多中心、开放性标签研究评估 1%阿奇霉素滴眼液对睑缘炎患者的体征和症状的疗效。
Multicenter open-label study evaluating the efficacy of azithromycin ophthalmic solution 1% on the signs and symptoms of subjects with blepharitis.
机构信息
Inspire Pharmaceuticals, Durham, NC, USA.
出版信息
Cornea. 2010 Aug;29(8):871-7. doi: 10.1097/ICO.0b013e3181ca38a0.
PURPOSE
To evaluate the effect of 4 weeks of treatment with azithromycin ophthalmic solution 1% on eyelid bacterial load, tear cytokines, and signs and symptoms of blepharitis.
METHODS
Twenty-six subjects (mean age 64.2 years; 65% female; 100% white) with moderate to severe blepharitis received azithromycin ophthalmic solution 1% in the absence of warm compresses or eyelid scrubs for 28 days (twice a day on days 1 and 2 and once a day on days 3-28). Blepharitis signs and symptoms were evaluated at baseline (day 1) and compared with end of treatment (day 29) and 2 follow-up visits (2 and 4 weeks posttreatment). Tear collection and eyelid margin bacterial cultures were performed at baseline and end of treatment. Tear cytokines were measured by a multiplex immunobead assay.
RESULTS
Four-week azithromycin treatment demonstrated significant decreases from baseline in investigator-rated signs of meibomian gland plugging, eyelid margin redness, palpebral conjunctival redness, and ocular discharge (P < or = 0.002) at day 29, which persisted 4 weeks posttreatment (P < or = 0.006). Subject-reported symptoms of eyelid itching, foreign body sensation/sandiness/grittiness, ocular dryness, ocular burning/pain, and swollen/heavy eyelids also demonstrated significant improvement from baseline (P < 0.001 for all symptoms and time points, except P = 0.037 for ocular dryness at visit 4). Eyelid margin culture exhibited significant decreases in coagulase-negative staphylococci and Corynebacterium xerosis bacteria. Changes in tear cytokine concentrations were not observed. Twelve subjects experienced 19 adverse events, 15 of which were ocular and none of which were serious.
CONCLUSIONS
Azithromycin provided significant improvement in signs and symptoms of blepharitis after 4 weeks of treatment compared with baseline and persisted in the 4-week follow-up period.
目的
评估 4 周阿奇霉素滴眼液 1%治疗对眼睑细菌负荷、泪液细胞因子以及睑缘炎体征和症状的影响。
方法
26 名(平均年龄 64.2 岁;65%为女性;100%为白种人)中重度睑缘炎患者在无热敷或眼睑擦洗的情况下使用阿奇霉素滴眼液 1%,治疗 28 天(第 1 天和第 2 天每天 2 次,第 3-28 天每天 1 次)。在基线(第 1 天)、治疗结束时(第 29 天)和 2 次随访(治疗结束后 2 周和 4 周)时评估睑缘炎体征和症状。在基线和治疗结束时采集泪液并进行睑缘细菌培养。通过多重免疫珠测定法测量泪液细胞因子。
结果
4 周阿奇霉素治疗在第 29 天与基线相比,研究者评估的睑板腺阻塞、睑缘红肿、球结膜红肿和眼部分泌物等体征显著减少(P≤0.002),并且在治疗结束后 4 周仍持续存在(P≤0.006)。患者报告的眼睑瘙痒、异物感/磨砂感/颗粒感、眼干、眼灼痛和眼睑肿胀/沉重等症状也与基线相比有显著改善(所有症状和时间点 P<0.001,除了眼干在第 4 次就诊时 P=0.037)。睑缘培养显示凝固酶阴性葡萄球菌和干燥棒状杆菌的数量显著减少。未观察到泪液细胞因子浓度的变化。12 名受试者出现 19 起不良事件,其中 15 起为眼部不良事件,无严重不良事件。
结论
与基线相比,阿奇霉素治疗 4 周后可显著改善睑缘炎的体征和症状,并在 4 周随访期内持续存在。