乌司他丁对二尖瓣置换术后出血、输血及预后的影响

The effect of Ulinastatin on postoperative blood loss,transfusion and clinical recovery in patients undergoing mitral valve replacement

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,doubleblind 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（cTnI）,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,cTnI,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.