法国圣埃洛伊医院Samir Jaber联合克莱蒙奥弗涅大学Emmanuel Futier课题组，研究比较了羟乙基淀粉和生理盐水对腹部大手术高危患者进行容量替代治疗对死亡或术后并发症的影响。相关论文于2020年1月21日发表于国际顶尖学术期刊《美国医学会杂志》上。

目前尚不清楚使用含羟乙基淀粉（HES）的胶体溶液来纠正高危外科患者的血管内缺损是否安全有效。

为了比较HES 130/0.4和0.9%生理盐水用于腹部大手术后血管容量扩张对死亡率和术后并发症的影响，2016年2月至2018年7月，研究组在法国20所大学医院进行了一项多中心、双盲、平行组、随机、临床试验，共招募了775名腹部大手术后肾损伤风险增加的成人患者。将这些患者随机分组，其中389名接受含6%HES 130/0.4的0.9%生理盐水，386名仅接受0.9%的生理盐水。手术期间采用个体化血流动力学算法。随访至2018年10月。

参与者的平均年龄为68岁，女性占12%。HES组中有139例患者（36%）在术后14天死亡或发生严重并发症，生理盐水组中有125例（32%），差异无统计学意义。两组的其他临床指标均无显著差异，但HES组第一天给药的研究液体的中位容量为1250毫升，显著低于生理盐水组（1500毫升）。术后28天，HES组和生理盐水组中分别有4.1%和2.3%的患者死亡，差异不显著。

总之，对于腹部大手术后肾损伤风险增加的患者，采用HES进行容量替代治疗，与0.9%生理盐水相比，并未显著改善术后14天死亡和并发症的综合结局。该发现不支持在此类患者中使用HES进行容量替代治疗。

附：英文原文

Title: Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial

Author: Emmanuel Futier, Matthias Garot, Thomas Godet, Matthieu Biais, Daniel Verzilli, Alexandre Ouattara, Olivier Huet, Thomas Lescot, Gilles Lebuffe, Antoine Dewitte, Anna Cadic, Aymeric Restoux, Karim Asehnoune, Catherine Paugam-Burtz, Philippe Cuvillon, Marion Faucher, Camille Vaisse, Younes El Amine, Hélène Beloeil, Marc Leone, Eric Noll, Vincent Piriou, Sigismond Lasocki, Jean-Etienne Bazin, Bruno Pereira, Samir Jaber

Issue&Volume: 2020/01/21

Abstract: 

Importance  It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe.

Objective  To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery.

Design, Setting, and Participants  Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018.

Interventions  Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day.

Main Outcomes and Measures  The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90.

Results  Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, −3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, −0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17).

Conclusions and Relevance  Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients.

DOI: 10.1001/jama.2019.20833

Source: https://jamanetwork.com/journals/jama/article-abstract/2759003