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晚期癌症患者早期及系统专科姑息治疗的效果:随机对照试验 PALINT。

Effects of Early and Systematic Integration of Specialist Palliative Care in Patients with Advanced Cancer: Randomized Controlled Trial PALINT.

机构信息

Masaryk Memorial Cancer Institute, Brno, Czech Republic.

Department of Comprehensive Oncology Care, Masaryk University, Brno, Czech Republic.

出版信息

J Palliat Med. 2020 Dec;23(12):1586-1593. doi: 10.1089/jpm.2019.0697. Epub 2020 May 8.

DOI:10.1089/jpm.2019.0697
PMID:32391740
Abstract

A broad consensus on the optimal structure, intensity, and timing of early specialist palliative care (SPC) intervention is lacking. To evaluate the benefit of an early and systematic palliative intervention alongside standard oncology care compared with standard oncology care alone in patients with advanced solid tumors. PALINT, a single-center RCT, conducted at the Masaryk Memorial Cancer Institute, the largest comprehensive cancer center in the Czech Republic (CR). Patients with newly diagnosed advanced cancer within six weeks from the start of the palliative systemic therapy were randomly assigned to the integration of SPC (intervention; a consultation with a PC physician every six to eight weeks) or to the standard oncology care (control). The primary endpoint was the quality of life (QOL) assessed by EORTC QLQ C30 and Hospital Anxiety and Depression Scale (HADS) at three and six months. From 2015 to 2017, a total of 126 patients were randomly assigned to intervention (60) or to control (66) arm. At baseline, at three and six months, the global QOL scores (mean, 95% CI) in the intervention and control arm were 58.6 (53.9-63.3), 61.9 (56.4-67.4) and 66.7 (60.2-73.2) versus 54.2 (49.4-58.9), 59.0 (53.7-64.3), and 62.8 (56.7-68.9), respectively. The prevalence of anxiety (HADS-A; value >7) was 36.7%, 27.5%, and 18.9% versus 34.8%, 23.5%, and 16.3% and the prevalence of depression (HADS-D; value >7) was 28.3%, 25.4%, and 29.7% versus 28.8%, 29.4%, and 27.9%, respectively. There was no significant difference between the two arms. The overall survival was similar in both arms (347 vs. 310 days;  = 0.203). A model of early integration of SPC consisting of a consultation with a PC physician alone every six to eight weeks did not increase the QOL of patients with advanced cancer compared with routine oncology care in a center with widely available supportive services. These negative results underline the importance of the multidisciplinary patient centered approach in the early SPC.

摘要

目前,对于早期专科姑息治疗(SPC)的最佳结构、强度和时机,尚未达成广泛共识。本研究旨在评估与单纯接受标准肿瘤治疗相比,在新诊断为晚期实体瘤的患者中,同时接受早期系统姑息治疗和标准肿瘤治疗的效果。PALINT 是一项在捷克共和国最大的综合性癌症中心——马萨里克纪念癌症研究所进行的单中心 RCT 研究。研究纳入了在姑息性全身治疗开始后 6 周内新诊断为晚期癌症的患者,随机分配至 SPC 整合组(干预组,每 6-8 周接受一次姑息治疗医师咨询)或标准肿瘤治疗组(对照组)。主要终点为欧洲癌症研究与治疗组织生活质量核心问卷(EORTC QLQ C30)和医院焦虑抑郁量表(HADS)评估的 3 个月和 6 个月时的生活质量。2015 年至 2017 年,共有 126 名患者被随机分配至干预组(60 名)或对照组(66 名)。在基线时、3 个月和 6 个月时,干预组和对照组的总体生活质量评分(均值,95%CI)分别为 58.6(53.9-63.3)、61.9(56.4-67.4)和 66.7(60.2-73.2),54.2(49.4-58.9)、59.0(53.7-64.3)和 62.8(56.7-68.9)。焦虑的发生率(HADS-A;评分>7)分别为 36.7%、27.5%和 18.9%,34.8%、23.5%和 16.3%;抑郁的发生率(HADS-D;评分>7)分别为 28.3%、25.4%和 29.7%,28.8%、29.4%和 27.9%。两组之间无显著差异。两组的总生存期相似(347 天 vs. 310 天; = 0.203)。在一个广泛提供支持服务的中心中,由姑息治疗医师每 6-8 周进行一次咨询组成的早期 SPC 整合模式并不能提高晚期癌症患者的生活质量,这一阴性结果凸显了在早期 SPC 中采用多学科以患者为中心方法的重要性。

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