Institute of Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Germany.
Curr Med Res Opin. 2011 Apr;27(4):871-8. doi: 10.1185/03007995.2011.557719. Epub 2011 Feb 18.
To demonstrate the efficacy and safety of an antibiotic ear drop formulation combining polymyxin B sulfate, neomycin sulfate and gramicidin (PS) in patients with acute bacterial otitis externa (AOE). The combination was compared to glycerol ear drops, a non-pharmacologic treatment of AOE.
An active controlled, double-blind, randomized, parallel group, multicenter clinical trial study design was performed in ear, nose and throat (ENT) practices with a planned interim analysis for sample size adaptation. In total, 244 patients aged 19-84 with no previous episode of otitis externa within the last year were randomized to receive either PS or glycerol ear drops thrice daily for 10 ± 2 days.
Absolute change in the clinical symptom score (CSS) (with subscores redness, swelling, pain, and secretion) from Day 1 to 4 was measured. As second endpoints, absolute change in CSS, individual subscores, pain perception measured on a visual analog scale (VAS) and intake of paracetamol 500 mg tablets were noted. Moreover, patient's assessment of efficacy at Day 10 and the frequency and type of adverse events were noted.
On Day 4, the CSS showed a clear advantage for the PS group over the glycerol group, being lower by 0.6 (p < 0.03); the clinical outcome was even more pronounced after 10 days (p = 0.006). The swelling subscore showed a statistically significant difference favoring the PS treatment group in Days 1-4 (p = 0.01) and Days 1-10 (p = 0.003). More PS- than glycerol-receiving patients rated the efficacy as good (glycerol: 32%; PS: 36%) or very good (glycerol: 38%; PS: 48%). Males, patients with AOE for >2 days and those with positive microbiologic findings profited most from PS therapy.
This study proves that PS is an effective and well-tolerated drug, showing results superior to glycerol, especially in patients with a longer pre-existing condition before therapy. The absence of a group treated with another established antibiotic is a limitation of this trial.
展示一种结合硫酸多粘菌素 B、硫酸新霉素和短杆菌素（PS）的抗生素滴耳液配方在急性细菌性外耳炎（AOE）患者中的疗效和安全性。该组合与甘油滴耳液（一种非药物治疗 AOE 的方法）进行了比较。
在耳鼻喉科（ENT）诊所进行了一项积极对照、双盲、随机、平行组、多中心临床试验研究设计，并进行了计划中的中期分析以适应样本量。共有 244 名年龄在 19-84 岁之间、过去一年中没有外耳炎发作的患者被随机分为 PS 或甘油滴耳液组，每日 3 次，持续 10±2 天。
从第 1 天到第 4 天，测量临床症状评分（CSS）（包括红肿、肿胀、疼痛和分泌物）的绝对变化。作为次要终点，还记录了 CSS 的绝对变化、个别亚评分、视觉模拟量表（VAS）上的疼痛感知和对乙酰氨基酚 500mg 片剂的摄入。此外，还记录了患者在第 10 天的疗效评估以及不良反应的频率和类型。
在第 4 天，PS 组的 CSS 明显优于甘油组，低 0.6（p<0.03）；在第 10 天，临床疗效更为显著（p=0.006）。肿胀亚评分在第 1-4 天（p=0.01）和第 1-10 天（p=0.003）更倾向于 PS 治疗组。更多接受 PS 治疗的患者认为疗效良好（甘油组：32%；PS 组：36%）或非常好（甘油组：38%；PS 组：48%）。男性、AOE 持续时间>2 天的患者和微生物学检查阳性的患者从 PS 治疗中获益最多。
这项研究证明 PS 是一种有效且耐受性良好的药物，其疗效优于甘油，尤其是在治疗前病情较长的患者中。该试验的一个局限性是没有一个用另一种已确立的抗生素治疗的组。
