多中心试验:围手术期方案减少消化性溃疡穿孔患者死亡率。
Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation.
机构信息
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev, Herlev, Denmark.
出版信息
Br J Surg. 2011 Jun;98(6):802-10. doi: 10.1002/bjs.7429. Epub 2011 Mar 25.
BACKGROUND
Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU.
METHODS
This was an externally controlled multicentre trial set in seven gastrointestinal departments in Denmark. Consecutive patients who underwent surgery for gastric or duodenal PPU between 1 January 2008 and 31 December 2009 were treated according to a multimodal and multidisciplinary evidence-based perioperative care protocol. The 30-day mortality rate in this group was compared with rates in historical and concurrent national controls.
RESULTS
The 30-day mortality rate following PPU was 17·1 per cent in the intervention group, compared with 27·0 per cent in the three control groups (P = 0·005). This corresponded to a relative risk of 0·63 (95 per cent confidence interval 0·41 to 0·97), a relative risk reduction of 37 (5 to 58) per cent and a number needed to treat of 10 (6 to 38).
CONCLUSION
The 30-day mortality rate in patients with PPU was reduced by more than one-third after the implementation of a multimodal and multidisciplinary perioperative care protocol, compared with conventional treatment.
REGISTRATION NUMBER
NCT00624169 (http://www.clinicaltrials.gov).
背景
穿孔性消化性溃疡(PPU)患者的发病率和死亡率仍然很高。本研究旨在评估多模式多学科围手术期护理方案对 PPU 患者死亡率的影响。
方法
这是在丹麦 7 个胃肠科进行的外部对照多中心试验。2008 年 1 月 1 日至 2009 年 12 月 31 日期间,连续接受胃或十二指肠 PPU 手术的患者根据多模式多学科循证围手术期护理方案进行治疗。将该组的 30 天死亡率与历史和同期全国对照进行比较。
结果
干预组 PPU 后 30 天死亡率为 17.1%,而三组对照组为 27.0%(P=0.005)。这相当于相对风险 0.63(95%置信区间 0.41 至 0.97),相对风险降低 37(5 至 58)%,治疗需要数为 10(6 至 38)。
结论
与常规治疗相比,多模式多学科围手术期护理方案实施后,PPU 患者的 30 天死亡率降低了三分之一以上。
注册号
NCT00624169(http://www.clinicaltrials.gov)。