随机对照临床试验：基于阑尾炎炎症反应评分的疑似阑尾炎患者管理。

Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

机构信息

Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden.

Department of Surgery, Ryhov County Hospital, County Council of Jönköping, Jönköping, Sweden.

出版信息

Br J Surg. 2017 Oct;104(11):1451-1461. doi: 10.1002/bjs.10637. Epub 2017 Jul 21.

DOI:10.1002/bjs.10637

PMID:28730753

Abstract

BACKGROUND

The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment.

METHOD

Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment.

RESULTS

The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P < 0·001), fewer admissions (29·5 versus 42·8 per cent; P < 0·001), and fewer negative explorations (1·6 versus 3·2 per cent; P = 0·030) and operations for non-perforated appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020).

CONCLUSION

AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov).

摘要

背景

影像学在阑尾炎诊断中的作用存在争议。这项前瞻性干预性研究和嵌套随机试验分析了实施基于阑尾炎炎症反应（AIR）评分的风险分层算法的影响，并比较了临床重新评估后常规影像学与选择性影像学的结果。

方法

2009 年 9 月至 2012 年 1 月，年龄在 10 岁以上的患者在 21 个急诊外科中心就诊，年龄在 5 岁以上的患者在 3 个大学儿科中心就诊，怀疑患有阑尾炎。在基线期开始登记临床特征、治疗和结局。在干预期实施基于 AIR 评分的算法。中危患者在临床重新评估后随机分为常规影像学检查或选择性影像学检查。

结果

基线期包括 1152 例患者，干预期包括 2639 例患者，其中 1068 例中危患者随机分组。低危患者使用基于 AIR 评分的算法后，影像学检查减少（19.2%比 34.5%；P<0.001），住院人数减少（29.5%比 42.8%；P<0.001），非穿孔性阑尾炎阴性探查率降低（1.6%比 3.2%；P=0.030）和手术率降低（6.8%比 9.7%；P=0.034）。随机分为影像学检查和观察组的中危患者，阴性阑尾切除术的比例相同（分别为 6.4%和 6.7%；P=0.884），住院人数、穿孔数量和住院时间也相同，但常规影像学检查与更多的患者接受阑尾炎治疗相关（53.4%比 46.3%；P=0.020）。