i3 Drug Safety, Ann Arbor, MI 48108, USA.
Neurology. 2010 Oct 12;75(15):1326-32. doi: 10.1212/WNL.0b013e3181f73600.
To estimate the incidence rate (IR) of progressive multifocal leukoencephalopathy (PML) in patients without HIV.
Within a large US health insurer database between January 2000 and June 2008, we conducted a retrospective observational study. We identified people with autoimmune diseases, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), or history of bone marrow or solid organ transplantation, and a general population cohort. We developed a PML case-finding algorithm and validated PML diagnoses in medical charts.
There were 138,469 patients with autoimmune diseases, 25,706 with NHL or CLL, and 8,778 with transplants. Among 699 people who met screening criteria for potential PML, 89 had a claim diagnosis of PML (International Classification of Diseases-9 046.3). Medical records were sought for 24 patients without HIV, and 6 had confirmed PML upon review of medical records. The PML IR was 2.4 (95% confidence interval [CI] 0.06-13.18) in the systemic lupus erythematosus cohort and 10.8 (95% CI 0.27-60.39) in the autoimmune vasculitis cohort per 100,000 person-years. In the NHL and CLL cohorts, the IR was 8.3 (95% CI 1.71-24.24) and 11.1 (0.28-61.74) per 100,000 person-years. The IR among patients with bone marrow transplantation was 35.4 per 100,000 person-years (95% CI 0.90-197.29). There were no cases of PML among patients with rheumatoid arthritis (95% CI 0.0-2.24), multiple sclerosis (95% CI 0.0-5.24), Sjögren disease (95% CI 0.0-21.84), or solid organ transplantation (95% CI 0.0-26.81).
In this large population-based investigation of PML with thorough case finding and a known source population, the IR of medical record-confirmed PML was rare in non-HIV patient cohorts.
估计无 HIV 患者中进行性多灶性白质脑病(PML)的发病率(IR)。
在 2000 年 1 月至 2008 年 6 月期间,我们在美国一家大型健康保险公司的数据库中进行了一项回顾性观察性研究。我们确定了患有自身免疫性疾病、慢性淋巴细胞白血病(CLL)、非霍奇金淋巴瘤(NHL)或有骨髓或实体器官移植史的人群,以及一个普通人群队列。我们开发了一种 PML 病例发现算法,并在病历中验证了 PML 诊断。
共有 138469 名自身免疫性疾病患者、25706 名 NHL 或 CLL 患者和 8778 名接受过移植的患者。在符合潜在 PML 筛查标准的 699 人中,有 89 人有 PML 的索赔诊断(国际疾病分类第 9 版 046.3)。对 24 名无 HIV 的患者进行了病历检索,其中 6 名经病历审查后确诊为 PML。系统性红斑狼疮队列的 PML IR 为每 100000 人年 2.4(95%置信区间[CI]0.06-13.18),自身免疫性血管炎队列为 10.8(95%CI0.27-60.39)。在 NHL 和 CLL 队列中,IR 分别为每 100000 人年 8.3(95%CI1.71-24.24)和 11.1(0.28-61.74)。骨髓移植患者的 IR 为每 100000 人年 35.4(95%CI0.90-197.29)。类风湿关节炎(95%CI0.0-2.24)、多发性硬化症(95%CI0.0-5.24)、干燥综合征(95%CI0.0-21.84)或实体器官移植(95%CI0.0-26.81)患者均无 PML 病例。
在这项基于人群的 PML 大型调查中,我们进行了彻底的病例发现,并对已知的源人群进行了研究,在非 HIV 患者队列中,经病历证实的 PML 的发病率(IR)非常罕见。