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抑肽酶与去氨加压素减少体外循环心脏手术后出血的随机研究。

Randomized study of aprotinin and DDAVP to reduce postoperative bleeding after cardiopulmonary bypass surgery.

作者信息

Rocha E, Hidalgo F, Llorens R, Melero J M, Arroyo J L, Páramo J A

机构信息

Hematology Department, Clinica Universitaria, School of Medicine, University of Navarra, Pamplona, Spain.

出版信息

Circulation. 1994 Aug;90(2):921-7. doi: 10.1161/01.cir.90.2.921.

Abstract

BACKGROUND

Patients on cardiopulmonary bypass (CPB) have an increased susceptibility to postoperative bleeding. Previous reports using desmopressin acetate (DDAVP) for the prevention of postoperative bleeding have given contradictory results, whereas the protease inhibitor aprotinin has been shown to reduce blood loss after this type of surgery. This randomized study was performed to assess the efficacy of DDAVP versus aprotinin in the prevention of bleeding after CPB.

METHODS AND RESULTS

One hundred nine of 122 eligible patients were randomized to four different groups: Group A (n = 28) received aprotinin starting with a bolus of 2 x 10(6) KIU followed by a continuous infusion of 0.5 x 10(6) KIU/h until the end of surgery; group B (n = 25) received of DDAVP 0.3 micrograms/kg i.v. on completion of CPB; group C (n = 28) received two doses of DDAVP, the first as in group B and an additional dose 6 hours after surgery; group D (n = 28) received no treatment. There was a marked reduction of postoperative blood loss either at 12 hours (P < .01) or 72 hours (P < .02) in the aprotinin group compared with all other groups, whereas no significant effect was observed in either of the two DDAVP regimens. A significant reduction in the amount of blood used was observed only in the aprotinin group (P < .01). Of the plasma fibrinolytic components assayed, there was a significant reduction of the fibrin degradation product generation in the aprotinin group (P < .001), whereas a significant systemic hyperfibrinolysis was observed in both DDAVP-treated groups and the control group. No side effects related to the study drugs were observed in any patient.

CONCLUSIONS

Aprotinin inhibited fibrinolysis; this correlated with a significant reduction of postoperative blood loss and need for blood replacement after CPB. Neither one nor two doses of DDAVP had a beneficial effect. Aprotinin offers a better alternative than DDAVP in the prevention of bleeding after CPB.

摘要

背景

接受体外循环(CPB)的患者术后出血的易感性增加。先前使用醋酸去氨加压素(DDAVP)预防术后出血的报告结果相互矛盾,而蛋白酶抑制剂抑肽酶已被证明可减少此类手术后的失血量。进行这项随机研究以评估DDAVP与抑肽酶在预防CPB后出血方面的疗效。

方法与结果

122例符合条件的患者中有109例被随机分为四组:A组(n = 28)接受抑肽酶,先静脉推注2×10⁶KIU,然后持续输注0.5×10⁶KIU/h直至手术结束;B组(n = 25)在CPB结束时静脉注射DDAVP 0.3微克/千克;C组(n = 28)接受两剂DDAVP,第一剂与B组相同,术后6小时追加一剂;D组(n = 28)不接受治疗。与所有其他组相比,抑肽酶组在术后12小时(P <.01)或72小时(P <.02)的术后失血量均显著减少,而两种DDAVP方案均未观察到显著效果。仅在抑肽酶组观察到使用的血液量显著减少(P <.01)。在所检测的血浆纤溶成分中,抑肽酶组的纤维蛋白降解产物生成显著减少(P <.001),而在两个DDAVP治疗组和对照组中均观察到显著的全身高纤溶状态。未在任何患者中观察到与研究药物相关的副作用。

结论

抑肽酶抑制纤维蛋白溶解;这与CPB后术后失血量显著减少以及输血需求减少相关。一剂或两剂DDAVP均无有益效果。在预防CPB后出血方面,抑肽酶比DDAVP提供了更好的选择。

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