In an open, multi-centre study in general practice, a comparison was made of the efficacy, tolerability and acceptability of a neomycin/dexamethasone preparation administered by metered-dose spray ('Otomize') and a framycetin/gramicidin/dexamethasone preparation ('Sofradex') administered as drops in 60 patients with otitis externa. Patients were allocated at random to receive one or other preparations 3-times daily for 10 days and were followed-up again 14 days after cessation of therapy. Clinical assessments were carried out under observer blind conditions on entry (Day 0) and on Days 10 and 24 of the severity of erythema, swelling and debris in the affected ear(s). A global assessment of clinical outcome was made by the doctor on Day 10. There were no significant differences in the two groups at the start of treatment. Significant improvement occurred in both groups from Day 0 to Day 10 and from Day 10 to Day 24 in all symptoms, with the proportion symptom-free in the 'Otomize' group significantly greater than in the 'Sofradex' group at 24 days, and approaching significance at 10 days. Significantly more patients in the 'Otomize' group were rated as having a good clinical outcome by the physician, and fewer patients experienced discomfort on application. Few side-effects were reported by either treatment group, none necessitating discontinuation of therapy.

译文

在一项常规的开放,多中心研究中,比较了通过定量喷雾 ('Otomize') 和framycetin/gramicidin/地塞米松制剂的疗效,耐受性和可接受性。地塞米松制剂 ('Sofradex') 以滴剂形式在60例外耳道炎患者中使用。患者被随机分配接受一种或其他制剂,每天3次,持续10天,并在停止治疗后14天再次随访。在进入 (第0天) 以及受影响的耳朵中红斑,肿胀和碎屑的严重程度的第10天和第24天,在观察者盲条件下进行临床评估。医生在第10天对临床结果进行了全面评估。治疗开始时两组无显著差异。在所有症状中,两组从第0天到第10天以及从第10天到第24天均出现显着改善,“otomize” 组无症状的比例在24天显着高于 “sofradex” 组,并在10天接近显着性。医生将 “otomize” 组中的更多患者评为具有良好的临床结果,并且更少的患者在应用中出现不适。任何治疗组都很少报告副作用,没有必要停止治疗。

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