Hesham Ahmed, Hussien Ayman, Hussein Ahmed
Department of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.
Ear Nose Throat J. 2012 Aug;91(8):E1-4.
Previous animal studies have shown that the topical application of mitomycin C is safe and effective in prolonging the patency of myringotomy openings in ears that have not received a ventilation tube. We conducted a randomized, controlled study in humans to determine if this treatment would make a difference in outcomes when a ventilation tube is inserted. To that end, we prospectively studied a group of patients with resistant otitis media with effusion who underwent bilateral myringotomy and ventilation tube insertion. Our original study population was made up of 55 children aged 2 to 12 years; 15 of these patients were lost to follow-up, leaving us with 40 patients and 80 ears. Each patient served as his or her own control, as mitomycin C was applied to the tympanic membrane on one side just prior to myringotomy creation and normal saline was applied to the other side. Our main outcomes measures were the duration of tube placement (i.e., the length of time before extrusion of the tube) and the incidence of other early and late postoperative complications. We found no statistically significant difference between the mitomycin C-treated ears and the control ears in any of these parameters. We conclude that the use of mitomycin C prior to myringotomy and ventilation tube insertion is not worthwhile.
以往的动物研究表明，在未置入通气管的耳朵中，局部应用丝裂霉素C对于延长鼓膜切开术开口的通畅时间是安全有效的。我们在人体中进行了一项随机对照研究，以确定在置入通气管时这种治疗方法是否会对治疗结果产生影响。为此，我们前瞻性地研究了一组患有难治性分泌性中耳炎且接受双侧鼓膜切开术和通气管置入的患者。我们最初的研究对象包括55名年龄在2至12岁的儿童；其中15名患者失访，最终我们有40名患者和80只耳朵。由于在鼓膜切开术前，丝裂霉素C应用于一侧鼓膜，而生理盐水应用于另一侧鼓膜，所以每位患者都作为自己的对照。我们的主要结局指标是通气管留置时间（即通气管脱出前的时间长度）以及其他早期和晚期术后并发症的发生率。我们发现，在这些参数中，丝裂霉素C治疗组的耳朵与对照组的耳朵之间没有统计学上的显著差异。我们得出结论，在鼓膜切开术和通气管置入前使用丝裂霉素C是不值得的。
