VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA; Department of Medicine, Boston University School of Medicine, Boston, MA, USA.
Pharmacoepidemiol Drug Saf. 2014 May;23(5):480-8. doi: 10.1002/pds.3585. Epub 2014 Feb 20.
We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD).
Using a retrospective, observational cohort study design to analyze databases from the New England Veterans Healthcare System, we identified 979 patients diagnosed with HCV-positive CLD treated solely with PEG-IFN plus ribavirin. The cohort was stratified by pre-treatment platelet counts of 50,000-100,000/μL (N = 90), >100,000-150,000/μL (N = 162), and >150,000μL (N = 727). The cumulative incidence of severe thrombocytopenia and major bleeding events were determined for each baseline platelet group for 48 weeks following treatment initiation. Multivariable Cox regression was used to identify risk factors for incident severe thrombocytopenia.
Overall, severe thrombocytopenia occurred in 6.1% (N = 60), but in 41.1% of patients with pre-treatment platelet counts 50, 000-100,000/μL compared with 11.7% (p < 0.001) and 0.55% (p < 0.001) in the two higher pre-treatment platelet groups. Most episodes occurred within the first 12 weeks of treatment. Median nadir count for these 60 patients was 35,000/μL (inter-quartile range 28,000, 44,000). Baseline platelet counts of 50,000-100,000/μL [adjusted hazard ratio (HR) = 3.81; 95%CI = 2.07-7.00] and hemoglobin <10 g/dL (adjusted HR = 3.39; 95%CI = 1.45-7.960) associated with severe thrombocytopenia. Major bleeding events during the 48-week observation period were rare (N = 5, 0.51%).
The incidence of severe thrombocytopenia in a large, observational cohort of veteran patients with HCV CLD treated with PEG-IFN plus ribavirin was 6.1%. Low pre-treatment platelet counts and hemoglobin levels associated with early, incident severe thrombocytopenia.
我们旨在确定美国退伍军人患者在接受聚乙二醇干扰素（PEG-IFN）联合利巴韦林治疗丙型肝炎病毒阳性（HCV）慢性肝病（CLD）时发生严重血小板减少症（血小板<50,000/μL）的发生率和风险。
使用回顾性观察队列研究设计，分析来自新英格兰退伍军人医疗保健系统的数据库，我们确定了 979 名仅接受 PEG-IFN 联合利巴韦林治疗的 HCV 阳性 CLD 患者。该队列根据治疗开始后 48 周时的预处理血小板计数分为 50,000-100,000/μL（N=90）、>100,000-150,000/μL（N=162）和>150,000μL（N=727）。为每个基线血小板组确定严重血小板减少症和主要出血事件的累积发生率。多变量 Cox 回归用于确定发生严重血小板减少症的危险因素。
总体而言，严重血小板减少症的发生率为 6.1%（N=60），但在预处理血小板计数为 50,000-100,000/μL 的患者中发生率为 41.1%，而在两个较高的预处理血小板组中发生率分别为 11.7%（p<0.001）和 0.55%（p<0.001）。大多数事件发生在治疗的前 12 周内。这 60 名患者的中位最低计数为 35,000/μL（四分位距 28,000，44,000）。血小板计数为 50,000-100,000/μL[调整后的危险比（HR）=3.81；95%CI=2.07-7.00]和血红蛋白<10 g/dL（调整后的 HR=3.39；95%CI=1.45-7.960）与严重血小板减少症相关。在 48 周观察期间，严重出血事件（N=5，0.51%）很少见。
在接受 PEG-IFN 联合利巴韦林治疗的 HCV CLD 退伍军人大型观察队列中，严重血小板减少症的发生率为 6.1%。低预处理血小板计数和血红蛋白水平与早期发生的严重血小板减少症相关。
