一项关于新型热处理静脉注射免疫球蛋白的前瞻性对照交叉试验。
A prospective controlled crossover trial of a new heat-treated intravenous immunoglobulin.
作者信息
Zuhrie S R, Webster A D, Davies R, Fay A C, Wallington T B
机构信息
Immunodeficiency Research Group, Clinical Research Centre, Harrow, UK.
出版信息
Clin Exp Immunol. 1995 Jan;99(1):10-5. doi: 10.1111/j.1365-2249.1995.tb03465.x.
Twenty-one patients with primary immunoglobulin deficiency were enrolled in a crossover study to test the efficacy and safety of Alphaglobin in comparison with the licensed preparations Sandoglobulin and Gamimune. There was no statistical difference in these parameters between Alphaglobin and Sandoglobulin/Gamimune. The level of total serum IgG and specific IgG to pneumococcal polysaccharides was similar in individual patients when they were receiving Alphaglobin or one of the other products. Transient increases in serum alanine transferase occurred in five patients on Sandoglobulin/Gamimune and two patients on Alphaglobin. Some patients showed a rise in total serum IgM afterwards, indicating a response to infection. However, serum hepatitis C virus (HCV) RNA was not found during the alanine transferase (ALT) rises, and IgM antibody to hepatitis A virus (HAV) was negative afterwards. We conclude that Alphaglobin is a safe, well tolerated and clinically efficacious treatment for patients with primary antibody deficiency.
21例原发性免疫球蛋白缺乏症患者参与了一项交叉研究，以测试与已获许可的制剂沙格司亭和静注人免疫球蛋白相比，α球蛋白的疗效和安全性。α球蛋白与沙格司亭/静注人免疫球蛋白在这些参数上无统计学差异。个体患者接受α球蛋白或其他产品之一时，血清总IgG水平和针对肺炎球菌多糖的特异性IgG水平相似。接受沙格司亭/静注人免疫球蛋白的5例患者和接受α球蛋白的2例患者出现血清丙氨酸转氨酶短暂升高。一些患者随后血清总IgM升高，表明对感染有反应。然而，在丙氨酸转氨酶升高期间未发现血清丙型肝炎病毒（HCV）RNA，之后甲型肝炎病毒（HAV）IgM抗体为阴性。我们得出结论，对于原发性抗体缺乏症患者，α球蛋白是一种安全、耐受性良好且临床有效的治疗方法。
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