Allergy Associates of the Palm Beaches, 840 US Highway 1, Suite 235, North Palm Beach, FL 33408, USA.
Postgrad Med. 2010 Sep;122(5):176-84. doi: 10.3810/pgm.2010.09.2214.
Intravenous immunoglobulin (IGIV) replacement therapy is the standard of care for primary immunodeficiencies with impaired humoral immunity. It is also the immunomodulatory therapy of choice for some types of neuroimmunologic and autoimmune hematologic disorders and for immunomodulation in bone marrow and some solid organ transplants. Currently available IGIV products include older lyophilized formulations, 5% liquid products, and newer, liquid, ready-to-use, 10% formulations. Differences in the formulations, manufacturing processes, excipients, pH, and other physicochemical properties of IGIV products may affect their clinical efficacy and tolerability. Among at-risk patients, the possibility of serious complications such as renal insufficiency, heart failure, thrombotic events, and immunological reactions may be increased if an IGIV formulation has sugar as a stabilizer, has high sodium or immunoglobulin A (IgA) content, or is hyperosmolar. The 10% liquid formulations may offer advantages because of their lower IgA concentrations, optimal pH, glycine or proline stabilizers, low sodium content, and lower osmolality. Liquid formulations are more convenient for patients and health care providers due to shorter infusion times and easier preparation and administration.
静脉注射免疫球蛋白 (IGIV) 替代疗法是针对体液免疫受损的原发性免疫缺陷的标准治疗方法。它也是某些类型的神经免疫和自身免疫性血液疾病以及骨髓和某些实体器官移植中免疫调节的首选治疗方法。目前可用的 IGIV 产品包括较旧的冻干制剂、5%的液体产品以及更新的、液体的、即用型的 10%制剂。IGIV 产品在配方、制造工艺、赋形剂、pH 值和其他物理化学特性方面的差异可能会影响其临床疗效和耐受性。在高风险患者中,如果 IGIV 制剂的稳定剂是糖、含有高浓度的钠或免疫球蛋白 A (IgA)、或高渗透压,则可能会增加发生肾功能不全、心力衰竭、血栓形成事件和免疫反应等严重并发症的可能性。由于其较低的 IgA 浓度、最佳 pH 值、甘氨酸或脯氨酸稳定剂、低钠含量和较低的渗透压,10%的液体制剂可能具有优势。由于输注时间更短、更容易准备和给药,液体制剂对患者和医疗保健提供者来说更加方便。