人工泪管留置对内窥镜下泪囊鼻腔吻合术疗效影响的随机对照研究

目的观察环形人工泪管植入对慢性泪囊炎内窥镜下泪囊鼻腔吻合术（EES-DCR）疗效的影响,为规范EES-DCR提供证据。方法临床随机对照试验。选取单纯性慢性泪囊炎180例180眼根据常规EES＋常规DCR手术后是否植入人工泪管分为人工泪管留置组和人工泪管非留置组,患者的入院组别分配按随机分配的原则,并签署知情同意书。人工泪管留置组术中环形植入人工泪管,泪管留置3～6个月后拔出。术后定期随访,鼻内窥镜下观察造瘘口开放情况。根据造瘘口形态及慢性泪囊炎治愈率进行疗效对比。结果 23例23眼不符合入选标准,资料齐全且符合研究标准者共157例157眼,其中人工泪管留置组73例,人工泪管非留置组84例。2组患者性别、年龄构成比差异无统计学意义（P〉0.05）,术后随访12～18个月,平均（14.1±1.1）个月,人工泪管留置组、人工泪管非留置组慢性泪囊炎治愈率分别为89.0%（65/73）、92.9%（78/84）,二者比较差异无统计学意义（χ2=0.700,P=0.403）。2组患者在术后7～14d鼻内窥镜下观察吻合口愈合情况,人工泪管留置组62例、人工泪管非留置组70例泪囊鼻腔吻合口黏膜完全上皮化。长期随访发现人工泪管留置组11例（15.1%,11/73）、人工泪管非留置组8例（9.5%,8/84）患者泪囊鼻腔吻合口及周围2～3mm存在明显瘢痕增生和/或肉芽组织形成,二者比较差异有统计学意义（χ2=157.000,P=0.000）。结论人工泪管留置与否对EES-DCR的疗效无明显影响,一定程度上可刺激造瘘口周围组织增生。

A randomized controlled trial of influence of bicanalicular silicone intubation for endonasal endoscopical dacryocystorhinostomy

Background Endonasal endoscopic dacryocystorhinostomy （EES-DCR） has been evidenced with a quite satisfying outcome for chronic dacryocystitis.But whether the artificial lacrimal silicone intubation in this procedure can improve the operative effectiveness was still in controversy.Objective The aim of this trial was to investigate the influence of artificial lacrimal silicone intubation in EES-DCR on the outcome of the treatment of chronic dacryocystitis.Methods This is a prospective clinically randomized controlled trial.One hundred eighty patients with chronic dacryocystitis were randomly assigned to bicanalicular silicone intubation＋EES-DCR group and only EES-DCR group.Conventional EES-DCR was performed for the patients in only EES-DCR group,and artificial lacrimal silicone tube was intubated after EES-DCR in bicanalicular silicone intubation group.The regular follow-up was curried out after surgery.The status of wound was examined under the nasal endoscope.The patency rate of ostium was recorded and compared between two groups.Written informed consent was obtained from each patient prior to surgery.Results 23 cases（23 eyes） was excluded in this study because of the accordance of operation,and 157 cases finished this trial with 73 cases in bicanalicular silicone intubation group and 84 cases in conventional EES-DCR group.No evident differences were found in demography between two groups （P0.05）.The post-operation follow-up duration was from 12 to 18 months （mean 14.1±1.1 months）.The successful rate of lacrimal system reconstruction was 89.0%（65/73）in bicanalicular silicone intubation group and 92.9%（78/84）in conventional EES-DCR group.No significant statistical difference was found between two groups （χ2=0.700,P=0.403）.From 7 to 14 days （mean 9.3±1.7 d） after operation,the wound surface around the lacrimal ostia was covered by a perfectly epithelized mucosa in 62 cases of bicanalicular silicone intubation group and 70 cases of conventional EES-DCR group.Scar and/or granulation around the lacrimal ostia was found in 15.1% （11/73） patients in bicanalicular silicone intubation group and 9.5% （8/84） patients in conventional EES-DCR group,showing a statistical difference between two groups （χ2=157.000,P=0.000）.Conclusion Bicanalicular silicone intubation＋EES-DCR could not improve the therapeutic outcome of EES-DCR.Moreover,bicanalicular silicone intubation,to some extent,stimulates scar formation and/or granulation around the lacrimal ostia after operation.