TRIAL OF FLUDROCORTISONE FOR CHRONIC FATIGUE SYNDROME

该试验基于显示直立倾斜工作台的初步数据 测试可以引起血压下降，这与神经学上的一致 中介性低血压(NMH)在慢性高血压患者中的高比例 疲劳综合征(CFS)，以及对NMH导联的非盲目治疗 40%-70%的CFS患者的CFS症状得到改善。这个 这项研究的具体目的是确定18岁至18岁的患者 在CFS和NMH工作50年将在(1)自我提高方面有更大的进步 报告的一般幸福感和(2)客观直立 用氟可的松治疗的耐受性比用氟可的松 安慰剂。符合条件的受试者被随机接受 氟可的松(升级至0。1毫克/天)或安慰剂治疗9周。 在治疗的第8-9周，受试者接受重复的倾斜测试。这个 主要结果衡量标准是改善15个百分点的比例 在100分的健康评分上，次要结果是 在比赛前的分钟数有所改善的比例 直立倾斜时发生低血压。第一个病人是 1996年3月4日作为本议定书的一部分进行了研究。自该日起至30日止 1997年11月，我们对124例慢性疲劳综合征患者进行了评估。 在这些患者中，有72人(58%)在前两次出现低血压。 直立倾斜测试的各个阶段。一名患者在手术过程中出现低血压 倾斜测试的健康评分在70分以上 倾斜试验呈阳性，因此没有资格参加。二 其他倾斜试验呈阳性的患者未被随机分组，原因是 对他们的心理健康的担忧。第四例阳性患者 在NIH进行尿检后，倾斜试验没有随机进行，结果显示 病人对她正在服用的药物没有诚实，并且 因此没有资格参加这项研究。其余68名受试者为 随机服用氟化可的松或安慰剂。其中，有7名受试者有 因副作用而退学。有两个科目没有完成全部考试 按要求提交文件，未按规定返回进行后续倾斜测试 由于患有无关疾病，因此被算作辍学。 此外，1名受试者因担心 静脉穿刺术和我的受试者因文书工作量而退出 必填项。计为退学的总人数为11人。 研究程序似乎得到了很好的容忍，而且没有 倾斜测试或研究药物出现意想不到的问题。 除了极少数例外，研究结果数据已在#年收到 及时由公司协调数据录入。 在随机抽样调查的人中，47人(69%)是女性。报名的70个科目为 白人，两名受试者是黑人。没有西班牙裔、亚洲人或太平洋人 Islander，或美国印第安人或阿拉斯加原住民已申请进行这项研究。 这些人口统计特征反映了流行病学模式。 在其他关于CFS的研究中可以看到。

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 to 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. I 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 4 March 1996. From that date until 30 November 1997, we evaluated 124 patients with chronic fatigue syndrome. In 72 of these (58%), hypotension was documented during the first two stages of upright tilt testing. One patient with hypotension during the tilt test had a wellness score that was above 70 at the time of the positive tilt test, and was therefore ineligible for participation. Two other patients with positive tilt tests were not randomized due to concerns about their mental health. A fourth patient with a positive tilt test was not randomized after urinalysis at NIH showed that the patient had not been honest about the medications she was taking and was therefore ineligible for the study. The remaining 68 subjects were randomized to fludrocortisone or placebo. Of these, 7 subjects have dropped out due to side effects. Two subjects did not complete all paperwork as required and did not return for follow-up tilt testing due to unrelated illness, and were therefore counted as drop outs. Additionally, 1 subject withdrew from the study due to fear of venipuncture and I subject withdrew due to the amount of paperwork required. The total number of subjects counted as drop outs is 11. 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 randomized, 47 (69 %) are female. 70 subjects enrolled are Caucasian, 2 subjects are black. No Hispanic, Asian or Pacific Islander, or American Indian or Alaskan Native has applied to the study. These demographic characteristics reflect the epidemiologic patterns seen in other studies of CFS.