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泛影葡胺用于粘连性小肠梗阻的随机对照试验

Randomized controlled trial of Gastrografin in adhesive small bowel obstruction.

作者信息

Burge Jonathan, Abbas Saleh M, Roadley Graeme, Donald Jennifer, Connolly Andrew, Bissett Ian P, Hill Andrew G

机构信息

Middlemore Hospital, University of Auckland, Auckland, New Zealand.

出版信息

ANZ J Surg. 2005 Aug;75(8):672-4. doi: 10.1111/j.1445-2197.2005.03491.x.

DOI:10.1111/j.1445-2197.2005.03491.x
PMID:16076330
Abstract

BACKGROUND

Several previous studies have shown that Gastrografin can be utilized to triage patients with adhesive small bowel obstruction (ASBO) to an operative or a non-operative course. Previous studies assessing the therapeutic effect of Gastrografin have been confounded by post-administration radiology alerting the physician to the treatment group of the patient. Therefore the aim of the present paper was to test the hypothesis that Gastrografin hastens the non-operative resolution of (ASBO).

METHODS

Patients, diagnosed with ASBO on clinical and radiological grounds, were randomized to receive Gastrografin or placebo in a double-blinded fashion. Patients did not undergo further radiological investigation. If the patient required subsequent radiological intervention or surgical intervention they were excluded from the study. End-points were passage of time to resolution of ASBO (flatus and bowel motion), length of hospital stay and complications.

RESULTS

Forty-five patients with ASBO were randomized to receive either Gastrografin or placebo. Two patients were excluded due to protocol violations. Four patients in each group required surgery. Eighteen of the remaining patients received Gastrografin and 17 received placebo. Patients who received Gastrografin had complete resolution of their ASBO significantly earlier than placebo patients (12 vs 21 h, P = 0.009) and this translated into a median of a 1-day saving in time in hospital (3 vs 4 days, P = 0.03).

CONCLUSIONS

Gastrografin accelerates resolution of ASBO by a specific therapeutic effect.

摘要

背景

先前的多项研究表明,泛影葡胺可用于对粘连性小肠梗阻(ASBO)患者进行分流,以确定其采取手术治疗还是非手术治疗。以往评估泛影葡胺治疗效果的研究因给药后影像学检查向医生提示患者的治疗分组而受到干扰。因此,本文的目的是检验泛影葡胺能加速ASBO非手术缓解的假设。

方法

根据临床和影像学诊断为ASBO的患者,以双盲方式随机接受泛影葡胺或安慰剂治疗。患者未接受进一步的影像学检查。如果患者需要后续的影像学干预或手术干预,则将其排除在研究之外。观察终点为ASBO缓解(排气和排便)的时间、住院时间和并发症。

结果

45例ASBO患者被随机分为接受泛影葡胺或安慰剂治疗组。2例患者因违反方案被排除。每组有4例患者需要手术。其余患者中,18例接受泛影葡胺治疗,17例接受安慰剂治疗。接受泛影葡胺治疗的患者ASBO完全缓解的时间明显早于接受安慰剂的患者(12小时对21小时,P = 0.009),这意味着住院时间中位数节省1天(3天对4天,P = 0.03)。

结论

泛影葡胺通过特定的治疗作用加速ASBO的缓解。

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