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首页> 美国卫生研究院文献>British Medical Journal >Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial.
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Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial.

机译：奥美拉唑与安慰剂治疗急性上消化道出血：随机双盲对照试验。

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OBJECTIVE--To investigate the possible therapeutic role of omeprazole, a powerful proton pump inhibitor, in unselected patients presenting with upper gastrointestinal bleeding. DESIGN--Double blind placebo controlled parallel group study. Active treatment was omeprazole 80 mg intravenously immediately, then three doses of 40 mg intravenously at eight hourly intervals, then 40 mg orally at 12 hourly intervals. Treatment was started within 12 hours of admission and given for four days or until surgery, discharge, or death. SETTING--The medical wards of University and City Hospitals, Nottingham. SUBJECTS--1147 consecutive patients aged 18 years or more admitted over 40 months with acute upper gastrointestinal bleeding. MAIN OUTCOME MEASURES--Mortality from all causes; rate of rebleeding, transfusion requirements, and operation rate; effect of treatment on endoscopic appearances at initial endoscopy. RESULTS--Of 1147 patients included in the intention to treat analysis, 569 received placebo and 578 omeprazole. No significant differences were found between the placebo and omeprazole groups for rates of transfusion (302 (53%) placebo v 298 (52%) omeprazole), rebleeding (100 (18%) v 85 (15%)), operation (63 (11%) v 62 (11%)), and death (30 (5.3%) v 40 (6.9%)). However, there was an unexpected but significant reduction in endoscopic signs of upper gastrointestinal bleeding in patients treated with omeprazole compared with those treated with placebo (236 (45%) placebo v 176 (33%) omeprazole; p less than 0.0001). CONCLUSIONS--Omeprazole failed to reduce mortality, rebleeding, or transfusion requirements, although the reduction in endoscopic signs of bleeding suggests that inhibition of acid may be capable of influencing intragastric bleeding. Our data do not justify the routine use of acid inhibiting drugs in the management of haematemesis and melaena.
机译：目的-研究强大的质子泵抑制剂奥美拉唑在未选择的上消化道出血患者中的可能治疗作用。设计-双盲安慰剂对照平行组研究。积极治疗的方法是立即立即静脉内注射80毫克的奥美拉唑，然后每8小时间隔三剂40 mg静脉内给药，然后每12小时间隔口服40 mg。在入院后12小时内开始治疗，持续4天或直到手术，出院或死亡。地点-诺丁汉大学和城市医院的医疗病房。受试者--1147年连续18岁或以上的患者入院40个月以上，有上消化道急性出血。主要观察指标-各种原因造成的死亡率；再出血率，输血要求和手术率；内窥镜检查对内窥镜外观的治疗效果。结果-在打算进行治疗分析的1147例患者中，有569例接受了安慰剂和578例奥美拉唑。安慰剂组与奥美拉唑组之间的输血率（302（53％）安慰剂v 298（52％）奥美拉唑），再出血（100（18％）v 85（15％）），手术（63（ 11％）v 62（11％））和死亡（30（5.3％）v 40（6.9％））。但是，与安慰剂组相比，奥美拉唑组患者的上消化道内窥镜征象出乎意料地显着减少（236（45％）安慰剂对奥美拉唑176（33％）； p小于0.0001）。结论-奥美拉唑未能降低死亡率，再出血或输血需求，尽管内镜下出血迹象的减少表明酸的抑制可能影响胃内出血。我们的数据不能证明在治疗呕血和黑斑病中常规使用抑酸药物是合理的。

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