Ramírez Elena, Romero-Garrido José A, López-Granados Eduardo, Borobia Alberto M, Pérez Tamara, Medrano Nicolás, Rueda Cristina, Tong Hoi Y, Herrero Alicia, Frías Jesús
Department of Clinical Pharmacology, Hospital Universitario La Paz, IdiPAZ, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
Department of Pharmacy, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
Thromb Res. 2014 Jun;133(6):1045-51. doi: 10.1016/j.thromres.2014.03.046. Epub 2014 Apr 1.
To estimate the incidence and predictors of symptomatic arterial and venous thromboembolic events (TEE) from intravenous immunoglobulin (IVIg) therapy according to its indications.
We performed a retrospective cohort study of patients seen at our institution and treated with IVIg over a 36-month period. Indications, comorbility and comedication associated with TEE were identified by a stepwise logistic regression analysis.
Of 303 patients included with at least one infusion of IVIg over three years, TEE were identified in a total of 50 patients treated with IVIg, for an incidence of 16.9% (CI 95%: 13.0-21.6); 27 (54%) arterial (9.1%;CI 95%: 6.3-13.0%) and 23 (46%) venous TEE (7.8%; CI95%: 5.2-11.4%), overall mortality was 32%. Per indication there were more patients with autoimmune conditions, secondary immunodeficiency, dysimmune neuropathies, acute rejection of solid organ transplantation and sepsis. Patients with TEE were significantly older, were more likely to be men, they had more comorbid conditions; the doses of IVIg were high (589.4mg/kg/day vs 387.0mg/kg/day, p<0.001) and differences in comedication were found. The stepwise logistic regression analysis retained high doses of IVIg (OR 3.03; CI 95%: 1.49-5.67) and diuretics therapy (OR 1.69; CI 95%: 1.06-3.97) when combined with the usual comorbid confounders.
The incidence of TEE from IVIg therapy remains high at one in six patients treated. The most remediable factor is a high daily IVIg load. Decreasing the daily IVIg dose together with carefully weighing diuretics therapy and comorbid risk factors may be the keys to saving lives.
根据静脉注射免疫球蛋白(IVIg)治疗的适应症,评估有症状的动脉和静脉血栓栓塞事件(TEE)的发生率及预测因素。
我们对在我院接受治疗且在36个月内接受IVIg治疗的患者进行了一项回顾性队列研究。通过逐步逻辑回归分析确定与TEE相关的适应症、合并症和联合用药情况。
在303例三年内至少接受一次IVIg输注的患者中,共有50例接受IVIg治疗的患者发生了TEE,发生率为16.9%(95%置信区间:13.0 - 21.6);27例(54%)为动脉TEE(9.1%;95%置信区间:6.3 - 13.0%),23例(46%)为静脉TEE(7.8%;95%置信区间:5.2 - 11.4%),总死亡率为32%。按适应症来看,自身免疫性疾病、继发性免疫缺陷、免疫性神经病、实体器官移植急性排斥反应和脓毒症患者更多。发生TEE的患者年龄显著更大,男性居多,合并症更多;IVIg剂量较高(589.4mg/kg/天 vs 387.0mg/kg/天,p<0.001),且联合用药存在差异。逐步逻辑回归分析在纳入常见合并症混杂因素后,保留了高剂量IVIg(比值比3.03;95%置信区间:1.49 - 5.67)和利尿剂治疗(比值比: 1.69;95%置信区间:1.06 - 3.97)。
IVIg治疗导致的TEE发生率在接受治疗的患者中仍高达六分之一。最可补救的因素是每日IVIg负荷量高。降低每日IVIg剂量,同时仔细权衡利尿剂治疗和合并症风险因素可能是挽救生命的关键。