Lussier A, Arsenault A, Varady J, de Médicis R, Lussier Y, LeBel E
Faculty of Medicine, University of Sherbrooke, Quebec, Canada.
Semin Arthritis Rheum. 1988 Feb;17(3 Suppl 2):40-5. doi: 10.1016/0049-0172(88)90044-3.
Of techniques used to evaluate gastrointestinal (GI) bleeding, use of radiochromium (51Cr)-tagged erythrocytes is the most quantitative and scientifically acceptable method. The value of this technique as well as systematic errors possible with its use are discussed. The medical literature concerning 51Cr evaluation of GI microbleeding with naproxen therapy is critically reviewed. We suggest that future studies using this technique be parallel, randomized, double-blind, and include a 1-week placebo baseline phase for all subjects. Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) should last 3 to 4 weeks. A parallel group of subjects should receive placebo throughout the study. For valid statistical analyses, randomization must achieve baseline comparability of weight, height, age, and sex in the treatment groups. Data transformations may be necessary to satisfy the assumptions of the statistical model. Following these guidelines will enable investigators to better evaluate GI microbleeding during treatment with naproxen or other NSAIDs, and, hopefully, to establish the safety profiles of these drugs.
在用于评估胃肠道(GI)出血的技术中,使用放射性铬(51Cr)标记的红细胞是最具定量性且科学上可接受的方法。本文讨论了该技术的价值以及使用过程中可能出现的系统误差。对有关萘普生治疗胃肠道微出血的51Cr评估的医学文献进行了批判性综述。我们建议,未来使用该技术的研究应采用平行、随机、双盲设计,并为所有受试者设置为期1周的安慰剂基线期。非甾体抗炎药(NSAIDs)治疗应持续3至4周。在整个研究过程中,应有一组平行的受试者接受安慰剂治疗。为了进行有效的统计分析,随机分组必须使治疗组在体重、身高、年龄和性别方面达到基线可比性。可能需要进行数据转换以满足统计模型的假设。遵循这些指导原则将使研究人员能够更好地评估萘普生或其他NSAIDs治疗期间的胃肠道微出血情况,并有望确定这些药物的安全性。