Hu M, Wu Q, Fan Y W, Cao W W, Lin Q, Yu G
National Key Discipline of Pediatrics, Ministry of Education, Department of Ophthalmology, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.
Zhonghua Yan Ke Za Zhi. 2016 Feb;52(2):123-8. doi: 10.3760/cma.j.issn.0412-4081.2016.02.009.
To determine the success rates and compare the results of balloon catheter dilation and nasolacrimal intubation as treatment for congenital nasolacrimal duct obstruction after failed probing, stratified by category of age and type of obstruction.
It was a prospective, randomized, clinical trial that enrolled 189 children (245 eyes) aged between 6 months to 48 months who had a history of failed nasolacrimal duct probing. All eyes underwent either balloon catheter nasolacrimal duct dilation or nasolacrimal duct intubation randomly. The eyes were divided into 2 age categories: category 1 (6-24 months) and category 2 (>24 months) and into 2 types of obstructions: simple obstruction and complex obstruction. Treatment success was defined as absence of epiphora, mucous discharge, or increased lacrimal lake at the outcome visit 6 months after surgery. Complications were also compared.
In 124 eyes treated with balloon catheter dilatation, 112 were successful (90.3%) comparing with 106 successful eyes (87.6%) in 121 eyes treated with nasolacrimal duct intubation. The risk ratio for success between intubation and balloon dilation was 0.971, and the 95% confidence interval was 0.95-1.22. Within each age category, the success rate varied but did not show significant difference: In those under 24 months, success rate was 89.7% in 97 eyes treated with intubation, and 91.9% in 99 eyes treated with balloon dilation (RR, 0.976; 95% CI, 0.590-0.956). In those above 24 months, success rate was 79.1% in 24 eyes treated with intubation, and 84.0% in 25 eyes treated with balloon dilation (RR, 0.942; 95%CI, 0.813-1.387). In the group of simple obstruction, success rate was 96.5% in 87 eyes treated with intubation, and 93.1% in 88 eyes treated with balloon dilation (RR, 1.036; 95% CI, 0.967-1.105). In the group of complex obstruction, Success rate was 64.7% in 34 eyes treated with intubation, and 86.1% in 36 eyes treated with balloon dilation. The success rate of balloon dilatation showed slightly higher than that of intubation (RR, 0.751; 95% CI, 0.590-0.956). There were 59 eyes showed complications in intubation group, while only 2 eyes in balloon dilation group.
Both balloon catheter dilation and nasolacrimal duct intubation could alleviate the clinical signs of persistent nasolacrimal duct obstruction with a similar percentage of patients. In the complex obstruction group, balloon catheter dilation showed better efficacy than nasolacrimal duct intubation.
确定球囊导管扩张术和鼻泪管插管术作为先天性鼻泪管阻塞探通失败后的治疗方法的成功率，并按年龄类别和阻塞类型进行分层比较结果。
这是一项前瞻性、随机临床试验，纳入了189名年龄在6个月至48个月之间且有鼻泪管探通失败病史的儿童（245只眼）。所有眼睛随机接受球囊导管鼻泪管扩张术或鼻泪管插管术。眼睛分为2个年龄类别：第1类（6 - 24个月）和第2类（>24个月），以及2种阻塞类型：单纯性阻塞和复杂性阻塞。治疗成功定义为术后6个月随访时无溢泪、黏液性分泌物或泪湖增大。还比较了并发症情况。
在124只接受球囊导管扩张术治疗的眼中，112只成功（90.3%），而在121只接受鼻泪管插管术治疗的眼中，106只成功（87.6%）。插管术与球囊扩张术成功的风险比为0.971，95%置信区间为0.95 - 1.22。在每个年龄类别中，成功率有所不同但无显著差异：在24个月以下的儿童中，97只接受插管术治疗的眼中成功率为89.7%，99只接受球囊扩张术治疗的眼中成功率为91.9%（RR，0.976；95%CI，0.590 - 0.956）。在24个月以上的儿童中，24只接受插管术治疗的眼中成功率为79.1%，25只接受球囊扩张术治疗而眼中成功率为84.0%（RR，0.942；95%CI，0.813 - 1.387）。在单纯性阻塞组中，87只接受插管术治疗的眼中成功率为96.5%，88只接受球囊扩张术治疗的眼中成功率为93.1%（RR，1.036；95%CI，0.967 - 1.105）。在复杂性阻塞组中，34只接受插管术治疗的眼中成功率为64.7%，36只接受球囊扩张术治疗的眼中成功率为86.1%。球囊扩张术的成功率略高于插管术（RR，0.751；95%CI，0.590 - 0.956）。插管组有59只眼出现并发症，而球囊扩张组仅有2只眼出现并发症。
球囊导管扩张术和鼻泪管插管术均可缓解持续性鼻泪管阻塞的临床症状，患者比例相似。在复杂性阻塞组中，球囊导管扩张术的疗效优于鼻泪管插管术。
