Department of Interventional Radiology, Hospital Virgen de Salud, Complejo Hospitalario de Toledo, Avenida de Barber 30, 45004 Toledo, Spain.
J Vasc Interv Radiol. 2009 Dec;20(12):1588-96. doi: 10.1016/j.jvir.2009.08.026.
To evaluate the efficacy of plastic polyurethane stents compared with nasolacrimal cryoplasty in the management of epiphora in adults.
Patients (N = 37; mean age, 64 years; range, 34-86 y; six men, 31 women) with severe epiphora with partial/complete obstruction of the nasolacrimal system were randomized to have a plastic stent inserted (n = 19) or to undergo balloon dilation cryoplasty (n = 18). Both procedures were conducted on an outpatient basis. Patency was assessed with Kaplan-Meier curves.
Initial technical success rate and immediate resolution of epiphora was complete in all cases. At 6 months of follow-up, outcomes were already significantly different between the treatment groups and hence the study was discontinued. Plastic stent placement achieved a primary patency rate of 59.6% at 6 months, compared with 12.4% in the cryoplasty group (P < .0004). Multivariate analysis indicated that other measured variables (sex, age, etiology, previous treatment, and the interventional radiologist's expertise) had no significant effect on the outcomes (P > .05).
Initial success was good in both treatment groups, with nasolacrimal plastic stent placement achieving a level of primary patency superior to the cryoplasty procedure for the relief of epiphora on short-term follow-up. However, long-term outcome evaluation is needed before stent placement can be recommended as an alternative to more established surgical procedures.
评估塑料聚氨酯支架与鼻泪管冷冻成形术治疗成人溢泪的疗效。
将 37 例(平均年龄 64 岁;范围 34-86 岁;6 例男性,31 例女性)有严重溢泪、伴有鼻泪管部分/完全阻塞的患者随机分为植入塑料支架组(n=19)或行球囊扩张冷冻成形术组(n=18)。两组均在门诊进行。采用 Kaplan-Meier 曲线评估通畅率。
初始技术成功率和溢泪即刻缓解率均为 100%。6 个月随访时,两组间的疗效已存在显著差异,因此研究提前终止。6 个月时,塑料支架组的初次通畅率为 59.6%,冷冻成形术组为 12.4%(P<.0004)。多因素分析表明,其他测量变量(性别、年龄、病因、既往治疗和介入放射医师的专业知识)对结果无显著影响(P>.05)。
两组治疗的初始成功率均较好,鼻泪管塑料支架植入术在缓解溢泪方面的初次通畅率优于冷冻成形术,但需要进行长期的疗效评估,才能推荐将支架置入作为更成熟的手术方法的替代方案。