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上消化道出血患者鼻胃管置入的随机实用试验

Randomized pragmatic trial of nasogastric tube placement in patients with upper gastrointestinal tract bleeding.

作者信息

Rockey Don C, Ahn Chul, de Melo Silvio W

机构信息

Department of Internal Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.

Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

出版信息

J Investig Med. 2017 Apr;65(4):759-764. doi: 10.1136/jim-2016-000375. Epub 2017 Jan 9.

Abstract

UNLABELLED

The value of nasogastric (NG) tube placement in patients with upper gastrointestinal tract bleeding (UGIB) is unclear. We therefore aimed to determine the usefulness of NG tube placement in patients with UGIB. The study was a single-blind, randomized, prospective, non-inferiority study comparing NG placement (with aspiration and lavage) to no NG placement (control). The primary outcome was the probability that physicians could predict the presence of a high-risk lesion (ie, requiring endoscopic therapy). 140 patients in each arm were included; baseline clinical features were similar in each group. The probability that there would be a high-risk lesion in the control arm was predicted to be 35% compared with 39% in the NG arm (after NG placement)-a probability difference of -4% (95% CI -12% to 3%), which confirmed non-inferiority of the 2 arms (p=0.002). All patients underwent endoscopy and all patients with high-risk lesions had endoscopic therapy. Physicians predicted the specific culprit lesion in 38% (53/140) and 39% (55/140) of patients in the control and NG (after NG placement) groups, respectively. The presence of coffee grounds or red blood in the NG aspirate did not change physician assessments. Pain, nasal bleeding, or failure of NG occurred in 47/140 (34%) patients. There were no differences in rebleeding rates or mortality. In patients with acute UGIB, the ability of physicians to predict culprit bleeding lesions and/or the presence of high-risk lesions was poor. Routine NG placement did not improve physician's predictive ability, did not affect outcomes, and was complicated in one-third of patients.

TRAIL REGISTRATION NUMBER

NCT00689754.

摘要

未标注

鼻胃管(NG)置入在上消化道出血(UGIB)患者中的价值尚不清楚。因此,我们旨在确定NG管置入在UGIB患者中的效用。该研究是一项单盲、随机、前瞻性、非劣效性研究,比较NG管置入(包括抽吸和灌洗)与不置入NG管(对照组)。主要结局是医生能够预测高危病变(即需要内镜治疗)存在的概率。每组纳入140例患者;每组的基线临床特征相似。预计对照组出现高危病变的概率为35%,而NG管置入组(置入NG管后)为39%,概率差为-4%(95%CI -12%至3%),这证实了两组的非劣效性(p=0.002)。所有患者均接受了内镜检查,所有高危病变患者均接受了内镜治疗。对照组和NG管置入组(置入NG管后)分别有38%(53/140)和39%(55/140)的患者被医生预测出具体的罪魁祸首病变。NG管抽吸物中出现咖啡渣样物或红色血液并未改变医生的评估。47/140(34%)的患者出现疼痛、鼻出血或NG管置入失败。再出血率或死亡率无差异。在急性UGIB患者中,医生预测出血罪魁祸首病变和/或高危病变存在的能力较差。常规NG管置入并未提高医生的预测能力,不影响结局,且三分之一的患者出现并发症。

试验注册号

NCT00689754。

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