Brenner B
Institute of Hematology, Rambam Medical Center, Haifa, Israel.
Clin Exp Rheumatol. 1996 May-Jun;14 Suppl 15:S115-9.
The safety and efficacy of Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin, were evaluated in 54 patients who received 301 infusions of Octagam for a total amount of 9301 grams, during 24 months.
Adverse reactions during and after Octagam infusion were carefully recorded. Serum IgG and ALT levels were recorded monthly. Antibodies to HIV, HBV and HCV were recorded every 3 months.
In 22 chronic lymphocytic leukemia patients and 4 multiple myeloma patients, the monthly infusion of 0.4 gr/ kg Octagam proved safe and effective in increasing IgG levels and potentially reducing the rate of serious bacterial infections. In 20 patients with ITP, infusion of 2 gr/kg of Octagam was safe and effective in increasing the platelet count and in arresting spontaneous bleeding or preventing bleeding prior to surgical procedures. In 8 patients with the antiphospholipid syndrome monthly infusions of Octagam were found to be safe. Adverse reactions following Octagam infusion were uncommon, generally mild and all were transient. Viral safety assays for HIV, HBV and HCV were all negative.
Octagam is a safe intravenous gammaglobulin effective in patients with secondary hypogammaglobulinemia and ITP.
在24个月期间，对54例接受了301次奥克他滨输注、总量达9301克的患者，评估一种溶剂去污剂（SD）病毒灭活静脉注射免疫球蛋白奥克他滨的安全性和有效性。
仔细记录奥克他滨输注期间及之后的不良反应。每月记录血清IgG和ALT水平。每3个月记录HIV、HBV和HCV抗体。
在22例慢性淋巴细胞白血病患者和4例多发性骨髓瘤患者中，每月输注0.4克/千克奥克他滨被证明在提高IgG水平以及可能降低严重细菌感染率方面是安全有效的。在20例免疫性血小板减少症患者中，输注2克/千克奥克他滨在增加血小板计数以及在阻止自发性出血或预防手术前出血方面是安全有效的。在8例抗磷脂综合征患者中，发现每月输注奥克他滨是安全的。奥克他滨输注后的不良反应不常见，一般较轻且均为短暂性。HIV、HBV和HCV的病毒安全性检测均为阴性。
奥克他滨是一种安全的静脉注射免疫球蛋白，对继发性低丙种球蛋白血症和免疫性血小板减少症患者有效。
