Ari Seyhmus, Gun Ramazan, Surmeli Serdar, Atay Ahmet Engin, Caca Ihsan
Department of Ophthalmology, Diyarbakir State Hospital, Diyarbakir, Turkey.
Department of Otolaryngology, Dicle University Faculty of Medicine, Diyarbakir, Turkey.
Curr Ther Res Clin Exp. 2009 Aug;70(4):267-73. doi: 10.1016/j.curtheres.2009.08.003.
The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus.
The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year).
In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group.
One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based on nasolacrimal duct irrigation, significantly fewer patients in the MMC group than the control group had an enclosed naso-lacrimal duct (2/50 [4%] vs 8/50 [16%]). No adverse effects (eg, abnormal nasal bleeding, mucosal necrosis, infection) or any other surgical adverse events were observed.
In the management of these patients with primary acquired nasolacrimal duct obstruction, adjunctive intraoperative MMC application with standard DCR surgery had a significantly higher success rate than did standard DCR surgery alone. Further large, double-masked, randomized studies are needed to confirm these findings.
外部泪囊鼻腔吻合术（DCR）手术失败的最常见原因是截骨部位或总泪小管形成肉芽组织。
本研究旨在评估术中辅助使用丝裂霉素C（MMC）治疗外部DCR手术的疗效，并将该手术与单纯标准DCR手术进行长期（1年）比较。
在这项前瞻性、双盲、随机对照试验中，将原发性获得性鼻泪管阻塞患者根据手术方式（使用随机数字表）随机分为2组。在MMC组中，将术中辅助使用的0.2 mg/mL MMC应用于截骨部位30分钟。对照组仅接受标准DCR手术。使用客观指标（如通过鼻泪管冲洗停止过度流泪以及泪液弯月面高度的改善）和主观症状（询问患者描述流泪改善程度）评估DCR手术的结果。评估研究结果的患者和研究人员均对治疗组情况不知情。
对100名土耳其患者的100只眼睛进行了评估，并将其平均随机分为MMC组（27名女性，23名男性；平均[标准差]年龄，47.0[7.6]岁）和对照组（26名女性，24名男性；平均年龄，46.6[8.8]岁）。MMC组和对照组的随访期无显著差异（13.1[1.1]个月对13.2[1.4]个月）。在1年的随访期内，MMC组无症状的眼睛明显多于对照组（45/50[90%]对33/50[66%]；P=0.005）。在1年随访时，对照组症状改善的患者明显多于MMC组（8/50[16%]对2/50[4%]只眼睛；P=0.005）。基于引流系统的通畅情况，MMC组的成功率明显高于对照组（48/50[96%]对42/50[84%]；P=0.005）。基于鼻泪管冲洗，MMC组鼻泪管阻塞的患者明显少于对照组（2/50[4%]对8/50[16%]）。未观察到不良反应（如异常鼻出血、黏膜坏死、感染）或任何其他手术不良事件。
在这些原发性获得性鼻泪管阻塞患者的治疗中，标准DCR手术术中辅助应用MMC的成功率明显高于单纯标准DCR手术。需要进一步进行大规模、双盲、随机研究来证实这些发现。
