TRIAL OF FLUDROCORTISONE FOR CHRONIC FATIGUE SYNDROME

这项试验是基于初步数据显示，直立倾斜台， 测试可以引起血压下降， 高比例的慢性低血压患者存在介导的低血压（NMH） 疲劳综合征（CFS），以及NMH电极导线的非盲治疗 在40-70%的CFS患者中，CFS症状得到改善。 的 本研究的具体目的是确定18-50岁的患者是否 与CFS和NMH的年将有更大的改善（1）自我- 报告的一般幸福感和（2）客观直立 氟氢可的松治疗时的耐受性高于 安慰剂 合格受试者随机接受以下治疗： 氟氢可的松（递增至0.1 mg/天）或安慰剂治疗9周。 在治疗的第8-9周，受试者进行重复倾斜测试。 的 主要结局指标是改善15分的比例 在健康100分的健康评分，和次要结果是 在治疗前的分钟数有所改善的比例 直立倾斜时发生低血压。 第一例患者于1996年3月4日作为本方案的一部分进行研究。 从那天到1996年11月30日，我们评估了70名患者， 慢性疲劳综合症 其中36例（54%）低血压是 在直立倾斜测试的前两个阶段记录。 一 在测试期间低血压患者的健康评分为 在倾斜试验阳性时高于70， 没有资格参加。 其余35例受试者为 随机分为氟氢可的松组和安慰剂组。 其中，4名受试者 因为副作用退出了 研究程序似乎很好 容忍，并没有意外的问题，倾斜 测试或研究药物。 除了极少数例外， 公司已及时收到研究结果数据 协调数据输入。 其中25人（71%）为女性。 都是高加索人。 这些 人口统计学特征反映了 CFS的其他研究。 只有一名后卫被评估为 参与，但她的倾斜测试是不完整的;没有西班牙裔，亚洲或 太平洋岛民、美洲印第安人或阿拉斯加原住民申请 书房

The trial is based on preliminary data showing that upright tilt table testing can provoke a drop in blood pressure consistent with neurally mediated hypotension (NMH) in a high proportion of those with chronic fatigue syndrome (CFS), and that unblinded treatment of the NMH leads to an improvement in CFS symptoms in 40-70% of CFS patients. The specific aim of this study is to determine whether patients aged 18-50 years with CFS and NMH will have a greater improvement in (1) self- reported general sense of well being and (2) objective orthostatic tolerance when treated with fludrocortisone than when treated with placebo. Eligible subjects are randomized to receive either fludrocortisone (escalating to 0.1 mg/day) or placebo for nine weeks. In week 8-9 of treatment, subjects undergo repeat tilt testing. The primary outcome measure is the proportion with a 15 point improvement in wellness on a 100 point wellness score, and a secondary outcome is the proportion with improvement in the number of minutes before the development of hypotension during upright tilt. The first patient was studied as part of this protocol March 4, 1996. From that date until November 30, 1996, we evaluated 70 patients with chronic fatigue syndrome. In 36 of these (54%), hypotension was documented during the first two stages of upright tilt testing. One patient with hypotension during the test had a wellness score that was above 70 at the time of the positive tilt test, and was therefore ineligible for participation. The remaining 35 subjects were randomized to fludrocortisone or placebo. Of these, 4 subjects have dropped out due to side effects. The study procedures appear to be well tolerated, and there have been no unanticipated problems with tilt testing or with the study medications. With very few exceptions, the study outcome data have been received in a timely manner by the company coordinating data entry. Of those enrolled, 25(71%) are female. All are Caucasian. These demographic characteristics reflect the epidemiologic patterns seen in other studies of CFS. Only one back individual has been evaluated for participation, but her tilt test was incomplete; no Hispanic, Asian or Pacific Islander, or American Indian or Alaskan Native has applied to the study.