Post‐marketing observational study on 5% intravenous immunoglobulin therapy in patients with secondary immunodeficiency and recurrent serious bacterial infections
Post‐marketing observational study on 5% intravenous immunoglobulin therapy in patients with secondary immunodeficiency and recurrent serious bacterial infections
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5%静脉注射免疫球蛋白治疗继发性免疫缺陷伴反复严重细菌感染患者的上市后观察研究
DOI：
10.1111/1348-0421.12060
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发表时间：
2013
影响因子：
2.6
通讯作者：
Bettina Dreger
中科院分区：
文献类型：
--
作者：
G. Günther;Bettina Dreger
继发性低丙种球蛋白血症是慢性淋巴细胞白血病（CLL）患者感染易感性增加的原因之一。本研究评估了5%静脉注射免疫球蛋白、继发性免疫缺陷和复发性严重细菌感染的治疗结果、合并用药和耐受性。对10例1994年6月至2009年5月接受IVIG输注的各种血液恶性肿瘤（CLL、滤泡性非霍奇金淋巴瘤、分泌IgM的免疫细胞瘤、伊加浆细胞瘤和骨髓增生异常综合征/非霍奇金淋巴瘤）患者进行了一项单中心、上市后、观察性临床研究。通过比较开始该治疗前后细菌感染的发生率来评估IVIG的临床益处。记录血浆免疫球蛋白浓度和相关血液学变量。对于安全性评估，监测不良事件。标准IVIG剂量为每3-4周约0.35 g/kg体重。在IVIG治疗期间，大多数患者具有>600 mg/dL的正常IgG谷值。细菌感染率从IVIG治疗前3个月的2.4例/患者降低至IVIG治疗期间的0.7例/患者/年（0-1.5）。所有患者均接受伴随用药，主要为抗癌和抗贫血治疗（100%）。未观察到与IVIG相关的严重不良事件。至少1例轻微不良反应的发生率为1.44%（8/556次输注）。总之，所研究的IVIG制剂耐受性良好，并且在降低接受恶性疾病伴随治疗的患者中严重细菌感染的长期发生率方面具有临床益处。
Secondary hypogammaglobulinemia is one of the factors responsible for the increased susceptibility to infection in patients with chronic lymphocytic leukemia (CLL). This study assessed the therapeutic results, concomitant medication and tolerance of administering 5% intravenous immunoglobulin, secondary immunodeficiency and recurrent serious bacterial infections. A single center, post‐marketing, observational clinical study was performed on 10 patients with a variety of hematological malignancies (CLL, follicular non‐Hodgkin lymphoma, IgM‐secreting immunocytoma, IgA plasmacytoma and myelodysplastic syndrome/non‐Hodgkin lymphoma) who had been infused with IVIG from June 1994 to May 2009. The clinical benefit of IVIG was assessed by comparing the incidence of bacterial infections before and after starting this therapy. Plasma immunoglobulin concentrations and relevant hematological variables were recorded. For safety assessment, adverse events were monitored. The standard IVIG dosage was approximately 0.35 g/kg body weight every 3–4 weeks. Most patients had normal IgG trough values of >600 mg/dL during the IVIG treatment period. The rate of bacterial infections was reduced from 2.4 per patient in the 3 months before IVIG to 0.7 (0–1.5) per patient per year during IVIG treatment. All patients received concomitant medication, mainly anticancer and anti‐anemia therapy (100%). No serious adverse events related to IVIG were observed. The frequency of at least one minor adverse reaction was 1.44% (8/556 infusions). In conclusion, the investigated IVIG preparation was well tolerated and clinically beneficial in reducing the long term rate of serious bacterial infections in patients receiving concomitant treatment for malignant diseases.
影响因子：
11.2
作者：
P. Carbone;H. Kaplan;K. Musshoff;D. Smithers;M. Tubiana
通讯作者：
P. Carbone;H. Kaplan;K. Musshoff;D. Smithers;M. Tubiana