The Antibiotic Treatment Trial of Gulf War Veterans' Illnesses: issues, design, screening, and baseline characteristics
The Antibiotic Treatment Trial of Gulf War Veterans' Illnesses: issues, design, screening, and baseline characteristics
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DOI：
10.1016/s0197-2456(02)00192-7
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发表时间：
2002-06-01
期刊：
影响因子：
--
通讯作者：
Feussner, JR
中科院分区：
文献类型：
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作者：
Collins, JF;Donta, ST;Feussner, JR
在1990-1991年海湾战争期间，许多被派往波斯湾的退伍军人出现了多种无法解释的症状，如疼痛、疲劳和神经认知问题。这些症状被称为海湾战争退伍军人病（GWVI）。虽然对GWVI的原因没有证实的解释，但一个相当普遍的解释是系统性发酵支原体感染。GWVI的抗生素治疗试验是一项随机安慰剂对照试验，旨在确定在海湾战争中服役的GWVI退伍军人接受1年的多西环素治疗，并检测为支原体物种阳性，是否会改善他们的整体功能状态（通过SF-36V问卷的物理成分摘要测量）。对于像GWVI这样的多症状疾病的研究，由于疾病的非特异性、未知的病因和缺乏广泛接受的结果测量而变得复杂。支原体感染的推定引起了对支原体感染的确定方法、治疗方法的选择和治疗时间的关注。然而，这样的假设可以形成一个明确的可检验的假设，可以用已知不良事件发生率和已知抗支原体活性的治疗方法进行检验。本文描述了研究者在计划、研究设计、患者筛查结果和研究患者基线特征时面临的主要问题。在26个退伍军人事务部和2个国防部医疗中心筛选了2712名患者作为研究对象。其中，491人符合所有研究入组标准，随机分为1年多西环素组（200 mg/天）和1年安慰剂组。所有患者在治疗期间和治疗结束后6个月每月随访一次。研究患者的平均年龄为41岁，主要为男性（86%）、白人（64%）、已婚（68%）和全职工作（71%）。(C) 2002爱思唯尔科学有限公司版权所有。
Many veterans who were deployed to the Persian Gulf during the 1990-1991 Gulf War developed multiple unexplained symptoms such as pain, fatigue, and neurocognitive problems. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWVI). Although there is no proven explanation for the cause of GWVI, one fairly widespread explanation is systemic Mycoplasma fermentans infection. The Antibiotic Treatment Trial of GWVI is a randomized placebo-controlled trial to determine whether a 1-year course of doxycycline treatment in deployed Gulf War veterans with GWVI and testing as Mycoplasma species positive will improve-their overall functional status as measured by the Physical Component Summary of the SF-36V questionnaire. The study of a multisymptom illness such as GWVI is complicated by the nonspecific nature of the illness, the unknown etiology, and the lack of a widely accepted outcome measure. The presumption of mycoplasma infection raises concerns regarding the methodology for determination of mycoplasma infection, the choice of treatment, and the duration of treatment. However, such a presumption allows the formulation of a clear testable hypothesis that can be tested with treatments with known rates of adverse events and known activity against Mycoplasma species. This paper describes the major issues faced by the investigators during planning, the study design, the patient screening results, and the baseline characteristics of the study patients. There were 2712 patients screened for study entry at 26 Department of Veterans Affairs and two Department of Defense medical centers. Of these, 491 met all study entry criteria and were randomized to either 1 year of doxycycline (200 mg/day) or 1 year of placebo. All patients were seen monthly during treatment and at 6 months after the end of treatment. Study patients had a mean age of 41 years and were mostly male (86%), white (64%), married (68%), and employed full-time (71%). (C) 2002 Elsevier Science Inc. All rights reserved.