Treatment with the antibiotic roxithromycin in patients with acute non-Q-wave coronary syndromes - The final report of the ROXIS study

Treatment with the antibiotic roxithromycin in patients with acute non-Q-wave coronary syndromes - The final report of the ROXIS study
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DOI:
10.1053/euhj.1998.1283
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发表时间:
1999-01-01
影响因子:
39.3
通讯作者:
Mautner, B
Mautner, B
中科院分区:
医学1区
文献类型:
--
作者:
Gurfinkel, E;Bozovich, G;Mautner, B

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越来越多的证据表明,感染,特别是肺炎衣原体,在动脉粥样硬化中起作用。我们检测了大环内酯类罗红霉素抗生素治疗是否改善急性非Q波冠状动脉综合征患者的临床结局。初步报告显示,罗红霉素组在30天时的事件减少。我们现在报告的长期随访result.Methods和结果64%的初始202例不稳定型心绞痛患者被随机分配到接受罗红霉素或安慰剂30天完成了积极的治疗期。在第30天,安慰剂组的主要三重和双重终点发生率分别为9%和4%,而罗红霉素组为2%和0%(未校正的P值分别为0.032和0.058)。安慰剂组在第90天(12.5%和6.25% vs 4.37%和0%,未校正的P值分别为0.065和0.029)和第180天(14.6%和7.29% vs 8.69%和2.17%,未校正的P值分别为0.259和0.17)的次要三重和双重终点发生率再次较高。抗C两组的肺炎IgG滴度均无变化,而C反应蛋白水平均降低,罗红霉素组降低更为显著(P=0.03)。升高的C-反应蛋白水平预测需要revascular.Conclusions在这项试点试验中,罗红霉素似乎延长了预防死亡和再梗死的临床获益至少6个月后,初步治疗。
Aims Mounting evidence suggests infection, specifically Chlamydia pneumoniae, plays a role in atherosclerosis. We tested whether antibiotic treatment with the macrolide roxithromycin improves clinical outcome in patients with acute non-Q-wave coronary syndromes. Preliminary reports revealed a reduction in events in the roxithromycin group at 30 days. We now report the long-term follow-up results.Methods and Results Sixty-four per cent of the initial 202 patients with unstable angina who were randomly assigned to receive either roxithromycin or placebo for 30 days completed the active treatment period. At day 30, the primary triple and double end-point rates were 9% and 4% in the placebo group compared to 2% and 0% in the roxithromycin group (unadjusted P=0.032 and 0.058, respectively). The secondary triple and double end-point rates were again higher in the placebo group at day 90 (12.5% and 6.25% vs 4.37% and 0%, unadjusted P=0.065 and 0.029, respectively), and at day 180 (14.6% and 7.29% vs 8.69% and 2.17%, unadjusted P=0.259 and 0.17, respectively). Anti-C. pneumoniae IgG titres were unchanged in both groups while C-reactive protein levels decreased in both strategies, with a more significant decrease in the roxithromycin arm (P=0.03). Elevated C-reactive protein levels predicted the need for revascularization.Conclusions In this pilot trial, roxithromycin appears to extend the clinical benefit of preventing death and re-infarction for at least 6 months after initial treatment.