Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
Laryngoscope. 2011 Feb;121(2):433-6. doi: 10.1002/lary.21292. Epub 2011 Jan 4.
OBJECTIVES/HYPOTHESIS: To evaluate the efficacy of intraoperative mitomycin C (MMC) in endonasal endoscopic dacryocystorhinostomy.
Randomized controlled trial.
Fifty patients with primary acquired nasolacrimal duct obstruction were enrolled and randomly allocated into the treatment and control group. The patients underwent standard endonasal endoscopic dacryocystorhinostomy with mucosal flaps and mitomycin C or placebo on each group. The ostium size was measured at 3 months, 6 months, and 12 months to evaluate the effect of mitomycin C and placebo, and the patency of the lacrimal drainage system was assessed.
There was no statistical significance in the success rate between the MMC group and the control group at 1-year follow-up (84.6% vs.79.2%, respectively, P = .59). At the 6-month and 12-month visits, the mean ostium size in the MMC group was 10.8 mm(2) (SD = 3.17) and 3.0 mm(2) (SD = 1.78), respectively, which were prominently larger than the control group at 7.1 mm(2) (SD = 2.62; P < .001, 95% CI, 0.84-5.45) and 1.6 mm(2) (SD = 1.18; P = .004, 95% CI, 0.49-2.38).
There was no statistically significant difference in the success rates of both groups, but MMC seems to have a conspicuous effect on the healing process at the ostium.
目的/假设:评估术中丝裂霉素 C(MMC)在鼻内内镜下泪囊鼻腔吻合术中的疗效。
随机对照试验。
纳入 50 例原发性获得性鼻泪管阻塞患者,并将其随机分配至治疗组和对照组。两组患者均行标准鼻内内镜下泪囊鼻腔吻合术,术中使用黏膜瓣和丝裂霉素 C 或安慰剂。术后 3 个月、6 个月和 12 个月测量泪囊造口大小,以评估丝裂霉素 C 和安慰剂的效果,并评估泪液引流系统的通畅性。
在 1 年随访时,MMC 组和对照组的成功率无统计学差异(分别为 84.6%和 79.2%,P =.59)。在 6 个月和 12 个月时,MMC 组的平均泪囊造口大小分别为 10.8 mm²(SD = 3.17)和 3.0 mm²(SD = 1.78),显著大于对照组的 7.1 mm²(SD = 2.62;P <.001,95%CI,0.84-5.45)和 1.6 mm²(SD = 1.18;P =.004,95%CI,0.49-2.38)。
两组的成功率无统计学差异,但 MMC 似乎对吻合口愈合过程有显著影响。