目的 评估玻璃酸钠滴眼液联合热敷贴治疗干眼症的临床疗效及安全性。方法 采用多中心前瞻性真实世界临床研究,纳入303例干眼症患者,通过干眼问卷量表、视觉疲劳评分、SchirmerⅠ试验、角膜荧光素染色及泪膜破裂时间等指标,分别于治疗1周和4周评估疗效。结果 治疗4周后,总有效率达94.0%。治疗1周、治疗4周干眼问卷评分、视觉疲劳评分低于治疗前,且治疗4周各评分低于治疗1周(P＜0.01)。治疗1周、治疗4周双眼Schirmer I试验值高于治疗前,且治疗4周高于治疗1周(P＜0.01);治疗1周、治疗4周角膜荧光素颜色评分低于治疗前,且治疗4周低于治疗1周(P＜0.01);治疗1周、治疗4周泪膜破裂时间长于治疗前,且治疗4周长于治疗1周(P＜0.01)。不良事件发生率为0.03%,无严重不良事件及药物相关性反应。结论 玻璃酸钠滴眼液联合热敷贴可有效缓解干眼症状、减轻角膜损伤并延长泪膜稳定性,4周疗程安全有效,长期疗效需进一步验证。
Abstract
Objective To evaluate the clinical efficacy and safety of sodium hyaluronate eye drops combined with hot compress patches in the treatment of dry eye syndromes. Methods A multicenter prospective real-world clinical study was conducted, involving 303 patients with dry eye syndrome. The efficacy were evaluated at 1 week and 4 weeks of treatment through dry eye questionnaire, visual fatigue score, Schirmer I test, corneal fluorescein staining, and tear film break-up time. Results After 4 weeks of treatment, the total effective rate reached 94.0%. The dry eye questionnaire scores and visual fatigue scores at 1 week and 4 weeks of treatment were lower than those before treatment, and the scores at 4 weeks of treatment were lower than those at 1 week of treatment (P<0.01). The Schirmer I test values of both eyes at 1 week and 4 weeks of treatment were higher than those before treatment, and those at 4 weeks of treatment were higher than those at 1 week of treatment (P<0.01). The corneal fluorescein color scores at 1 week and 4 weeks of treatment were lower than those before treatment, and the scores at 4 weeks of treatment were lower than those at 1 week of treatment (P<0.01). The tear film break-up time at 1 week and 4 weeks of treatment was longer than that before treatment, and the time at 4 weeks of treatment was longer than at 1 week of treatment (P<0.01). The incidence of adverse events was 0.03%, with no serious adverse events or drug-related reactions. Conclusions Sodium hyaluronate eye drops combined with hot compress patches can effectively improve dry eye symptoms, reduce corneal damage and prolong the stability of the tear film. A 4-week treatment course is safe and effective, but the long-term efficacy needs further verification.
关键词
干眼症 /
玻璃酸钠 /
热敷 /
联合治疗 /
滴贴并用
Key words
dry eye syndrome /
sodium hyaluronate /
hot compress /
combined therapy /
eye drops and patches used together
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