Warrington S J, Debbas N M, Farthing M, Horton M, Johnston A, Thillainayagam A, Turner P, Ferber H
Charterhouse Clinical Research Unit Limited, London, UK.
Postgrad Med J. 1990 Aug;66(778):622-6. doi: 10.1136/pgmj.66.778.622.
Forty-five healthy men aged 21-34 years took part in a double-blind, parallel-group, placebo-controlled study of the effects of 28 days' treatment with lornoxicam 4 mg twice daily or indomethacin 50 mg twice daily on faecal blood loss and the endoscopic appearances of gastric and duodenal mucosa. After an initial endoscopic examination, subjects received, intravenously, on day 0, autologous erythrocytes labelled with 51Cr. Complete daily faecal collections were then made from days 6-12, 20-26 and 34-40. The drug treatments or placebo were given from days 13-41. Faecal blood loss was calculated from 51Cr-specific activity of blood and faeces. Endoscopy was repeated 4-8 hours after the last dose of medication; mucosal appearance was graded on a 5-point scale. Lornoxicam caused no more adverse events than placebo; indomethacin caused more indigestion and central nervous system effects, and one subject in this group was withdrawn from the study. Median total blood losses during the pre-treatment and the second and fourth weeks of treatment were respectively 3.33, 3.95 and 5.71 ml for lornoxicam, 2.87, 7.04 and 7.75 ml for indomethacin, and 4.55, 3.64 and 4.13 ml for placebo. Differences between treatments were not statistically significant (P = 0.081 for second week of treatment, P = 0.383 for fourth week of treatment; Kruskal-Wallis test). The effect of chlortenoxicam on faecal blood loss in this study was thus intermediate between placebo and indomethacin, but within- and between-subject variability was such that the differences were not statistically significant. Endoscopic findings were normal in most subjects before and after all treatments, but indomethacin was associated with a slightly greater deterioration in endoscopic score and was the only treatment associated with Grade 3 appearance (in a single patient) in post-treatment endoscopy.
45名年龄在21至34岁之间的健康男性参与了一项双盲、平行组、安慰剂对照研究，该研究旨在探讨每日两次服用4毫克氯诺昔康或每日两次服用50毫克吲哚美辛进行28天治疗对粪便失血以及胃和十二指肠黏膜内镜表现的影响。在进行初始内镜检查后，受试者于第0天静脉注射用51Cr标记的自体红细胞。然后在第6 - 12天、20 - 26天和34 - 40天进行每日完整的粪便收集。药物治疗或安慰剂从第13 - 41天给予。根据血液和粪便中51Cr的比活度计算粪便失血量。在最后一剂药物服用后4 - 8小时重复进行内镜检查；黏膜外观按5分制进行评分。氯诺昔康引起的不良事件不比安慰剂多；吲哚美辛引起更多消化不良和中枢神经系统效应，该组中有一名受试者退出研究。氯诺昔康治疗前、治疗第二周和第四周期间的中位总失血量分别为3.33毫升、3.95毫升和5.71毫升；吲哚美辛分别为2.87毫升、7.04毫升和7.75毫升；安慰剂分别为4.55毫升、3.64毫升和4.13毫升。治疗组之间的差异无统计学意义（治疗第二周P = 0.081，治疗第四周P = 0.383；Kruskal - Wallis检验）。因此，在本研究中氯诺昔康对粪便失血的影响介于安慰剂和吲哚美辛之间，但个体内和个体间的变异性使得差异无统计学意义。在所有治疗前后，大多数受试者的内镜检查结果均正常，但吲哚美辛与内镜评分的轻微恶化相关，并且是治疗后内镜检查中唯一与3级外观（在一名患者中）相关的治疗方法。
