[A multicenter, randomized, double-masked, placebo-controlled trial of compound wild chrysanthemum eye masks for mild and moderate dry eye].

Objective: To investigate the clinical efficacy and safety of compound wild chrysanthemum eye masks for mild and moderate dry eye. Methods: In this double-masked, multicenter, placebo-controlled, randomized trial, middle-aged and elderly patients with mild and moderate dry eye were enrolled from six hospitals (Xiamen Eye Center of Xiamen University, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Wangjing Hospital of China Academy of Chinese Medical Sciences, Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine and Hebei Eye Hospital). The patients were assigned to the compound wild chrysanthemum eye mask group and the eye mask simulator group based on the random number table. Subjective symptoms of dry eye, visual acuity, break-up time (BUT), Schirmer Ⅰ test, and corneal fluorescent staining were evaluated in all patients before treatment and at 1 and 2 weeks after treatment. All adverse reactions during the treatment and follow-up were recorded. Results: A total of 120 patients were enrolled. Among them, 112 subjects were included for statistical analyses after the exclusion of 8 subjects who were lost for follow-up or had an adverse event, with an age of (54.26±7.44) years. All the indicators were equally comparable between the two groups. Before treatment and at 1 and 2 weeks after treatment, the median (lower quartile, upper quartile) of total score of questionnaires in the eye mask group was 14.50 (10.00, 19.00), 9.00 (5.00, 14.00) and 7.00 (4.00, 10.00), respectively, and that in the control group was 14.00 (9.00, 22.50), 12.00 (6.00, 20.00) and 10.00 (3.50, 17.00), respectively. The score decreased significantly in both groups after 1 week (t=9.1604, S=398.00; P<0.01) and 2 weeks (S=681.00, 575.50; P<0.05) of treatment. The total score of questionnaires in the eye mask group was significantly lower than that in the control group (Z=3.27, 2.81; P<0.05) after treatment. After 1 week of treatment, the average BUT of the eye mask group was (5.71±2.31) s, which was significantly longer than that before treatment (5.06±2.00) s (S =208.50, P<0.05). But there was no significant difference in the control group (S=150.00, P>0.05). After 2 weeks of treatment, there was statistically significant difference in BUT between the two groups (S=407.00, t=3.07; P<0.01). After 1 week of the treatment, the amount of tear secretion in the eye mask group [(6.88±4.78) mm] was significantly larger than that before treatment (S=196.50, P<0.05), while the control group [(6.80±5.85) mm] showed no significant difference (S=55.00, P<0.05). After 2 weeks of the treatment, the amount increased significantly to (7.43±4.86) mm and (7.29±4.56) mm, respectively, in both groups (t=-3.29, -2.26; P<0.05). The difference in the average BUT, Schirmer Ⅰ test result and corneal fluorescent staining between both groups was not statistically significant at each time point. Five mild adverse events occurred, including 2 adverse events (2 times, 3.51%) in the eye mask group and 3 adverse events (4 times, 5.36%) in the control group. Conclusions: Compound wild chrysanthemum eye masks can effectively improve the symptoms and physical signs of mild and moderate dry eye and can be used as an auxiliary treatment. (Chin J Ophthalmol, 2021, 57: 601-607).目的： 探讨局部使用复方野菊花眼贴治疗轻中度干眼的临床效果与安全性。 方法： 前瞻性多中心、随机、双盲、安慰剂平行对照研究。受试者为自2019年4月至9月就诊于厦门大学附属厦门眼科中心、中日友好医院、北京协和医院、中国中医科学院望京医院、山东中医药大学附属眼科医院和河北省眼科医院6家三级甲等医院的中老年轻中度干眼患者。采用计算机区组随机方法将纳入者按1∶1 的比例随机分为试验组和对照组，分别采用复方野菊花眼贴及模拟剂眼贴进行治疗。在治疗前和治疗后1、2周记录并观察患者的干眼相关症状、泪膜破裂时间（BUT）、基础泪液分泌试验（SⅠt）及角膜荧光素钠染色评分，记录治疗过程中的不良事件及不良反应。定量资料的比较采用t检验或Wilcoxon秩和检验，若考虑协变量的影响则采用协方差分析；计数资料的比较采用卡方检验或Fisher确切概率法。 结果： 本研究共纳入符合入选标准的干眼患者120例，排除脱落且未用药的8例后，最终进入统计分析的受试者共有112例，其中男性32例，女性80例，年龄（54.26±7.44）岁（41~75岁）。试验组与对照组各56例（56只眼），各基线指标具有可比性。治疗前和治疗后1、2周，试验组干眼症状总评分分别为14.50（10.00，19.00）、9.00（5.00，14.00）、7.00（4.00，10.00）分，对照组分别为14.00（9.00，22.50）、12.00（6.00，20.00）、10.00（3.50，17.00）分；治疗1周后与治疗前相比，差异均有统计学意义（t=9.16，S=398.00；P<0.01）；治疗2周后与治疗前总评分的差异均有统计学意义（S=681.00，575.50；P<0.05）；试验组治疗后干眼症状总评分均低于对照组（Z=3.27，2.81；P<0.05）。治疗后1周，试验组BUT为（5.71±2.31）s，较治疗前的（5.06±2.00s）s明显延长（S=208.50，P<0.05），而对照组与治疗前相比差异无统计学意义（S=150.00，P>0.05）；治疗2周后两组BUT与治疗前相比差异均有统计学意义（S=407.00，t=3.07；P<0.01）。治疗1周后，两组SⅠt结果分别为（6.88±4.78）和（6.80±5.85）mm，试验组较治疗前明显延长（S=196.50，P<0.05），而对照组与治疗前相比差异无统计学意义（S=55.00，P>0.05）；治疗2周后分别增加至（7.43±4.86）和（7.29±4.56）mm。治疗后各时间点两组的BUT、SⅠt结果及角膜荧光素钠染色评分差异均无统计学意义（P>0.05）。试验过程中共发生5例不良事件（其中不良反应3例），均为轻度不良事件。 结论： 复方野菊花眼贴可缓解轻中度干眼的症状、改善体征，在轻中度干眼的辅助治疗中安全性较好，具有临床应用价值。（中华眼科杂志，2021，57：601-607）.