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接受利巴韦林和直接抗病毒药物治疗的丙型肝炎患者的贫血预测因素

Anaemia predictors in patients with chronic hepatitis C treated with ribavirin and direct-acting antiviral agents.

作者信息

Molina-Cuadrado Emilio, Mateo-Carrrasco Héctor, Collado Antonio, Casado Martín Marta

机构信息

Pharmacy Department, Torrecárdenas University Hospital, Almería, Spain.

Pharmacy Department, The Royal Marsden Hospital, London, UK.

出版信息

Eur J Hosp Pharm. 2018 May;25(3):132-137. doi: 10.1136/ejhpharm-2017-001277. Epub 2017 Jun 21.

Abstract

OBJECTIVES

Anaemia is the most common side effect associated with ribavirin (RBV). This study intended to assess its incidence and determine its predictive factors in patients with hepatitis C virus on RBV plus direct-acting antiviral agents (DAAs).

METHODS

A retrospective study of patients receiving RBV+DAA was conducted. Serum haemoglobin (Hb) was determined at baseline and monitored 4 weekly. Anaemia was defined as a single occurrence of Hb <10 g/dL. Bivariate and multivariate logistic regression analyses were conducted to assess the relationship between the occurrence of anaemia and the following factors: age, gender, FibroScan score, viral load, cirrhotic status (yes/no), RBV dose, glomerular filtration rate (GFR), alanine amino transferase, albumin, treatment duration (12 vs ≥12 weeks), baseline Hb, and Hb% drop (weeks 0-2).

RESULTS

152 patients were included, of which 15.1% experienced anaemia. The analysis revealed that estimated GFR (eGFR), baseline Hb, 12-week treatment duration and Hb% drop (weeks 0-2) were significantly associated with the likelihood of developing anaemia (p<0.05). Two mathematical models were subsequently developed to predict patients at risk of anaemia: a pretreatment model (positive predictive value 86.6%) which included eGFR, baseline Hb and 12-week treatment duration and an intratreatment model (positive predictive value of 90.48%) which in addition included the Hb% drop (weeks 0-2).

CONCLUSION

Anaemia was found to be less significant in this cohort compared with studies on RBV plus pegylated interferon, telaprevir or boceprevir combinations, but higher than those on newer DAAs. Baseline Hb, eGFR, 12-week treatment duration and Hb% drop (weeks 0-2) significantly predicted the risk of anaemia and were used to construct two predictive models.

摘要

目的

贫血是与利巴韦林(RBV)相关的最常见副作用。本研究旨在评估丙型肝炎病毒患者接受RBV加直接抗病毒药物(DAA)治疗时贫血的发生率并确定其预测因素。

方法

对接受RBV+DAA治疗的患者进行回顾性研究。在基线时测定血清血红蛋白(Hb),并每4周监测一次。贫血定义为Hb<10 g/dL的单次发生。进行双变量和多变量逻辑回归分析,以评估贫血发生与以下因素之间的关系:年龄、性别、FibroScan评分、病毒载量、肝硬化状态(是/否)、RBV剂量、肾小球滤过率(GFR)、丙氨酸氨基转移酶、白蛋白、治疗持续时间(12周与≥12周)、基线Hb以及Hb%下降(第0 - 2周)。

结果

纳入152例患者,其中15.1%发生贫血。分析显示,估计肾小球滤过率(eGFR)、基线Hb、12周治疗持续时间和Hb%下降(第0 - 2周)与发生贫血的可能性显著相关(p<0.05)。随后建立了两个数学模型来预测有贫血风险的患者:一个预处理模型(阳性预测值86.6%),包括eGFR、基线Hb和12周治疗持续时间;一个治疗中模型(阳性预测值90.48%),此外还包括Hb%下降(第0 - 2周)。

结论

与关于RBV加聚乙二醇干扰素、特拉匹韦或博赛匹韦联合治疗的研究相比,该队列中贫血的影响较小,但高于使用新型DAA的研究。基线Hb、eGFR、12周治疗持续时间和Hb%下降(第0 - 2周)显著预测了贫血风险,并用于构建两个预测模型。

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