带细菌滤过装置的滴眼液瓶在自体血清治疗干眼中的应用

摘要

目的 评估带有特殊细菌滤过装置的、无需添加防腐剂的滴眼液瓶装载的自体血清治疗干眼的安全性与有效性.方法 前瞻性队列研究.共纳入60例干眼患者,按随机数字表法分为2组.常规制备自体血清后,均不添加防腐剂,一组装载于带有特殊过滤装置滴眼液瓶(装置瓶组),另一组装载于普通瓶(普通瓶组).开启后装置瓶使用期限为14 d,普通瓶为3d.2组参与者在用药前和用药后2、4周均行表面麻醉后的Schirmer Ⅰ试验(主要疗效指标)、干眼症状问卷表、泪膜破裂时间和角膜荧光素染色检测来评估自体血清疗效.另采用家兔60只,2组各30只,装置瓶和普通瓶自体血清开启后按常规方法给家兔点眼,使用后第3、7、14、21天行瓶中血清细菌培养检测污染率.数据分析采用重复测量的方差分析和基于秩次的重复测量方差分析.结果 30瓶普通瓶中,第3、7、14与21天分别有0、2、4、12瓶污染;30瓶装置瓶中,均未出现污染.4周治疗时期内,2组间表面麻醉后Schirmer Ⅰ试验、干眼症状评分、泪膜破裂时间和角膜荧光素染色差异均无统计学意义.结论 带细菌滤过装置的滴眼液瓶可以有效降低自体血清污染风险,在不影响临床疗效的前提下延长单包装制剂使用期限.%Objective To assess the effect of the use of containers with a sterilizing filter in autologous serum eye drops for the treatment of dry eye.Methods Sixty dry eye patients were recruited for this prospective cohort study.Autologous serum was kept in containers with a sterilizing filter for 30 patients and,for the other 30 patients,autologous serum was kept in conventional containers.Subjects completed the Schirmer Ⅰ test (S Ⅰ T,main outcome),ocular surface disease index (OSDI),fluorescein tear breakup time (BUT),and corneal fluorescein staining (CFS) at baseline,and 2 weeks and 4 weeks after treatment.During home therapy,it is recommended not to use the same conventional container for more than 3 days,and the same containers with a sterilizing filter for more than 14 days.Sixty rabbits were selected for contamination test.Containers with a sterilizing fliter (30 rabbits) or conventional containers (30 rabbits) opened to give drops to rabbits.Contamination of autologous serum was tested at 3,7,14 and 21 days after use.A repeated measured ANOVA and Friedman repeated measured ANOVA on ranks were used for statistical analysis.Results In the group using conventional containers,contamination was found in zero bottle at day 3,2 bottles at day 7,4 bottles at day 14 and 12 bottles at day 21 while no contamination was found in containers with a sterilizing filter.No significant difference was found in S Ⅰ T,OSDI score,BUT and CFS between the two groups during 4 weeks treatment.Conclusion Containers with an adapted filter can reduce the contamination rates in autologous serum eye drops and extend the use of autologous serum eye drops without affecting therapeutic efficacy.