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【文摘发布】一项随机双盲试验显示环氧化酶-

RESOURCE: The Lancet 2007; 369:1621-1626

DOI:10.1016/S0140-6736(07)60749-1

TITLE: Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial

AUTHOR: Prof Francis Ka Leung Chan MD a , Vincent Wai Sun Wong MD a, Bing Yee Suen BSc a, Justin Che Yuen Wu MD a, Jessica Yuet Ling Ching MPH a, Lawrence Cheung Tsui Hung MD a, Aric Josun Hui MD a, Vincent King Sun Leung MD c, Vivian Wing Yan Lee PharmD b, Larry Hin Lai MD a, Grace Lai Hung Wong MD a, Dorothy Kai Lai Chow MD a, Ka Fa To MD a, Wai Keung Leung MD a, Philip Wai Yan Chiu MD a, Yuk Tong Lee MD a, James Yun Wong Lau MD a, Henry Lik Yuen Chan MD a, Enders Kwok Wai Ng MD a and Prof Joseph Jao Yiu Sung MD a

Summary

Background
Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding.

Methods
441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313.

Findings
Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4–13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups.

Interpretation
Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. 本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领。 RESOURCE: The Lancet 2007; 369:1621-1626

DOI:10.1016/S0140-6736(07)60749-1

TITLE: Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
一项随机双盲试验显示环氧化酶-2(COX-2)抑制剂联合质子泵抑制剂能预防高危患者周期性溃疡出血
AUTHOR: Prof Francis Ka Leung Chan MD a , Vincent Wai Sun Wong MD a, Bing Yee Suen BSc a, Justin Che Yuen Wu MD a, Jessica Yuet Ling Ching MPH a, Lawrence Cheung Tsui Hung MD a, Aric Josun Hui MD a, Vincent King Sun Leung MD c, Vivian Wing Yan Lee PharmD b, Larry Hin Lai MD a, Grace Lai Hung Wong MD a, Dorothy Kai Lai Chow MD a, Ka Fa To MD a, Wai Keung Leung MD a, Philip Wai Yan Chiu MD a, Yuk Tong Lee MD a, James Yun Wong Lau MD a, Henry Lik Yuen Chan MD a, Enders Kwok Wai Ng MD a and Prof Joseph Jao Yiu Sung MD a

Summary

Background背景
Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. 疼痛处理指南推荐环氧化酶-2(COX-2)抑制剂或者非甾体类抗炎药(NSAID)与质子泵抑制剂同时使用时,有出现溃疡的风险。这两个治疗具有相似的效果,但是在应用这两种治疗方法,他们都不能阻止高风险的溃疡出血。 We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding.为了验证这个假设,我们选择以前使用非选择性非甾体类抗炎药出现溃疡出血的患者,给与环氧化酶-2(COX-2)抑制剂塞来考昔和质子泵***拉唑抑制剂联合治疗,发现在预防溃疡出血方面要优于单独使用塞来考昔。

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作者:admin@医学,生命科学    2011-03-13 05:11
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