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经皮经食管胃造瘘术(PTEG)作为恶性肠梗阻患者姑息治疗的疗效的随机对照试验:JIVROSG0805 试验。

A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial.

机构信息

Division of Interventional Radiology, Shizuoka Cancer Center, 1007 Shimonagakubo, Sunto-gun Nagaizumi-cho, Shizuoka, Japan.

Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.

出版信息

Support Care Cancer. 2020 Jun;28(6):2563-2569. doi: 10.1007/s00520-019-05066-8. Epub 2019 Sep 7.

DOI:10.1007/s00520-019-05066-8
PMID:31494734
Abstract

BACKGROUND

A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted.

SUBJECTS AND METHODS

The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life.

RESULTS

Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3-178.8) and 44.9 (16.4-73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed.

CONCLUSIONS

In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.

摘要

背景

一项旨在评估经皮经食管胃管与鼻胃管作为终末期恶性肿瘤伴肠梗阻患者姑息治疗的优越性的随机对照试验已经开展。

受试者和方法

受试者为恶性肠梗阻且无改善希望、不适合手术且姑息预后指数(Palliative Prognostic Index)<6 的患者。他们以 1:1 的比例随机分配至经皮经食管胃管(PTEG 组)或鼻胃管(NGT 组)。在入组后 2 周内测量他们的症状评分(最差 0 分为无症状,10 分为最严重症状),并比较两组的曲线下面积。还使用 EQ-5D 和 SF-8 来评估总体生活质量。

结果

2009 年 10 月至 2015 年 1 月期间共纳入 40 例患者,其中 21 例分配至 PTEG 组,19 例分配至 NGT 组。PTEG 组和 NGT 组的曲线下面积(95%置信区间)平均值分别为 149.6(120.3-178.8)和 44.9(16.4-73.5),NGT 组明显更高(p<0.0001)。PTEG 组的 EQ-5D 和 SF-8 评分的次要终点的生活质量也明显更高(p=0.0036,p=0.0020)。两组的生存率无差异。未观察到严重不良事件。

结论

在生活质量方面,经皮经食管胃管优于鼻胃管,是终末期恶性肿瘤伴肠梗阻患者的一种姑息治疗选择。

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