Price T H, Goodnough L T, Vogler W R, Sacher R A, Hellman R M, Johnston M F, Bolgiano D C, Abels R I
Puget Sound Blood Center, Seattle, Washington 98104, USA.
Am J Med. 1996 Aug 26;101(2A):22S-27S. doi: 10.1016/s0002-9343(96)00165-9.
The effects of therapy with recombinant human erythropoietin (Epoetin alfa) on erythropoiesis, preoperative autologous blood donation, and risk of exposure to allogeneic blood were evaluated in 204 patients scheduled to undergo elective orthopedic surgery. Study protocol required patients to have a baseline hematocrit < or = 39% and surgery scheduled 25-35 days in advance. Patients were randomized to two equal groups and were seen at study centers every 3-4 days within the 21-day trial period. At each visit, phlebotomy(< or = 450 mL) was performed if the hematocrit was > or = 33%, and Epoetin alfa (600 U/kg) or placebo was administered intravenously. A total of 173 patients were assessable; 31% of placebo recipients and 20% of Epoetin alfa recipients required allogeneic transfusion (p = 0.09). Logistic regression modeling showed that the risk of allogeneic transfusion was reduced by Epoetin alfa (p = 0.025). When patients receiving > 6 units of blood (necessitating allogeneic units) were excluded from analysis, 29% of placebo recipients and 14% of Epoetin alfa recipients were exposed to allogeneic blood (p = 0.015). Epoetin alfa recipients predonated more autologous units than did placebo recipients (4.5 vs 3.0 units, respectively; p < 0.001), and their production of red blood cells increased significantly more over baseline production values (668 vs 353 mL, respectively; p < 0.05). These results demonstrate that administration of Epoetin alfa stimulates erythropoiesis, allows predonation of more units of autologous blood, and reduces the risk of exposure to allogeneic blood. Optimal dosing regimens and surgical patients most likely to benefit fro Epoetin alfa therapy must be established.
在204例计划接受择期骨科手术的患者中，评估了重组人促红细胞生成素（阿法依泊汀）治疗对红细胞生成、术前自体献血以及异体输血风险的影响。研究方案要求患者基线血细胞比容≤39%，且手术提前25 - 35天安排。患者被随机分为两组，在21天的试验期内每3 - 4天在研究中心就诊一次。每次就诊时，如果血细胞比容≥33%，则进行静脉放血（≤450 mL），并静脉注射阿法依泊汀（600 U/kg）或安慰剂。共有173例患者可进行评估；31%的安慰剂接受者和20%的阿法依泊汀接受者需要异体输血（p = 0.09）。逻辑回归模型显示，阿法依泊汀降低了异体输血风险（p = 0.025）。当排除接受超过6单位血液（需要异体血单位）的患者进行分析时，29%的安慰剂接受者和14%的阿法依泊汀接受者接受了异体血（p = 0.015）。阿法依泊汀接受者预先捐献的自体血单位比安慰剂接受者更多（分别为4.5单位和3.0单位；p < 0.001），并且他们的红细胞生成量相对于基线生成值显著增加更多（分别为668 mL和353 mL；p < 0.05）。这些结果表明，给予阿法依泊汀可刺激红细胞生成，允许更多单位的自体血预先捐献，并降低异体输血风险。必须确定最佳给药方案以及最可能从阿法依泊汀治疗中获益的手术患者。
