Sandler S G
Department of Medicine (Hematology/Oncology), Georgetown University Medical Center, Washington, DC, USA.
Curr Opin Hematol. 2001 Nov;8(6):417-20. doi: 10.1097/00062752-200111000-00017.
Intravenous Rh [corrected] immune globulin was licensed by the U. S. Food and Drug administration in 1995 for the treatment of acute and chronic immune thrombocytopenic purpura in children and chronic immune thrombocytopenic purpura in adults. In 1996, the American Society of Hematology published a practice guideline for immune thrombocytopenic purpura, but treatment recommendations of necessity were formulated using only results of early clinical trials with intravenous Rh immune globulin. To date, there are no published results of large-scale clinical trials comparing conventional doses of intravenous immune globulin with the most promising dose range for intravenous Rh immune globulin (50-75 microg/kg). However, clinical experience is accumulating to indicate that intravenous Rh immune globulin is as effective, probably safer, and easier to administer than intravenous immune globulin. Acute intravascular hemolysis after infusions of intravenous Rh immune globulin for immune thrombocytopenic purpura has been reported with an estimated incidence of 1 in 1,115 patients. The risk factors for this adverse event have not been defined.
静脉注射Rh免疫球蛋白于1995年获美国食品药品监督管理局批准，用于治疗儿童急性和慢性免疫性血小板减少性紫癜以及成人慢性免疫性血小板减少性紫癜。1996年，美国血液学会发布了免疫性血小板减少性紫癜的实践指南，但必要的治疗建议仅基于早期静脉注射Rh免疫球蛋白的临床试验结果制定。迄今为止，尚无大规模临床试验的结果发表，比较常规剂量的静脉注射免疫球蛋白与静脉注射Rh免疫球蛋白最有前景的剂量范围（50 - 75微克/千克）。然而，临床经验不断积累表明，静脉注射Rh免疫球蛋白与静脉注射免疫球蛋白一样有效，可能更安全，且更易于给药。据报道，因免疫性血小板减少性紫癜输注静脉注射Rh免疫球蛋白后发生急性血管内溶血，估计发病率为1/1115患者。该不良事件的危险因素尚未明确。
