Graham D Y, White R H, Moreland L W, Schubert T T, Katz R, Jaszewski R, Tindall E, Triadafilopoulos G, Stromatt S C, Teoh L S
Veterans Affairs Medical Center/Baylor College of Medicine, Houston, Texas.
Ann Intern Med. 1993 Aug 15;119(4):257-62. doi: 10.7326/0003-4819-119-4-199308150-00001.
To determine the efficacy of misoprostol for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced duodenal and gastric ulcers in arthritis patients receiving NSAID therapy.
A randomized, double-blind, multicenter, placebo-controlled trial.
Six hundred thirty-eight private, Veterans Affairs, health maintenance, and academic practices.
Six hundred thirty-eight patients with chronic inflammatory or noninflammatory arthritis who were taking an NSAID but who did not have a gastric or duodenal ulcer on screening endoscopy received treatment with ibuprofen, piroxicam, naproxen, sulindac, tolmetin, indomethacin, or diclofenac daily for 3 months. Four hundred fifty-five (71%) patients completed the trial.
Patients meeting the entry criteria were randomized to receive either misoprostol, 200 micrograms, or placebo, four times a day for 12 weeks.
The endoscopy was repeated at 4, 8, and 12 weeks. The development of a duodenal or gastric ulcer (defined as a circumscribed mucosal defect > or = 0.5 cm in diameter and with perceptible depth) was regarded as prophylactic failure.
By 12 weeks, a duodenal ulcer developed in 2 of 320 (0.6%; 95% CI, 0.2% to 3.9%) patients randomized to receive misoprostol, compared with 15 of 323 (4.6%; CI, 2.8% to 8%) patients receiving placebo (P = 0.002). A gastric ulcer developed in 6 of 320 (1.9%; (CI, 0.8% to 4.4%) patients, compared with in 25 of 323 (7.7%; CI, 5.1% to 11.4%), respectively.
Misoprostol significantly lowers the frequency of both duodenal and gastric ulcer development in patients who require long-term therapy with NSAIDS.
确定米索前列醇对接受非甾体抗炎药（NSAID）治疗的关节炎患者预防NSAID引起的十二指肠和胃溃疡的疗效。
一项随机、双盲、多中心、安慰剂对照试验。
638家私人诊所、退伍军人事务部诊所、健康维护组织诊所和学术机构诊所。
638例患有慢性炎症性或非炎症性关节炎且正在服用NSAID但在筛查内镜检查时无胃或十二指肠溃疡的患者，每天接受布洛芬、吡罗昔康、萘普生、舒林酸、托美丁、吲哚美辛或双氯芬酸治疗3个月。455例（71%）患者完成了试验。
符合入选标准的患者被随机分为接受200微克米索前列醇或安慰剂治疗，每日4次，共12周。
在第4、8和12周重复进行内镜检查。十二指肠或胃溃疡的发生（定义为直径≥0.5 cm且有明显深度的局限性黏膜缺损）被视为预防失败。
到12周时，随机接受米索前列醇治疗的320例患者中有2例（0.6%；95%可信区间，0.2%至3.9%）发生十二指肠溃疡，而接受安慰剂治疗的323例患者中有15例（4.6%；可信区间，2.8%至8%）发生十二指肠溃疡（P = 0.002）。320例患者中有6例（1.9%；可信区间，0.8%至4.4%）发生胃溃疡，而323例患者中有25例（7.7%；可信区间，5.1%至11.4%）发生胃溃疡。
米索前列醇可显著降低需要长期使用NSAID治疗的患者发生十二指肠和胃溃疡的频率。
