摘要:目的 观察乌司他丁对体外循环下心脏直视手术后出血、输血及临床预后的影响.方法 62例在体外循环和心脏停搏下行二尖瓣置换患者纳入本前瞻、随机、双盲临床研究,患者于术前随机分配到乌司他丁组和对照组,每组31例,乌司他丁组患者体外循环预充乌司他丁5 000U/kg,对照组患者给予等量生理盐水,检测围术期凝血功能参数:血小板计数,凝血酶原时间(PT),国际标准化比值(INR),活化部分凝血酶时间测定(aPTT),纤维蛋白原和D-二聚体;心肌血清标志物:肌酸激酶同工酶(CK-MB)和肌钙蛋白-I(cTnI);同时检测肌酐,乳酸;记录术后24 h内引流量、输血量、拔管时间、ICU时间、正性肌力药物使用情况等临床数据.结果 与术前比较,血小板计数、纤维蛋白原含量显著下降,PT、INR和aPTT显著延长,血清中D-二聚体、CK-MB、cTnI、肌酐和乳酸含量显著上升,但是乌司他丁组和对照组之间比较没有显著差异.围术期出血量和输血量比较也没有显著差异.但是乌司他丁组患者ICU时间显著低于对照组(42.6 h vs 50.2 h,P=0.02).结论 体外循环二尖瓣置换手术中给予乌司他丁5 000U/kg不能降低术后失血量和输血量,但能够缩短患者术后ICU停留时间.%Objective To investigate the effect of ulinastatin on postoperative blood loss, transfusion requirements and clinical recovery of patients underwent mitral valve replacement under cardiopulmonary bypass ( CPB ) and aortic cross — clamping ( ACC ). Methods Sixty —two patients underwent mitral valve replacement with CPB and ACC included in this prospective, randomized, dou-bleblind study. Eligible patients were randomized to ulinastatin group ( n = 31 ), who received ulinastatin 5 000 U/kg in prime solution, or control group ( n =31 ), who received equal volume of saline. Peri — operative coagulation parameters such as platelet count, plasminogen time ( PT ), international normalized ratio ( INR ), activated part thrombin time ( aPTT ), Fibrinogen, D — dimer were assessed before surgery and on admittance to the ICU. The cardiac markers isoenzyme creatine kinase ( CK — MB ) and troponin — I ( cT-nl), as well as creatinine and lactate were assessed at the same time. Post — operative data such as drainage volume, transfusion volume, extubation time, ICU stay and inotropic drug using were also recorded. Results Compared with pre — operative values, the post — operative platelet count, and fibrinogen concentration were decreased significantly, PT, INR and aPTT were significantly increased, serum D — dimer, CK — MB, cTnl, creatinine and lactate were also significantly increased, but there were no significant differences between the two groups. There was no statistically significant differences between — group in postoperative blood loss and transfusion requirements. Ulinastatin caused a non — significant decrease in duration of intubation and inotropic drug using. But the ICU time was shorter in ulinastatin group comparing with control group (42. 6 h vs 50.2 h, P =0.02 ). Conclusion Ulinastatin, 5,000 U/kg in prime solution, could not decrease the peri —operative blood loss and transfusion requirement, but could decrease the ICU time in patients underwent mitral valve replacement operation with CPB and ACC.