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聚乙二醇干扰素α-2a与聚乙二醇干扰素α-2b治疗慢性乙型肝炎的效果及安全性比较
Clinical effect and safety of pegylated interferon-α-2a versus pegylated interferon-α-2b in treatment of chronic hepatitis B
文章发布日期:2019年01月07日  来源:  作者:嵇玮嘉,颜学兵  点击次数:431次  下载次数:54次

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【摘要】:目的 比较PEG-IFNα-2a与PEG-IFNα-2b治疗慢性乙型肝炎(CHB)的效果和安全性。方法 选取2017年1月-2018年6月在徐州医科大学附属医院感染科接受PEG-IFNα-2a(180 μg/周)(n=34)和PEG-IFNα-2b(180 μg/周)(n=32)治疗的CHB患者,观察2组治疗4、12、24、48周时HBsAg、HBV DNA、HBeAg、ALT水平及应答率等指标,将第48周抗病毒疗效结果作为主要观察指标,同时比较应答组与非应答组上述指标有无统计学差异。服从正态分布的计量资料2组间比较采用独立样本t检验;非正态分布的计量资料2组间比较采用Mann- Whitney U检验;计数资料2组间比较采用χ2检验或Fisher确切概率法检验。结果 PEG-IFNα-2a、PEG-IFNα-2b治疗48周时CHB患者的血清HBV DNA应答率分别为67.6%、59.4%,HBeAg血清学转换率分别为27.3%、34.6%,2组比较差异均无统计学意义(P值均>0.05)。PEG-IFNα-2a组中,HBV DNA应答组较非应答组基线ALT水平更低,差异有统计学意义(Z=2.390,P=0.016);HBeAg应答组基线HBeAg水平比非应答组更低,差异有统计学意义(Z=2.286,P=0.021)。PEG-IFNα-2b组中,HBV DNA应答组较非应答组具有更低的基线HBV DNA水平、基线HBeAg水平(Z值分别为 2.154、2.057,P值分别为0.030、0.041);HBeAg应答组较非应答组具有更低的基线HBV DNA水平(Z=2.052,P=0.042)。2组不良反应发生率差异均无统计学意义(P值均>0.05),PEG-IFNα-2b治疗组1例发生Purtscher样视网膜病变,1例发生血小板减少,而PEG-IFNα-2a组未见Purtscher样视网膜病变和血小板减少相关不良反应。结论 PEG-IFNα-2a、PEG-IFNα-2b治疗CHB均有较强的抗病毒疗效和免疫调节作用,治疗效果及安全性相近。
【Abstract】:Objective To investigate the clinical effect and safety of pegylated interferon-α-2a (PEG-IFN-α-2a) versus pegylated interferon-α-2b (PEG-IFN-α-2b) in the treatment of chronic hepatitis B (CHB). Methods The CHB patients who were treated with PEG-IFN-α-2a (180 μg/week) or PEG-IFN-α-2b (180 μg/week) in Department of Infectious Diseases in our hospital from January 2017 to June 2018 were enrolled. The two groups were compared in terms of the levels of HBsAg, HBV DNA, HBeAg, and alanine aminotransferase (ALT) at 4, 12, 24, and 48 weeks of treatment, and the indices for antiviral effect at 48 weeks were used as main outcome measures. The above indices were compared between response group and non-response group. The independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. Results There were no significant differences between the PEG-IFN-α-2a group and the PEG-IFN-α-2b group in serum HBV DNA clearance rate (67.6% vs 59.4%, P>0.05) and HBeAg seroconversion rate (27.2% vs 34.6%, P>0.05). In the PEG-IFN-α-2a group, the HBV DNA response group had a significantly lower baseline ALT level than the HBV DNA non-response group (Z=2.390, P=0.016); the HBeAg response group had a significantly lower baseline HBeAg level than the HBeAg non-response group (Z=2.286, P=0.021). In the PEG-IFN-α-2b group, the HBV DNA response group had significantly lower baseline HBV DNA level and baseline HBeAg level than the HBV DNA non-response group (Z=2.154 and 2.057, P=0.030 and 0.041); the HBeAg response group had a significantly lower baseline HBV DNA level than the HBeAg non-response group (Z=2.052, P=0.042). There were no significant differences in the incidence rates of adverse reactions between the two groups (P>0.05); in the PEG-IFN-α-2b group, one patient experienced Purtscher’s retinopathy and one experienced thrombocytopenia, while no similar adverse reactions were observed in the PEG-IFN-α-2a group. Conclusion Both PEG-IFN-α-2a and PEG-IFN-α-2b have strong antiviral and immunomodulatory effects in the treatment of CHB, with similar clinical effect and safety.
【关键字】:肝炎, 乙型, 慢性; 聚乙烯二醇类; 干扰素类; 治疗结果; 临床对照试验
【Key words】:hepatitis B, chronic; polyethylene glycols; interferons; treatment outcome; controlled clinical trial
【引证本文】:JI WJ, YAN XB. Clinical effect and safety of pegylated interferon-α-2a versus pegylated interferon-α-2b in treatment of chronic hepatitis B[J]. J Clin Hepatol, 2019, 35(2): 309-314. (in Chinese)
嵇玮嘉, 颜学兵. 聚乙二醇干扰素α-2a与聚乙二醇干扰素α-2b治疗慢性乙型肝炎的效果及安全性比较[J]. 临床肝胆病杂志, 2019, 35(2): 309-314.

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