摘要
目的:提供一种新型可降解泪道栓子的制备方法并对其临床疗效进行评估。
方法:生物材料X、Y的去离子水溶液与CaCl_2相混合,经过离子交换反应生成我们所需要的Z物质,风干后作为一种新型泪道栓子,放入微型PCR管中密封,锢60灭菌常温备用。规格为:直径0.5~1.0mm,长度1.5mm。筛选2006年3~6月我院门诊及术后中度水样液缺乏性干眼(ATD)患者16例(32只眼),女性患者10例,男性患者6例。患者年龄25~50岁,平均年龄35.3±5.7岁。所有患者确诊为干眼并排除其他眼科疾病。全部患者用本文所述栓子治疗,2周内按医嘱随诊,检测7项指标:问卷调查、裂隙灯显微镜检查、干眼仪检查、Schirmer test I(STI)、泪膜破裂时间(BUT)、角膜荧光素染色检查(FL)和结膜印记细胞学检查(CIC)以评估自制可降解泪道栓子的临床疗效。
结果:自制可降解泪道栓子质韧,眼科显微镊正常强度夹取未见变形、破碎现象;栓子浸泡于37℃含有溶菌酶的生理盐水中,5分钟后可复水膨胀为原来的2.0~2.5倍;体外37℃含有溶菌酶的生理盐水中浸泡栓子,每天换液冲洗, 3周内栓子可完全溶解;测得栓子溶解液的PH值为7.3~7.4。临床应用2周内按医嘱随诊,未见泪小管炎、泪囊炎等并发症;1只眼(占3.1%)发生严重的泪溢,冲出上泪道栓子后症状缓解;2例患者(3只眼占9.4%)有轻微的泪溢,第3天症状消失;4例患者(6只眼占18.8%)主诉稍有异物感,1小时后消失。其中显效22只眼,显效率62.5%;有效10只眼,有效率37.5%;无效0例。问卷评分:治疗前评分为40.69±5.32分,治疗后为23.69±3.79分,统计学分析,P<0.01;裂隙灯显微镜检查:治疗前有4只眼下睑缘处可见泪河基本处于完全干涸状态,治疗2周后泪河线形成。有28只眼泪河线远窄于0.3mm,治疗后泪河宽达0.3mm;干眼仪检查:治疗前患者的干眼级别以“Ⅲ/Ⅳ级”为主,治疗后以“Ⅱ/Ⅲ级”为主,统计学分析,p<0.01;STI:治疗前数值为3.47±1.19mm,治疗后数值为5.16±1.17mm,统计学分析,p<0.01;BUT:治疗前数值为3.59±1.10s,治疗后数值为5.25±1.30s,统计学分析,p<0.01;FL:治疗前染色级别以“++/+++”为主,治疗后级别以“+/++”为主,统计学分析,P<0.01;CIC:治疗前患者的CIC分级以Nelson 2级为主,有结膜上皮细胞鳞状化生的现象,治疗后以Nelson 1级为主,杯状细胞增多。对分级进行统计学分析,p<0.05。
结论:自制可降解泪道栓子生物相容性好,复水膨胀后可达到阻塞泪道的作用;临床应用方便,并发症少,可有效改善干眼患者眼表状态,提高泪膜稳定性,对于中度ATD患者短期疗效确切,且制备成本低廉,便于临床推广。
Purpose:To provide the preparative method of a new dissolvable lacrimal plug and evaluate it’s clinical efficacy.
Method:To mix the deionized water-solution of biomaterial X, Y and CaCl_2, through the ion exchange reaction,we got the target material Z, dried and made it as a new kind of lacrimal plug. Stand: diameter(0.5-1.0mm), length(1.5mm), Sterilized with Co60, reserved in PCR tube in RT. 16 patients (32 eyes) with moderate dry eye syndrome from screening clinic service of drye eye from 2006, March to Aril, 10 femals and 6 mals, aging form 25 to 50 years old with average of 35.3±5.7 years old. All the patients were final diagnosed as dry eye without any other eye diseases. All the patients used the self-made lacrimal plug,rechecked in 2 weeks. Questionnaire, Slit lamp micrography examination, DR-1 dry eye meter test,Schirmer test I,BUT test, FL examination and CIC examination were used to evaluate the efficacy of the plug.
Results:Self-made dissolvable lacrimal plug was soft and tenacious, held it with microforceps, we did not find the plug deformed or break ; while soaked in PS and LZM, it could expand to 2.0~2.5 times than before in 5 min. Vitro:37℃:LZM:PS: change PS per day, it could completely dissolve automatically in about 3 weeks. The plug’s PH was 7.3-7.4. Rechecked in 2 weeks after clinical application, we did not find the severe complication such as dacryocanaliculitis and dacrycystitis; 1 eyes (3.1%) happended severe epiphora, after run-out the up lacrimal plug, the syndrome relieved, 2 patients (3 eyes, 9.4%) happened mild epiphora, relieved after 3 days;4 patients (6 eyes, 18.8%) happened slight foreign body sension, disappeared 1 hour later. Post-treatment the subjective symptoms of allpatients relieved, objective index had some improvement. 22 eyes (62.5%) were excellent, 10 eyes (37.5%) were effective, none invalid. Questionnaire: prior treatment the score was 40.69±5.32, post-treatment the score was 23.69±3.79, analysed by SPSS, the P<0.01 ; Slit lamp micrography examination: prior treatment, the lacrimal river of 4 eyes was completely dry, 2 weeks of post-treatment, the lacrimal river appeared, the lacrimal river of 28 eyes was far narrow to 0.3mm, post-treatment, it became broad, the width reached to 0.3mm;DR-1 dry eye meter test:prior treatment the grade value was mainly with“Ⅲ/Ⅳ”, post-treatment the value was mainly with“Ⅱ/Ⅲ”, analysed by SPSS, the p<0.01;Schirmer test I:prior treatment the STI value was 3.47±1.19mm, post-treatment the value was 5.16±1.17mm, analysed by SPSS, the p<0.01;BUT test:prior treatment the value was 3.59±1.10s, post-treatment the value was 5.25±1.30s, analysed by SPSS, the p<0.01;FL examination:prior treatment, the the grade of cornea color were mainly with“++/+++”, post-treatment were mainly with“+/++”, analysed by SPSS, the P<0.01 ; CIC examination:prior treatment the Nelson grade was mainly with grade 2, some of the conjunctiva epithelium happened squamous metaplasia, post-treatment it was mainly with grade 1, goblet cell increased, analysed by SPSS, the p<0.05.
Conclusion:Self-made lacrimal plug had nice biocompatibility, could lock the lacrimal passages after expand through absorb PS. It is convenient to be used in clinical with few complication, it was effective to improve the ocular surface condition of dry eye patients, raise the tear film’s stability, the short-term therapeutic effect was sure for moderate ATD, even more,the preparative cost was low, easy to extend in clinic.
引文
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