用于免疫缺陷和自身免疫性疾病的人免疫球蛋白（KIOVIG®/GAMMAGARD LIQUID®）：一项观察性队列研究。
Human immunoglobulin (KIOVIG®/GAMMAGARD LIQUID®) for immunodeficiency and autoimmune diseases: an observational cohort study.
作者信息
Blažek Bohumír, Misbah Siraj A, Soler-Palacin Pere, McCoy Barbara, Leibl Heinz, Engl Werner, Empson Victoria, Gelmont David, Nikolov Nikolai
机构信息
Faculty Hospital Ostrava, 17 Listopadu 1790, 708 52 Ostava-Poruba, Czech Republic.
John Radcliffe 2 Hospital Academic Centre L4, Oxford, OX3 9DU, UK.
出版信息
Immunotherapy. 2015;7(7):753-63. doi: 10.2217/imt.15.30. Epub 2015 Apr 13.
AIM
To document the therapeutic efficacy and safety of Human Normal Immunoglobulin 10% Liquid (KIOVIG(®)/GAMMAGARD LIQUID(®) [IVIG 10%]) under clinical routine conditions.
PATIENTS & METHODS: Subjects received IVIG 10% according to the prescribing information and were followed for 6 ± 1 weeks to 12 ± 2 months depending on indication. Efficacy, adverse events, infusion rates and duration and dose were recorded.
RESULTS
Overall efficacy of IVIG 10% was rated as good or very good by the investigator in 81.8% of subjects; overall tolerability was good or very good in 87.5%. One serious adverse drug reaction (ADR) occurred (urticaria); no severe ADRs occurred.
CONCLUSION
In this observational study, the efficacy and safety of IVIG 10% in routine clinical practice was similar to that previously reported in clinical studies.
目的
记录10%人正常免疫球蛋白液（基奥维格（®）/伽玛莱士液（®）[静脉注射用免疫球蛋白10%]）在临床常规条件下的治疗效果和安全性。
患者与方法
受试者根据处方信息接受静脉注射用免疫球蛋白10%，并根据适应症随访6±1周或12±2个月。记录疗效、不良事件、输注速率、持续时间和剂量。
结果
研究者将81.8%受试者的静脉注射用免疫球蛋白10%总体疗效评定为良好或非常好；总体耐受性良好或非常好的比例为87.5%。发生了1例严重药物不良反应（荨麻疹）；未发生严重药物不良反应。
结论
在这项观察性研究中，静脉注射用免疫球蛋白10%在常规临床实践中的疗效和安全性与先前临床研究报告的相似。
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