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术前地塞米松给药对心脏手术后认知功能的纵向评估:一项随机对照试验的 4 年随访。

Longitudinal assessment of preoperative dexamethasone administration on cognitive function after cardiac surgery: a 4-year follow-up of a randomized controlled trial.

机构信息

Department of Anesthesiology and Intensive Care, University Hospital of Split, Spinciceva 1, 21000, Split, Croatia.

Department of Psychology, Faculty of Humanities and Social Sciences, University of Split, Split, Croatia.

出版信息

BMC Anesthesiol. 2021 Apr 23;21(1):129. doi: 10.1186/s12871-021-01348-z.

Abstract

BACKGROUND

The pathogenesis of postoperative cognitive decline (POCD) is still poorly understood; however, the inflammatory response to surgical procedures seems likely to be involved. In addition, our recent randomized controlled trial showed that perioperative corticosteroid treatment may ameliorate early POCD after cardiac surgery. To assess the long-term effect of dexamethasone administration on cognitive function, we conducted a 4-year follow-up.

METHODS

The patients were randomized to receive a single intravenous bolus of 0.1 mg kg dexamethasone or placebo 10 h before elective cardiac surgery. The endpoint in both groups was POCD incidence on the 6th day and four years postoperatively.

RESULTS

Of the 161 patients analyzed previously, the current follow-up included 116 patients. Compared to the 62 patients in the placebo group, the 54 patients in the dexamethasone group showed a lower incidence of POCD on the 6th day (relative risk (RR), 0.510; 95 % confidence interval (CI), 0.241 to 1.079; p = 0.067, time interval also analyzed previously) and four years (RR, 0.459; 95 % CI, 0.192 to 1.100; p = 0.068) after cardiac surgery. The change in cognitive status between the two postoperative measurements was not significant (p = 0.010) among the patients in the dexamethasone group, in contrast to patients in the placebo group (p = 0.673).

CONCLUSIONS

Although statistical significance was not reached in the current study, the prophylactic administration of dexamethasone seems to be useful to prevent POCD development following cardiac surgery. However, further large multicenter research is needed to confirm these directions.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02767713 (10/05/2016).

摘要

背景

术后认知功能障碍(POCD)的发病机制仍不清楚;然而,手术引起的炎症反应似乎与此有关。此外,我们最近的一项随机对照试验表明,围手术期皮质类固醇治疗可能改善心脏手术后早期 POCD。为了评估地塞米松给药对认知功能的长期影响,我们进行了 4 年的随访。

方法

患者随机接受术前 10 小时静脉注射 0.1mg/kg 地塞米松或安慰剂,接受择期心脏手术。两组的终点均为术后第 6 天和 4 年时 POCD 的发生率。

结果

在之前分析的 161 例患者中,目前的随访包括 116 例患者。与安慰剂组的 62 例患者相比,地塞米松组的 54 例患者在术后第 6 天(相对风险(RR),0.510;95%置信区间(CI),0.241 至 1.079;p=0.067,时间间隔也进行了之前的分析)和 4 年后(RR,0.459;95%CI,0.192 至 1.100;p=0.068)发生 POCD 的几率较低。与安慰剂组患者相比,地塞米松组患者的认知状态在两次术后测量之间的变化无显著差异(p=0.010)。

结论

尽管在本研究中未达到统计学意义,但预防性给予地塞米松似乎有助于预防心脏手术后 POCD 的发生。然而,需要进一步的大型多中心研究来证实这些方向。

试验注册

ClinicalTrials.gov 标识符:NCT02767713(2016 年 10 月 5 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2008/8063389/1e6c06c787e4/12871_2021_1348_Fig1_HTML.jpg

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