Wang Xianqiang, Zheng Zhe, Ao Hushan, Zhang Shiju, Wang Yang, Zhang Hao, Li Lihuan, Hu Shengshou
Department of Cardiovascular Surgery and Research Center for Cardiovascular Regenerative Medicine, Cardiovascular Institute and Fuwai Hospital, Beijing, China.
J Thorac Cardiovasc Surg. 2009 Oct;138(4):897-903. doi: 10.1016/j.jtcvs.2009.03.021. Epub 2009 May 21.
Use of aprotinin has been suspended in cardiac surgery since recent studies reported its risks associated with mortality and other adverse events. This study was to investigate the safety and efficacy of aprotinin through a comparison before and after aprotinin was suspended in cardiac surgery.
We designed a case-control study in two groups of patients who underwent cardiac surgery just before and after aprotinin was suspended in China. The aprotinin group (n = 1699) was defined as operations performed from June 19, 2007, to December 18, 2007, when aprotinin was used in all the patients. The control group (n = 2225) was defined as operations performed from December 19, 2007, to June 18, 2008, when aprotinin was not used. We compared early postoperative outcomes between the two groups.
The aprotinin group had less postoperative blood loss, transfusion requirement, and reoperation for bleeding. Application of aprotinin did not increase the risk of in-hospital mortality (0.5% vs 1.0%; P = .08) and other major adverse outcome events, including renal, cardiac, neurologic, and pulmonary complications. The aprotinin group had a shorter mechanical ventilation time (P = .04), a lower rate of delayed mechanical ventilation time (P = .04), and a higher arterial oxygen tension/inspired oxygen fraction ratio in arterial blood gas analysis (P < .001). Multivariable logistic regression analysis confirmed findings from univariate analysis. After propensity adjustment for the baseline characteristics, we obtained similar results.
Use of aprotinin in cardiac surgery could reduce blood loss and transfusion requirement significantly and showed a protective effect on the lungs, but it did not increase the risk of mortality or major complications.
由于近期研究报道了抑肽酶与死亡率及其他不良事件相关的风险，心脏手术中已暂停使用抑肽酶。本研究旨在通过比较心脏手术中暂停使用抑肽酶前后的情况，探讨抑肽酶的安全性和有效性。
我们设计了一项病例对照研究，纳入在中国抑肽酶暂停使用前后接受心脏手术的两组患者。抑肽酶组（n = 1699）定义为2007年6月19日至2007年12月18日期间进行的手术，此期间所有患者均使用抑肽酶。对照组（n = 2225）定义为2007年12月19日至2008年6月18日期间进行的手术，此期间未使用抑肽酶。我们比较了两组患者术后早期的结果。
抑肽酶组术后失血量、输血需求及因出血进行再次手术的情况较少。使用抑肽酶并未增加住院死亡率（0.5%对1.0%；P = 0.08）及其他主要不良结局事件的风险，包括肾脏、心脏、神经和肺部并发症。抑肽酶组机械通气时间较短（P = 0.04），延迟机械通气时间发生率较低（P = 0.04），动脉血气分析中动脉血氧分压/吸入氧分数比值较高（P < 0.001）。多变量逻辑回归分析证实了单变量分析的结果。在对基线特征进行倾向调整后，我们获得了相似的结果。
在心脏手术中使用抑肽酶可显著减少失血量和输血需求，并对肺部有保护作用，但并未增加死亡风险或主要并发症的风险。
