Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a
Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a
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DOI：
10.1111/j.1478-3231.2008.01696.x
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发表时间：
2008-04-01
影响因子：
6.7
通讯作者：
Pluck, Nigel
中科院分区：
文献类型：
--
作者：
Marcellin, Patrick;Lau, George K. K.;Pluck, Nigel
背景/目的：乙型肝炎病毒和丙型肝炎病毒是临床上既不同又有联系的两种疾病。将聚乙二醇型干扰素α-2a在慢性丙型肝炎病毒感染(CHC)患者中的五项研究与该药物在慢性乙肝病毒感染(CHB)患者中的两项研究进行了比较。方法：研究对象包括乙型肝炎e抗原(HBeAg)阳性(271例)和HBeAg阴性(177例)患者，791例患者参加了丙型肝炎病毒试验。在所有研究中，患者接受180毫克聚乙二醇α-2a单一治疗，每周一次，为期48周。记录不良事件(AE)、停药和剂量调整的数量。健康相关生活质量(HRQL)采用简明36问卷进行测评。在整个治疗期间对安全性进行了评估。24周的无治疗随访期也包括在内。结果：两组在不良反应发生率(88-89对96-100%)、严重不良反应发生率(4-5%对7-16%)和停药发生率(6-8对17-33%)方面存在差异。慢性乙型病毒性肝炎患者抑郁相关事件的发生率较低(4vs22%，P<；0.001)，治疗对患者生活质量的影响也较低。结论：聚乙二醇型干扰素α-2a治疗慢性乙型病毒性肝炎的安全性和耐受性优于慢性丙型肝炎患者，其常见干扰素相关不良反应的发生率较低，抑郁症的发生率明显较低。
Background/Aims: Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB). Method: The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 mu g peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed throughout the treatment period. A 24-week treatment-free follow-up period was also included. Results: Differences (HBV vs HCV) were observed in the incidence of AEs (88-89 vs 96-100%), serious AEs (4-5 vs 7-16%) and treatment withdrawals (6-8 vs 17-33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P < 0.001), as was the impact of treatment on HRQL. Conclusions: The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression.