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随机临床对照试验:晚期癌症患者中早期专科姑息治疗加标准治疗与单纯标准治疗的对比-丹麦姑息治疗试验

Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial.

机构信息

1 The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen NV, Denmark.

2 Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

出版信息

Palliat Med. 2017 Oct;31(9):814-824. doi: 10.1177/0269216317705100. Epub 2017 May 12.

DOI:10.1177/0269216317705100
PMID:28494643
Abstract

BACKGROUND

Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal.

AIM

To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments.

SETTING/PARTICIPANTS: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival.

RESULTS

Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect.

CONCLUSION

We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

摘要

背景

在晚期癌症中已经发现早期姑息治疗的有益效果,但证据并不明确。

目的

调查在肿瘤内科确定的晚期癌症患者中早期专科姑息治疗的效果。

设置/参与者:丹麦姑息治疗试验(DanPaCT)(ClinicalTrials.gov NCT01348048)是一项多中心随机临床试验,比较了早期转介到专科姑息治疗团队加标准护理与单独标准护理。计划样本量为 300 例。在五个肿瘤内科,对晚期癌症患者进行姑息治疗需求筛查。根据欧洲癌症研究与治疗组织生活质量问卷(EORTC QLQ-C30),功能(身体、情感或角色)或恶心/呕吐、疼痛、呼吸困难或食欲减退方面存在问题,得分超过预定阈值的患者符合条件。主要结局是 3 周和 8 周随访时每位患者主要需求(七个 QLQ-C30 量表中最严重的一个)的变化。进行了五项敏感性分析。次要结局是七个 QLQ-C30 量表的变化和生存情况。

结果

总共 145 例患者被随机分配到早期专科姑息治疗组,152 例患者被分配到标准护理组。早期专科姑息治疗对主要结局(主要需求的变化)没有影响(-4.9 分(95%置信区间-11.3 至 +1.5 分);p = 0.14)。敏感性分析结果相似。包括生存情况在内的次要结局分析也未显示差异,可能除了恶心/呕吐,早期专科姑息治疗可能在此方面具有有益效果。

结论

我们没有观察到早期专科姑息治疗的有益或有害效果,但也不能排除重要的有益效果。

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