Clinic of Otorhinolaryngology-Head and Neck Surgery, University Hospital Zurich, Zurich, Switzerland.
Otol Neurotol. 2011 Oct;32(8):1224-9. doi: 10.1097/MAO.0b013e31822e96bc.
Patients with tympanic membrane (TM) perforations often have infections, and repetitive topical treatment may be required. These infections can be prevented by permanent closure of the TM perforation. Different surgical treatment options have been described, but noninvasive techniques may be preferred as they carry less risk than surgery. One noninvasive approach is to induce wound healing by application of growth factors. The effect and clinical use of applying topical platelet-derived growth factor (PDGF) for decrease of size and closure of chronic TM perforations is evaluated.
Prospective, randomized, placebo-controlled, double-blind study.
Tertiary referral center.
Twenty patients with chronic suppurative otitis media without cholesteatoma for more than 3 months.
Topical treatment with PDGF or placebo applied weekly to the TM for 6 weeks.
Success rate, defined as a reduction of perforation size of 50% or more to determine relative changes of the perforation size; effect of initial size and location of TM perforation on success rate; and air and bone conduction thresholds to determine air-bone gap measured before treatment.
Randomization made matching pretreatment perforation size of the 2 study groups impossible, and the initial rate perforation/TM was significantly smaller in the PDGF group. No difference between the 2 groups was found for perforation/TM less than 10%. However, success rate did not differ significantly between the 2 groups (power = 0.8), and the effect of PDGF was found to be small (-2%; standard deviation, ±49%). Initial size and position of the TM perforation were not significant factors determining success. Mean air-bone gap for the frequencies of 0.5, 1, 2, and 4 kHz was 22.5 dB.
The topical application of PDGF as an office treatment for chronic otitis media is not a favorable alternative to surgery.
鼓膜（TM）穿孔的患者常发生感染，可能需要重复局部治疗。TM 穿孔的永久性封闭可预防这些感染。已描述了不同的手术治疗选择，但由于非侵入性技术的风险低于手术，因此可能更倾向于选择非侵入性技术。一种非侵入性方法是通过应用生长因子来诱导伤口愈合。本文评估了局部应用血小板衍生生长因子（PDGF）减少慢性 TM 穿孔的大小和闭合的效果和临床应用。
前瞻性、随机、安慰剂对照、双盲研究。
三级转诊中心。
20 例患有慢性化脓性中耳炎且无胆脂瘤的患者，病程超过 3 个月。
每周将 PDGF 或安慰剂局部应用于 TM 进行 6 周的治疗。
成功率，定义为穿孔大小减少 50%或更多，以确定穿孔大小的相对变化；TM 穿孔的初始大小和位置对成功率的影响；以及空气和骨导阈值，以确定治疗前测量的气骨间隙。
随机分组使得 2 组患者的治疗前穿孔大小无法匹配，并且 PDGF 组的初始穿孔/ TM 比显著更小。然而，2 组之间的成功率没有显著差异（功率=0.8），并且 PDGF 的作用较小（-2%；标准差，±49%）。TM 穿孔的初始大小和位置不是决定成功率的重要因素。0.5、1、2 和 4 kHz 频率的平均气骨间隙为 22.5 dB。
将 PDGF 局部应用作为慢性中耳炎的门诊治疗方法，并不优于手术。
