1.5%阿奇霉素滴眼液与0.3%妥布霉素对脓性细菌性结膜炎临床症状的疗效评估
[Efficacy assessment of azithromycin 1.5% eye drops versus tobramycin 0.3% on clinical signs of purulent bacterial conjunctivitis].
作者信息
Robert P-Y, Bourcier T, Meddeb-Ouertani A, Khairallah M, Zaghloul K, Amraoui A, Bhagat Y, Pop M, Cochereau I
机构信息
Service d'Ophtalmologie, CHU Dupuytren, 2, avenue Martin Luther King, 87042 Limoges Cedex, France.
出版信息
J Fr Ophtalmol. 2010 Apr;33(4):241-8. doi: 10.1016/j.jfo.2010.01.005. Epub 2010 Mar 10.
INTRODUCTION
Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5% eye drops with tobramycin 0.3%.
PATIENTS AND METHODS
This was a multicenter, randomized, investigator-masked study including 1,043 patients with purulent bacterial conjunctivitis. Patients received either azithromycin twice daily for 3 days or tobramycin, 1 drop every 2 hours for 2 days, then four times daily for 5 days. The primary variable was clinical cure at the test-of-cure (TOC) visit (D9) on the worst eye. The cure was defined as bulbar conjunctival injection and discharge scores of 0. Clinical signs were evaluated at D0, D3, and D9.
RESULTS
In the azithromycin group 87.8% of patients and in the tobramycin group 89.4% were clinically cured at D9. Clinical cure with azithromycin was not inferior to tobramycin at D9: discharge was absent in 96.3% of patients treated with azithromycin and 95.1% with tobramycin. Azithromycin was well tolerated.
CONCLUSIONS
Azithromycin 1.5% for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis.
引言
细菌性结膜炎的特征是一只或两只眼睛出现充血和分泌物。这些临床症状出现迅速且具有传染性。本研究比较了1.5%阿奇霉素滴眼液与0.3%妥布霉素滴眼液的临床疗效(体征和症状)及安全性。
患者与方法
这是一项多中心、随机、研究者设盲的研究,纳入了1043例脓性细菌性结膜炎患者。患者接受每日两次阿奇霉素治疗,共3天,或每2小时滴1次妥布霉素,共2天,然后每日4次,共5天。主要变量是在治疗结束检查(TOC)访视(第9天)时患眼情况最差的那只眼睛的临床治愈情况。治愈定义为球结膜充血和分泌物评分均为0。在第0天、第3天和第9天评估临床体征。
结果
在阿奇霉素组中,87.8%的患者在第9天临床治愈,在妥布霉素组中这一比例为89.4%。在第9天,阿奇霉素的临床治愈率不低于妥布霉素:接受阿奇霉素治疗的患者中96.3%无分泌物,接受妥布霉素治疗的患者中这一比例为95.1%。阿奇霉素耐受性良好。
结论
3天(6滴)使用1.5%阿奇霉素与7天(36滴)使用妥布霉素效果相同。此外,使用阿奇霉素的患者在第3天的临床治愈时间比使用妥布霉素的患者更早。阿奇霉素给药方便(每日两次,共3天),在脓性细菌性结膜炎的治疗方面向前迈进了一步。