Graham D Y, Agrawal N M, Roth S H
Veterans Administration Medical Center, Houston, Texas.
Lancet. 1988 Dec 3;2(8623):1277-80. doi: 10.1016/s0140-6736(88)92892-9.
A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 micrograms or 200 micrograms misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0.3 cm in diameter or greater) occurred less frequently (p less than 0.001) in both misoprostol treatment groups (5.6% 100 micrograms and 1.4% 200 micrograms) than in the placebo group (21.7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0.5 cm in diameter (12.3% placebo, 4.2% 100 micrograms misoprostol, and 0.7% 200 micrograms misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. These results provide the first clear indication that NSAID-induced ulcers are preventable.
进行了一项双盲、安慰剂对照研究，以观察合成的E型前列腺素米索前列醇是否能预防非甾体抗炎药（NSAIDs）所致的胃溃疡。对420例骨关节炎且伴有NSAIDs相关腹痛的患者进行了研究；这些患者正在服用布洛芬、吡罗昔康或萘普生。在入组时以及在连续1、2和3个月接受100微克或200微克米索前列醇或安慰剂治疗后进行内镜检查，米索前列醇或安慰剂每日4次与食物同服及睡前服用，同时服用NSAIDs。腹痛由患者和医生分别进行评估。治疗失败定义为出现胃溃疡。在两个米索前列醇治疗组中，直径0.3厘米或更大的胃溃疡发生率（100微克组为5.6%，200微克组为1.4%）均低于安慰剂组（21.7%）（p<0.001）。当仅比较直径大于0.5厘米的溃疡时，安慰剂组与米索前列醇治疗组在溃疡形成方面仍存在显著差异（安慰剂组为12.3%，100微克米索前列醇组为4.2%，200微克米索前列醇组为0.7%）。轻度至中度、自限性腹泻是最常报告的与米索前列醇有关的不良反应。这些结果首次明确表明NSAIDs所致溃疡是可预防的。
