Institute of General Practice and Public Health, Claudiana College of Health Professions, Lorenz Böhler Street 13, 39100, Bolzano, Italy.
BMC Surg. 2022 Apr 12;22(1):140. doi: 10.1186/s12893-022-01588-x.
A meta-analysis of randomized controlled trials was recently published in BMC Surgery that compared the use of human albumin with 6% hydroxyethyl starches 130/0.4 for cardiopulmonary bypass prime and perioperative fluid management in pediatric and adult cardiac surgery patients. The two plasma expanding solutions are described as equivalent for efficacy and safety outcomes, and, on that basis, the preferential use of hydroxyethyl starches 130/0.4 was recommended for economic reasons because of the higher unit costs of human albumin solutions.
In addition to the fact that trials were mostly small, single-center studies and the number of total participants was low, making the meta-analysis underpowered for several outcomes, selective reporting of data for ICU length of stay was identified. Re-calculation of statistics at higher precision showed that ICU length of stay of patients in the human albumin group was significantly shorter than that of patients in the 6% hydroxyethyl starches 130/0.4 group (standard mean difference - 0.181, 95% confidence interval - 0.361 to - 0.001, P = 0.049), which may offset any proposed economic advantage of using 6% hydroxyethyl starches 130/0.4. At the same time, the renal safety of 6% hydroxyethyl starches 130/0.4 in surgical patients is under regulatory review.
Underpowered trials and selective reporting may impair the validity of the meta-analysis. A more cautious conclusion about the interchangeability between human albumin and 6% hydroxyethyl starches 130/0.4 in cardiac surgery should have been reached.
最近在 BMC 外科杂志上发表了一项荟萃分析，该分析比较了在儿科和成人心脏手术患者的体外循环预充和围手术期液体管理中使用人血白蛋白与 6%羟乙基淀粉 130/0.4 的效果。这两种血浆扩容剂在疗效和安全性方面被描述为等效，基于此，出于经济原因，推荐优先使用羟乙基淀粉 130/0.4，因为人血白蛋白溶液的单位成本更高。
除了试验大多为小样本、单中心研究且总参与者数量较低，使得荟萃分析对几个结果的效力不足外，还发现 ICU 住院时间的数据存在选择性报告。更高精度的重新计算统计数据表明，人血白蛋白组患者的 ICU 住院时间明显短于 6%羟乙基淀粉 130/0.4 组（标准均数差-0.181，95%置信区间-0.361 至-0.001，P=0.049），这可能抵消了使用 6%羟乙基淀粉 130/0.4 的任何拟议的经济优势。同时，6%羟乙基淀粉 130/0.4 在手术患者中的肾脏安全性正在接受监管审查。
效力不足的试验和选择性报告可能会影响荟萃分析的有效性。对于心脏手术中 6%羟乙基淀粉 130/0.4 与人血白蛋白之间的可互换性，应该得出更谨慎的结论。
