Center for Observational Research (CfOR), Amgen Inc., Thousand Oaks, CA 91320-1799, USA.
Am J Hematol. 2011 Sep;86(9):738-42. doi: 10.1002/ajh.22089. Epub 2011 Jul 22.
Renal impairment (RI) and events potentially leading to RI were reported in idiopathic thrombocytopenic purpura (ITP) patients with specific medications. This study was conducted to estimate the incidence rate (IR) of RI, hemoglobinuria and hemoglobinemia (HE) and characterize baseline risk factors in ITP and ITP-free patients. Incident ITP and matched non-ITP patients were identified from an electronic medical record database from 1990 to 2002. ITP patients were classified by the treatment first received (initiators) or ever received (users). All cohorts were followed for study outcomes. IRs were calculated and standardized by age and gender. A total of 881 ITP and 4,496 ITP-free patients yielded 3,044 and 16,006 person-years, respectively. The ITP cohort had a slightly higher prevalence of autoimmune diseases and infections than the ITP-free cohort. The IR (/10,000 person-years) for RI, hemoglobinuria and HE was 14.2, 35.7, and 7.1 in the ITP cohort; 10.0, 48.8, and 0 in the ITP-free cohort; and 18.3, 37.1, and 6.1 in untreated ITP patients, respectively. The risk of RI, HE or hemoglobinuria was not found to differ substantially between ITP and non-ITP patients or across ITP treatments.
在特发性血小板减少性紫癜(ITP)患者中,某些药物会导致肾功能损害(RI)和潜在的 RI 事件。本研究旨在评估 RI、血红蛋白尿和血红蛋白血症(HE)的发生率(IR),并描述 ITP 和非 ITP 患者的基线风险因素。从 1990 年至 2002 年的电子病历数据库中确定了新发 ITP 和匹配的非 ITP 患者。根据首次接受的治疗(起始剂)或曾经接受的治疗(使用者)对 ITP 患者进行分类。所有队列均进行了研究结局随访。通过年龄和性别对 IR 进行标准化计算。共纳入 881 例 ITP 和 4496 例非 ITP 患者,分别获得 3044 和 16006 人年。与非 ITP 患者相比,ITP 患者的自身免疫性疾病和感染发生率略高。ITP 队列的 RI、血红蛋白尿和 HE 的 IR(/10,000 人年)分别为 14.2、35.7 和 7.1;非 ITP 队列分别为 10.0、48.8 和 0;未治疗的 ITP 患者分别为 18.3、37.1 和 6.1。ITP 和非 ITP 患者或 ITP 治疗之间,RI、HE 或血红蛋白尿的风险差异不显著。