目的：评估3%地夸磷索钠滴眼液在配戴角膜塑形镜且患干眼病(DED)或有DED风险的儿童中的有效性和安全性。

方法：随机对照试验。纳入于2023年11月至2024年11月在重庆爱尔儿童眼科医院就诊的DED患儿或有DED风险的患儿，按1：1的比例随机分配受试者接受每日6次3%地夸磷索钠滴眼液或空白对照。主要指标为基线至第12 wk干眼问卷-5(DEQ-5)评分的变化。次要指标包括非侵入性泪膜破裂时间(NIBUT)、泪河高度、Schirmer试验、角膜荧光染色评分以及眼轴长度。

结果：共纳入80名受试者(80眼，两组各40眼)，平均年龄为11.11±1.88岁，其中女43例(54%)，男37例(46%)，均完成试验。12 wk后，地夸磷索钠组与空白对照组的DEQ-5评分分别为1.88±2.02与2.88±2.79(P=0.079)。地夸磷索钠组在DEQ-5评分的干燥症状评分(-0.33±0.66 vs 0.05±0.81，P=0.023)及NIBUT(6.18±3.73 vs -1.09±4.40 s，P<0.001)在第12 wk显著改善。此外，地夸磷索钠组眼轴未出现增长，而空白对照组出现了眼轴增长(0.00±0.08 vs 0.05±0.10 mm，P=0.013)。次要指标均未观察到其他显著差异。试验期间未发生不良事件。

结论：虽然总体DEQ-5评分无显著改善，但与空白对照相比，3%地夸磷索钠滴眼液可显著改善干燥症状及NIBUT。

METHODS: Randomized controlled trials. Children with DED or at risk of DED were randomly assigned in a 1:1 ratio to receive either 3% diquafosol sodium eye drops 6 times daily or a blank control at Chongqing Aier Children's Eye Hospital from November 2023 to November 2024. The primary endpoint was the change in the Dry Eye Questionnaire-5(DEQ-5)score from baseline at 12 wk. Secondary assessments included non-invasive breakup time(NIBUT), tear meniscus height, Schirmer's test, corneal fluorescein staining score, and axial length.

RESULTS: A total of 80 participants(80 eyes)were enrolled(40 in each group), the average age of the participants was 11.11±1.88 years, with 43 females(54%)and 37 males(46%), and all completed the trial. After 12 wk, the DEQ-5 scores for the diquafosol sodium group and the blank control group were 1.88±2.02 and 2.88±2.79, respectively(P=0.079). The diquafosol sodium group demonstrated a significant improvement in DEQ-5 dryness symptom scores(-0.33±0.66 vs. 0.05±0.81, P=0.023)and NIBUT(6.18±3.73 vs. -1.09±4.40 s, P<0.001)at 12 wk. Additionally, the diquafosol sodium group showed no axial length elongation, in contrast to the blank control group, which exhibited elongation(0.00±0.08 vs. 0.05±0.10 mm, P=0.013). No other significant differences were found in the secondary endpoints. No adverse events occurred during the trial.

CONCLUSION: Although no statistically significant improvements were noted in the overall DEQ-5 scores, the 3% diquafosol sodium eye drops significantly improved dryness symptoms and NIBUT when compared to the blank control group.