Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, HKSAR, China; Department of Ophthalmology and Visual Science, The Chinese University of Hong Kong, HKSAR, China.
Ophthalmology. 2013 Oct;120(10):2139-45. doi: 10.1016/j.ophtha.2013.02.036. Epub 2013 May 11.
To study the effect of bicanalicular silicone intubation on endonasal endoscopic mechanical dacryocystorhinostomy (EEM-DCR) for primary acquired nasolacrimal duct obstruction (PANDO).
Randomized clinical trial.
A total of 120 consecutive adults (103 females) with a presenting age of 64 ± 13.7 years (range, 39-92 years) underwent EEM-DCR for PANDO from November 2005 to May 2009 in a lacrimal referral center.
The EEM-DCR was performed by 2 lacrimal surgeons using standard techniques. Patients were randomly assigned to receive or not receive bicanalicular silicone intubation for 8 weeks. No antimetabolite was used. All patients received a course of oral antibiotics during nonabsorbable nasal packing for flaps tamponade, which was removed at the first postoperative visit. Patients were assessed at 1, 3, 6, 12, 26, and 52 weeks after the operation.
Surgical success was defined by symptomatic relief of epiphora, reestablishment of nasolacrimal drainage confirmed by irrigation by 1 masked observer, and positive functional endoscopic dye test by the operative surgeon at 12 months postoperatively. Intraoperative and postoperative complications were recorded.
A total of 118 of the 120 randomized cases completed 12 months of follow-up. Two patients died of unrelated medical illnesses during follow-up. At 12 months postoperatively, there was no statistical difference in the success rate between patients with (96.3%) and without (95.3%) intubation (P=0.79). The odds ratio of failure without silicone intubation was 1.28 (95% confidence interval, 0.21-7.95). There was no difference in the incidence (P=0.97) or the time to develop (P=0.12) granulation tissue between the 2 groups. No significant difference was found between successful and failed cases in terms of age (P=0.21), sex (P=0.37), laterality (P=0.46), mode of anesthesia (P=0.14), surgeon (P=0.26), use of stent (P=0.79), or presence of granulation tissue postoperatively (P=0.39).
The current study design provided 90% statistical power to detect more than 21% difference in surgical outcome, and no such difference was found whether intubation was used or not used in EEM-DCR for PANDO at the 12-month follow-up.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
研究双鼻内硅胶插管对内窥鼻窦内镜下机械泪囊鼻腔吻合术（EEM-DCR）治疗原发性获得性鼻泪管阻塞（PANDO）的影响。
随机临床试验。
2005 年 11 月至 2009 年 5 月，在一家泪道转诊中心，共有 120 名连续的成年患者（103 名女性）接受了 EEM-DCR 治疗 PANDO，其就诊年龄为 64±13.7 岁（范围为 39-92 岁）。
2 位泪道外科医生使用标准技术进行 EEM-DCR。患者被随机分配接受或不接受双鼻内硅胶插管 8 周。未使用代谢抑制剂。所有患者在不可吸收的鼻腔填塞期间接受了一个疗程的口服抗生素，以填塞皮瓣，在第一次术后就诊时取出。术后 1、3、6、12、26 和 52 周对患者进行评估。
手术成功的定义为术后 12 个月，1 名盲法观察者通过冲洗确认溢泪症状缓解、鼻泪管再通，并由手术医生进行阳性功能性内镜染料试验。记录术中及术后并发症。
120 例随机病例中有 118 例完成了 12 个月的随访。2 例患者在随访期间因无关的医疗疾病死亡。术后 12 个月，插管组（96.3%）和无插管组（95.3%）的成功率无统计学差异（P=0.79）。无硅胶插管失败的优势比为 1.28（95%置信区间，0.21-7.95）。两组之间肉芽组织的发生率（P=0.97）或发生时间（P=0.12）无差异。成功病例和失败病例在年龄（P=0.21）、性别（P=0.37）、侧别（P=0.46）、麻醉方式（P=0.14）、手术医生（P=0.26）、支架使用（P=0.79）或术后肉芽组织存在（P=0.39）方面均无显著差异。
目前的研究设计提供了 90%的统计学效能来检测手术结果的 21%以上差异，但在 EEM-DCR 治疗 PANDO 时，无论是否使用插管，在 12 个月的随访中均未发现这种差异。
作者没有与本文讨论的材料有关的专有或商业利益。
