脱氧核苷酸联合聚乙二醇化干扰素α-2a治疗慢性乙型肝炎(CHB)的疗效和安全性

Efficacy and Safety of Oligonucleotides combined Pegylated Interferon α-2a in Treatment with Chronic hepatitis B

目的观察脱氧核苷酸联合聚乙二醇化干扰素α-2a治疗慢性乙型肝炎的疗效和安全性。方法于2012年3月至2014年3月,入选104例CHB患者,对照组给予PEG-IFNα-2a,180μg皮下注射,1次/周,治疗组在对照组基础上给予脱氧核苷酸注射液静脉滴注,200毫克/次,1次/周。连续24周,停药后继续随访24周,随访指标主要包括HBV-DNA阴转率,HBeAg血清转换率、HBeAg阴转率,两组总的不良事件发生率。结果治疗组HBV-DNA阴转率(66.7%vs44.4%),HBeAg阴转率(46.7%vs22.2%),HBeAg/抗-HBe血清学转换率(37.8%vs 17.8%),HBsAg/抗HBs血清学转换(20.0%vs 4.4%),总应答率(73.3%vs 48.9%)均明显高于对照组,两组比较具有统计学差异(P<0.05)。另外治疗过程,治疗组白细胞减少(4.4%vs 31.1%)、血小板减少(4.4%vs 20.0%)、黄疸发生率(2.2%vs 13.3%)均显著低于对照组(P<0.05)。结论脱氧核苷酸联合聚乙二醇化干扰素α-2a可提高病毒治疗的转阴率,减少干扰素的骨髓抑制,肝损伤等不良反应。

Objective To observe deoxynucleotide joint pegylated interferon α-2a treatment of chronic hepatitis B treatment efficiency and safety. Methods March 2012-2014 in March, selected 104 cases of CHB patients, the control group received PEG-IFNα-2a, 180 μg subcutaneous injection, 1 times/week treatment group received injections in the control group deoxynucleotide basis intravenous infusion, 200 mg/times, 1 times / week. 24 consecutive weeks and 24 weeks of follow-up after treatment to continue follow-up indicators include negative rate of HBV DNA, HBeAg seroconversion, HBeAg seroconversion rate between the two groups overall incidence of adverse events. Results The HBV-DNA negative rate（66.7% vs 44.4%）, HBeAg seroconversion rate（46.7% vs 22.2%）, HBeAg/anti-HBe seroconversion rate（37.8% vs 17.8%）, HBsAg/anti-HBs seroconversion（20.0% vs 4.4%）, overall response rate（73.3% vs 48.9%） were significantly higher, with a significant difference between the two groups（P〈0.05）. Another course of treatment, the treatment group leukopenia（4.4% vs 31.1%）, thrombocytopenia（4.4% vs 20.0%）, jaundice incidence（2.2% vs 13.3%） were significantly lower than the control group（P〈0.05） Conclusion Deoxynucleotide pegylated interferon α-2a-viral treatment can increase the negative rate, reduce interferon marrow suppression, liver damage and other adverse reactions.