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针对无法治愈的实体癌患者的随机临床试验中的营养干预:一项系统综述。

Nutritional interventions in randomised clinical trials for people with incurable solid cancer: A systematic review.

作者信息

Mcluskie Amy, Bowers Megan, Bayly Jo, Yule Michael S, Maddocks Matthew, Fallon Marie, Skipworth Richard Je, Laird Barry J A

机构信息

Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK.

Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College, London, UK.

出版信息

Clin Nutr. 2025 Jan;44:201-219. doi: 10.1016/j.clnu.2024.12.008. Epub 2024 Dec 6.

Abstract

BACKGROUND & AIMS: Malnutrition is highly prevalent in those with cancer and more so in those with incurable cancer. In incurable cancer, it is widely agreed that optimal nutritional care has the potential to positively impact patient and caregiver distress and oncological outcomes. The aim of this systematic review was to describe the diversity and frequency of nutritional interventions, whether given in isolation or as part of a multimodal intervention in those with incurable cancer, in randomised controlled trials. The secondary aims were to describe adherence and their efficacy.

METHODS

This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. The following databases were searched electronically: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Cumulated Index to Nursing and Allied Health Literature (CINAHL) and Cochrane Central Register of Controlled Trials (CENTRAL) with the time frame from January 2000 to 7th September 2023. Eligible studies included adult patients (≥18 years) diagnosed with incurable solid cancer with a sample size ≥40. Studies were to be primary research and delivered for at least 14 days to allow for efficacy. They were to include a nutritional intervention encompassing at least one of the following: dietary counselling, oral nutritional supplements (ONS), enteral tube feeding and/or parenteral nutrition (PN), given in isolation or as part of a multi-modal intervention. Studies were excluded if the population contained patients who had completed curative treatment or are being treated with curative intent, haematological cancers, or if they examined the effects of micronutrients, proteins, amino acids or fatty acids given in isolation. The quality of the included studies was assessed using the Cochrane risk of bias tool for randomised trials (RoB2). A balloon plot was produced to present the results in addition to a table with a narrative summary of the primary outcomes.

RESULTS

A total of 7968 studies were identified, of which 18 met the eligibility criteria. This included 2720 study participants. The included studies comprised: multimodal interventions (n = 7), dietary counselling (n = 2), nutritional supplementation with or without dietary counselling (n = 7) and PN (n = 2). Primary outcomes included quality of life (QoL), body composition and nutritional status. For QoL, this was reported in 15 studies, 4 studies showed a significant improvement. Body composition was evaluated in 15 studies, 5 of which showed a significant improvement in body weight and two in fat-free mass (FFM). Nutritional status was reported in 6 studies with one showing a significant difference in Patient-Generated Subjective Global Assessment (PG-SGA) score. The risk of bias was deemed 'low' in 6 studies, with 'some concerns' in 10 studies and a 'high risk' in 2 studies. There was heterogeneity between the studies.

CONCLUSION

This systematic review has highlighted some positive findings in regard to QoL, body weight and nutritional intake. Optimum nutritional intervention was not identified. Future studies should evaluate the effectiveness of earlier nutritional interventions at the point of diagnosis, including regular reviews and the impact this has on nutritional outcomes, QoL and overall survival (OS).

摘要

背景与目的

营养不良在癌症患者中极为普遍,在无法治愈的癌症患者中更为常见。在无法治愈的癌症患者中,人们普遍认为最佳的营养护理有可能对患者和护理人员的痛苦以及肿瘤治疗结果产生积极影响。本系统评价的目的是描述在随机对照试验中,针对无法治愈的癌症患者,单独或作为多模式干预的一部分进行的营养干预的多样性和频率。次要目的是描述依从性及其疗效。

方法

本系统评价按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行。通过电子方式检索以下数据库:医学文献分析与检索系统在线数据库(MEDLINE)、医学文摘数据库(EMBASE)、护理及相关健康文献累积索引(CINAHL)和Cochrane对照试验中央注册库(CENTRAL),时间范围为2000年1月至2023年9月7日。符合条件的研究包括年龄≥18岁、被诊断为无法治愈的实体癌且样本量≥40的成年患者。研究应为原始研究,干预持续至少14天以评估疗效。研究应包括至少一种以下营养干预措施:饮食咨询、口服营养补充剂(ONS)、肠内管饲和/或肠外营养(PN),单独或作为多模式干预的一部分。如果研究人群包含已完成根治性治疗或正在接受根治性治疗的患者、血液系统癌症患者,或者研究单独给予的微量营养素、蛋白质、氨基酸或脂肪酸的效果,则排除该研究。使用Cochrane随机试验偏倚风险工具(RoB2)评估纳入研究的质量。除了列出主要结果的叙述性总结的表格外,还制作了一个气泡图来展示结果。

结果

共识别出7968项研究,其中18项符合纳入标准。这包括2720名研究参与者。纳入的研究包括:多模式干预(n = 7)、饮食咨询(n = 2)、有或无饮食咨询的营养补充(n = 7)和PN(n = 2)。主要结果包括生活质量(QoL)、身体成分和营养状况。对于QoL,15项研究报告了相关结果,4项研究显示有显著改善。15项研究评估了身体成分,其中5项显示体重有显著改善,2项显示去脂体重(FFM)有显著改善。6项研究报告了营养状况,其中1项显示患者主观整体评估(PG-SGA)评分有显著差异。6项研究的偏倚风险被认为“低”,10项研究有“一些担忧”,2项研究有“高风险”。研究之间存在异质性。

结论

本系统评价突出了在QoL、体重和营养摄入方面的一些积极发现。未确定最佳营养干预措施。未来的研究应评估在诊断时早期营养干预的有效性,包括定期评估及其对营养结果、QoL和总生存期(OS)的影响。

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