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美国普通慢性丙型肝炎患者人群中聚乙二醇干扰素或利巴韦林的绝对和相对禁忌证:来自美国数据库中 45000 多名丙型肝炎病毒感染患者评估结果。

Absolute and relative contraindications to pegylated-interferon or ribavirin in the US general patient population with chronic hepatitis C: results from a US database of over 45 000 HCV-infected, evaluated patients.

机构信息

State University of New York, Buffalo, NY 14203, USA.

出版信息

Aliment Pharmacol Ther. 2013 Feb;37(4):473-81. doi: 10.1111/apt.12200. Epub 2013 Jan 7.

DOI:10.1111/apt.12200
PMID:23289640
Abstract

BACKGROUND

Chronic hepatitis C (HCV) treatment with pegylated-interferon (PEG-IFN)/ribavirin (RBV) is often limited by preexisting medical, psychiatric and psychosocial contraindications. However, limited data exist in general patient populations.

AIM

To evaluate the percentage of HCV-infected patients in the general US population who may have contraindications to PEG-IFN/RBV.

METHODS

The General Electric (GE) Centricity dataset was used to screen the US population between 2004 and 2009 for HCV infection and contraindications to PEG-IFN/RBV. HCV diagnosis and contraindications were identified using ICD-9-CM codes or laboratory values. Only patients with an encounter 180 days prior to HCV diagnosis were included. Demographic differences were calculated using Pearson's chi-squared test. Frequencies and percentages for absolute and relative contraindications to PEG-IFN and/or RBV were determined and proportions and rates/1000 person-months were calculated.

RESULTS

A total of 15 561 021 patients were screened, and 45 690 (0.3%) were HCV-positive and were evaluated. Those with contraindications were significantly younger, female, White, not currently married and receiving Medicare or Medicaid coverage (all P < 0.0001). 17.3% had at least one contraindication to PEG-IFN/RBV (5.5 events/1000 person-months); bipolar disorder (6.5%), anaemia (Hgb < 10 g/dL; 5.9%), pregnancy (1.9%) and neutropenia (neutrophils <750 cells/mm(3) ; 1.2%) were most frequently cited.

CONCLUSIONS

Approximately, 17% of HCV-infected patients in the general US population had at least one contraindication to PEG-IFN/RBV. Most contraindications were relative and potentially modifiable. Clinical assessment of contraindications as relative and/or modifiable should be considered and used to determine if patients could benefit from current PEG-IFN-containing triple therapy or future PEG-IFN- or RBV-free regimens.

摘要

背景

慢性丙型肝炎(HCV)的治疗采用聚乙二醇干扰素(PEG-IFN)/利巴韦林(RBV),但常受到预先存在的医学、精神和社会心理禁忌的限制。然而,一般患者人群中的相关数据有限。

目的

评估美国一般人群中感染 HCV 的患者中可能对 PEG-IFN/RBV 有禁忌的比例。

方法

使用通用电气(GE)Centricity 数据集,筛选 2004 年至 2009 年美国人群中 HCV 感染和 PEG-IFN/RBV 禁忌证。HCV 诊断和禁忌证采用 ICD-9-CM 编码或实验室值来确定。仅纳入 HCV 诊断前 180 天内有就诊记录的患者。采用 Pearson χ2 检验比较人口统计学差异。确定 PEG-IFN 和/或 RBV 的绝对和相对禁忌证的频率和百分比,并计算比例和每千人月发生率/率。

结果

共筛选出 15 561 021 例患者,其中 45 690(0.3%)例 HCV 阳性并进行了评估。有禁忌证的患者明显更年轻、女性、白人、未婚且接受医疗保险或医疗补助(均 P < 0.0001)。17.3%的患者至少有一种 PEG-IFN/RBV 的禁忌证(5.5 例/千人月);最常见的是双相情感障碍(6.5%)、贫血(Hb < 10 g/dL;5.9%)、妊娠(1.9%)和中性粒细胞减少症(中性粒细胞 <750 个/μL;1.2%)。

结论

美国一般 HCV 感染人群中,约 17%的患者至少有一种 PEG-IFN/RBV 的禁忌证。大多数禁忌证是相对的,且可能是可改变的。应考虑将禁忌证评估为相对和/或可改变,并用于确定患者是否能从当前含 PEG-IFN 的三联疗法或未来的 PEG-IFN 或 RBV 无方案中获益。

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