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神经外科加速康复外科(ERAS)方案对脑胶质瘤患者健康相关生活质量的影响:一项随机对照试验的二次分析。

Impact of neurosurgical enhanced recovery after surgery (ERAS) program on health-related quality of life in glioma patients: a secondary analysis of a randomized controlled trial.

机构信息

Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.

Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.

出版信息

J Neurooncol. 2020 Jul;148(3):555-567. doi: 10.1007/s11060-020-03548-y. Epub 2020 Jun 6.

Abstract

INTRODUCTION

A novel neurosurgical enhanced recovery after surgery (ERAS) program shortens postoperative hospital stay and accelerates functional recovery in elective craniotomy patients. There is a need to evaluate the impact of ERAS program on patients' health-related quality of life (HRQOL).

METHODS

In a single-center randomized controlled trial, patients were randomized 1:1 to receive perioperative ERAS or conventional care. As a secondary outcome, HRQOL was measured with the EORTC QLQ-C30/BN20 prior to randomization (baseline), at discharge, and at 3- and 6-month follow-up.

RESULTS

A total of 65 patients (ERAS: n = 36, conventional care: n = 29) with pathologically confirmed glioma (WHO grade 2-4) were included in the analysis. Progression-free survival at 6 months and HRQOL at baseline were similar between the two groups. Changes of scores did not vary significantly over time, but differed significantly between intervention groups. A clinically relevant better QoL (at 3-month follow-up), physical functioning (at 6-month follow-up) and role functioning (at discharge) was observed in patients in the ERAS group. Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness (at 3- and 6-month follow-up), weakness of legs (at 3-month follow-up), and nausea/vomiting (at discharge and 6-month follow-up) were significantly lower in the ERAS group.

CONCLUSIONS

The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care. The intervention has a significant main effect HRQOL changes without significant interaction with time. Future well-powered multicenter studies are warranted to confirm this result and address long-term benefits. This study has been registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/showproj.aspx?proj=16480 ) with registration number ChiCTR-INR-16009662.

摘要

简介

一种新的神经外科术后加速康复(ERAS)方案可缩短择期开颅手术患者的术后住院时间并加速其功能恢复。有必要评估 ERAS 方案对患者健康相关生活质量(HRQOL)的影响。

方法

在一项单中心随机对照试验中,患者以 1:1 的比例随机分配接受围手术期 ERAS 或常规护理。作为次要结局,在随机分组前(基线)、出院时以及 3 个月和 6 个月随访时,使用 EORTC QLQ-C30/BN20 评估 HRQOL。

结果

共纳入 65 例(ERAS 组:n=36,常规护理组:n=29)经病理证实的脑胶质瘤(WHO 分级 2-4 级)患者。两组患者的 6 个月无进展生存率和基线 HRQOL 相似。两组的评分随时间变化无显著差异,但干预组之间存在显著差异。ERAS 组患者在 3 个月随访时 QoL(生活质量)有临床相关改善,在 6 个月随访时体力功能和角色功能更好,在出院时运动功能更好。ERAS 组患者的便秘症状评分(出院时)、运动障碍(出院时、3 个月和 6 个月随访时)、嗜睡(3 个月和 6 个月随访时)、下肢无力(3 个月随访时)和恶心/呕吐(出院时和 6 个月随访时)评分明显更低。

结论

与常规护理相比,神经外科 ERAS 方案可在 6 个月随访内改善脑胶质瘤患者的功能和症状评分。该干预措施对 HRQOL 变化具有显著的主要影响,与时间无显著交互作用。需要进一步开展更大规模、多中心的研究来证实这一结果并评估长期获益。本研究已在中国临床试验注册中心(http://www.chictr.org.cn/showproj.aspx?proj=16480)注册,注册号 ChiCTR-INR-16009662。

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