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口服左氧氟沙星与克拉霉素治疗成人急性鼻窦炎的疗效与安全性:一项多中心、双盲、随机研究。加拿大鼻窦炎研究组

Efficacy and safety of oral levofloxacin compared with clarithromycin in the treatment of acute sinusitis in adults: a multicentre, double-blind, randomized study. The Canadian Sinusitis Study Group.

作者信息

Lasko B, Lau C Y, Saint-Pierre C, Reddington J L, Martel A, Anstey R J

机构信息

Janssen-Ortho Inc., Toronto, Ontario, Canada.

出版信息

J Int Med Res. 1998 Dec;26(6):281-91. doi: 10.1177/030006059802600602.

DOI:10.1177/030006059802600602
PMID:10399110
Abstract

Adult patients with acute sinusitis (n = 236) were randomized in a double-blind study to levofloxacin 500 mg orally once daily (n = 119) or clarithromycin 500 mg orally twice daily (n = 117) for 10-14 days. Between 2 and 5 days after therapy participants were evaluated as cured (no symptoms), improved (symptoms improved, no further therapy required), or failed (further therapy required). Clinical response rates (cured plus improved) for clinically evaluable patients were 93.9% for levofloxacin (n = 98) and 93.5% for clarithromycin (n = 93). The proportion of patients evaluated as cured was higher in the levofloxacin (40.8%) than in the clarithromycin arm (29.0%) and individual symptoms showed higher rates of resolution. Of patients receiving levofloxacin and clarithromycin, 22.5% and 39.3%, respectively, experienced adverse events related or possibly related to the study therapy. This study showed that, in the treatment of acute sinusitis, daily levofloxacin therapy is as effective as twice-daily clarithromycin therapy with more complete clearing of symptoms and a more tolerable side-effect profile.

摘要

236例急性鼻窦炎成年患者被纳入一项双盲研究,随机分为两组,一组每日口服1次500mg左氧氟沙星(119例),另一组每日口服2次500mg克拉霉素(117例),疗程为10 - 14天。治疗后2至5天,对参与者进行评估,分为治愈(无症状)、改善(症状改善,无需进一步治疗)或失败(需要进一步治疗)。可进行临床评估的患者中,左氧氟沙星组(98例)的临床有效率(治愈加改善)为93.9%,克拉霉素组(93例)为93.5%。左氧氟沙星组被评估为治愈的患者比例(40.8%)高于克拉霉素组(29.0%),且各单项症状的缓解率更高。接受左氧氟沙星和克拉霉素治疗的患者中,分别有22.5%和39.3%出现与研究治疗相关或可能相关的不良事件。该研究表明,在治疗急性鼻窦炎时,每日一次的左氧氟沙星治疗与每日两次的克拉霉素治疗效果相当,症状清除更彻底,副作用更易耐受。

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