safe and effective in comparison with administration alone in patients with chronic HBV infection.