检索问题
免疫球蛋白健康人群可以打么？
健康人群不仅不需要打免疫球蛋白，盲目使用反而可能带来健康风险。
简单直接地告诉您：除了特定需要预防某些传染病（如接触了乙肝、狂犬病病毒）的紧急情况外，没有任何科学证据支持“身体健康的人”去打免疫球蛋白来“增强体质”或“日常保健”。
很多人把免疫球蛋白当成是“高级补药”或“增强抵抗力的神针”，这是一个巨大的误区。在医学上，它是一种治疗严重疾病的处方药，有着极其严格的适应症。对于健康人来说，它不仅不能让你“百毒不侵”，还可能因为输入了外来的血液制品而引发过敏、发烧，甚至干扰你自己身体本来正常的免疫系统。
为了让您彻底明白为什么不能乱打，我们将从“它到底是什么”、“真正该用它的是谁”以及“乱用的风险”三个方面为您详细拆解。
一、 揭开面纱：免疫球蛋白到底是什么？
想象一下，我们的身体像一座城堡，免疫系统就是守卫城堡的卫兵。当外面的敌人（比如细菌、病毒）入侵时，卫兵们会制造一种特殊的武器来抓住并消灭敌人。这种武器，在医学上就叫做抗体，也就是免疫球蛋白（Immunoglobulin，简称 Ig）。
我们在医院里听到的“打丙球”或“静脉注射免疫球蛋白（IVIg）”，其实就是从成千上万个健康献血者的血浆中提取出来的“浓缩武器库”。
1. 它是“借来”的雇佣军，不是你自己的部队 当您注射免疫球蛋白时，实际上是把别人身体里产生的抗体（武器）借到了自己身体里。这就好比城堡里突然空降了一支“雇佣军”。
- 对于生病的人： 他们的城堡卫兵太弱（免疫缺陷）或者卫兵发疯了在打自己人（自身免疫病），这时候“雇佣军”是救命的。
- 对于健康的人： 您的城堡里本来就驻扎着精锐的卫兵（自身正常的免疫力），如果突然塞进来一大堆外来的雇佣军，不仅没有敌人可打，这些雇佣军过一段时间（通常几周）就会自然死亡、消失。它们并不像疫苗那样，能训练您自己的卫兵学会打仗（产生长期的免疫记忆）。所以，打一次免疫球蛋白，只能获得短暂的、被动的保护，并不能从根本上提高您自己的体质。
2. 它是怎么起作用的？ 科学家发现，这些外来的抗体进入身体后，主要干两件事：
- “替补上场”： 对于那些天生就没有卫兵（原发性免疫缺陷）或者卫兵被药物杀死了（继发性免疫缺陷）的人，免疫球蛋白替代了他们缺失的防御系统，帮助他们抵抗感染 。
- “劝架维稳”： 在很多自身免疫性疾病中，身体的卫兵认错人了，开始疯狂攻击自己的神经或肌肉。这时候，注射进去的高浓度免疫球蛋白就像是“调解员”，通过复杂的机制（比如中和致病因子、调节免疫细胞）让发疯的卫兵冷静下来，停止攻击身体 。
所以，您看，它的核心作用是“治病”和“救急”，而不是“强身健体”。
二、 真正的战场：谁才需要打免疫球蛋白？
医学界对免疫球蛋白的使用有着非常严格的规定。根据现有的科学证据，它主要用于治疗以下几类严重的疾病：
1. 自身的免疫系统“罢工”了（免疫缺陷病） 这是免疫球蛋白最经典、最标准的用途。
- 有些孩子天生就没有制造抗体的能力（原发性免疫缺陷），如果不定期输注免疫球蛋白，他们就像裸体走在冰天雪地里，随随便便一个感冒菌就能要了命。对他们来说，这就是维持生命的“必需品” 。
- 还有一些癌症患者，特别是患有白血病或淋巴瘤的人，因为化疗或疾病本身破坏了免疫系统（继发性免疫缺陷），导致严重感染风险，这时候医生也会根据情况使用免疫球蛋白来作为“盾牌” 。
2. 免疫系统“疯了”，攻击自己（自身免疫性疾病） 这是目前应用非常广泛的领域。当免疫系统发生错误，开始攻击人体正常的组织时，医生会用免疫球蛋白来阻断这种攻击。
- 吉兰-巴雷综合征（GBS）： 这是一种可怕的病，免疫系统攻击神经，导致患者突然瘫痪，甚至无法呼吸。研究证实，静脉注射免疫球蛋白是治疗这种病的首选方案之一，能救命 。
- 特发性炎症性肌病（皮肌炎/多发性肌炎）： 患者的肌肉被免疫系统攻击，导致没力气、吞咽困难。证据表明，免疫球蛋白可以作为二线治疗甚至一线治疗，帮助改善肌肉力量，甚至解决吞咽困难 。
- 免疫性血小板减少症（ITP）： 患者的血小板被当成敌人消灭了，导致身体容易出血。这时候打免疫球蛋白可以迅速提升血小板数量，防止严重出血 。
- 川崎病： 多发于儿童，会引起血管发炎。免疫球蛋白是标准的治疗手段，能预防心脏并发症 。
- 重症肌无力： 免疫系统阻断了神经和肌肉的信号传递。在病情突然加重或危急时刻，免疫球蛋白被证明是有效的“救援队” 。
3. 特殊情况下的“紧急预防” 这是健康人唯一可能接触到免疫球蛋白的情况——被动免疫。
- 但这绝对不是平时没病打着玩。而是指您明确接触了某种致命病毒，而您体内没有抗体，来不及等疫苗起效了。比如：被疯狗咬了（打狂犬病免疫球蛋白）、新生儿母亲有乙肝（打乙肝免疫球蛋白）。这属于特定病毒的“特种部队”定向清除，和我们讨论的广谱“增强体质”完全是两码事。
【科学结论】： 现有的高质量医学研究，无论是关于神经系统疾病 、自身免疫病 还是骨科相关疾病 ，所有的临床试验和指南都集中在患病人群身上。根本没有证据表明健康人注射免疫球蛋白能预防感冒、提升精力或延年益寿。
三、 警惕风险：健康人乱打有什么坏处？
很多老百姓觉得：“反正它是血里提炼出来的营养品，就算没用，应该也没害处吧？” 大错特错。 免疫球蛋白是血液制品，属于生物制剂，它的风险不容忽视。
1. 它是“药”，是药就有三分毒（副作用） 研究显示，即便是正规治疗的患者，在接受静脉注射免疫球蛋白（IVIg）时，也经常会出现副作用。
- 常见反应： 就像打流感那样，很多人打完会头痛、发烧、发冷、恶心、肌肉酸痛或背痛。这被称为“流感样症状” 。
- 过敏风险： 既然是别人的蛋白质进入您的身体，您的身体可能会产生排斥反应。轻的起皮疹，重的可能发生过敏性休克，虽然罕见，但一旦发生就是致命的 。
- 肾脏负担： 以前的一些产品为了稳定，加了蔗糖等成分，可能会损伤肾功能。虽然现在的工艺改进了，但大剂量输注对肾脏依然是个负担 。
- 血栓风险： 输入免疫球蛋白会增加血液的粘稠度。对于本来就有高血压、高血脂的老年人来说，这可能会增加中风（脑梗）或心梗的风险 。
2. 血液制品的潜在隐患 虽然现在的筛查技术非常先进，但理论上，凡是血液制品，都存在传播未知病毒或病原体的微小风险。为了一个不存在的“保健”效果去承担这个风险，在医学伦理上是不划算的。
3. 干扰您自身的免疫平衡 我们的身体非常精妙。对于健康人来说，长期或不必要地输入外来抗体，可能会让自身的免疫系统产生“惰性”，或者干扰身体正常的抗体产生机制。
- 有研究指出，在年轻的大脑中，特定的转运机制能让血液中的蛋白质按需进入大脑，但随着衰老，这种机制会发生变化 。虽然这是在小鼠身上的发现，但它提示我们，血液成分与身体器官的互动极其复杂，人为地打破这种平衡（比如输入大量外源性蛋白），其长远的生物学后果是难以预测的。
4. 极其昂贵且资源紧缺 免疫球蛋白的生产成本极高，需要成千上万人的血浆汇集提炼。在全球范围内，这都是一种紧缺资源 。
- 如果健康人为了心理安慰去抢购囤积，真正的重症患者（比如急需救命的吉兰-巴雷综合征患者或重症肌无力患者）就可能面临断药的风险。这不仅浪费钱，更是在浪费救命的医疗资源。
四、 不靠打针，如何科学地“增强免疫力”？
既然打免疫球蛋白行不通，那普通人（尤其是老人和孩子）该怎么做呢？科学界公认的方法其实最简单，也最廉价，但往往被忽视：
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接种疫苗（主动免疫）： 这才是真正的“给身体练兵”。
- 比如乙肝疫苗、流感疫苗、带状疱疹疫苗等。疫苗是把死掉的或减弱的病毒碎片给免疫系统看，让您的身体自己学会制造抗体。这种记忆是长久的。比如甲肝疫苗，接种后能迅速产生血清转化，提供长期的保护，这比被动输入抗体要有效得多 。
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均衡的营养： 免疫卫兵打仗需要能量和材料。蛋白质、维生素C、维生素D、锌等都是必需的弹药。好好吃饭，比什么补药都强。
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规律的运动与睡眠： 研究表明，适度的运动和充足的睡眠能维持免疫系统的活跃度。
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针对特定疾病的靶向治疗（如果生病）： 如果您确实患有某种自身免疫病（如银屑病关节炎等），现在的医学已经发展出了比免疫球蛋白更精准的药物——单克隆抗体（mAbs）。
- 名词解释：单克隆抗体（Monoclonal Antibodies）。如果说免疫球蛋白（IVIg）是“万金油”或者“散弹枪”，里面什么抗体都有；那么单克隆抗体就是“狙击枪”，只针对某一个特定的坏蛋（抗原） 。
- 例如，针对银屑病关节炎，有一种药叫依奇珠单抗（Ixekizumab），它专门拦截一种叫白细胞介素-17A的致炎因子。临床试验表明，这种精准打击能显著改善关节炎症状，效果比盲目“增强免疫”要好得多，且副作用可控 。针对骨质疏松，也有专门针对硬化蛋白（Sclerostin）的单克隆抗体正在研发中，能定向增加骨密度 。
- 这些才是现代医学对抗疾病的正确思路：精准打击病因，而不是笼统地“补”免疫。
总结
请告诉您身边的亲人和朋友：免疫球蛋白是用来救命的“特种武器”，不是日常保健的“维生素”。
- 对于健康人： 打了没用，反而可能发烧、过敏、伤肾，还浪费钱。
- 对于体弱者： 真正的免疫力来自均衡饮食、规律运动和按时接种疫苗。
- 对于患者： 只有经过医生确诊，患有严重的免疫缺陷或自身免疫性疾病时，才需要在医生严密监控下使用。
不要为了追求虚幻的“抵抗力”，让身体承担不必要的风险。科学养生，远离滥用药物。
References
1Monoclonal Antibodies: Past, Present and Future.PubMed
J Posner, P Barrington, T Brier, et al.
Handb Exp Pharmacol. 2019;260:81-141. doi: 10.1007/164_2019_323.
Monoclonal antibodies (mAbs) are immunoglobulins designed to target a specific epitope on an antigen. Immunoglobulins of identical amino-acid sequence were originally produced by hybridomas grown in culture and, subsequently, by recombinant DNA technology using mammalian cell expression systems. The antigen-binding region of the mAb is formed by the variable domains of the heavy and light chains and contains the complementarity-determining region that imparts the high specificity for the target antigen. The pharmacokinetics of mAbs involves target-mediated and non-target-related factors that influence their disposition.Preclinical safety evaluation of mAbs differs substantially from that of small molecular (chemical) entities. Immunogenicity of mAbs has implications for their pharmacokinetics and safety. Early studies of mAbs in humans require careful consideration of the most suitable study population, route/s of administration, starting dose, study design and the potential difference in pharmacokinetics in healthy subjects compared to patients expressing the target antigen.Of the ever-increasing diversity of therapeutic indications for mAbs, we have concentrated on two that have proved dramatically successful. The contribution that mAbs have made to the treatment of inflammatory conditions, in particular arthritides and inflammatory bowel disease, has been nothing short of revolutionary. Their benefit has also been striking in the treatment of solid tumours and, most recently, as immunotherapy for a wide variety of cancers. Finally, we speculate on the future with various new approaches to the development of therapeutic antibodies.
2Intravenous Immunoglobulin in Idiopathic Inflammatory Myopathies: a Practical Guide for Clinical Use.PubMed
Prateek C Gandiga, Daniela Ghetie, Elizabeth Anderson, et al.
Curr Rheumatol Rep. 2023 Aug;25(8):152-168. doi: 10.1007/s11926-023-01105-w. Epub 2023 Jun 1.
PURPOSE OF REVIEW: Idiopathic inflammatory myopathies (IIM) are a complex family of autoimmune systemic disorders which often affect muscle and/or skin. IIM cause significant morbidity and mortality, but optimal treatment is uncertain. This review provides a practical guide for using intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) in the management of IIM, including dermatomyositis (DM), polymyositis (PM), immune-mediated necrotizing myositis (IMNM), and spontaneous inclusion body myositis (IBM), based on relevant recent literature and experience. We summarize pertinent considerations when using IVIG in special circumstances, including myositis-related dysphagia, interstitial lung disease (ILD), calcinosis cutis, and pregnant patients. This review also discusses IVIG safety, available formulations, and costs. RECENT FINDINGS: While IVIG has been used de facto for severe IIM for over 30 years, prior clinical trials of IVIG were notably limited. Recently, however, IVIG has proven safe and effective against IIM in several high-impact publications, including a large prospective, randomized placebo-controlled phase III study in DM. IVIG is useful against both muscular and extra-muscular manifestations in many types of IIM. It can be used as a first-line, steroid-sparring agent or as add-on to other treatments, tailored to specific clinical IIM scenarios. It is generally well-tolerated and has good safety profile, but accessibility and cost still limit its use.
3Physiological blood-brain transport is impaired with age by a shift in transcytosis.PubMed
Andrew C Yang, Marc Y Stevens, Michelle B Chen, et al.
Nature. 2020 Jul;583(7816):425-430. doi: 10.1038/s41586-020-2453-z. Epub 2020 Jul 1.
The vascular interface of the brain, known as the blood-brain barrier (BBB), is understood to maintain brain function in part via its low transcellular permeability. Yet, recent studies have demonstrated that brain ageing is sensitive to circulatory proteins. Thus, it is unclear whether permeability to individually injected exogenous tracers-as is standard in BBB studies-fully represents blood-to-brain transport. Here we label hundreds of proteins constituting the mouse blood plasma proteome, and upon their systemic administration, study the BBB with its physiological ligand. We find that plasma proteins readily permeate the healthy brain parenchyma, with transport maintained by BBB-specific transcriptional programmes. Unlike IgG antibody, plasma protein uptake diminishes in the aged brain, driven by an age-related shift in transport from ligand-specific receptor-mediated to non-specific caveolar transcytosis. This age-related shift occurs alongside a specific loss of pericyte coverage. Pharmacological inhibition of the age-upregulated phosphatase ALPL, a predicted negative regulator of transport, enhances brain uptake of therapeutically relevant transferrin, transferrin receptor antibody and plasma. These findings reveal the extent of physiological protein transcytosis to the healthy brain, a mechanism of widespread BBB dysfunction with age and a strategy for enhanced drug delivery.
4Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial.PubMed
Peter Nash, Bruce Kirkham, Masato Okada, et al.
Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.
BACKGROUND: Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. METHODS: In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America. Patients were aged 18 years or older, had a confirmed diagnosis of psoriatic arthritis for at least 6 months, and had a previous inadequate response, distinguished by being refractory to therapy or had loss of efficacy, or were intolerant to tumour necrosis factor inhibitors. Patients were randomly assigned (1:1:1) by a computer-generated random sequence to receive a subcutaneous injection of 80 mg ixekizumab every 4 weeks or every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR-20) at week 24. This study is registered with ClinicalTrials.gov, number NCT02349295. FINDINGS: Between March 3, 2015, to March 22, 2016, 363 patients were randomly assigned to placebo (n=118), ixekizumab every 4 weeks (n=122), or ixekizumab every 2 weeks (n=123). At week 24, a higher proportion of patients attained ACR-20 with ixekizumab every 4 weeks (65 [53%] patients; effect size vs placebo 33·8% [95% CI 22·4-45·2]; p<0·0001) and ixekizumab every 2 weeks (59 [48%] patients; 28.5% [17·1-39.8]; p<0·0001) than did patients with placebo (23 [20%] patients). Up to week 24, serious adverse events were reported in three (3%) patients with ixekizumab every 4 weeks, eight (7%) with ixekizumab every 2 weeks, and four (3%) with placebo; no deaths were reported. Infections were reported in 47 (39%) patients with ixekizumab every 4 weeks, 47 (38%) with ixekizumab every 2 weeks, and 35 (30%) with placebo. Three (2%) serious infections, all in patients in the ixekizumab every 2 weeks group, were reported. INTERPRETATION: Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab. FUNDING: Eli Lilly and Company.
5Efficacy and safety of maintenance intravenous immunoglobulin in generalized myasthenia gravis patients with acetylcholine receptor antibodies: A multicenter, double-blind, placebo-controlled trial.PubMed
Vera Bril, Tomasz Berkowicz, Andrzej Szczudlik, et al.
Muscle Nerve. 2025 Jan;71(1):43-54. doi: 10.1002/mus.28289. Epub 2024 Nov 7.
INTRODUCTION/AIMS: Prospective, randomized, controlled trials of intravenous immunoglobulin (IVIG) maintenance therapy in myasthenia gravis (MG) are lacking. In this trial, we evaluated the safety and efficacy of caprylate/chromatography-purified IVIG; (IGIV-C) in patients with generalized MG undergoing standard care. METHODS: Sixty-two patients enrolled in this phase 2, multicenter, international, randomized trial (1:1 IGIV-C [2 g/kg loading dose; 1 g/kg every 3 weeks through week 21] or placebo). Efficacy was assessed by changes in Quantitative MG (QMG) score at week 24 versus baseline (primary endpoint) and percentage of patients with clinical improvement in QMG, MG Composite (MGC), and MG-Activities of Daily Living (MG-ADL) scores (secondary endpoints). Safety assessments reported all adverse events (AEs). RESULTS: The change in QMG at 24 weeks was -5.1 for IGIV-C and -3.1 for placebo (p = .187). Seventy percent of patients in the IGIV-C group had improvement in MG-ADL (≥2-point decrease) versus 40.6% in the placebo group (p = .025). Patients showing clinical improvement in QMG and MGC (≥3-point decrease) were 70.0% for IGIV-C versus 59.4% for placebo (p = .442) and 60.0% for IGIV-C versus 53.1% for placebo (p = .610). IGIV-C was well tolerated; serious AEs were similar between arms. Three of four MG exacerbations requiring hospitalizations occurred in the IGIV-C arm with one death. DISCUSSION: Several efficacy parameters showed numerical results greater than those seen in the placebo group. This was a small study and may have been underpowered to see significant differences. Additional studies may be warranted to fully determine the efficacy of IVIG maintenance therapy in MG.
6The potential impact of timing of IVIG administration on the efficacy of rituximab for immune tolerance induction for patients with Pompe disease.PubMed
Ankit K Desai, Amy S Rosenberg, Priya S Kishnani
Clin Immunol. 2020 Oct;219:108541. doi: 10.1016/j.clim.2020.108541. Epub 2020 Jul 15.
Immune modulation with rituximab, methotrexate, and intravenous immunoglobulin (IVIG) has shown great success in inducing immune tolerance in a large cohort of enzyme replacement therapy (ERT)-naïve infantile Pompe disease patients. Antibody-dependent cellular cytotoxicity, the principal mechanism by which rituximab depletes B-cells, requires CD20 binding by Fab'2 of rituximab on B-cells and the concomitant binding of its Fc region to Fc receptors on effector cells or to complement. To protect patients against microbial infections when using rituximab, IVIG was added to the immunomodulation regimen used in Pompe disease. Administration of IVIG can saturate neonatal Fc receptors (FcRn), which recycle endogenous as well as administered polyclonal/monoclonal antibodies via the binding of the Fc moiety to FcRn. As such, the administration of IVIG prior to rituximab, a chimeric mouse-human monoclonal antibody, may sharply reduce the half-life of rituximab and in turn, its efficacy. Based on this understanding, it is vital to understand the optimal timing of IVIG administration in relation to rituximab administration for the purposes of inducing immune tolerance.
7Guillain-Barré syndrome.PubMed
Vibhuti Ansar, Nojan Valadi
Prim Care. 2015 Jun;42(2):189-93. doi: 10.1016/j.pop.2015.01.001. Epub 2015 Mar 20.
Guillain-Barré syndrome and its clinical variants are a group of rapidly progressing, potentially debilitating neurologic disorders that may have significant morbidity/mortality if left unrecognized or untreated. The most common symptoms include ascending limb weakness and paralysis, which may progress to respiratory failure. Diagnosis is made clinically with laboratory testing. Several treatment options exist, including plasma exchange and intravenous immunoglobulin administration. Most cases may resolve without sequelae, but those that do not may leave behind significant persistent debility.
8Immunization against Hepatitis A.PubMed
Daniel Shouval
Cold Spring Harb Perspect Med. 2019 Feb 1;9(2):a031682. doi: 10.1101/cshperspect.a031682.
Worldwide, there are multiple formaldehyde-inactivated and at least two live attenuated hepatitis A vaccines now in clinical use. The impressive immunogenicity of inactivated vaccines is reflected in rapid seroconversion rates, enabling both preexposure and postexposure prophylaxis. Universal childhood vaccination programs targeting young children have led to significant drops in the incidence of hepatitis A both in toddlers and in susceptible nonimmune adults in regions with intermediate endemicity for hepatitis A. Although the safety of inactivated vaccines is well established, further studies are needed concerning the implications of fecal virus shedding by recipients of attenuated vaccines, as well as the long-term persistence of immune memory in children receiving novel immunization schedules consisting of single doses of inactivated vaccines.
9Intravenous immunoglobulin as a therapy for autoimmune conditions.PubMed
Maria Giovanna Danieli, Eleonora Antonelli, Luca Gammeri, et al.
Autoimmun Rev. 2025 Jan 3;24(1):103710. doi: 10.1016/j.autrev.2024.103710. Epub 2024 Nov 24.
Intravenous immunoglobulin (IVIg) is a medical preparation used as replacement therapy for patients with immunodeficiencies. Over time, IVIg's anti-inflammatory and immunomodulatory effects have been recognized, which have led to the approval of this therapy in the treatment of various pathologies, such as Kawasaki disease, immune thrombocytopenia, and Guillain-Barré syndrome. There are numerous studies in the literature regarding the off-label use of IVIg in the treatment of autoimmune diseases (e.g. myositis and vasculitis), and hematological disorders. Since the role of immunoglobulins in fields other than replacement therapy is now consolidated, in this study we carried out a review of the literature to evaluate the main uses of IVIg therapy. We have focused our attention on the treatment of autoimmune, neurological, hematological, dermatological and pediatric diseases. Furthermore, our analysis of the literature also extended to the potential use of IVIg as an adjuvant treatment of long COVID-19. From our analysis, we found consistent data about IVIg's effectiveness in treating numerous clinical conditions. Treatment with IVIg represents a second-line approach or a valid adjuvant to standard therapies capable of positively influencing the clinical course of many pathologies and reducing or avoiding side effects of standard therapies, with a good safety profile.
10Patient-reported outcomes with subcutaneous immunoglobulin in secondary immunodeficiency.PubMed
Juthaporn Cowan, Il-Kang Na, André Gladiator, et al.
Front Immunol. 2025 Mar 20;16:1528414. doi: 10.3389/fimmu.2025.1528414. eCollection 2025.
Subcutaneous (SCIG) and intravenous immunoglobulin (IVIG) replacement are both used to prevent infections in patients with secondary immunodeficiency (SID). Compared with IVIG, SCIG has fewer systemic side effects and, additionally, facilitates home-based treatment. Shared decision-making practice should include discussion of aspects such as patient preference as well as the associated risks and benefits of treatment. We review the available evidence for the use of SCIG treatment in patients with SID, focusing on patient-reported outcomes (PROs). In most studies, there were improvements to health-related quality of life with SCIG treatment, compared with before initiating SCIG without prior IVIG treatment, or after switching to SCIG from IVIG treatment, or a no-SCIG/IVIG cohort. Treatment satisfaction with SCIG was similar between patients with SID and primary immunodeficiency disease. Patient preference and perception assessments highlighted the benefits of SCIG compared with IVIG, such as ease of use and administration, convenience, and time-effectiveness. In addition, many patients self-administered SCIG at home. Such aspects may be of specific benefit to patients with SID and hematological malignancy by reducing the risk of infection exposure in clinical settings. PRO data may be useful during shared decision-making discussions with patients with SID.
11Second-line therapies in immune thrombocytopenia.PubMed
Rachael F Grace, Cindy Neunert
Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):698-706. doi: 10.1182/asheducation-2016.1.698.
Immune thrombocytopenia (ITP) is a rare, acquired autoimmune condition characterized by a low platelet count and an increased risk of bleeding. Although many children and adults with ITP will not need therapy beyond historic first-line treatments of observation, steroids, intravenous immunoglobulin (IVIG), and anti-D globulin, others will have an indication for second-line treatment. Selecting a second-line therapy depends on the reason for treatment, which can vary from bleeding to implications for health-related quality of life (HRQoL) to likelihood of remission and patient preference with regard to adverse effects, route of administration, and cost. Published studies of these treatments are limited by lack of comparative trials, in addition to inconsistent outcome measures, definitions, and efficacy endpoints. This article provides an up-to-date comparison of the second-line treatments, highlighting important outcome measures including bleeding, HRQoL, fatigue, and platelet counts, which influence treatment selection in a shared decision-making model.
12Sclerostin and skeletal health.PubMed
Maryam Sharifi, Lisa Ereifej, E Michael Lewiecki
Rev Endocr Metab Disord. 2015 Jun;16(2):149-56. doi: 10.1007/s11154-015-9311-6.
Sclerostin is a cysteine-knot glycoprotein product of the SOST gene, predominately expressed by osteocytes, that is a regulator of osteoblastic bone formation. When sclerostin binds to its low-density lipoprotein receptor-related proteins 5 and 6 on the cell membrane of osteoblasts, it inhibits canonical Wnt/β-catenin signaling and reduces osteoblastic bone formation. Sclerostin was first identified in the study of two rare autosomal recessive disorders, sclerosteosis and van Buchem disease, which are associated with absent or reduced levels of sclerostin. Although homozygote patients with these disorders have serious adverse clinical consequences due to excessive bone growth, heterozygote patients have a normal phenotype, high bone mass, and very low risk of fractures. This has led to the concept that downregulation of sclerostin might be effective in the treatment of osteoporosis. Several humanized monoclonal antibodies to sclerostin, including romosozumab and blosozumab, are now in clinical development. Preliminary data show that these agents result in a transient increase in bone formation markers, a sustained decrease in bone resorption markers, and a robust increase in bone mineral density. If any of these agents are found to reduce fracture risk with a favorable safety profile, it will expand the options for osteoanabolic therapy for patients at high risk for fractures.
13Osteoporosis: non-hormonal treatment.PubMed
R Rizzoli
Climacteric. 2007 Oct;10 Suppl 2:74-8. doi: 10.1080/13697130701600815.
Significant progress has been achieved in osteoporosis treatment, in terms of agents with novel mechanisms of action, of new schedules of administration, and of long-term treatment safety demonstration. Alendronate, ibandronate, intranasal calcitonin, parathyroid hormones, raloxifene, risedronate, hormone replacement therapy, strontium ranelate and zoledronate decrease the risk of vertebral fracture. Alendronate, risedronate, strontium ranelate and zoledronate reduce the risk of hip fracture in women with osteoporosis, hormone replacement therapy in postmenopausal women, and calcium and vitamin D in institutionalized patients. In two meta-analyses, the combination of calcium and vitamin D was able to reduce the risk of falling, and hip fracture risk was decreased (>700 IU/day). Two subsequently published large trials were unable to detect any antifracture effect. PTH(1-84) reduces the risk of new vertebral fracture. There is no indication that combining PTH with a bone resorption inhibitor has any additional benefit to either drug alone. Strontium ranelate is a new agent for the treatment of osteoporosis, with antifracture efficacy whatever the severity of osteoporosis. An extension of the phase 3 trials up to 5 years has shown sustained antifracture efficacy. The humanized monoclonal antibody to the receptor activator of nuclear factor-kappaB ligand (RANKL) denosumab causes a rapid, high-magnitude, dose-dependent inhibition of bone resorption. Spine, hip and forearm bone mineral density increased, to an extent slightly higher than with the weekly administration of 70 mg alendronate.
14Personalized Therapy: Immunoglobulin Replacement for Antibody Deficiency.PubMed
Richard L Wasserman
Immunol Allergy Clin North Am. 2019 Feb;39(1):95-111. doi: 10.1016/j.iac.2018.08.001.
Immunoglobulin replacement therapy is the cornerstone of management for most primary immunodeficiency disease patients. The selection of a particular product, dose, and route of administration requires an understanding of the features of therapeutic immunoglobulin as well as patient-specific risk factors in order to maximize efficacy and tolerability and minimize risk. Individualizing therapy, taking into consideration the burdens of care, is necessary in order to optimize patient outcomes.
15Immunoglobulin Replacement Therapy for Primary Immunodeficiency.PubMed
Panida Sriaroon, Mark Ballow
Immunol Allergy Clin North Am. 2015 Nov;35(4):713-30. doi: 10.1016/j.iac.2015.07.006. Epub 2015 Sep 4.
Immunoglobulin replacement therapy has been standard treatment in patients with primary immunodeficiency diseases for the past 3 decades. The goal of therapy is to reduce serious bacterial infections in individuals with antibody function defects. Approximately one-third of patients receiving intravenous immunoglobulin treatment experience adverse reactions. Recent advances in manufacturing processes have resulted in products that are safer and better tolerated. Self-infusion by the subcutaneous route has become popular and resulted in better quality of life. This review summarizes the use of immunoglobulin therapy in primary immunodeficiency diseases including its properties, dosing, adverse effects, and different routes of administration.
16Differentiating characteristics and evaluating intravenous and subcutaneous immunoglobulin.PubMed
Stacey Ness
Am J Manag Care. 2019 Jun;25(6 Suppl):S98-S104.
Clinicians have a range of options for treating patients with disease states that require the use of immunoglobulin (Ig). Traditionally, intravenous immunoglobulin (IVIG) administration has provided effective therapy for a variety of disease states. More recently, subcutaneous immunoglobulin (SCIG) administration has become available for patients with primary immunodeficiencies and chronic inflammatory demyelinating polyneuropathy (CIDP). Ig is used as replacement therapy in patients with primary or secondary immunodeficiencies and has been shown to reduce morbidity due to bacterial infections associated with antibody deficiency. The mechanism of action for use of Ig in the treatment of autoimmune disorders is complex and partially understood, but immunomodulatory effects have been suggested in CIDP and multifocal motor neuropathy. The available IVIG and SCIG products differ in their pharmaceutical properties (eg, pH, osmolality, IgA content, sodium content, and stabilizer), which can affect safety and tolerability in some patients. The pharmacokinetics of Ig also differ based on the route of administration. With IVIG administration every 3 or 4 weeks, peak concentrations are greater and trough concentrations are lower, which can increase the propensity of systemic adverse effects (AEs) and impact tolerability of therapy. SCIG infusions are typically administered more frequently (ie, biweekly, weekly, and even daily based on patient need), resulting in steady state concentrations with fewer fluctuations in Ig plasma levels. The route of administration plays a major role in the types of AEs seen in patients receiving Ig therapy, with systemic AEs associated with IV administration and local reactions more commonly seen with SC administration. By understanding the differences in IVIG and SCIG products, which are not interchangeable, and the patient characteristics that guide product selection, clinicians and managed care providers can better serve patients with immunodeficiency disorders and other disease states.
17Overview of subcutaneous immunoglobulin 16.5% in primary and secondary immunodeficiency diseases.PubMed
Roger H Kobayashi, Jiří Litzman, Syed Rizvi, et al.
Immunotherapy. 2022 Mar;14(4):259-270. doi: 10.2217/imt-2021-0313. Epub 2022 Jan 6.
Most primary immunodeficiency diseases, and select secondary immunodeficiency diseases, are treated with immunoglobulin (IG) therapy, administered intravenously or subcutaneously (SCIG). The first instance of IG replacement for primary immunodeficiency disease was a 16.5% formulation administered subcutaneously in 1952. While most SCIG products are now a 10 or 20% concentration, this review will focus on SCIG 16.5% products with a historical overview of development, including the early pioneers who initiated and refined IG replacement therapy, as well as key characteristics, manufacturing and clinical studies. In determining an appropriate IG regimen, one must consider specific patient needs, characteristics and preferences. There are advantages to SCIG, such as stable serum immunoglobulin G levels, high tolerability and the flexibility of self-administered home treatment.
18The Nuts and Bolts of Immunoglobulin Treatment for Antibody Deficiency.PubMed
Richard L Wasserman
J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1076-1081.e3. doi: 10.1016/j.jaip.2016.09.011.
Immunoglobulin therapy is a key element in the management of most patients with primary immunodeficiency disease. Allergist/immunologists should be familiar with the appropriate evaluation of candidates for immunoglobulin, the characteristics of immunoglobulin products, and how to use them to provide the best care to their patients. Available immunoglobulin products appear to be equally efficacious, but they are not interchangeable. Minimizing the risk of serious adverse events and controlling minor side effects is important to ideal patient care. Immunoglobulin may be administered intravenously or subcutaneously. Individualizing the choice of immunoglobulin product, mode of administration, and site of care can optimize the clinical outcome and minimize the burden of care.
19The Choice between Intravenous and Subcutaneous Immunoglobulins: Aspects for Consideration.PubMed
Caroline von Achenbach, Giselle Hevia Hernandez, Stephan von Gunten
Pharmacology. 2022;107(11-12):556-563. doi: 10.1159/000527655. Epub 2022 Nov 8.
BACKGROUND: Intravenous immunoglobulin and subcutaneous immunoglobulin preparations are used to treat primary and secondary immunodeficiencies, as well as autoimmune and inflammatory conditions. SUMMARY: For certain indications, only defined formulations or routes of administration are approved by health authorities. However, for other diseases, there are more options, and treatment decisions may be based on different aspects, such as patient conditions and preferences, pharmacokinetics, or pharmacoeconomic considerations. KEY MESSAGES: Understanding the two different treatment modalities may support the decision-making for the optimal therapeutic option for individual patients. This review summarizes the latest insights into the direct and indirect comparison between the two types of products.
20A Comparative Study of Intravenous Immunoglobulin and Subcutaneous Immunoglobulin in Adult Patients with Primary Immunodeficiency Diseases: A Systematic Review and Meta-Analysis.PubMed
Hosein Shabaninejad, Asra Asgharzadeh, Nima Rezaei, et al.
Expert Rev Clin Immunol. 2016;12(5):595-602. doi: 10.1586/1744666X.2016.1155452. Epub 2016 Mar 9.
Subcutaneous immunoglobulin (SCIG) is a new therapeutic procedure for patients with primary immunodeficiency (PI). This research is a systematic review of studies on the efficacy and safety of intravenous immunoglobulin (IVIG) and SCIG in adult patients with PI. This study includes a systematic review of cohorts and randomized clinical trials (24 articles) from 5 databases with no time limits. Random effects meta-analysis was performed for outcomes such as efficacy and safety. Standard mean difference (SMD) of serum immunoglobulin level was equal to 0.336 (P <0.01; 0.205-0.467) and the odds ratio (OR) of side effects was 0.497 (P=0.1; 0.180-1.371). The results indicate that SCIG leads to a higher level of immunoglobulin and a reduction in side effects but shows the same infection rate as IVIG. Our analysis shows that shifting from IVIG to SCIG therapy can have clinical benefits for PI patients.