Chan Francis K L, Hung Lawrence C T, Suen Bing Y, Wong Vincent W S, Hui Aric J, Wu Justin C Y, Leung Wai K, Lee Yuk T, To Ka F, Chung S C Sydney, Sung Joseph J Y
Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
Gastroenterology. 2004 Oct;127(4):1038-43. doi: 10.1053/j.gastro.2004.07.010.
BACKGROUND & AIMS: The gastric safety of cyclooxgenase-2 inhibitors and prophylactic antisecretory therapy in high-risk arthritis patients is unclear. We studied the ulcer incidence and factors predicting ulcer recurrence in a prospective, double-blinded trial.
We studied patients who presented with nonsteroidal anti-inflammatory drug-associated ulcer bleeding. After ulcer healing, patients who were negative for Helicobacter pylori were randomly assigned to celecoxib 200 mg twice a day plus omeprazole placebo once daily or diclofenac 75 mg twice daily plus omeprazole 20 mg once daily for 6 months. Patients underwent endoscopy if they developed recurrent bleeding. Those without recurrent events underwent endoscopy at their last follow-up visit.
Two hundred eighty-seven patients were enrolled; 24 had recurrent gastrointestinal complications. Among 259 patients without events, 222 underwent endoscopy (116 received celecoxib and 106 received diclofenac plus omeprazole). The probability of recurrent ulcers in 6 months was 18.7% in the celecoxib group and 25.6% in the diclofenac plus omeprazole group (difference, -6.7%; 95% CI: -17.8% to 3.9%) (P = 0.21). Combining bleeding and endoscopic ulcers, 24.1% in the celecoxib group and 32.3% in the diclofenac plus omeprazole group had recurrent ulcers in 6 months (difference, -8.2%; 95% CI: -19.5% to 2.9%) (P = 0.15). Treatment-induced significant dyspepsia (hazard ratio, 5.3; 95% CI: 2.6-10.8), age > or =75 (hazard ratio, 2.0; 95% CI: 1.1-3.5), and comorbidity (hazard ratio, 2.1; 95% CI: 1.2-3.7) independently predicted ulcer recurrence.
Among patients with previous ulcer bleeding, neither celecoxib nor diclofenac plus omeprazole adequately prevents ulcer recurrence. Treatment-induced significant dyspepsia is an indication for endoscopic evaluation.
环氧化酶-2抑制剂和预防性抗分泌治疗在高危关节炎患者中的胃安全性尚不清楚。我们在一项前瞻性双盲试验中研究了溃疡发生率及预测溃疡复发的因素。
我们研究了非甾体抗炎药相关性溃疡出血的患者。溃疡愈合后，幽门螺杆菌检测阴性的患者被随机分为两组，一组每天两次服用200毫克塞来昔布加每日一次奥美拉唑安慰剂，另一组每天两次服用75毫克双氯芬酸加每日一次20毫克奥美拉唑，疗程6个月。出现复发性出血的患者接受内镜检查。未出现复发性事件的患者在最后一次随访时接受内镜检查。
共纳入287例患者；24例出现复发性胃肠道并发症。在259例无事件发生的患者中，222例接受了内镜检查（116例接受塞来昔布治疗，106例接受双氯芬酸加奥美拉唑治疗）。塞来昔布组6个月内复发性溃疡的发生率为18.7%，双氯芬酸加奥美拉唑组为25.6%（差异为-6.7%；95%可信区间：-17.8%至3.9%）（P = 0.21）。综合出血和内镜下溃疡情况，塞来昔布组6个月内复发性溃疡的发生率为24.1%，双氯芬酸加奥美拉唑组为32.3%（差异为-8.2%；95%可信区间：-19.5%至2.9%）（P = 0.15）。治疗引起的严重消化不良（风险比为5.3；95%可信区间：2.6 - 10.8）、年龄≥75岁（风险比为2.0；95%可信区间：1.1 - 3.5）和合并症（风险比为2.1；95%可信区间：1.2 - 3.7）是溃疡复发的独立预测因素。
在既往有溃疡出血的患者中，塞来昔布和双氯芬酸加奥美拉唑均不能充分预防溃疡复发。治疗引起的严重消化不良是进行内镜评估的指征。
