心脏外科停用抑肽酶前后围术期结果比较

目的 比较2007年12月19日中国食品及药品监督管理局下令心脏外科术中停用抑肽酶前、后心脏手术围术期结果,进一步探讨在心脏外科病人应用抑肽酶的作用及安全性.方法 回顾分析停用抑肽酶前、后各6个月的病人资料,所有人选者均在体外循环下行心脏外科手术,年龄均大于18岁.2007年6月19日至2007年12月18日的手术者为抑肽酶组,入选者均在术中应用抑肽酶.2007年12月19日至2008年6月18日手术者为对照组,入选者在术中均未用抑肽酶.比较两组围术期结果.包括术后失血量、输血量、二次开胸发生率、住院病死率及心、脑、肾、肺等重大并发症的发生率.同时进行多因素Lo~tic回归分析进一步确认初步比较的结果.结果 抑肽酶组入选1699例,对照组2225例.抑肽酶组与对照组比较,术后24 h出血量[(402.5±267.3)ml对(628.1±378.2)ml,P

A comparison of post-operative results for cardiac patients without aprotinin

Objective Aprotinin has been suspended in cardiac surgery since risks factors associated with mortality and other adverse events in western Literatures.This study was to investigate the effect of aprotinin on short-term outcomes in cardiac surgery in Chinese patients.Methods Two groups of patients who underwent cardiac surgery during equal period just before and after aprotinin was suspended in China.Aprotinin groupp(n=1699) was defined as operations from june 19,2007 to Dec 18,2007,when aprotinin was used in all the patients.Control group(n=2225)was defined as operations from Dec19,2007 to June 18,2008,when aprotinin was not umed.Postoperative outcomes between the two groups,including blood loes and transfusion requirement,in-hospital mortality and major adveme outcome events were compared,using univariate analysis and mulfivariable logistic regression analysis.Results Aprotinin group had less postoperative blood loes,transfusion requirement and reoperation for bleeching as compared with the control group.Application of aprotinin did not increase the risk of in-hospital mortality (0.5%vs.10%,P=0.08)and other major ad-verse events,including renal dysfunction,renal failure requiring dialysis,low cardiac output syndrome (LCOS),neurological and pulmonary complications.Aprltinin group also had and shorter mechanical ventilation time(P=0.04),a lowwer rate of delayed mechan-ical ventilation time(P=0.04)and a higher PaO2/FiO2 in the bolld gas analysis(P<0.001).which presented a better respiratory function.Multivariable Logistic regression analysis got identical results with univariate analysis.Conclusion The use of aprotinin in cardiac surgery could reduce blood loss and transfusion requirement significantly,and showed a protective effect on the lungs.In the mean time it did not increase the risk of mortality or major complications.We suggest further studies should be performed to make a decision of continuing or stopping the use of aprotinin in cardisc surgery in Chinese or Asian population.