Petris Carisa, Liu Don
Ophthalmic Plastic, Reconstructive, and Orbital Surgery, Mason Eye Institute, University of Missouri Health Care, Columbia, Missouri, USA, 65211.
Cochrane Database Syst Rev. 2017 Jul 12;7(7):CD011109. doi: 10.1002/14651858.CD011109.pub2.
Congenital nasolacrimal duct obstruction (NLDO) is a common condition causing excessive tearing in the first year of life. Infants present with excessive tearing or mucoid discharge from the eyes due to blockage of the nasolacrimal duct system, which can result in maceration of the skin of the eyelids and local infections, such as conjunctivitis, that may require antibiotics. The incidence of nasolacrimal duct obstruction in early childhood ranges from 5% to 20% and often resolves without surgery. Treatment options for this condition are either conservative therapy, including observation (or deferred probing), massage of the lacrimal sac and antibiotics, or probing the nasolacrimal duct to open the membranous obstruction at the distal nasolacrimal duct. Probing may be performed without anesthesia in the office setting or under general anesthesia in the operating room. Probing may serve to resolve the symptoms by opening the membranous obstruction; however, it may not be successful if the obstruction is due to a bony protrusion of the inferior turbinate into the nasolacrimal duct or when the duct is edematous (swollen) due to infection such as dacryocystitis. Additionally, potential complications with probing include creation of a false passage and injury to the nasolacrimal duct, canaliculi and puncta, bleeding, laryngospasm, or aspiration.
To assess the effects of probing for congenital nasolacrimal duct obstruction.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2016, Issue 8); MEDLINE Ovid (1946 to 30 August 2016); Embase.com (1947 to 30 August 2016); PubMed (1948 to 30 August 2016); LILACS (Latin American and Caribbean Health Sciences Literature Database; 1982 to 30 August 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), last searched 14 August 2014; ClinicalTrials.gov (www.clinicaltrials.gov), searched 30 August 2016; and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en), searched 30 August 2016. We did not use any date or language restrictions in the electronic searches for trials.
We included randomized controlled trials (RCTs) that compared probing (office-based or hospital-based under general anesthesia) versus no (or deferred) probing or other interventions (observation alone, antibiotic drops only, or antibiotic drops plus massage of the nasolacrimal duct). We did not include studies that compared different probing techniques or probing compared with other surgical procedures. We included studies in children aged three weeks to four years who may have presented with tearing and conjunctivitis.
Two review authors independently screened studies for inclusion and independently extracted data and assessed risk of bias for the included studies. We analyzed data using Review Manager software and evaluated the certainty of the evidence using GRADE.
We identified two RCTs and no ongoing studies; one of the included RCTs was registered. The studies reported on 303 eyes of 242 participants who had unilateral or bilateral congenital nasolacrimal duct obstruction. For both included studies, the interventions compared were immediate office-based probing to remove the duct obstruction versus deferred probing, if needed, after 6 months of observation or once the child reached a certain age.The primary outcome of the review, treatment success at 6 months, was reported partially in one study. Treatment success was not reported at this time point for all children in the immediate probing group; however, 77 of 117 (66%) eyes randomized to deferred probing had resolved without surgery 6 months after randomization and 40 (34%) eyes did not resolve without probing. For children who had unilateral NLDO, those randomized to immediate probing had treatment success more often than those who were randomized to deferred probing (RR 1.41, 95% CI 1.12 to 1.78; 163 children; moderate-certainty evidence). Treatment success for all children was assessed in the study at age 18 months; as an ad hoc analysis in the included study, results were presented separately for children with unilateral and bilateral NLDO (RR 1.13, 95% CI 0.99 to 1.28 and RR 0.86, 95% CI 0.70 to 1.06, respectively; very low-certainty evidence).In the other small study (26 eyes of 22 children), more eyes that received immediate probing were cured within one month after surgery compared with eyes that were randomized to deferred probing and analyzed at age 15 months (RR 2.56, 95% CI 1.16 to 5.64). We considered the evidence to be low-certainty due to imprecision from the small study size and risk of bias concerns due to attrition bias.One study reported on the number of children that required reoperation; however, these data were reported only for immediate probing group. Nine percent of children with unilateral NLDO and 13% with bilateral NLDO required secondary procedures.One study reported cost-effectiveness of immediate probing versus deferred probing. The mean cost of treatment for immediate probing was less than for deferred probing; however, there is uncertainty as to whether there is a true cost difference (mean difference USD -139, 95% CI USD -377 to 94; moderate-certainty evidence).Reported complications of the treatment were not serious. One study reported that there were no complications for any surgery and no serious adverse events, while the other study reported that bleeding from the punctum occurred in 20% of all probings.
AUTHORS' CONCLUSIONS: The effects and costs of immediate versus deferred probing for NLDO are uncertain. Children who have unilateral NLDO may have better success from immediate office probing, though few children have participated in these trials, and investigators examined outcomes at disparate time points. Determining whether to perform the procedure and its optimal timing will require additional studies with greater power and larger, well-run clinical trials to help our understanding of the comparison.
先天性鼻泪管阻塞(NLDO)是导致婴儿出生后第一年流泪过多的常见病症。由于鼻泪管系统阻塞,婴儿会出现流泪过多或眼部分泌黏液的症状,这可能导致眼睑皮肤浸渍和局部感染,如结膜炎,可能需要使用抗生素治疗。幼儿鼻泪管阻塞的发生率在5%至20%之间,通常无需手术即可自行缓解。该病症的治疗选择包括保守治疗,如观察(或延迟探查)、泪囊按摩和使用抗生素,或探查鼻泪管以打通鼻泪管远端的膜性阻塞。探查可在门诊无麻醉的情况下进行,也可在手术室全身麻醉下进行。探查可通过打通膜性阻塞来缓解症状;然而,如果阻塞是由于下鼻甲向鼻泪管的骨性突出,或者鼻泪管因泪囊炎等感染而水肿(肿胀),则探查可能不会成功。此外,探查的潜在并发症包括形成假道以及对鼻泪管、泪小管和泪点的损伤、出血、喉痉挛或误吸。
评估探查先天性鼻泪管阻塞的效果。
我们检索了Cochrane对照试验中心注册库(CENTRAL),其中包含Cochrane眼科和视力试验注册库(2016年第8期);Ovid MEDLINE(1946年至2016年8月30日);Embase.com(1947年至2016年8月30日);PubMed(1948年至2016年8月30日);拉丁美洲和加勒比卫生科学文献数据库(LILACS,1982年至2016年8月30日),对照试验元注册库(mRCT)(www.controlled-trials.com),最后检索时间为2014年8月14日;ClinicalTrials.gov(www.clinicaltrials.gov),检索时间为2016年8月30日;以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en),检索时间为2016年8月30日。我们在电子检索试验时未使用任何日期或语言限制。
我们纳入了比较探查(门诊或全身麻醉下住院探查)与不探查(或延迟探查)或其他干预措施(仅观察、仅使用抗生素滴眼液或抗生素滴眼液加鼻泪管按摩)的随机对照试验(RCT)。我们未纳入比较不同探查技术或探查与其他外科手术的研究。我们纳入了年龄在三周至四岁之间、可能出现流泪和结膜炎症状的儿童的研究。
两位综述作者独立筛选纳入研究,独立提取数据并评估纳入研究的偏倚风险。我们使用Review Manager软件分析数据,并使用GRADE评估证据的确定性。
我们确定了两项RCT,且无正在进行的研究;其中一项纳入的RCT已注册。这些研究报告了242名单侧或双侧先天性鼻泪管阻塞参与者的303只眼睛的情况。对于两项纳入研究,所比较的干预措施为立即在门诊进行探查以解除管道阻塞,与必要时在观察6个月后或儿童达到特定年龄后进行延迟探查。综述的主要结局,即6个月时的治疗成功率,在一项研究中部分报告。立即探查组并非所有儿童在该时间点均报告了治疗成功率;然而,随机分配至延迟探查的117只眼中,有77只(66%)在随机分组6个月后未经手术自行缓解,40只(34%)眼未经探查未缓解。对于单侧鼻泪管阻塞的儿童,随机分配至立即探查的儿童治疗成功率高于随机分配至延迟探查的儿童(RR 1.41,95%CI 1.12至1.78;163名儿童;中等确定性证据)。在18个月龄时对所有儿童的治疗成功率进行了评估;作为纳入研究中的一项临时分析,分别给出了单侧和双侧鼻泪管阻塞儿童的结果(RR 1.13,95%CI 0.99至1.28和RR 0.86,95%CI 0.70至1.06,分别为;极低确定性证据)。在另一项小型研究(22名儿童的26只眼)中,与随机分配至延迟探查并在15个月龄时进行分析的眼睛相比,接受立即探查手术后一个月内治愈的眼睛更多(RR 2.56,95%CI 1.16至5.64)。由于研究规模小导致的不精确性以及因失访偏倚引起的偏倚风险问题,我们认为证据的确定性较低。一项研究报告了需要再次手术的儿童数量;然而,这些数据仅针对立即探查组报告。单侧鼻泪管阻塞儿童中有9%,双侧鼻泪管阻塞儿童中有13%需要二次手术。一项研究报告了立即探查与延迟探查的成本效益。立即探查的平均治疗成本低于延迟探查;然而,是否存在真正的成本差异尚不确定(平均差异为-139美元,95%CI为-377美元至94美元;中等确定性证据)。报告的治疗并发症并不严重。一项研究报告称,所有手术均无并发症,也无严重不良事件,而另一项研究报告称,所有探查中有20%出现泪点出血。
对于鼻泪管阻塞,立即探查与延迟探查的效果和成本尚不确定。患有单侧鼻泪管阻塞的儿童可能从立即门诊探查中获得更好的治疗效果,尽管参与这些试验的儿童很少,且研究人员在不同时间点检查结局。确定是否进行该手术及其最佳时机将需要更多有更大样本量和设计良好的大型临床试验,以帮助我们理解两者的比较。