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首页> 外文期刊>The New England journal of medicine >Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease.
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Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease.

机译：有持续症状和莱姆病病史的患者的两项抗生素治疗对照试验。

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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 the seropositive patients who were treated with antibiotics, there was improvement in the score on the physical-component summary scale of the SF-36, the mental-component summary scale, or both in 37 percent, no change in 29 percent, and worsening in 34 percent; among seropositive patients receiving placebo, there was improvement in 40 percent, no change in 26 percent, and worsening in 34 percent (P=0.96 for the comparison between treatment groups). The results were similar for 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.
机译：背景：对于急性莱姆病的推荐抗生素治疗后，症状持续存在的患者是否延长抗生素治疗是否有效仍存在争议。方法：我们进行了两项随机试验：入选时78名患者对伯氏疏螺旋体的IgG抗体呈血清反应阳性，另一名51名血清阴性。患者要么接受静脉注射头孢曲松钠，每天2 g，共30天，然后接受口服强力霉素，每天200 mg，共60天，或匹配静脉和口服安慰剂。每位患者都有文献充分证明的，先前接受过治疗的莱姆病，但患有持续性的肌肉骨骼疼痛，神经认知症状或感觉异常，通常与疲劳有关。主要结局指标是改善医学成果研究36项简短形式的一般健康调查（SF-36）的身体和精神健康成分汇总量表，该量表用于测量与健康相关的生活质量， -在研究的第180天。结果：经过计划的中期分析后，数据和安全监控委员会建议中止研究，因为前107名患者的数据表明，按计划进行充分治疗的情况下，两组之间的治疗效果差异不大招收260名患者。基线评估记录了患者健康相关生活质量的严重损害。在意向性治疗分析中，与安慰剂相比，延长抗生素治疗的预后没有显着差异。在接受抗生素治疗的血清反应阳性患者中，SF-36的身体成分汇总量表，心理成分汇总量表的得分均有所改善，或两者的得分分别提高了37％，29％没有变化和恶化占34％;在接受安慰剂的血清反应阳性患者中，有40％的改善，没有26％的变化，而有34％的情况恶化（治疗组之间的比较，P = 0.96）。对于血清阴性患者，结果相似。结论：尽管先前曾接受过针对急性莱姆病的抗生素治疗，但持续性症状患者的健康相关生活质量仍受到很大损害。但是，在这两项试验中，静脉和口服抗生素治疗90天并没有比安慰剂改善更多的症状。

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