1176例接受家庭输液治疗患者静脉注射免疫球蛋白安全性的回顾性分析

A Retrospective Analysis of the Safety Profile of Intravenous Immunoglobulin in 1176 Patients Receiving Home Infusion Therapy.

作者信息

Souayah Nizar, Pahwa Ankit, Burawski Lauren, Opila Tamara, Sander Howard W

机构信息

Department of Neurology and Neurosciences, Rutgers New Jersey Medical School, Newark, NJ.

Innovative Research Associates, Philadelphia, PA.

出版信息

J Clin Neuromuscul Dis. 2018 Jun;19(4):181-195. doi: 10.1097/CND.0000000000000201.

DOI:10.1097/CND.0000000000000201

PMID:29794573

Abstract

OBJECTIVES

This analysis assessed the safety of intravenous immunoglobulin (IVIg) in the treatment of patients with neuroimmunological and immunological disorders in a home-based setting.

METHODS

Adverse reactions (ARs) were assessed in a retrospective review of 1176 patients receiving 28,677 home-based IVIg infusions between 1996 and 2013.

RESULTS

Of 1176 patients, 648 (55.1%) experienced IVIg-related ARs; 536 (45.6%) were mild, 78 (6.6%) moderate, and 34 (2.9%) severe. Thirty-seven (3.1%) patients were hospitalized because of ARs; of these, headache was most common (51.4%). Mean number of ARs per patient increased from 1.4 (low dose) to 3.6 (high dose). Incidence of ARs increased from 41% in the first 5-year moving average in 2003 to 65% in 2008. The number of ARs correlated with the number of infusions (ρ = 0.24; P < 0.001) and the average IVIg dose (ρ = 0.10; P < 0.001).

CONCLUSIONS

Low- and high-dose IVIg were safe and well tolerated with a few serious ARs in patients with neuroimmunological and immunological disorders.

摘要

目的

本分析评估了在家中使用静脉注射免疫球蛋白（IVIg）治疗神经免疫和免疫性疾病患者的安全性。

方法

通过回顾性研究评估了1996年至2013年间接受28,677次家庭IVIg输注的1176例患者的不良反应（ARs）。

结果

1176例患者中，648例（55.1%）出现与IVIg相关的ARs；536例（45.6%）为轻度，78例（6.6%）为中度，34例（2.9%）为重度。37例（3.1%）患者因ARs住院；其中，头痛最为常见（51.4%）。每位患者的ARs平均数量从1.4（低剂量）增加到3.6（高剂量）。ARs的发生率从2003年第一个5年移动平均值的41%增加到2008年的65%。ARs的数量与输注次数（ρ = 0.24；P < 0.001）和IVIg平均剂量（ρ = 0.10；P < 0.001）相关。