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首页> 外文期刊>International journal of rheumatic diseases >Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis.
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Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis.

机译:塞来昔布或双氯芬酸治疗期间胃十二指肠溃疡的发病率:来自中国骨关节炎或类风湿关节炎患者的三项为期12周的试验汇总结果。

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摘要

AIM: To test whether treatment with celecoxib reduces the incidence of gastroduodenal ulcers compared to diclofenac in Asian patients with osteoarthritis (OA) or rheumatoid arthritis (RA) with minimal significant risk factors. METHODS: Patients with a clinical diagnosis of OA or RA of at least 3 months were randomized to 12 weeks of double-blind treatment with celecoxib 100 mg twice daily (n = 440) or diclofenac 50 mg twice daily (n = 440). The primary outcome was the gastric and/or duodenal ulcer rate at endpoint as determined by upper gastrointestinal endoscopy performed during the screening week, and at endpoint. RESULTS: There was no significant difference in the overall incidence of gastroduodenal ulcers at 12-week endpoint for celecoxib compared to diclofenac (2.8% vs. 5.1%; Cochran-Mantel-Haenszel [CMH] chi(2) P = 0.083). However, there was a significantly lower incidence of gastric ulcers on celecoxib versus diclofenac (0.5% vs. 3.6%; CMH chi(2) P = 0.002). Approximately 59% of patients in both treatment groups had no visible gastric lesions at endpoint; and a similar proportion were found to have one or more erosions on celecoxib (n = 85; 21.4%) and diclofenac (N = 91; 23.3%). A survival analysis of time to ulcer was significant for gastric ulcers (log-rank P = 0.004), but not for duodenal ulcers, or for gastroduodenal ulcers combined. Fewer patients reported at least one adverse event on celecoxib compared to diclofenac (42.4% vs. 50.3%; chi(2), 5.52; P = 0.019). CONCLUSIONS: In Asian patients with minimal significant risk factors, treatment with celecoxib was associated with a modest but significantly reduced incidence of gastric ulcers at the end of 12 weeks.
机译:目的:测试与双氯芬酸相比,塞来昔布治疗是否能降低亚洲地区骨关节炎(OA)或类风湿性关节炎(RA)患者的胃十二指肠溃疡发生率,而这些因素的危险因素极小。方法:将临床诊断为OA或RA至少3个月的患者随机分为12周的双盲治疗,每日两次两次塞来昔布100 mg(n = 440)或每天两次双氯芬酸50 mg(n = 440)。主要结局是在筛查周和终点通过上消化道内窥镜检查确定的终点处的胃和/或十二指肠溃疡发生率。结果:与双氯芬酸相比,塞来昔布在12周终点时胃十二指肠溃疡的总发生率与双氯芬酸没有显着差异(2.8%比5.1%; Cochran-Mantel-Haenszel [CMH] chi(2)P = 0.083)。但是,塞来昔布与双氯芬酸相比,胃溃疡的发生率显着降低(0.5%比3.6%; CMH chi(2)P = 0.002)。两个治疗组中约有59%的患者终点没有可见的胃部病变。发现塞来昔布(n = 85; 21.4%)和双氯芬酸(n = 91; 23.3%)有一种或多种侵蚀的比例相似。胃溃疡的生存时间分析对胃溃疡很重要(log-rank P = 0.004),但对于十二指肠溃疡或合并胃十二指肠溃疡则没有意义。与双氯芬酸相比,报告塞来昔布发生至少一种不良事件的患者更少(42.4%比50.3%; chi(2),5.52; P = 0.019)。结论:在亚洲,具有显着危险因素的患者中,塞来昔布治疗与12周末胃溃疡的发生率适中但显着降低有关。

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