Olivera María E, Bistoni Adriana, Anun Hugo E, Salinas Aquiles, Manzo Ruben H
Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Argentina.
Ear Nose Throat J. 2004 Sep;83(9):625-6, 628, 630 passim.
We conducted a prospective, randomized, controlled, double-blind study of 33 patients to compare the efficacy and tolerability of a new glycerin formulation of ototopical 0.3% ciprofloxacin with that of a conventional aqueous formulation of ciprofloxacin for the treatment of acute external otitis. Outcomes measures were resolution of discharge, swelling, pain, and redness and the incidence of adverse side effects. Patients were examined on three occasions: on the day of enrollment (visit 1), 48 to 72 hours later (visit 2), and 7 days after enrollment (visit 3). At visit 2, the patients in the glycerin group showed a significantly greater resolution of discharge. We observed the same pattern with respect to swelling, pain, and redness, which resolved more quickly in the glycerin group, although not significantly so. All patients were cured by visit 3, and the two treatments were equally well tolerated. On the basis of our findings, we conclude that the glycerin formulation of ototopical 0.3% ciprofloxacin appears to be at least as effective as the aqueous form in the treatment of acute external otitis--and in the case of otorrhea, more so.
我们对33例患者进行了一项前瞻性、随机、对照、双盲研究，以比较新的0.3%环丙沙星甘油耳用制剂与传统的环丙沙星水性制剂治疗急性外耳道炎的疗效和耐受性。观察指标为分泌物、肿胀、疼痛和发红的消退情况以及不良反应的发生率。患者在三个时间点接受检查：入组当天（第1次就诊）、48至72小时后（第2次就诊）和入组7天后（第3次就诊）。在第2次就诊时，甘油组患者的分泌物消退情况明显更好。我们在肿胀、疼痛和发红方面也观察到了相同的模式，甘油组的这些症状消退得更快，尽管差异不显著。到第3次就诊时所有患者均治愈，两种治疗的耐受性相当。根据我们的研究结果，我们得出结论，0.3%环丙沙星甘油耳用制剂在治疗急性外耳道炎方面似乎至少与水性制剂一样有效——在有耳漏的情况下，效果更显著。
