Randomized Trial of Diaspirin Cross-linked Hemoglobin Solution as an Alternative to Blood Transfusion after Cardiac Surgery
Randomized Trial of Diaspirin Cross-linked Hemoglobin Solution as an Alternative to Blood Transfusion after Cardiac Surgery
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地阿司匹林交联血红蛋白溶液作为心脏手术后输血替代方案的随机试验
DOI：
10.1097/00000542-200003000-00007
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发表时间：
2000
期刊：
影响因子：
8.8
通讯作者：
R. Przybelski
中科院分区：
文献类型：
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作者：
M. Lamy;E. Daily;J. Brichant;R. Larbuisson;R. Demeyere;E. Vandermeersch;J. Lehot;M. Parsloe;J. Berridge;C. J. Sinclair;J. Baron;R. Przybelski
背景：与异体输血相关的风险已经促使避免或减少输血的方法的发展。新的携氧化合物，如地阿司匹林交联血红蛋白(DCLHb)，可以使更多的患者避免异基因输血。方法：采用随机、积极对照、单盲、多中心研究方法，观察DCLHb对体外循环术后患者的疗效、安全性、血流动力学效应和血浆持久性。在筛选的1,956名患者中，有209名患者被确定需要输血，并在体外循环后24小时内符合纳入标准。这些患者随机接受最多3次250毫升的DCLHb输注(n=104)或3单位的包装红细胞(pRBC；n=105)。如果需要，允许进一步输注红细胞或全血。主要疗效终点是避免通过出院或术后7天输血，以先到者为准，并减少在同一时间段内输血的pRBC单位数。监测了各种实验室、生理和血流动力学参数，以确定DCLHb在该患者群体中的安全性和药理作用。结果：从体外循环手术结束到术后第7天或出院，104例DCLHb受者中有20例(19%)未输注pRBC，而对照组为100%(P<；0.05)。术后7天期间应用pRBC的总数没有显著差异。DCLHb组(104名患者中有6名)和对照组(105名患者中有8名)的死亡率相似。DCLHb组中高血压、黄疸/高胆红素血症、血清谷草转氨酶升高、尿液异常和血尿的发生率较高，每组均有1例肾功能衰竭。与pRBC相比，DCLHb的血流动力学效应包括体循环和肺血管阻力的持续增加和稍大幅度的增加，并伴随着体循环和肺动脉压的增加。DCLHb组患者首次给药后心输出量下降幅度大于对照组患者。在输注后24小时，血浆血红蛋白水平不到任何剂量DCLHb最高水平的一半。结论：使用DCLHb可使相当数量(19%)的心脏手术患者避免术后暴露于红细胞。
Background: Risks associated with transfusion of allogeneic blood have prompted development of methods to avoid orreduce blood transfusions. New oxygen-carrying compounds such as diaspirin cross-linked hemoglobin (DCLHb) could enable more patients to avoid allogeneic blood transfusion. Methods: The efficacy, safety, hemodynamic effects, and plasma persistence of DCLHb were investigated in a randomized, active-control, single-blind, multicenter study in post–cardiac bypass surgery patients. Of 1,956 screened patients, 209 were determined to require a blood transfusion and met the inclusion criteria during the 24-h post–cardiac bypass period. These patients were randomized to receive up to three 250-ml infusions of DCLHb (n = 104) or three units of packed erythrocytes (pRBCs; n = 105). Further transfusions of pRBCs or whole blood were permitted, if indicated. Primary efficacy end points were the avoidance of blood transfusion through hospital discharge or 7 days postsurgery, whichever came first, and a reduction in the number of units of pRBCs transfused during this same time period. Various laboratory, physiologic, and hemodynamic parameters were monitored to define the safety and pharmacologic effect of DCLHb in this patient population. Results: During the period from the end of cardiopulmonary bypass surgery through postoperative day 7 or hospital discharge, 20 of 104 (19%) DCLHb recipients did not receive a transfusion of pRBCs compared with 100% of control patients (P < 0.05). The overall number of pRBCs administered during the 7-day postoperative period was not significantly different. Mortality was similar between the DCLHb (6 of 104 patients) and the control (8 of 105 patients) groups. Hypertension, jaundice/hyperbilirubinemia, increased serum glutamic oxalo-acetic transaminase, abnormal urine, and hematuria were reported more frequently in the DCLHb group, and there was one case of renal failure in each group. The hemodynamic effects of DCLHb included a consistent and slightly greater increase in systemic and pulmonary vascular resistance with associated increases in systemic and pulmonary arterial pressures compared with pRBC. Cardiac output values decreased more in the DCLHb group patients after the first administration than the control group patients. At 24 h postinfusion, the plasma hemoglobin level was less than one half the maximal level for any amount of DCLHb infused. Conclusions: Administration of DCLHb allowed a significant number (19%) of cardiac surgery patients to avoid exposure to erythrocytes postoperatively.
DOI：
10.1016/s0021-9258(18)67605-7
发表时间：
1986-07
期刊：
The Journal of biological chemistry
影响因子：
--
作者：
R. Chatterjee;E. Welty;R. Walder;S. Pruitt;P. Rogers;A. Arnone;J. A. Walder
通讯作者：
R. Chatterjee;E. Welty;R. Walder;S. Pruitt;P. Rogers;A. Arnone;J. A. Walder