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α-骨化醇对瓣膜置换术患者住院时间的短期影响:一项随机临床试验。

Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial.

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

出版信息

Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16.

Abstract

PURPOSE

Vitamin D deficiency is highly prevalent in critically ill patients, and has been associated with more prolonged length of hospital stay and poor prognosis. Patients undergoing open-heart surgery are at higher risk due to the associated life-threatening postoperative complications. This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery.

METHODS

This single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points were lengths of stay (LOS) in the intensive care unit (ICU) and in the hospital. Secondary end points were the prevalence of postoperative hospital-acquired infections, cardiac complications, and in-hospital mortality.

FINDINGS

A total of 86 patients were included in the final analysis, with 51 (59.3%) being vitamin D deficient on hospital admission. Treatment with alfacalcidol was associated with a statistically significant decrease in ICU LOS (hazard ratio = 1.61; 95% CI, 1.77-2.81; P = 0.041) and hospital LOS (hazard ratio = 1.63; 95% CI, 1.04-2.55; P = 0.034). Treated patients had a significantly lower postoperative infection rate than did the control group (35.5% vs 56.1%; P = 0.017). The median epinephrine dose was lower in the intervention group compared to that in the control group (5.9 vs 8.2 mg; P = 0.019). The rate of in-hospital mortality was not significantly different between the 2 groups.

IMPLICATIONS

Early treatment with 2 μg of alfacalcidol in patients undergoing valve-replacement surgery is promising and well tolerated. This effect may be attributed to its immunomodulatory and cardioprotective mechanisms. ClinicalTrials.gov identifier: NCT04085770.

摘要

目的

危重症患者普遍存在维生素 D 缺乏,且与住院时间延长和预后不良有关。由于术后危及生命的并发症,行心脏直视手术的患者风险更高。本研究旨在调查 AlfaCalcidol 治疗对行瓣膜置换术患者住院时间的影响。

方法

这是一项于 2017 年 4 月至 2018 年 1 月在埃及开罗 El-Demerdash 心脏学院医院进行的单中心、随机、开放标签、对照试验。本研究纳入了行瓣膜置换术的成年患者,随机分为干预组(n=47;AlfaCalcidol 2μg/d,术前 48 小时开始,并持续整个住院期间)或对照组(n=42)。主要终点为 ICU 住院时间和总住院时间。次要终点为术后院内获得性感染、心脏并发症和院内死亡率的发生率。

结果

共有 86 例患者纳入最终分析,入院时 51 例(59.3%)维生素 D 缺乏。AlfaCalcidol 治疗与 ICU 住院时间(风险比=1.61;95%CI,1.77-2.81;P=0.041)和总住院时间(风险比=1.63;95%CI,1.04-2.55;P=0.034)的显著降低相关。与对照组相比,治疗组术后感染率显著降低(35.5% vs 56.1%;P=0.017)。与对照组相比,干预组的肾上腺素剂量中位数较低(5.9 与 8.2mg;P=0.019)。两组的院内死亡率无显著差异。

结论

在接受瓣膜置换术的患者中,早期使用 2μg AlfaCalcidol 治疗具有前景且耐受性良好。这种效果可能归因于其免疫调节和心脏保护机制。临床试验编号:NCT04085770。

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