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首页> 外文期刊>Circulation: An Official Journal of the American Heart Association >Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1)
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Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1)

机译：抗衣原体抗生素治疗外周枢动症的症状改善：利福拉西患者对肺炎肺炎血清血管阳性患者的间歇性跛行血管症状的前瞻性评价对衣原体肺炎阳性血清阳性患者（Providence-1）

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BACKGROUND: A potentially strong association exists between Chlamydia pneumoniae and atherosclerosis, but the clinical benefits of antibiotic therapy have not been demonstrated. Preliminary studies of antibiotic therapy in peripheral artery disease have shown a decreased need for revascularization and improved walking ability. The objective of this phase-III trial was to assess the effect of a potent anti-Chlamydial agent, rifalazil, on peak walking time in patients with symptomatic peripheral artery disease. METHODS AND RESULTS: Patients with intermittent claudication secondary to peripheral artery disease who were seropositive for C pneumoniae were randomized to 25 mg rifalazil once weekly for 8 weeks or matching placebo. Two hundred ninety-seven patients were enrolled from 3 countries and were followed up for 1 year. The mean+/-SD ankle brachial index at baseline was 0.63+/-0.16. The primary end point, change from baseline in log peak walking time on a graded treadmill, was assessed 180 days after randomization. Secondary end points included changes in claudication onset time and quality of life, assessed with the Walking Impairment Questionnaire and the Short Form Medical Outcomes 36. No benefit of rifalazil therapy was found in the primary or any secondary end point among this cohort of patients with peripheral artery disease. The group treated with rifalazil improved their peak walking times by 23% (95% confidence interval, 15 to 31) from baseline to day 180, whereas the placebo group improved by 18% (95% confidence interval, 11 to 26; P=0.38). Peak walking time, claudication onset time, Walking Impairment Questionnaire, and Short Form Medical Outcomes 36 showed no treatment-by-time interaction during the 360-day study period. Thirty-two adjudicated cardiovascular events occurred, 16 in each treatment group. CONCLUSIONS: Rifalazil did not improve exercise performance or quality of life in patients with intermittent claudication. No safety concerns were identified. Given the very small effect size, it is unlikely that larger studies would demonstrate a symptomatic benefit of this therapy in peripheral artery disease.
机译：背景：衣原体肺炎和动脉粥样硬化之间存在潜在强烈的关联，但抗生素治疗的临床益处尚未证明。外周血疾病抗生素治疗的初步研究表明，需要降低血运重建和改善的行走能力。该阶段III试验的目的是评估有效的抗衣原体，利福利唑，症状外周血疾病患者峰值行走时间的作用。方法和结果：患有间歇性跛行的患者继发于对C肺炎的血管阳性血管阳性血管阳性，每周一次随机转移到25毫克Rifalazil，持续8周或匹配安慰剂。从3个国家注册了两百九十七名患者，随访1年。基线的平均+/- SD踝臂指数为0.63 +/- 0.16。在随机化后180天评估了在分级跑步机上的日志峰值步行时间的基线中的主要终点。次要终点包括跛行发病时间和生活质量的变化，随着步行损伤问卷评估和短的形式医疗结果36.在这一患者的主要或任何次要终点中没有任何次要的患者患者患者的患者的副作用动脉疾病。通过基准将其峰值步行时间从基线提高23％（95％置信区间，15至31），而安慰剂组升高18％（95％置信区间，11至26天; P = 0.38 ）。高峰步行时间，克劳特发病时间，步行障碍问卷和短型医疗结果36在360天的研究期间没有在360天的逐时相互作用。发生了三十二次判决的心血管事件，每次治疗组16例。结论：利福拉西没有改善间歇性跛行患者的运动表现或生活质量。没有发现任何安全问题。鉴于效果大小非常小，更大的研究不太可能在外周血动脉疾病中表现出这种治疗的症状性益处。

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