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目的评价泛昔洛韦片剂治疗经干扰素α治疗12周无应答的慢性乙型肝炎患者的疗效和安全性。方法212例患者接受3MU干扰素α治疗12周,复查乙型肝炎e抗原(HBeAg)、乙型肝炎病毒(HBV) DNA仍阳性、HBV DNA定量≥106拷贝/ml的患者,按随机双盲的方法,以1:1的比例分配到试验组和对照组治疗24周,停药后随访24周。结果治疗24周末,HBV DNA定量对数值比较,泛昔洛韦组由(6.54 ±1.26)拷贝/ml下降至(5.70±2.03)拷贝/ml,安慰剂组由(6.30±1.32)拷贝/ml上升至(6.51±1.65)拷贝/ml,x2=3.04,P<0.01;血清HBV DNA定量下降≥2log率比较,泛昔洛韦组为28.28% (28/99),安慰剂组为9.47%,x2=13.10,P<0.01;HBV DNA水平下降至<105拷贝/ml率比较,泛昔洛韦组为28.28%,安慰剂组为14.74%,P<0.05;泛昔洛韦组HBeAg阴转率为7.69%,安慰剂组为3.33%; 泛昔洛韦组HBeAg/抗-HBe血清转换率为4.40%,安慰剂组为2.22%,差异均无统计学意义;丙氨酸氨基转移酶复常率泛昔洛韦组为15.15%,安慰剂组为6.35%,P<0.05。HBV DNA定量<105拷贝/ml的患者停药24周反跳率泛昔洛韦组为25.00%,安慰剂组为14.29%,差异无统计学意义。结论泛昔洛韦治疗经干扰素α治疗12周无应答的慢性乙型肝炎患者能有效抑制其病毒复制,但HBeAg/抗-HBe的血清转换率变化不明显。试验6个月疗程内泛昔洛韦使用安全且耐受性良好。
Objective To evaluate the efficacy and safety of famciclovir tablets in the treatment of chronic hepatitis B patients who did not respond to interferon α for 12 weeks. Methods 212 patients were treated with 3MU interferon α for 12 weeks. The patients with HBeAg, HBV DNA still positive and HBV DNA ≥ 106 copies / ml were randomly divided into two groups according to randomized, double-blind Methods: The experimental group and the control group were assigned to a ratio of 1: 1 for 24 weeks, followed up for 24 weeks after discontinuation. Results At the end of the 24th week of treatment, HBV DNA quantitative logarithm decreased from (6.54 ± 1.26) copies / ml to (5.70 ± 2.03) copies / ml in the famciclovir group and from (6.30 ± 1.32) copies / ml to ± 1.65 copies / ml, x2 = 3.04, P <0.01; serum HBV DNA quantification decreased ≥2 log rate compared with famciclovir 28.28% (28/99), placebo was 9.47%, x2 = 13.10, P ; HBeAg negative conversion rate was 7.69% in famciclovir group and 3.33% in placebo group compared with 28.28% in famciclovir group and 14.74% in placebo group; HBeAg / anti-HBe seroconversion rate was 4.40%, placebo group was 2.22%, the difference was not statistically significant; alanine aminotransferase normalization rate of famciclovir group was 15.15%, placebo group was 6.35%, P < 0.05. Patients with a HBV DNA titre of <105 copies / ml discontinued for 24 weeks in the famciclovir-resistant group with 25.00% discontinuation and 14.29% in the placebo group, with no significant difference. Conclusions Famciclovir can effectively inhibit its viral replication in chronic hepatitis B patients who have not responded to interferon α for 12 weeks. However, the seroconversion rate of HBeAg / anti-HBe is not obvious. Famciclovir was safe to use and well tolerated during the 6-month trial.