Xu Yi, Wang Siying, He Leilei, Yu Hong, Yu Hai
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.
Perioper Med (Lond). 2021 May 11;10(1):16. doi: 10.1186/s13741-021-00182-8.
The safety of perioperative intravenous hydroxyethyl starch (HES) products, specifically HES 130/0.4, continues to be the source of much debate. The aim of this meta-analysis was to update the existing evidence and gain further insight into the clinical effects of HES 130/0.4 on postoperative outcomes for volume replacement therapy in surgical patients.
MEDLINE, EMBASE, and Cochrane Library databases were searched from inception to March 2020 for relevant randomized controlled trials (RCTs) on perioperative use of HES 130/0.4 in adult surgical patients. The primary outcome was postoperative mortality and secondary outcomes were the incidence of acute kidney injury (AKI) and requirement for renal replacement therapy (RRT). The analysis was performed using the random-effects method and the risk ratio (RR) with a 95% confidence interval (CI). We performed the risk-of-bias assessment of eligible studies and assessed the overall quality of evidence for each outcome.
Twenty-five RCTs with 4111 participants were finally included. There were no statistical differences between HES 130/0.4 and other fluids in mortality at 30 days (RR 1.28, 95% CI 0.88 to 1.86, p = 0.20), the incidence of AKI (RR 1.23, 95% CI 0.99 to 1.53, p = 0.07), or requirement for RRT (RR 0.75, 95% CI 0.37 to 1.53, p = 0.43). Overall, there was a moderate certainty of evidence for all the outcomes. There was no subgroup difference related to the type of surgery (p = 0.17) in the incidence of AKI. As for the type of comparator fluids, however, there was a trend that was not statistically significant (p = 0.06) towards the increased incidence of AKI in the HES 130/0.4 group (RR 1.22, 95% CI 0.97 to 1.54) compared with the crystalloid group (RR 1.21, 95% CI 0.27 to 3.91). Subgroup analyses according to the type of surgery demonstrated consistent findings.
This systematic review and meta-analysis suggests that the use of HES 130/0.4 for volume replacement therapy compared with other fluids resulted in no significant difference in postoperative mortality or kidney dysfunction among surgical patients. Given the absent evidence of confirmed benefit and the potential trend of increased kidney injury, we cannot recommend the routine clinical use of HES 130/0.4 for volume replacement therapy in surgical patients from the perspective of benefit/risk profile. However, the results need to be interpreted with caution due to the limited sample size, and further well-powered RCTs are warranted.
PROSPERO registry reference: CRD42020173058.
围手术期静脉输注羟乙基淀粉（HES）产品，特别是HES 130/0.4的安全性，仍然是诸多争论的焦点。本荟萃分析的目的是更新现有证据，并进一步深入了解HES 130/0.4对手术患者容量替代治疗术后结局的临床影响。
检索MEDLINE、EMBASE和Cochrane图书馆数据库，从数据库建立至2020年3月，查找关于成年手术患者围手术期使用HES 130/0.4的相关随机对照试验（RCT）。主要结局是术后死亡率，次要结局是急性肾损伤（AKI）的发生率和肾脏替代治疗（RRT）的需求。采用随机效应方法和风险比（RR）及95%置信区间（CI）进行分析。我们对符合条件的研究进行了偏倚风险评估，并评估了每个结局的总体证据质量。
最终纳入了25项RCT，共4111名参与者。HES 130/0.4与其他液体在30天死亡率（RR 1.28，95%CI 0.88至1.86，p = 0.20）、AKI发生率（RR 1.23，95%CI 0.99至1.53，p = 0.07）或RRT需求（RR 0.75，95%CI 0.37至1.53，p = 0.43）方面均无统计学差异。总体而言，所有结局的证据确定性为中等。在AKI发生率方面，与手术类型无关的亚组差异（p = 0.17）。然而，就对照液体类型而言，与晶体液组（RR 1.21，95%CI 0.27至3.91）相比，HES 130/0.4组（RR 1.22，95%CI 0.97至1.54）的AKI发生率有升高趋势，但无统计学意义（p = 0.06）。根据手术类型进行的亚组分析显示了一致的结果。
本系统评价和荟萃分析表明，与其他液体相比，使用HES 130/0.4进行容量替代治疗在手术患者的术后死亡率或肾功能障碍方面无显著差异。鉴于缺乏已证实的益处的证据以及肾脏损伤增加的潜在趋势，从获益/风险角度来看，我们不建议在手术患者中常规临床使用HES 130/0.4进行容量替代治疗。然而，由于样本量有限，结果需要谨慎解读，有必要进行进一步的大样本RCT。
PROSPERO注册编号：CRD42020173058。
