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聚乙二醇干扰素 - 利巴韦林联合治疗在日常实践中治疗慢性丙型肝炎的疗效、耐受性和安全性。

Efficacy, tolerability and safety in the treatment of chronic hepatitis C with combination of PEG-Interferon - Ribavirin in daily practice.

机构信息

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno, CEMIC, Ciudad Autónoma de Buenos Aires, Argentina.

出版信息

Ann Hepatol. 2010 Jan-Mar;9(1):46-51.

PMID:20308722
Abstract

BACKGROUND

Efficacy and safety of Pegylated Interferon alfa (PegIFN)-Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) in routine clinical practice seems to be comparable with results of randomized-controlled trials.

AIMS

To evaluate the efficacy, tolerability and safety of CHC treatment with PegIFN + RBV in .real world. patients in Argentina and to analyze factors associated with SVR.

METHODS

Medical records of patients treated according to current guidelines from 2001 to 2008 were reviewed.

RESULTS

235 patients were included and 80.8% completed treatment. Discontinuation occurred in 7.6% due to adverse events (AE), and 1.2% dropped-out treatment. Overall SVR was 60.8%. Multivariate analysis demonstrated that being naive (p 0.031) and low basal viral load (p 0.006) were associated with SVR, whereas F3-F4 (p 0.001) and elevated ALT (p 0.023) were associated with non-response. 80% of planned doses completed was associated with 74% SVR (p <0.001). At least one AE was reported in 93.6% of the patients: neutropenia in 27.6%, thrombocytopenia in 15.3%, anemia in 38.7%, psychiatric symptoms in 63.4%, thyroid dysfunction in 10.2%.

CONCLUSION

Efficacy, tolerability and safety of treatment of CHC in daily practice in Argentina are similar to those reported in randomized controlled trials.

摘要

背景

聚乙二醇干扰素 alfa(PegIFN)-利巴韦林(RBV)在常规临床实践中治疗慢性丙型肝炎(CHC)的疗效和安全性似乎与随机对照试验的结果相当。

目的

评估聚乙二醇干扰素+利巴韦林治疗阿根廷真实世界 CHC 患者的疗效、耐受性和安全性,并分析与 SVR 相关的因素。

方法

回顾了 2001 年至 2008 年根据现行指南治疗的患者的病历。

结果

共纳入 235 例患者,80.8%完成了治疗。因不良反应(AE)停药的发生率为 7.6%,1.2%的患者因其他原因退出治疗。总体 SVR 为 60.8%。多因素分析显示,初治(p 0.031)和低基础病毒载量(p 0.006)与 SVR 相关,而 F3-F4(p 0.001)和升高的 ALT(p 0.023)与无应答相关。完成计划剂量的 80%与 74%的 SVR 相关(p <0.001)。93.6%的患者报告至少有一种 AE:中性粒细胞减少症 27.6%、血小板减少症 15.3%、贫血 38.7%、精神症状 63.4%、甲状腺功能障碍 10.2%。

结论

阿根廷常规临床实践中 CHC 治疗的疗效、耐受性和安全性与随机对照试验报道的结果相似。

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