Woolf G M, Townsend M, Guyatt G
McMaster University Medical Center, Department of Medicine, Hamilton Ontario, Canada.
J Clin Gastroenterol. 1987 Dec;9(6):632-4. doi: 10.1097/00004836-198712000-00005.
We describe a randomized, double-blind, placebo-controlled, crossover trial with spiramycin in a single patient with acquired immune deficiency syndrome (AIDS) and a severe secretory diarrhea caused by cryptosporidium. Spiramycin, a potentially harmful antibiotic, had no clinical or microbiological effect in this patient. The application of the single patient (N of 1) trial to common clinical problems is a simple way to analyze the value of different therapeutic approaches. The time-consuming, expensive, multi-patient trial with ultimate extrapolation to the individual patient can be avoided. Single-patient trials can influence management and improve patient care and have potentially wide use in patients with gastrointestinal disease.
我们描述了一项针对一名获得性免疫缺陷综合征（AIDS）患者且患有由隐孢子虫引起的严重分泌性腹泻的单病例随机、双盲、安慰剂对照交叉试验，该试验使用了螺旋霉素。螺旋霉素是一种潜在有害的抗生素，对该患者没有临床或微生物学效应。将单病例（N=1）试验应用于常见临床问题是分析不同治疗方法价值的一种简单方式。可以避免耗时、昂贵且最终需外推至个体患者的多病例试验。单病例试验可影响治疗管理并改善患者护理，在胃肠疾病患者中可能有广泛应用。
