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静脉注射免疫球蛋白相关血栓栓塞事件的病例对照研究

Case-control study of thromboembolic events associated with IV immunoglobulin.

作者信息

Caress James B, Hobson-Webb Lisa, Passmore Leah V, Finkbiner Anne P, Cartwright Michael S

机构信息

Dept. of Neurology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.

出版信息

J Neurol. 2009 Mar;256(3):339-42. doi: 10.1007/s00415-009-0969-0. Epub 2009 Mar 1.

DOI:10.1007/s00415-009-0969-0
PMID:19253011
Abstract

Serious adverse events related to IVIg treatment are unusual, and interventions can be taken to reduce the risk of anaphylaxis, congestive heart failure and renal failure. Stroke and other thromboembolic (TE) events have also been associated with IVIg administration but the risk factors are unknown. This paper investigates whether typical cardiovascular risk factors increase the risk of thromboembolic (TE) events during intravenous immunoglobulin infusion. This case-control study compares 19 patients (mean age = 71 +/- 9 years) who experienced a TE event within 2 weeks of IVIg infusion with 38 age-matched controls who received IVIg without experiencing an event. No single cardiovascular risk factor increased the risk of TE event, but the risk was elevated when 2 or more cardiovascular risk factors were present (odds ratio = 1.39, 95 % CI: 0.45, 4.30) and became statistically significant when 4 or more risk factors were present (odds ratio = 10.50, 95 % CI: 1.91, 57.58). The 30 day mortality rate was high in cases (15.8 %) and controls (18.4 %) but not significantly different between the groups.The risk of TE events was increased in individuals with 4 or more cardiovascular risk factors, but, given the wide confidence intervals in our results, the degree of increased risk is difficult to predict. The data suggest that elderly, hospitalized patients receiving IVIg are at moderately elevated risk for TE events and 30 day mortality. Clinicians prescribing IVIg should carefully consider the risk of stroke and myocardial infarction in elderly patients with multiple cardiovascular risk factors, and this risk should be discussed with patients receiving IVIg. Prospective studies of TE events would most accurately demonstrate the incidence and risk factors for these complications.

摘要

与静脉注射免疫球蛋白(IVIg)治疗相关的严重不良事件并不常见,可以采取干预措施来降低过敏反应、充血性心力衰竭和肾衰竭的风险。中风和其他血栓栓塞(TE)事件也与IVIg给药有关,但风险因素尚不清楚。本文研究典型的心血管危险因素是否会增加静脉注射免疫球蛋白输注期间血栓栓塞(TE)事件的风险。这项病例对照研究比较了19例(平均年龄 = 71±9岁)在IVIg输注后2周内发生TE事件的患者与38例年龄匹配的接受IVIg但未发生事件的对照患者。没有单一的心血管危险因素会增加TE事件的风险,但当存在2个或更多心血管危险因素时风险会升高(比值比 = 1.39,95%可信区间:0.45,4.30),当存在4个或更多危险因素时具有统计学意义(比值比 = 10.50,95%可信区间:1.91,57.58)。病例组(15.8%)和对照组(18.4%)的30天死亡率都很高,但两组之间没有显著差异。有4个或更多心血管危险因素的个体发生TE事件的风险增加,但鉴于我们结果中较宽的可信区间,风险增加的程度难以预测。数据表明,接受IVIg的老年住院患者发生TE事件和30天死亡率的风险适度升高。开具IVIg处方的临床医生应仔细考虑具有多个心血管危险因素的老年患者中风和心肌梗死的风险,并应与接受IVIg的患者讨论这种风险。对TE事件的前瞻性研究将最准确地证明这些并发症的发生率和危险因素。

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