Department of Anaesthesiology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.
Eur J Clin Pharmacol. 2011 Aug;67(8):767-82. doi: 10.1007/s00228-011-1008-5. Epub 2011 Mar 2.
The objective of this study was to appraise the safety profiles of HES preparations and to find out which HES preparation was the most acceptable in cardiovascular surgery through a comparison with control solutions.
Pertinent randomized controlled trials were selected through a search of Pubmed, Embase, and Cochrane Controlled Trials Register. Quantitative and qualitative analysis was carried out to evaluate blood loss, blood transfusion, renal function, complications, reoperation, and mortality.
A total of 3,234 patients from 52 randomized controlled trials were included. HES preparations versus control solutions in blood loss: HES 130 kD vs. albumin (SMD -0.61, 95% CI -0.82, -0.40), HES 200 kD vs. albumin (SMD -0.01, 95% CI -0.29, 0.28), HES 450 kD vs. albumin (SMD 0.47, 95% CI 0.26, 0.68). When comparing control solutions with HES preparations, 50% (HES 450 kD), 40.9% (HES 200 kD), and 18.2% (HES 130 kD) of the comparisons showed more blood/blood products infusion with HES than with control solutions. A numerically lower mortality rate seemed to be related to HES preparations (2.68 vs 4.23%). No difference was found in terms of complications, renal failure, or reoperation.
Perioperative administration of HES preparations is comparatively safe. The data appraising safety profiles of HES preparations are insufficient to make direct comparisons among themselves. As the third generation of HES preparations, HES 130 kD showed a trend toward lower blood loss and transfusion rates and is a suitable choice for cardiovascular surgery.
本研究旨在评估羟乙基淀粉(HES)制剂的安全性,并通过与对照溶液比较,找出在心血管手术中最可接受的 HES 制剂。
通过检索 Pubmed、Embase 和 Cochrane 对照试验登记处,选择了相关的随机对照试验。进行了定量和定性分析,以评估出血量、输血、肾功能、并发症、再次手术和死亡率。
共有 52 项随机对照试验的 3234 名患者纳入本研究。HES 制剂与对照溶液在出血量方面的比较:HES130kD 与白蛋白(SMD-0.61,95%CI-0.82,-0.40),HES200kD 与白蛋白(SMD-0.01,95%CI-0.29,0.28),HES450kD 与白蛋白(SMD0.47,95%CI0.26,0.68)。当将对照溶液与 HES 制剂进行比较时,50%(HES450kD)、40.9%(HES200kD)和 18.2%(HES130kD)的比较显示,输注 HES 比输注对照溶液需要更多的血液/血液制品。与 HES 制剂相比,死亡率似乎呈下降趋势(2.68%比 4.23%)。在并发症、肾功能衰竭或再次手术方面未发现差异。
围手术期使用 HES 制剂相对安全。评估 HES 制剂安全性的资料不足以进行直接比较。作为第三代 HES 制剂,HES130kD 显示出较低的出血量和输血率的趋势,是心血管手术的合适选择。