Clinical effect and safety of pegylated interferon-α-2a versus pegylated interferon-α-2b in treatment of chronic hepatitis B
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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(180μg/周)(n=34)和PEG-IFNα-2b(180μg/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...
Abstract:Objective To investigate the clinical effect and safety of pegylated interferon-α-2 a ( PEG-IFN-α-2 a) versus pegylated interferon-α-2 b ( PEG-IFN-α-2 b) in the treatment of chronic hepatitis B ( CHB) . Methods The CHB patients who were treated with PEG-IFN-α-2 a ( 180 μg/week) or PEG-IFN-α-2 b ( 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-2 a group and the PEG-IFN-α-2 b 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-2 a 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-2 b 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 and0. 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-2 b group, one patient experienced Purtscher's retinopathy and one experienced thrombocytopenia, while no similar adverse reactions were observed in the PEG-IFN-α-2 a group. Conclusion Both PEG-IFN-α-2 a and PEG-IFN-α-2 b have strong antiviral and immunomodulatory effects in the treatment of CHB, with similar clinical effect and safety.
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[1]SARIN SK, KUMAR M, LAU GK, et al.Asian-Pacific clinical practice guidelines on the management of hepatitis B:A 2015update[J].Hepatol Int, 2016, 10 (1) :1-98. [2]LAMPERTICO P, AGARWAL K, BERG T, et al.EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection[J].J Hepatol, 2017, 67 (2) :370-398. [3]PAPATHEODORIDIS G, BUTI M, CORNBERG M, et al.EASLclinical practice guidelines:Management of chronic hepatitis Bvirus infection[J].J Hepatol, 2012, 57 (1) :167-185. [4]MARTIN P, LAU DT, NGUYEN MH, et al.A treatment algorithm for the management of chronic hepatitis B virus infection in the United States:2015 update[J].Clin Gastroenterol Hepatol, 2015, 13 (12) :2071-2087.e16. [5]WANG YJ, YANG L, ZUO JP.Recent developments in antivirals against hepatitis B virus[J].Virus Res, 2016, 213:205-213. [6]LIAW YF, KAO JH, PIRATVISUTH T, et al.Asian-Pacific consensus statement on the management of chronic hepatitis B:A 2012 update[J].Hepatol Int, 2012, 6 (3) :531-561. [7]YUEN MF, CHEN DS, DUSHEIKO GM, et al.Hepatitis B virus infection[J].Nat Rev Dis Primers, 2018, 4:18035. [8]Chinese Society of Hepatology and Chinese Society of Infectious Diseases Chinese, Medical Association.The guideline of prevention and treatment for chronic hepatitis B:A 2015 update[J].J Clin Hepatol, 2015, 31 (12) :1941-1960. (in Chinese) 中华医学会肝病学分会, 中华医学会感染病学分会.慢性乙型肝炎防治指南 (2015年更新版) [J].临床肝胆病杂志, 2015, 31 (12) :1941-1960. [9]TERRAULT NA, LOK ASF, MCMAHON BJ, et al.Update on prevention, diagnosis, and treatment of chronic hepatitis B:AASLD 2018 hepatitis B guidance[J].Hepatology, 2018, 67 (4) :1560-1599. [10]JANG JW, YOO SH, KWON JH, et al.Serum hepatitis B surface antigen levels in the natural history of chronic hepatitis Binfection[J].Aliment Pharmacol Ther, 2011, 34 (11-12) :1337-1346. [11] Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association.The guideline of prevention and treatment for chronic hepatitis B (2010 version) [J].JClin Hepatol, 2011, 27 (1) :Ⅰ-ⅩⅥ. (in Chinese) 中华医学会肝病学分会, 中华医学会感染病学分会.慢性乙型肝炎防治指南 (2010年版) [J].临床肝胆病杂志, 2011, 27 (1) :Ⅰ-ⅩⅥ. [12]ZHANG S, SUN J, XING HC.Progress on clinical cure of chronic hepatitis B[J/CD].Chin J Liver Dis:Electr Version, 2018, 10 (4) :54-58. (in Chinese) 张珊, 孙静, 邢卉春.慢性乙型肝炎临床治愈研究进展[J/CD].中国肝脏病杂志:电子版, 2018, 10 (4) :54-58. [13]ZHANG YS.Application of reasonable antiviral treatment of chronic hepatitis B in implementation of treatment goals in the guidelines[J/CD].Chin J Exp Clin Infect Dis:Electronic Edition, 2018, 12 (1) :15-19. (in Chinese) 张元山.合理抗病毒治疗在实现慢性乙型肝炎指南治疗目标中的应用[J/CD].中华实验和临床感染病杂志:电子版, 2018, 12 (1) :15-19. [14]HOPE VD, MANDAL S, CULLEN KJ, et al.Hepatitis B vaccination for people who inject drugs[J].Lancet, 2015, 385 (9963) :115-116. [15]KAO JH.HBe Ag-positive chronic hepatitis B:Why do I treat my patients with pegylated interferon?[J].Liver Int, 2014, 34 (Suppl 1) :112-119. [16]BRUNETTO MR.A new role for an old marker, HBsAg[J].JHepatol, 2010, 52 (4) :475-477. [17]CHAN HL, AHN SH, CHANG TT, et al.Peginterferon lambda for the treatment of HBe Ag-positive chronic hepatitis B:Arandomized phase 2b study (LIRA-B) [J].J Hepatol, 2016, 64 (5) :1011-1019. [18]SONNEVELD MJ, HANSEN BE, PIRATVISUTH T, et al.Response-guided peginterferon therapy in hepatitis B e antigen-positive chronic hepatitis B using serum hepatitis B surface antigen levels[J].Hepatology, 2013, 58 (3) :872-880. [19]LOU X, GAO YF, YE J, et al.Clinical effect of pegylated interferonα-2a in treatment of previously untreated HBe Ag-positive chronic hepatitis B patients and related predictive factors[J].J Clin Hepatol, 2018, 34 (5) :995-1000. (in Chinese) 娄鑫, 郜玉峰, 叶珺, 等.聚乙二醇干扰素α-2a初治HBe Ag阳性慢性乙型肝炎患者的效果及预测因素分析[J].临床肝胆病杂志, 2018, 34 (5) :995-1000. [20]BUSTER EH, FLINK HJ, CAKALOGLU Y, et al.Sustained HBe Ag and HBs Ag loss after long-term follow-up of HBe Ag-positive patients treated with peginterferon alpha-2b[J].Gastroenterology, 2008, 135 (2) :459-467. [21] LAU GK, PIRATVISUTH T, LUO KX, et al.Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B[J].N Engl J Med, 2005, 352 (26) :2682-2695. [22]JANCORIENE L, NORVYDAITE D, GALGAUSKAS S.Transient visual loss in a hepatitis C patient treated with pegylated interferon alfa-2a and ribavirin[J].Hepat Mon, 2014, 14 (2) :e15124. [23]LIU ZY, YUAN JS, PENG YZ.Observation on serious adverse events of phase 3 clinical trial in domestic Paigebin treatment of chronic hepatitis B[J].J Mod Med Health, 2016, 32 (17) :2644-2646. (in Chinese) 刘振宇, 袁劲松, 彭雁忠.国产派格宾治疗慢性乙型肝炎III期临床试验严重不良事件观察[J].现代医药卫生, 2016, 32 (17) :2644-2646. 期刊类型引用(15)
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5. 谭子跃. 干扰素合并恩替卡韦治疗乙型病毒性肝炎患者的疗效及对患者肝功能的影响. 医学信息. 2023(20): 137-140 . 百度学术
6. 李长安,赵巍峰,刘淑媛,窦芊,杜敬佩,杨瑞,王园园,李赢. 核苷类似物序贯联合聚乙二醇干扰素α-2b治疗乙型肝炎表面抗原低水平慢性乙型肝炎患者疗效观察. 新乡医学院学报. 2022(04): 323-329 . 百度学术
7. 窦文静,屈丹丹. 聚乙二醇干扰素α-2a联合替诺福韦治疗耐药慢性乙型病毒性肝炎的效果研究. 中国医学工程. 2022(05): 124-126 . 百度学术
8. 高欣欣. pegIFNα-2a联合恩替卡韦治疗CHB的效果. 中外医学研究. 2021(35): 33-36 . 百度学术
9. 张连峰,杨丽敏. 胸腺肽肠溶片联合聚乙二醇干扰素对慢性肝炎患者的治疗效果及其相关指标的影响. 中国当代医药. 2020(04): 50-52 . 百度学术
10. 张如幸. 恩替卡韦联合聚乙二醇干扰素α-2a对慢性乙型肝炎患者血清IFN-γ、IL-10水平及肝纤维化的影响. 临床医学工程. 2020(03): 293-294 . 百度学术
11. 李淑,彭雁忠,胡国信,齐明华,武敬. 聚乙二醇干扰素治疗低水平HBsAg慢性乙肝患者疗效. 中国热带医学. 2020(07): 676-681 . 百度学术
12. 周长雄,于文虎,陈卫兵,周琴,金笛. 聚乙二醇干扰素α-2b联合恩替卡韦对慢性乙肝患者RORγt eGFR的影响. 河北医学. 2020(12): 2087-2091 . 百度学术
13. 应玲玲,章国君,叶卫江. 干扰素治疗慢性乙型肝炎的研究进展. 国际流行病学传染病学杂志. 2020(06): 559-564 . 百度学术
14. 曾芬. 聚乙二醇干扰素α-2b治疗慢性乙型肝炎的疗效探讨. 世界复合医学. 2019(07): 183-185 . 百度学术
15. 支星,颜学兵. 外周血γδT细胞在评估Peg-IFN α-2a治疗慢性乙型肝炎效果中的应用价值. 肝脏. 2019(11): 1267-1269 . 百度学术
其他类型引用(5)
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