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首页> 外文期刊>Clinical ophthalmology >Assessment of the tolerability profile of an ophthalmic solution of 5% glycyrrhizin and copolymer PEG/PPG on healthy volunteers and evaluation of its efficacy in the treatment of moderate to severe blepharitis
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Assessment of the tolerability profile of an ophthalmic solution of 5% glycyrrhizin and copolymer PEG/PPG on healthy volunteers and evaluation of its efficacy in the treatment of moderate to severe blepharitis

机译：评估5％甘草甜素和PEG / PPG共聚物的滴眼液对健康志愿者的耐受性及其对中重度睑缘炎的治疗效果

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Purpose: To evaluate the tolerability on healthy volunteers and the efficacy on subjects affected by chronic moderate/severe blepharitis of a 5% glycyrrhizin and copolymer poly(ethylene glycol)/poly(propylene glycol)(PEG/PPG) ophthalmic solution.Methods: The study was a randomized, controlled, open label, intra-patient monocentric study. It consisted of two different phases, the assessment of tolerability phase on 20 healthy volunteers, and the evaluation of the efficacy on 21 subjects affected by chronic moderate/severe blepharitis; the treatment period was 2 weeks, followed by 1-week of follow-up. In the efficacy phase, in both eyes, eyelid hygiene was also performed. At day 0, 3, 7, 14, and 21 a complete ophthalmological examination was performed. In the tolerability phase, signs of clinical toxicity were recorded and subject-reported symptoms were collected using a questionnaire. In the efficacy phase, global signs and symptoms of blepharitis scores were collected using standardized photographic scales and questionnaire. The statistical analysis was performed using the Wilcoxon signed-rank test. Results: No ocular signs of drug toxicity were reported. During the treatment period for tolerability phase, there were statistically significant higher scores of tearing and ocular discomfort in the tolerability study group versus the tolerability control group. In the efficacy phase, differences between global scores of the two groups were statistically significant at day 0 (score of the efficacy study group was higher than the efficacy control group; P = 0.005) and at day 21 (score of the efficacy study group was lower than the efficacy control group (P ≤ 0.001).The difference of global scores at day 3, 7, 14, and 21 versus day 0 was statistically significant in both groups. No serious adverse events occurred.Conclusion: The 5% glycyrrhizin ophthalmic solution was well tolerated in healthy volunteers and in patients with chronic moderate/severe blepharitis, and in association with eyelid hygiene showed good clinical anti-inflammatory activity that lasted after instillation suspension.
机译：目的：评价5％甘草甜素和聚（乙二醇）/聚（丙二醇）（PEG / PPG）眼药水的慢性中度/重度睑缘炎对健康志愿者的耐受性和对受试者的疗效。这项研究是一项随机，对照，开放标签，患者内单中心研究。它包括两个不同的阶段，即对20名健康志愿者的耐受性评估，以及对21位受慢性中度/重度睑缘炎影响的受试者的疗效评估。治疗期为2周，然后进行1周的随访。在疗效阶段，两只眼睛都进行了眼睑卫生检查。在第0、3、7、14和21天进行了完整的眼科检查。在耐受性阶段，记录临床毒性迹象，并使用问卷调查收集受试者报告的症状。在疗效阶段，使用标准化照相量表和问卷调查收集眼睑炎评分的总体体征和症状。使用Wilcoxon符号秩检验进行统计分析。结果：未见药物毒性的眼部症状。在耐受性阶段的治疗期间，与耐受性对照组相比，耐受性研究组的撕裂和眼部不适得分在统计学上显着较高。在疗效阶段，两组的总体评分之间的差异在第0天（疗效研究组的得分高于疗效对照组; P = 0.005）和在第21天（疗效研究组的得分为0）具有统计学意义。两组均在第3、7、14和21天与第0天的总体评分差异具有统计学意义，且未发生严重不良事件。结论：5％的甘草酸眼药水在健康志愿者和慢性中度/重度睑缘炎患者中，该溶液的耐受性良好，并且与眼睑卫生有关，显示出良好的临床抗炎活性，可在滴注后持续。

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