Ryan J R, Vargas R, Clay G A, McMahon F G
Am J Med. 1987 Jul 27;83(1A):41-6. doi: 10.1016/0002-9343(87)90578-x.
Nonsteroidal anti-inflammatory drugs are used to control pain and inflammation in arthritic disorders. When used at recommended anti-inflammatory dose levels, however, they often produce injury to the gastric and duodenal mucosa and concomitant blood loss. A double-blind, parallel, placebo-controlled study was conducted to assess the effectiveness of misoprostol, a synthetic analogue of prostaglandin E1, in preventing gastrointestinal blood loss induced by acetylsalicylic acid in patients with degenerative joint disease. Forty-five arthritic patients (22 women and 23 men) were admitted to the study. All patients had received treatment with 3,900 mg of acetylsalicylic acid per day in four divided doses for at least two weeks and continued to receive that regimen for the duration of the study. Red blood cells were tagged with chromium-51, and fecal blood loss was determined from Days 4 to 7. Patients with a mean blood loss of at least 1.5 ml per day were randomly allocated to receive either placebo or 200 micrograms of misoprostol four times daily for seven days. Fecal blood loss was measured daily, and the results were compared with baseline determinations. Of 41 patients who completed the study, 19 were treated with misoprostol. Of these, 11 patients (57.9 percent) had at least a 50 percent reduction in blood loss. Of 22 patients receiving placebo, only one had a 50 percent reduction in blood loss (p = 0.003; Fisher's exact test). Mean blood loss in patients using misoprostol was reduced from 3.65 +/- 2.51 to 1.57 +/- 0.86 ml per day, whereas among those taking placebo, mean blood loss did not significantly change (2.98 +/- 1.24 to 2.79 +/- 1.63 ml per day). The difference in blood loss between the misoprostol and placebo groups was significant (p = 0.0023; Wilcoxon test). In those patients who completed the study, no significant changes were detected on laboratory tests. In conclusion, misoprostol effectively reduced fecal blood loss in arthritic patients treated with acetylsalicylic acid.
非甾体抗炎药用于控制关节炎疾病中的疼痛和炎症。然而，当以推荐的抗炎剂量水平使用时，它们常常会对胃和十二指肠黏膜造成损伤并伴有失血。开展了一项双盲、平行、安慰剂对照研究，以评估前列腺素E1的合成类似物米索前列醇在预防退行性关节病患者中由乙酰水杨酸引起的胃肠道失血方面的有效性。45名关节炎患者（22名女性和23名男性）纳入该研究。所有患者每天接受3900毫克乙酰水杨酸分四次服用，至少持续两周，并在研究期间继续接受该治疗方案。红细胞用铬-51标记，在第4天至第7天测定粪便失血量。平均每日失血量至少为1.5毫升的患者被随机分配接受安慰剂或每日四次、每次200微克米索前列醇，共七天。每天测量粪便失血量，并将结果与基线测定值进行比较。在完成研究的41名患者中，19名接受了米索前列醇治疗。其中，11名患者（57.9%）失血量至少减少了50%。在接受安慰剂的22名患者中，只有1名失血量减少了50%（p = 0.003；Fisher精确检验）。使用米索前列醇的患者平均失血量从每天3.65±2.51毫升降至1.57±0.86毫升，而服用安慰剂的患者中，平均失血量没有显著变化（从每天2.98±1.24毫升降至2.79±1.63毫升）。米索前列醇组和安慰剂组之间的失血量差异显著（p = 0.0023；Wilcoxon检验）。在完成研究的患者中，实验室检查未发现显著变化。总之，米索前列醇有效地减少了接受乙酰水杨酸治疗的关节炎患者的粪便失血量。
