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术前单次甲基强的松龙预防重大肝切除术后手术部位感染:一项随机对照试验。

Preoperative Single-dose Methylprednisolone Prevents Surgical Site Infections After Major Liver Resection: A Randomized Controlled Trial.

机构信息

Departments of Surgery, University of Calgary, Calgary, Alberta, Canada.

出版信息

Ann Surg. 2022 Feb 1;275(2):281-287. doi: 10.1097/SLA.0000000000004720.

Abstract

OBJECTIVE

The primary aim of this study was to evaluate the efficacy of a single preoperative dose of methylprednisolone for preventing postoperative complications after major liver resections.

SUMMARY BACKGROUND DATA

Hepatic resections are associated with a significant acute systemic inflammatory response. This effect subsequently correlates with postoperative morbidity, mortality, and length of recovery. Multiple small trials have proposed that the administration of glucocorticoids may modulate this effect.

METHODS

This study was a parallel, dual-arm, double-blind randomized controlled trial. Adult patients undergoing elective major hepatic resection (≥3 segments) at a quaternary care institution were included (2013-2019). Patients were randomly assigned to receive a single preoperative 500 mg dose of methylprednisolone versus placebo. The main outcome measure was postoperative complications after liver resection, within 90 days of the index operation. Standard statistical methodology was employed (P < 0.05 = significant).

RESULTS

A total of 151 patients who underwent a major hepatic resection were randomized (mean age = 62.8 years; 57% male; body-mass-index = 27.9). No significant differences were identified between the intervention and control groups (age, sex, body-mass-index, preoperative comorbidities, hepatic function, ASA class, portal vein embolization rate) (P > 0.05). Underlying hepatic diagnoses included colorectal liver metastases (69%), hepatocellular carcinoma (18%), noncolorectal liver metastases (7%), and intrahepatic cholangiocarcinoma (6%). There was a significant reduction in the overall incidence of postoperative complications in the methylprednisolone group (31.2% vs 47.3%; P = 0.042). Patients in the glucocorticoid group also displayed less frequent organ space surgical site infections (6.5% vs 17.6%; P = 0.036), as well as a shorter length of hospital stay (8.9 vs 12.5 days; P = 0.015). Postoperative serum bilirubin and prothrombin timeinternational normalized ratio (PT-INR) levels were also lower in the steroid group (P = 0.03 and 0.04, respectively). Multivariate analysis did not identify any additional significant modifying factor relationships (estimated blood loss, duration of surgery, hepatic vascular occlusion (rate or duration), portal vein embolization, drain use, etc) (P > 0.05).

CONCLUSIONS

A single preoperative dose of methylprednisolone significantly reduces the length of hospital stay, postoperative serum bilirubin, and PT-INR, as well as infectious and overall complications following major hepatectomy.

摘要

目的

本研究的主要目的是评估单次术前给予甲基强的松龙预防大肝切除术后并发症的疗效。

背景资料总结

肝切除术与明显的全身急性炎症反应有关。这种影响随后与术后发病率、死亡率和恢复时间相关。多项小型试验提出,给予糖皮质激素可能调节这种影响。

方法

这是一项平行、双臂、双盲随机对照试验。在一所四级医疗机构接受择期大肝切除术(≥3 段)的成年患者被纳入(2013-2019 年)。患者被随机分配接受单次术前 500mg 甲基强的松龙或安慰剂。主要观察指标是术后 90 天内的肝切除术后并发症。采用标准统计方法(P < 0.05=显著)。

结果

共有 151 名接受大肝切除术的患者被随机分组(平均年龄 62.8 岁;57%为男性;体重指数 27.9)。干预组和对照组之间无显著差异(年龄、性别、体重指数、术前合并症、肝功能、ASA 分级、门静脉栓塞率)(P > 0.05)。基础肝诊断包括结直肠肝转移(69%)、肝细胞癌(18%)、非结直肠肝转移(7%)和肝内胆管癌(6%)。甲基强的松龙组的总体术后并发症发生率显著降低(31.2%比 47.3%;P=0.042)。糖皮质激素组患者的器官间隙手术部位感染也较少(6.5%比 17.6%;P=0.036),住院时间也较短(8.9 天比 12.5 天;P=0.015)。类固醇组术后血清胆红素和凝血酶原时间国际标准化比值(PT-INR)水平也较低(P=0.03 和 0.04)。多变量分析未发现任何其他显著的调节因素关系(估计失血量、手术持续时间、肝血管闭塞(率或持续时间)、门静脉栓塞、引流使用等)(P > 0.05)。

结论

单次术前给予甲基强的松龙可显著降低大肝切除术后的住院时间、术后血清胆红素和 PT-INR 水平以及感染和总体并发症发生率。

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