抑肽酶在先天性心脏手术中的安全性：来自大型多中心数据库的结果。
Safety of aprotinin in congenital heart operations: results from a large multicenter database.
机构信息
Division of Pediatric Cardiology, Duke University Medical Center, Durham, North Carolina 27715, USA.
出版信息
Ann Thorac Surg. 2010 Jul;90(1):14-21. doi: 10.1016/j.athoracsur.2010.02.073.
BACKGROUND
Aprotinin was used frequently in children undergoing congenital heart operations with the aim of reducing bleeding, until it was taken off the market after adult studies reported increased renal failure and death. We evaluated the safety of aprotinin in a large multicenter cohort of children undergoing congenital heart operations.
METHODS
The Pediatric Health Information Systems Database was used to evaluate aprotinin in children (aged 0 to 18 years) undergoing congenital heart operations at 35 children's hospitals from 2003 to 2007. Propensity scores were constructed to account for potential confounders of age, sex, race, prematurity, genetic syndrome, type of operation (Risk Adjustment in Congenital Heart Surgery-1 category), center, and center volume. Multivariable analysis, adjusting for propensity score and individual covariates was performed to evaluate in-hospital mortality, postoperative renal failure requiring dialysis, and length of stay. Subanalysis was performed in the high-risk cohort undergoing reoperation.
RESULTS
The study included 30,372 patients (56% male) who were a median age of 7 months (interquartile range, 36 days to 3.2 years). Overall, 44% received aprotinin. Multivariable analysis found no difference in postoperative mortality (odds ratio, 1.00; 95% confidence interval [CI], 0.99 to 1.01), dialysis (odds ratio, 1.00; 95% CI, 0.99 to 1.01), or length of stay (least square mean difference, -0.44 days; 95% CI, -1.01 to 0.13) between aprotinin recipients and nonrecipients. No difference was found in mortality or dialysis in patients undergoing reoperation. Aprotinin recipients in the reoperation subgroup had significantly reduced length of stay (least square mean difference, -2.05 days; 95% CI -3.29 to -0.81),
CONCLUSIONS
These data suggest aprotinin is not associated with increased mortality or dialysis in children undergoing congenital heart operations and that further evaluation of aprotinin in this population could be undertaken without undue risk.
背景
抑肽酶曾广泛用于接受先天性心脏手术的儿童，以减少出血，但在成人研究报告其导致肾衰竭和死亡的风险增加后，该药物已被撤出市场。我们评估了抑肽酶在接受先天性心脏手术的大量多中心儿童队列中的安全性。
方法
我们使用儿科健康信息系统数据库，评估了 2003 年至 2007 年期间 35 家儿童医院的 35,372 名接受先天性心脏手术的儿童（年龄 0 至 18 岁）使用抑肽酶的情况。构建倾向评分以考虑年龄、性别、种族、早产、遗传综合征、手术类型（先天性心脏手术风险调整-1 类）、中心和中心容量等潜在混杂因素。进行多变量分析，调整倾向评分和个体协变量，以评估院内死亡率、需要透析的术后肾衰竭以及住院时间。在高危再手术队列中进行了亚组分析。
结果
研究包括 30,372 名患者（56%为男性），中位年龄为 7 个月（四分位距，36 天至 3.2 岁）。总体而言，44%的患者接受了抑肽酶。多变量分析发现，术后死亡率（优势比，1.00；95%置信区间[CI]，0.99 至 1.01）、透析（优势比，1.00；95%CI，0.99 至 1.01）或住院时间（最小二乘均数差，-0.44 天；95%CI，-1.01 至 0.13）在抑肽酶使用者和非使用者之间无差异。再手术患者的死亡率或透析率无差异。再手术亚组中抑肽酶使用者的住院时间明显缩短（最小二乘均数差，-2.05 天；95%CI，-3.29 至-0.81）。
结论
这些数据表明，抑肽酶与接受先天性心脏手术的儿童的死亡率或透析率增加无关，在该人群中进一步评估抑肽酶的使用不会带来不必要的风险。
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