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胃肠道癌症患者的支持性护理。

Supportive care for patients with gastrointestinal cancer.

作者信息

Ahmed N, Ahmedzai S, Vora V, Hillam S, Paz S

机构信息

Division of Clinical Sciences, Section of Surgical and Anaesthetic Sciences, Palliative Medicine, University of Sheffield, Royal Hallamshire Hospital, K floor, Glossop Road, Sheffield, South Yorkshire, UK, S10 2JF.

出版信息

Cochrane Database Syst Rev. 2004;2004(3):CD003445. doi: 10.1002/14651858.CD003445.pub2.

Abstract

BACKGROUND

Supportive care has traditionally been given to optimise the comfort of patients and their ability to function, as well as to minimise the side-effects of anti-cancer treatments. The scope of modern comprehensive supportive care however is broadening and covers not only specific palliative treatment but non-tumour specific treatment such as social, psychological and spiritual support. In oncology, best supportive care (BSC) has been used as a comparator arm of randomised controlled trials in chemotherapy. However the BSC arm is usually not well defined and its evaluation is therefore difficult because of the heterogeneity of the definitions. A systematic review was undertaken of the evidence from all RCTs of gastrointestinal cancers (includes gastrointestinal/gastric, colorectal/colon cancer but excludes pancreatic cancer trials) which include a BSC/SC arm.

OBJECTIVES

  1. To examine the effectiveness/outcomes of best supportive care interventions versus cancer therapies for gastrointestinal cancer trials;2. To determine whether trials containing best supportive care include a definition of this.

SEARCH STRATEGY

Electronic databases, grey literature sources, citation searching and reference checking, handsearches of journals and discussion with experts were used to identify potentially eligible trials from both published and unpublished sources.

SELECTION CRITERIA

RCTs comparing BSC/SC versus anticancer therapies in patients with gastrointestinal cancers.

DATA COLLECTION AND ANALYSIS

Four RCTs were found and reviewed. Because of the heterogeneity of studies, a meta-analysis was not attempted. Data was extracted from the included papers and the quality of each included study was assessed using the Jadad 1996 and Rinck 1997 methods of assessing the quality of RCTs.

MAIN RESULTS

Data from four trials (483 patients) were included. Due to the heterogeneity of studies (in terms of populations studied, the interventions used, the variety of outcomes and assessments used) it was not possible to make direct comparisons between the studies. The primary outcome in all four trials was survival, in spite of patients with advanced/metastatic gastrointestinal cancer having a poor prognosis, and the interventions being primarily palliative.

REVIEWERS' CONCLUSIONS: Overall the results show that for most of the trials included in this review, certain forms of chemotherapy plus supportive care improve both survival and quality of life in patients with gastrointestinal cancer (gastric and colorectal cancers) compared to receiving supportive care alone. Trials involving BSC/SC in patients with advanced gastrointestinal cancer require careful evaluation. Oncologists and researchers alike should strive for improvements in trial design and reporting. Future trials should focus on clearer definitions of supportive care. The EORTC definition of supportive care can be used as a guide. BSC/SC trials should use standardised validated outcome measures for symptom control, quality of life, toxicity and other useful palliative measures.

摘要

背景

传统上,支持性护理旨在优化患者的舒适度及其功能能力,并尽量减少抗癌治疗的副作用。然而,现代综合支持性护理的范围正在扩大,不仅涵盖特定的姑息治疗,还包括非肿瘤特异性治疗,如社会、心理和精神支持。在肿瘤学中,最佳支持性护理(BSC)已被用作化疗随机对照试验的对照臂。然而,BSC臂通常定义不明确,因此由于定义的异质性,其评估很困难。对所有包含BSC/SC臂的胃肠道癌症随机对照试验(包括胃肠道/胃癌/胃癌、结直肠癌但不包括胰腺癌试验)的证据进行了系统评价。

目的

  1. 检查胃肠道癌症试验中最佳支持性护理干预与癌症治疗相比的有效性/结果;2. 确定包含最佳支持性护理的试验是否对此有定义。

检索策略

使用电子数据库、灰色文献来源、引文检索和参考文献核对、期刊手工检索以及与专家讨论,从已发表和未发表的来源中识别潜在符合条件的试验。

选择标准

比较BSC/SC与胃肠道癌症患者抗癌治疗的随机对照试验。

数据收集与分析

找到并审查了四项随机对照试验。由于研究的异质性,未尝试进行荟萃分析。从纳入的论文中提取数据,并使用Jadad 1996年和Rinck 1997年评估随机对照试验质量的方法评估每个纳入研究的质量。

主要结果

纳入了四项试验(483名患者)的数据。由于研究的异质性(在研究人群、使用的干预措施、结果和评估的多样性方面),无法在研究之间进行直接比较。尽管晚期/转移性胃肠道癌症患者预后较差,且干预措施主要是姑息性的,但所有四项试验的主要结局都是生存。

综述作者的结论

总体而言,结果表明,对于本综述中纳入的大多数试验,与单独接受支持性护理相比,某些形式的化疗加支持性护理可改善胃肠道癌症(胃癌和结直肠癌)患者的生存率和生活质量。涉及晚期胃肠道癌症患者的BSC/SC试验需要仔细评估。肿瘤学家和研究人员都应努力改进试验设计和报告。未来的试验应侧重于更明确地定义支持性护理。欧洲癌症研究与治疗组织(EORTC)对支持性护理的定义可作为指导。BSC/SC试验应使用标准化的经过验证的结局指标来控制症状、评估生活质量、毒性和其他有用的姑息性指标。

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