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与静脉注射免疫球蛋白相关的溶血取决于抗A和抗B血型抗体的存在以及个体易感性。

Hemolysis related to intravenous immunoglobulins is dependent on the presence of anti-blood group A and B antibodies and individual susceptibility.

作者信息

Mielke Orell, Fontana Stefano, Goranova-Marinova Vesselina, Shebl Amgad, Spycher Martin O, Wymann Sandra, Durn Billie L, Lawo John P, Hubsch Alphonse, Salama Abdulgabar

机构信息

CSL Behring GmbH, Marburg, Germany.

Interregional Blood Transfusion Service SRC, Bern, Switzerland.

出版信息

Transfusion. 2017 Nov;57(11):2629-2638. doi: 10.1111/trf.14289. Epub 2017 Aug 25.

Abstract

BACKGROUND

Patients treated with intravenous immunoglobulins (IVIG) rarely experience symptomatic hemolysis. Although anti-A and anti-B isoagglutinins from the product are involved in most cases, the actual mechanisms triggering hemolysis are unclear.

STUDY DESIGN AND METHODS

A prospective, open-label, multicenter, single-arm clinical trial in 57 patients with immune thrombocytopenia treated with IVIG (Privigen, CSL Behring) was conducted.

RESULTS

Twenty-one patients received one infusion (1 g/kg) and 36 received two infusions (2 × 1 g/kg) of IVIG. After a study duration of more than 2 years, no cases of clinically significant hemolysis as defined in the protocol were identified. Data of patients with mild hematologic and biochemical changes were analyzed in more detail. Twelve cases (10/23 patients with blood group A1 and 2/11 patients with blood group B, all having received 2 g/kg IVIG) were adjudicated as mild hemolysis (median hemoglobin [Hb] decrease, -3.0 g/dL); Hb decreases were transient, with partial or full recovery achieved by last visit. Eighteen patients (31.6%), all with non-O blood group, of whom 16 (88.9%) received 2 g/kg IVIG, fulfilled post hoc criteria for hemolytic laboratory reactions. Red blood cell (RBC) eluates of all direct antiglobulin test-positive samples were negative for non-ABO blood group antibodies. Blood groups A and B antigen density on RBCs appeared to be a risk factor for hemolytic laboratory reactions. Platelet response to treatment was observed in 42 patients (74%); eight of 12 patients with complete response had blood group A1.

CONCLUSION

Isoagglutinins are involved in clinically nonsignificant hemolysis after treatment with IVIG, but individual susceptibility varies greatly.

摘要

背景

接受静脉注射免疫球蛋白(IVIG)治疗的患者很少出现有症状的溶血。虽然该产品中的抗A和抗B同种凝集素在大多数情况下都有涉及,但引发溶血的实际机制尚不清楚。

研究设计与方法

对57例接受IVIG(Privigen,CSL Behring)治疗的免疫性血小板减少症患者进行了一项前瞻性、开放标签、多中心、单臂临床试验。

结果

21例患者接受了一次IVIG输注(1 g/kg),36例患者接受了两次IVIG输注(2×1 g/kg)。经过超过2年的研究期,未发现符合方案中定义的具有临床意义的溶血病例。对有轻度血液学和生化变化的患者数据进行了更详细的分析。12例(血型为A1的23例患者中的10例和血型为B的11例患者中的2例,均接受了2 g/kg的IVIG)被判定为轻度溶血(血红蛋白[Hb]中位数下降,-3.0 g/dL);Hb下降是短暂的,在最后一次随访时部分或完全恢复。18例患者(31.6%),均为非O血型,其中16例(88.9%)接受了2 g/kg的IVIG,符合溶血实验室反应的事后标准。所有直接抗球蛋白试验阳性样本的红细胞(RBC)洗脱液中均未检测到非ABO血型抗体。红细胞上A和B血型抗原密度似乎是溶血实验室反应的一个危险因素。观察到42例患者(74%)对治疗有血小板反应;12例完全缓解的患者中有8例血型为A1。

结论

同种凝集素参与了IVIG治疗后临床上无显著意义的溶血,但个体易感性差异很大。

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