静脉注射枸橼酸西地那非与心脏手术后急性肾损伤:双盲随机安慰剂对照试验
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Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
背景与目的
本研究旨在评估静脉注射枸橼酸西地那非是否能预防体外循环心脏手术后高危患者的急性肾损伤。
方 法
我们在英国一家独立三级医疗中心进行双盲随机对照试验，心脏手术后急性肾损伤风险增加的成年患者，于手术开始时随机静脉输注12.5mg·kg-1枸橼酸西地那非，输注时间超过150min，或静脉输注5%葡萄糖。主要结果是测定随机分组后的6个时间点的血清肌酐值。初步分析采用线性混合效应模型，调整分层变量、基线估算的肾小球滤过率和外科过程。次要结果为临床事件及潜在的疾病机制。效果评估以均数差（MDs）或95%CI优势比来表示。
结 果
本试验纳入了2015年5月至2018年6月期间，接受体外循环下瓣膜手术或瓣膜手术联合冠状动脉旁路移植术的随机患者。西地那非组纳入60名患者，安慰剂对照组纳入69名患者。两组间血清肌酐值无统计学差异 (MD: 0.88 μmol·L-1[-5.82, 7.59])。西地那非组多器官功能障碍评分显著增加 (MD: 0.54 [0.02, 1.07]; P＝0.044)。两组间的次要结果以及肾脏损伤、内皮功能和炎症细胞活化的生物标志物无显著差异。
结 论
上述试验结果不支持在成人心脏手术中静脉注射枸橼酸西地那非保护肾脏功能。
原始文献来源及摘要
Kumar T, Aujla H, Woźniak M, et al. Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial.[J].Br J Anaesth 2020 Jun;124(6):693-701.
Abstract
Background: This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.
Methods: In a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg-1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals.
Results: The analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L-1[-5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P＝0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups.
Conclusions: These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery.
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贵州医科大学高鸿教授课题组
翻译：佟睿 编辑：冯玉蓉 审校：曹莹