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FDA 11月份曾报告,静脉免疫球蛋白(IGIV)制品其含蔗糖者较不含者似更易引起急性肾衰。FDA已发出新的推荐,旨在降低与IGIV相关的急性肾衰的危险性。新推荐与装盒将警告加到所有IGIV制品的标签上。FDA报告,过去18年代理处收到114份(83份来自美国)与IGIV应用相关的肾功能紊乱或急性肾衰的报告。有高百分率报告(占美国报告的88％)涉及到含蔗糖的制品。含蔗糖制品包括瑞士红十字生产的(Sandoglobin和Panglobulin,分别由Novastis和美国红十字分配)和Centenon生产的(Gammar-P Ⅰ.Ⅴ和以前的GammarⅠ.Ⅴ)。8篇急性肾衰报告包括了组织学发现,其中7篇异常与
The FDA reported in November that intravenous immunoglobulin (IGIV) products were more likely to cause acute renal failure than those without sucrose. FDA has issued a new recommendation to reduce the risk of acute renal failure associated with IGIV. New Recommendation and Boxing Add a warning to all IGIV products’ labels. FDA reports that in the past 18 years, the Agency received 114 reports (83 from the United States) of reports of renal dysfunction or acute renal failure associated with IGIV use. A high percentage of reports (88% of the U.S. reports) relate to products containing sucrose. Sucrose-containing products include those produced by the Swiss Red Cross (Sandoglobin and Panglobulin, assigned by Novastis and American Red Cross, respectively) and Centenon (Gammar-P I.V and former Gammar I.V). Eight acute renal failure reports included histological findings, seven of which were abnormal