南方医科大学学报

南方医科大学学报 ›› 2016, Vol. 36 ›› Issue (01): 13-.

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联合环形电极泪道成形术提高泪道支架管植入术疗效和安全性的随机临床试验

胡文学，郭海科，廖海兰，黄小花   

  • 出版日期:2016-01-20 发布日期:2016-01-20

Annular electrode lacrimal duct reconstruction for improving the safety and efficacy of
lacrimal stent implantation: a randomized clinical trial

  • Online:2016-01-20 Published:2016-01-20

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摘要： 目的评价联合环形电极泪道成形术是否能提高鼻泪管支架管植入术治疗鼻泪管阻塞的疗效及安全性。方法设计临床
随机对照试验，比较施行鼻泪管支架管植入联合环形电极鼻泪管成形术（联合组），与单纯鼻泪管支架管植入术（单纯组）的植管
成功率、植管耗时，术中患者的疼痛程度等，观察拔管并发症及疗效等。结果入选病例总的例数为119例。拔管后6个月时，总
的治愈率为70.9%（83/117），联合组（80.6%，54/67）疗效比单纯组（58.0%，29/50）好，χ2=7.093，P<0.05，差异有统计学意义。总的
植管成功率为98.3%（117/119），有2例患者无法完成支架管植入。植管成功率原联合组比原单纯组高，χ2=6.282，P<0.05，单纯组
的植管耗时较长，单纯组中位数为33 s，联合组中位数为12 s，差异有统计学意义（Z=-36.722，P<0.05）。联合组与单纯组术中疼
痛程度比较，差异无统计学意义（t=0.833，P=0.405）。入选病例总的泪点损伤率为43.6%（51/117），两组泪点损伤率比较，χ2=
1.459，P=0.227，差异无统计学意义。总的拔管困难发生率为9.4%（11/117），联合组（4.5%，3/67）比单纯组（16.0%，8/50）低，χ2=
4.463，P<0.05，差异有统计学意义。其中总的断管发生率为4.3%（11/117），两组断管率比较，χ2=2.964，P=0.085，差异无统计学意
义。Spearman双变量相关分析，植管耗时与疗效的相关系数r5=-0.584，植管耗时与拔管困难的相关系数r6=0.491，拔管困难与
疗效间的相关系数为r10=-0. 511，均P<0.05。结论鼻泪管支架管植入联合环形电极鼻泪管成形术是一种安全、有效的治疗鼻泪
管阻塞的方法。

Abstract: Abstract: Objective To evaluate the effect of annular electrode lacrimal duct reconstruction in improving the safety and efficacy
of nasolacrimal duct stent implantation for treatment of nasolacrimal duct obstruction. Methods This randomized clinical trial
was performed to compare the efficacy, success rate of intubation, time used for stent implantation, intraoperative pain, and
extubation-assciated complications between nasolacrimal stent implantation with and without annular electrode lacrimal duct
reconstruction. Results A total of 119 eligible patients were enrolled in this trial. The total curative rate at 6 months of follow up
after extubation was 70.9% (83/117) in these patients, and was significnatly higher in pateinets with lacrimal duct reconstruction
than in those without [80.6% (54/67) vs 58.0% (29/50); χ2=7.093, P<0.05]. The total success rate of stent implantation was 98.3%
(117/119) in all the patients initially enrolled, and two patients experienced failure of stent implantation and were excluded; the
success rate was signfiicantly higher in patients initially enrolled in the lacrimal duct reconstruction group (χ2=6.282, P<0.05).
The median time required for intubation was shorter in lacrimal duct reconstruction group (12 s vs 33 s; Z=-36.722, P<0.05). The
intendity of intraoperative pain was comparable between the two groups (t=0.833, P=0.405). The total rate of puncta injury was
43.6% (51/117) in these patients and similar between the two groups (χ2=1.459, P=0.227). The total rate of extubation difficulty
was 9.4% (11/117) in all the patients, and was lower in lacrimal duct reconstruction group [4.5% (3/67) vs 16% (8/50); χ2=4.463, P<
0.05]. Stent breakage in extubation occurred in 4.3% (11/117) of the patients with similar rates between the two groups (χ2=2.964,
P=0.085). Spearman bivariate correlation analysis showed that the time required for intubation was inversely correlated with
the treatment efficacy (r=-0.584, P<0.05) and positively with the occurrence of extubation difficulty (r=0.491, P<0.05); extubation
difficulty was inversely correlated with the curative effect (r=-0.511, P<0.05). Conclusion Annular electrode nasolacrimal duct
reconstruction can increase the safety and efficacy of nasolacrimal duct stent implantation for treatment of
nasolacrimal duct obstruction.