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[1395次使用不同静脉注射免疫球蛋白产品的输液中的不良事件]

[Adverse events in 1395 infusions with different intravenous gammaglobulin products].

作者信息

Malbrán Alejandro, Larrauri Blas, Juri María Cecilia, Fernández Romero Diego S

机构信息

Unidad de Alergia, Asma e Inmunología Clínica, Hospital Británico de Buenos Aires.

出版信息

Medicina (B Aires). 2013;73(5):433-7.

Abstract

The processes of isolation and sterilization of intravenous gamma globulin (IVIG) affect the end product characteristics and, therefore, its tolerability. Different products have different incidences of adverse reactions. The aim of this study was to quantify the immediate adverse events (AE) caused by the different IVIG preparations. We analyzed 1 395 infusions in 28 patients, with a median of 32.5 per subject (range 2-214), using six different IVIG preparations, with an average dose 40.3 ± 8.3 g. One thousand and thirty-one infusions were analyzed retrospectively and 364 prospectively. Patients used a mean of 2.68 ± 1.8 different IVIGs, with a median of 2 (range 1-6) per person. The number of trademarks used was related to the number of infusions received, r = 0.73. AE presented in 24 (2.3%) of 1 031 infusions retrospectively analyzed, affecting 11 of 23 patients enrolled, with a mean of 2.18 ± 1.08 AE per subject. Of 24 patients and 364 infusions prospectively analyzed, AE were observed in 14 patients and in 32 (7.2%) procedures. Twenty-four (42.9%) of 56 AE were mild, 31 (55.5%) moderate and one (1.8%) severe. The infusion rate was 9.04 ± 6 g/h for those presenting AE vs. 10.6 ± 4.6 g/h for those who did not (p = 0.31, NS). The incidence, severity and proportion of patients with AE for each brand of IVIG were very different from each other. This information should be taken into account when selecting the IVIG to be used.

摘要

静脉注射用丙种球蛋白(IVIG)的分离和灭菌过程会影响最终产品特性,进而影响其耐受性。不同产品的不良反应发生率不同。本研究的目的是量化不同IVIG制剂引起的即刻不良事件(AE)。我们分析了28例患者的1395次输注,每位患者的输注次数中位数为32.5次(范围为2 - 214次),使用了六种不同的IVIG制剂,平均剂量为40.3±8.3g。对1031次输注进行了回顾性分析,364次进行了前瞻性分析。患者平均使用2.68±1.8种不同的IVIG,每人的中位数为2种(范围为1 - 6种)。使用的商标数量与接受的输注次数相关,r = 0.73。在回顾性分析的1031次输注中,有24次(2.3%)出现AE,涉及23名入组患者中的11名,每位患者的AE平均为2.18±1.08次。在24例患者和364次前瞻性分析的输注中,14例患者出现AE,32次(7.2%)操作出现AE。56例AE中有24例(42.9%)为轻度,31例(55.5%)为中度,1例(1.8%)为重度。出现AE的患者输注速度为9.04±6g/h,未出现AE的患者输注速度为10.6±4.6g/h(p = 0.31,无统计学意义)。每种IVIG品牌的AE发生率、严重程度和患者比例彼此差异很大。在选择使用的IVIG时应考虑这些信息。

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