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食管癌切除术后癌症患者的免疫增强配方:系统评价方案

Immune-Enhancing Formulas for Patients With Cancer Undergoing Esophagectomy: Systematic Review Protocol.

作者信息

Naranjo Astrid, Isenring Elizabeth, Teleni Laisa

机构信息

Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.

出版信息

JMIR Res Protoc. 2017 Nov 17;6(11):e214. doi: 10.2196/resprot.7688.

Abstract

BACKGROUND

Adult patients with an esophageal cancer can potentially be compromised with postoperative leaks or fistulae if patients' nutritional status is in a vulnerable stage. Currently in Australia, there is a growing need for clinicians to know whether use of immune-enhancing formulas (IEFs) containing Arg, omega-3, and RNA are a cost-effective approach compared with isonitrogenous-isocaloric formulas to reduce postoperative infectious complications in esophagectomy patients. Since IEFs may carry higher costs, this has led to inconsistencies in practice among clinicians and hospitals.

OBJECTIVE

Our aim is to compile and present the most up-to-date nutrition evidence available regarding the provision of IEFs containing Arg, omega-3, and RNA to help clinicians develop an evidence-based nutrition care plan; identify available evidence of whether an esophagectomy patient should receive IEF; determine the cost-effectiveness and safety of such nutrition; and determine appropriate administration quantity and timing (pre-, peri-, or postesophagectomy).

METHODS

This review will include RCTs involving the use of IEFs enriched with Arg, omega-3 polyunsaturated fatty acids, and RNA in the pre-, peri-, or postoperative period (for at least 5-7 days) given orally or via enteral feeding tube, in adult cancer patients undergoing esophageal resection. Lower gastrointestinal, gastric, or head cancer surgery with parenteral nutrition or non-IEF or use of isolated immunonutrient (Arg vs omega-3 vs RNA) will be excluded. Primary outcome comprises postoperative infectious complications. Secondary outcomes (pre/postoperatively) consist of cost-effectiveness, length of stay, survival/mortality, quality of life, nutritional status, percentage of weight loss, and biochemical changes. The risk of bias will be independently assessed by the reviewers, using a domain-based evaluation tool. Blinding will be assessed for subjective and objective outcome measures. Publication bias will be visually assessed by funnel plots. A meta-analysis will be generated by the Review Manager 5.3 software and represented in forest plots.

RESULTS

The first results are expected in 2018. Outlining the protocol will ensure transparency for the completed review.

CONCLUSIONS

This protocol for a systematic review and meta-analysis will enable a comprehensive appraisal of the literature to help determine whether overall institutional savings are associated with this approach. Findings will form a knowledge base relevant to stakeholders across the health system and researchers who are involved in decision making on evidence-based nutrition care plan pathways for patients undergoing esophagectomy, as well as the use of IEF, timing, and administration quantity.

TRIAL REGISTRATION

PROSPERO Registration Number: CRD42017056908; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp? ID=CRD42017056908 (Archived by WebCite at http://www.webcitation.org/6rLyeqaD6).

摘要

背景

如果成年食管癌患者的营养状况处于脆弱阶段,那么术后发生渗漏或瘘管的可能性会增加。目前在澳大利亚,临床医生越来越需要了解,与等氮等热量配方相比,使用含有精氨酸、ω-3脂肪酸和RNA的免疫增强型配方(IEF)是否是一种具有成本效益的方法,以减少食管切除术患者的术后感染并发症。由于IEF可能成本更高,这导致临床医生和医院在实践中存在不一致的情况。

目的

我们的目的是汇编并呈现关于提供含有精氨酸、ω-3脂肪酸和RNA的IEF的最新营养证据,以帮助临床医生制定基于证据的营养护理计划;确定食管切除术患者是否应接受IEF的现有证据;确定这种营养的成本效益和安全性;并确定合适的给药量和时间(术前、围手术期或术后)。

方法

本综述将纳入涉及在术前、围手术期或术后(至少5 - 7天)口服或通过肠内喂养管使用富含精氨酸、ω-3多不饱和脂肪酸和RNA的IEF的随机对照试验,这些试验的对象为接受食管切除术的成年癌症患者。排除接受肠外营养或非IEF的下消化道、胃或头颈部癌症手术,或使用单一免疫营养物质(精氨酸与ω-3脂肪酸与RNA)的情况。主要结局包括术后感染并发症。次要结局(术前/术后)包括成本效益、住院时间、生存/死亡率、生活质量、营养状况、体重减轻百分比和生化变化。评审人员将使用基于领域的评估工具独立评估偏倚风险。将对主观和客观结局指标评估盲法情况。将通过漏斗图直观评估发表偏倚。将使用Review Manager 5.3软件进行荟萃分析,并以森林图表示。

结果

预计2018年得出首批结果。概述方案将确保完成综述后的透明度。

结论

本系统综述和荟萃分析方案将能够对文献进行全面评估,以帮助确定这种方法是否能带来整体机构节约。研究结果将形成一个知识库,供整个卫生系统的利益相关者以及参与为接受食管切除术患者制定基于证据的营养护理计划路径决策的研究人员使用,以及用于IEF的使用、时间和给药量。

试验注册

PROSPERO注册号:CRD42017056908;http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017056908(由WebCite存档于http://www.webcitation.org/6rLyeqaD6)

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