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包括Steinmuller博士报告的病例,FDA获知自1994年以来有四例病人发生溶血,都因在去血浆治疗中或后用注射用水将白蛋白(人)25％稀释到5％使用引起的。稀释液引起明显低渗代替溶液,在四例病人中发生低渗透压而溶血,其中两例急性肾衰。以前报告过一例,另外两例报告给FDA药物售后异常反应报告系统(MEDWatch)。各种浓度的人白蛋白都规定130-160mmol/L的钠离子浓度。因此,用注射用水1:4稀释后,溶液渗透压只有0.9％NaCl(等渗溶液)的五分之一。在去血浆治疗和血浆代替治疗中大容量可能引起溶血,因为低渗血浆代替物占人血浆容积最重要组成部分。在低渗环境里,去血浆设备的剪切力可能引起观察到的溶血。作者不知道在药房里的稀释错误是否经常发生。然而,目前人血白蛋白短缺导致用高浓度进行
Including the cases reported by Dr. Steinmuller, the FDA learned that four patients had hemolysis since 1994, both due to the 25% dilution of albumin (human) to 5% with or without water for injection during or after plasmapheresis. Dilution caused a significant hypotonic instead of solution, low pressure and hemolysis occurred in four patients, two cases of acute renal failure. One case was previously reported and the other two cases were reported to the FDA Drug Abuse Response Reporting System (MEDWatch). Various concentrations of human albumin provide a sodium concentration of 130-160 mmol / L. Therefore, after dilution with 1: 4 water for injection, the osmolality of the solution is only one-fifth that of 0.9% NaCl (isotonic solution). Large volumes of plasma and plasma replacement therapy may cause hemolysis, as hypotonic plasma surrogates represent the most important component of human plasma volume. In a hypotonic environment, the shearing force to the plasma device may cause the observed hemolysis. The authors do not know if dilution errors in pharmacies often happen. However, the current shortage of human albumin results in high concentrations