BACKGROUND/AIMS:Pegylated alfa interferon is the only immunomodulatory drug licensed for hepatitis B. We evaluated the safety and tolerability of peginterferon alfa-2a (40KD) in patients with chronic hepatitis B. MATERIALS AND METHODS:A total of 113 chronic hepatitis B patients under peginterferon alfa-2a (40KD; 180 μg/week) treatment were included in this multicenter, open label, non-interventional study, and 66 patients completed the follow-up period. Vital signs, physical examination and laboratory findings, concomitant medications, and adverse events were recorded. A Quality of Life questionnaire (Short Form-36) was performed twice, at the beginning and at the end of the study. RESULTS:There was no significant difference between initial and last visits in terms of physical examination findings and Short Form-36 scores. A total of 27 adverse events were reported in 15 patients (22.7%), with most of them being mild in intensity (70.4%). The rates of the adverse events were similar in the monotherapy and combination therapy groups (peginterferon alfa-2a + lamivudine, peginterferon alfa-2a + adefovir or peginterferon alfa-2a + entecavir therapy groups), at 23.7% and 14.3%, respectively. The dosage of peginterferon had to be reduced in 3 patients (4.5%) due to thrombocytopenia. Overall patient compliance to treatment was detected as 85.9%. CONCLUSIONS:Based on the lack of serious adverse events and absence of impairment in Quality of Life, peginterferon alfa-2a (40KD, 180 μg/week, subcutaneously) treatment for 48 weeks led to a high level of patient compliance and was associated with a high degree of safety and tolerability for the treatment of adult patients with chronic hepatitis B in real-life practice.

译文

背景/目的:聚乙二醇化α干扰素是唯一被许可用于乙型肝炎的免疫调节药物。我们评估了聚乙二醇干扰素α-2a(40KD)在慢性乙型肝炎患者中的安全性和耐受性。
材料与方法:这项多中心,开放性,非干预性研究共纳入113例接受聚乙二醇干扰素α-2a(40KD; 180μg/周)治疗的慢性乙型肝炎患者,其中66例患者完成了随访。记录生命体征,体格检查和实验室检查结果,伴随用药和不良事件。在研究的开始和结束时,进行了两次生活质量问卷(简短表格36)。
结果:体检结果和Short Form-36得分在初次就诊与最后一次就诊之间没有显着差异。 15例患者中报告了27例不良事件(22.7%),其中大多数为轻度(70.4%)。单一疗法和联合疗法组(peginterferon alfa-2a拉米夫定,peginterferon alfa-2a阿德福韦或peginterferon alfa-2a恩替卡韦治疗组)的不良事件发生率相似,分别为23.7%和14.3%。由于血小板减少症,必须减少3例患者(4.5%)的聚乙二醇干扰素的剂量。总体患者对治疗的依从性为85.9%。
结论:基于缺乏严重不良事件和生活质量的损害,peginterferon alfa-2a(40KD,180μg/ week,皮下)治疗48周导致患者依从性高,并且与在现实生活中,对成人慢性乙型肝炎患者的治疗具有很高的安全性和耐受性。

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