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高流量鼻导管在缓解晚期癌症患者呼吸困难中的 II 期研究。

A Phase II Study of High-Flow Nasal Cannula for Relieving Dyspnea in Advanced Cancer Patients.

机构信息

Internal Medicine III (E.T., H.A., S.T., K.N., M.T., T.K., K.F., K.S., E.M., T.S., R.S., D.F., A.H., N.T., Y.O., Y.K., M.N., N.Y.), Wakayama Medical University, Wakayama, Japan.

Internal Medicine III (E.T., H.A., S.T., K.N., M.T., T.K., K.F., K.S., E.M., T.S., R.S., D.F., A.H., N.T., Y.O., Y.K., M.N., N.Y.), Wakayama Medical University, Wakayama, Japan.

出版信息

J Pain Symptom Manage. 2024 Mar;67(3):204-211.e1. doi: 10.1016/j.jpainsymman.2023.11.009. Epub 2023 Nov 21.

DOI:10.1016/j.jpainsymman.2023.11.009
PMID:37992848
Abstract

CONTEXT

The efficacy and tolerability of high-flow nasal cannula (HFNC) for relieving dyspnea in advanced cancer patients with limited prognosis requires elucidation.

OBJECTIVES

The primary aim of this trial was to assess the efficacy and tolerability of HFNC regarding dyspnea including severe as well as moderate for longer durations in patients under palliative care.

METHODS

In this prospective study, hospitalized patients with advanced cancer who had dyspnea at rest (numeric rating scale, NRS≥3) and hypoxemia were enrolled. They were treated with HFNC for five days in the respiratory unit. Primary endpoint was mean change of modified Borg scale at 24 hours. Key secondary endpoints consisted of mean changes in modified Borg scale during the study period and feasibility (Trial Identifier, UMIN000035738).

RESULTS

Between February 2019 and February 2022, 25 patients were enrolled and 21 were analyzed. Twenty patients used inspired oxygen and the mean fraction of inspired oxygen (FiO2) was 0.34 (range, 0.21-1.0). At baseline, mean NRS (dyspnea) was 5.9 (range, 3-10). Median survival time was 19 days (range, 3-657). The mean change of modified Borg scale was 1.4 (80% confidence interval [CI]: 0.8-1.9) at 24 hours, 12 patients (57%) showed 1.0 points improvement of modified Borg scale. Within two hours, 15 patients showed 1.0 points improvement of modified Borg scale and such early responders were likely to maintain dyspnea improvement for 24 hours. Nineteen patients could continue HFNC for 24 hours and 11 patients completed five days of HFNC.

CONCLUSION

To our knowledge, this trial is the first prospective study to assess the five-day efficacy and tolerability of HFNC for dyspnea in patients under palliative care. Although this did not reach the prespecified endpoint, about half of the patients showed 1.0 point improvement, a minimally clinically important difference (MCID) in the chronic lung disease. HFNC can be a palliative treatment option in advanced cancer patients with dyspnea.

摘要

背景

高流量鼻导管(HFNC)在预后有限的晚期癌症患者中缓解呼吸困难的疗效和耐受性需要阐明。

目的

本试验的主要目的是评估 HFNC 在姑息治疗下的呼吸困难(包括严重和中度呼吸困难)的疗效和耐受性,时间更长。

方法

在这项前瞻性研究中,纳入了有静息时呼吸困难(数字评分量表,NRS≥3)和低氧血症的住院晚期癌症患者。他们在呼吸科病房接受 HFNC 治疗五天。主要终点是 24 小时时改良 Borg 量表的平均变化。主要次要终点包括研究期间改良 Borg 量表的平均变化和可行性(试验标识符,UMIN000035738)。

结果

2019 年 2 月至 2022 年 2 月期间,共纳入 25 例患者,其中 21 例进行了分析。20 例患者使用吸入氧,吸入氧分数(FiO2)平均值为 0.34(范围,0.21-1.0)。基线时,NRS(呼吸困难)平均为 5.9(范围,3-10)。中位生存时间为 19 天(范围,3-657)。24 小时时改良 Borg 量表的平均变化为 1.4(80%置信区间[CI]:0.8-1.9),12 例患者(57%)的改良 Borg 量表改善 1.0 分。在两小时内,15 例患者的改良 Borg 量表改善 1.0 分,这些早期反应者很可能在 24 小时内保持呼吸困难的改善。19 例患者可继续接受 HFNC 24 小时,11 例患者完成 HFNC 五天。

结论

据我们所知,这是第一项前瞻性研究,评估 HFNC 在姑息治疗下的呼吸困难的五天疗效和耐受性。尽管这没有达到预设的终点,但约一半的患者的改良 Borg 量表改善了 1.0 分,这是慢性肺部疾病的最小临床重要差异(MCID)。HFNC 可作为晚期癌症呼吸困难患者的姑息治疗选择。

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