【罂粟摘要】6%羟乙基淀粉130/0.4对心脏手术病人炎症反应和肺功能的影响：一项随机临床试验
6%羟乙基淀粉130/0.4对心脏手术病人炎症反应和肺功能的影响：一项随机临床试验
贵州医科大学 麻醉与电生理课题组
翻译：胡廷菊 编辑：佟睿 审校：曹莹
体外循环心脏手术引起严重的炎症反应，甚至会导致多器官功能障碍。前期数据表明羟乙基淀粉溶液的输注可能减轻炎症反应，改善肺功能。我们的目的是评估6%羟乙基淀粉130/0.4和5%人血白蛋白作为血管内血浆容量替代治疗对心脏手术病人围术期炎症反应和肺功能的效果。
这是一个盲法、平行分组，随机临床试验，在克利夫兰诊所主院区行择期主动脉瓣置换手术，一个题为“6%羟乙基淀粉130/0.4对心脏手术病人肾脏和止血功能影响”的子研究。141个病人随机分到6%羟乙基淀粉组和5%人血白蛋白组进行术中血浆容量置换。将135个病人数据进行分析（羟乙基淀粉组66，人血白蛋白组69）。我们通过比较两组患者在基线时候、术后1小时和术后24小时的血清肿瘤坏死因子-α (TNF-α)、白细胞介素-6 (IL-6)和巨噬细胞迁移抑制因子(MIF)浓度来评估体外循环诱导的炎症反应指标。我们也比较两组患者术后肺功能指标，包括到达重症监护室1小时内和拔出气管导管前动脉氧分压和吸入氧浓度的比值，动态肺顺应性，氧合指数和基线通气指数。采用线性混合模型分别评估HES组和白蛋白组术后炎症反应水平和肺功能的差异。
在接受6% HES 130/0.4和5%白蛋白治疗的患者之间，血清炎症标志物(TNF-α、IL-6、MIF)浓度无显著差异(P≥0.05)，治疗效果与时间无关(P≥0.15)。两组肺功能参数（动脉氧分压和吸入氧浓度的比值，动态肺顺应性，氧合指数和基线通气指数）无显著性差异，治疗效果与时间无关(P≥0.15)。
我们的研究发现，在接受6% HES 130/0.4和5%白蛋白治疗的心脏外科患者中，炎症标志物浓度和肺功能测量值没有显著差异。
Mee Jee Lee，Charles Tannenbaum，Guangmei Mao，et al.Effect of 6% Hydroxyethyl Starch 130/0.4 on
Inflammatory Response and Pulmonary Function in Patients Having Cardiac Surgery: A Randomized Clinical Trial.[J].Anesth Analg. 2021 Oct 1;133(4):906-914.
Effect of 6% Hydroxyethyl Starch 130/0.4 on Inflammatory Response and Pulmonary Function in PatientsHaving Cardiac Surgery: A Randomized Clinical Trial
Abstract
Background: Cardiac surgery with cardiopulmonary bypass induces a profound inflammatory response that, when severe, can lead to multiorgan system dysfunction. Preliminary data suggest that administration of hydroxyethyl starch (HES) solutions may mitigate an inflammatory response and improve pulmonary function. Our goal was to examine the effect of 6% HES 130/0.4 versus 5% human albumin given for intravascular plasma volume replacement on the perioperative inflammatory response and pulmonary function in patients undergoing cardiac surgery.
Method:This was a subinvestigation of a blinded, parallel-group, randomized clinical trial of patients undergoing elective aortic valve replacement surgery at the Cleveland Clinic main campus, titled “Effect of 6% Hydroxyethyl Starch 130/0.4 on Kidney and Haemostatic Function in Cardiac Surgical Patients.” Of 141 patients who were randomized to receive either 6% HES 130/0.4 or 5% human albumin for intraoperative plasma volume replacement, 135 patients were included in the data analysis (HES n = 66, albumin n = 69). We assessed the cardiopulmonary bypass–induced inflammatory response end points by comparing the 2 groups’ serum concentrations of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and macrophage migration inhibitory factor (MIF), measured at baseline and at 1 and 24 hours after surgery. We also compared the 2 groups’ postoperative pulmonary function end points, including the ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2:Fio2 ratio), dynamic lung compliance, oxygenation index (OI), and ventilation index (VI) at baseline, within 1 hour of arrival to the intensive care unit, and before tracheal extubation. The differences in the postoperative levels of inflammatory response and pulmonary function between the HES and albumin groups were assessed individually in linear mixed models.
Results:Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF) were not significantly different (P ≥ .05) between patients who received 6% HES 130/0.4 or 5% albumin, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15). The results of pulmonary function parameters (Pao2:Fio2 ratio, dynamic compliance, OI, VI) were not significantly different (P ≥ .05) between groups, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15).
Conclusion:Our investigation found no significant difference in the concentrations of inflammatory markers and measures of pulmonary function between cardiac surgical patients who received 6% HES 130/0.4 versus 5% albumin.
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