DUODENAL AND GASTRIC-ULCER PREVENTION WITH MISOPROSTOL IN ARTHRITIS PATIENTS TAKING NSAIDS
DUODENAL AND GASTRIC-ULCER PREVENTION WITH MISOPROSTOL IN ARTHRITIS PATIENTS TAKING NSAIDS
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DOI：
10.7326/0003-4819-119-4-199308150-00001
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发表时间：
1993-08-15
影响因子：
39.2
通讯作者：
TEOH, LS
中科院分区：
文献类型：
--
作者：
GRAHAM, DY;WHITE, RH;TEOH, LS
目的：确定米索前列醇在接受 NSAID 治疗的关节炎患者中预防非甾体类抗炎药 (NSAID) 诱发的十二指肠和胃溃疡的功效。设计：一项随机、双盲、多中心、安慰剂对照试验。背景：638 名私人、退伍军人事务部、健康维护和学术实践。患者：638 名患有慢性炎症或非炎症性关节炎的患者，他们正在服用 NSAID，但筛查内镜检查时没有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，持续 3 个月。 455 名 (71%) 患者完成了试验。 干预措施： 符合入组标准的患者被随机分配接受米索前列醇 200 杯或安慰剂，每天四次，持续 12 周。 主要结果指标： 在第 4、8 和 12 周重复内窥镜检查。出现十二指肠或胃溃疡（定义为直径小于或等于 0.5 cm、深度可察觉的局限性粘膜缺损）被视为预防性失败。结果：到 12 周时，随机接受米索前列醇治疗的 320 名患者中，有 2 名（0.6%；95% CI，0.2% 至 3.9%）出现十二指肠溃疡，而随机接受米索前列醇治疗的患者中，有 15 名出现十二指肠溃疡。 323 名患者（4.6%；CI，2.8% 至 8%）接受安慰剂治疗（P = 0.002）。 320 名患者中有 6 名（1.9%；（CI，0.8% 至 4.4%）患者出现胃溃疡，而 323 名患者中有 25 名（7.7%；CI，5.1% 至 11.4%）出现胃溃疡。结论：米索前列醇显着降低了需要长期接受 NSAIDS 治疗的患者十二指肠溃疡和胃溃疡发生的频率。
Objectives: 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.Design: A randomized, double-blind, multicenter, placebo-controlled trial.Setting: Six hundred thirty-eight private, Veterans Affairs, health maintenance, and academic practices.Patients: 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.Interventions: Patients meeting the entry criteria were randomized to receive either misoprostol, 200 mug, or placebo, four times a day for 12 weeks.Main Outcome Measures: The endoscopy was repeated at 4, 8, and 12 weeks. The development of a duodenal or gastric ulcer (defined as a circumscribed mucosal defect less-than-or-equal-to 0.5 cm in diameter and with perceptible depth) was regarded as prophylactic failure.Results: 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.Conclusion: Misoprostol significantly lowers the frequency of both duodenal and gastric ulcer development in patients who require long-term therapy with NSAIDS.