摘要
目的探讨羊膜泪道修复支架在泪道阻塞性疾病(LDOD)中的治疗效果及并发症。方法采用随机对照临床试验研究方法。收集2014年6月至2015年1月在江西省人民医院眼科就诊的LDOD患者72例72眼,按分区组随机法产生随机表将患者分为试验组和对照组,每组36例36眼。试验组和对照组分别经鼻腔泪道内逆行植入羊膜泪道修复支架和硅胶管,术后3个月和6个月时冲洗泪道,比较2个组泪道冲洗通畅率和不良反应发生率。结果术后3个月时试验组泪道冲洗通畅率为91.7%(33/36),高于对照组的80.6%(29/36),但差异无统计学意义(P=0.307);术后6个月时,试验组泪道冲洗通畅率为88.9%(32/36),高于对照组的75.0%(27/36),但差异无统计学意义(P=0.220)。术后3个月和6个月时,试验组的溢泪发生率均低于对照组,术后3个月时差异有统计学意义(Z=2.729,P=0.006),术后6个月时差异无统计学意义(Z=1.921,P=0.055)。术后6个月时,试验组泪小点充血和渗出物发生率为2.8%(1/36),低于对照组的13.9%(5/36),但差异亦无统计学意义(P=0.199)。结论羊膜泪道修复支架能有效治疗LDOD,其治愈率不低于经鼻腔逆行植入硅胶管的治疗。
Objective To investigate the efficacy and side effects of amnion stent implanted in lacrimal duct for the lacrimal duct obstruction diseases(LDOD).Methods A randomized controlled clinical trial was adopted.Seventy-two eyes of 72 patients with LDOD treated in Jiangxi Provincial People's Hospital from June 2014 to January 2015 was randomized into the experiment group and the control group with amnion stent or silicone tube retrogradely implanted according to grouping in accordance with block randomization with 36 eyes in each group.All patients were performed irrigation of lacrimal passage at 3 and 6 months postoperatively to compare the patency rate of lacrimal duct and side effects between the two groups.This study followed the Declaration of Helsinki.Written informed consent was obtained from each subject prior to entering the study cohort.The study protocol was approved by the Ethics Committee of Jiangxi Provincial People's Hospital(No.2014-002).Results The patency rate of lacrimal duct was 91.7%(33/36)and 80.6%(29/36)at 3 months postoperatively in the experimental and control group,respectively.Although the difference was obvious,there was no statistical significance(P=0.307).The patency rate of lacrimal duct was 88.9%(32/36)and 75.0%(27/36)at 6 months postoperatively in the experimental and control groups,respectively.Similarly,the difference was obvious,however there was no statistical significance(P=0.220).At 3 months and 6 months postoperatively,the incidence of epiphora in the experimental group was lower than that in the control group,it was significantly different(Z=2.729,P=0.006),and there was no significant difference at 6 months postoperatively(Z=1.921,P=0.055).At 6 months follow-up period,the attack rate of side effects,such as dacryon congestion and exudation,was 2.8%(1/36)and 13.9%(5/36)in the experiment and control groups,respectively,however,the difference was no statistical significance(P=0.199).Conclusions The implantation of amnion stent in lacrimal duct for LDOD is effective,and the patency rate of lacrimal duct is not lower than that of the implantation of silicone tube in the lacrimal duct.
作者
崔华
肖凡
赖平红
贺雅琳
周敏
赵家良
Cui Hua;Xiao Fan;Lai Pinghong;He Yalin;Zhou Min;Zhao Jialiang(Departemnt of Ophthalmology,Jiangxi Provincial People's Hospital,Nanchang 330006,China;Departemnt of Ophthalmology,Peking Union Medical College Hospital,Beijing 100010,China)
出处
《中华实验眼科杂志》
CAS
CSCD
北大核心
2020年第12期1061-1065,共5页
Chinese Journal Of Experimental Ophthalmology
关键词
泪道阻塞性疾病
羊膜泪道修复支架
硅胶管
Lacrimal duct obstruction diseases
Amnion lacrimal stent
Silicon tube
