Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease.
Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease.
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DOI：
10.1056/nejm200107123450202
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发表时间：
2001-07-12
影响因子：
158.5
通讯作者：
Weinstein, A
中科院分区：
文献类型：
--
作者：
Klempner, MS;Hu, LT;Weinstein, A
背景：在推荐的抗生素治疗急性莱姆病后，延长抗生素治疗对症状持续存在的患者是否有效存在争议。方法：我们进行了两个随机试验：一个是登记时伯氏疏螺旋体抗体血清阳性的患者，另一个是血清阴性的患者。患者接受头孢曲松静脉注射，每天2g，连续30天，然后口服多西环素，每天200 mg，连续60天，或匹配静脉和口服安慰剂。每个患者都有很好的记录，以前治疗过莱姆病，但有持续性的肌肉骨骼疼痛、神经认知症状或感觉障碍，通常与疲劳有关。主要的结果测量是在研究的第180天，医疗结果研究36项简式总体健康调查(SF-36)的身体和心理健康部分的简明量表的改善。结果：在计划的中期分析后，数据和安全监测委员会建议停止研究，因为来自前107名患者的数据表明，在260名患者的计划全面纳入的情况下，两组之间的治疗效果不太可能观察到显著差异。基线评估记录了患者与健康相关的生活质量严重受损。在意向处理分析中，与安慰剂相比，在血清阳性和阴性患者中，延长抗生素治疗的结果没有显著差异。结论：尽管有过急性莱姆病的抗生素治疗，但持续症状的患者的健康相关生活质量有相当大的下降。然而，在这两项试验中，静脉和口服抗生素治疗90天并没有比安慰剂更能改善症状。(N Engl J Med 2001；345：85-92)版权所有(C)2001年马萨诸塞州医学会。
Background: It is controversial whether prolonged antibiotic treatment is effective for patients in whom symptoms persist after the recommended antibiotic treatment for acute Lyme disease.Methods: We conducted two randomized trials: one in 78 patients who were seropositive for IgG antibodies to Borrelia burgdorferi at the time of enrollment and the other in 51 patients who were seronegative. The patients received either intravenous ceftriaxone, 2 g daily for 30 days, followed by oral doxycycline, 200 mg daily for 60 days, or matching intravenous and oral placebos. Each patient had well-documented, previously treated Lyme disease but had persistent musculoskeletal pain, neurocognitive symptoms, or dysesthesia, often associated with fatigue. The primary outcome measures were improvement on the physical- and mental-health-component summary scales of the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) - a scale measuring the health-related quality of life - on day 180 of the study.Results: After a planned interim analysis, the data and safety monitoring board recommended that the studies be discontinued because data from the first 107 patients indicated that it was highly unlikely that a significant difference in treatment efficacy between the groups would be observed with the planned full enrollment of 260 patients. Base-line assessments documented severe impairment in the patients' health-related quality of life. In intention-to-treat analyses, there were no significant differences in the outcomes with prolonged antibiotic treatment as compared with placebo among either the seropositive or the seronegative patients.Conclusions: There is considerable impairment of health-related quality of life among patients with persistent symptoms despite previous antibiotic treatment for acute Lyme disease. However, in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo. (N Engl J Med 2001;345:85-92.) Copyright (C) 2001 Massachusetts Medical Society.