Flos Buddlejae self-heating steam eye mask combined with sodium hyaluronate eye drops in the treatment of dry eye disease
10.12206/j.issn.2097-2024.202509010
- VernacularTitle:密蒙花中药蒸汽眼罩联合玻璃酸钠滴眼液治疗干眼症的临床研究
- Author:
Zhaodan TAN
1
;
Qian LI
2
;
Yan SHI
1
;
Kangyuan HU
1
;
Jin HUANG
3
Author Information
1. Drug Clinical Trial Institution Office.
2. Department of Ophthalmology, East Hospital Affiliated to Tongji University, Shanghai 200123, China.
3. Department of Pharmacy, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
- Publication Type:Medicine&Clinical
- Keywords:
Flos Buddlejae;
self-heating steam eye mask;
combined treatment of traditional Chinese medicine and western medicine;
dry eye disease
- From:
Journal of Pharmaceutical Practice and Service
2026;44(2):96-102
- CountryChina
- Language:Chinese
-
Abstract:
Objective To assess the clinical efficacy of sodium hyaluronate （0.3%） eye drops combined with herbal self-heating steam eye mask in the treatment of dry eye disease. Methods A prospective randomized controlled clinical trial was performed on 60 patients diagnosed with dry eye at the ophthalmic clinic of a Grade A, Class Ⅲ hospital in Shanghai from June 2023 to September 2024. Specifically, patients were randomly divided into control group and study group. Patients in the control group were treated with sodium hyaluronate （0.3%） eye drops for six weeks; while in the study group, patients received the eye drops combined with the herbal self-heating steam eye mask mainly containing powders of Flos Buddlejae. Subsequently, comparisons and analysis were performed before and after treatment between the two groups in the clinical symptom questionnaire score traditional Chinese medicine （TCM syndrome score），the Chinese dry eye questionnaire score and determination of tear film fluorscein breakup time （FBUT）, and curative effect. Results The quality control standard of the herbal powder in the self-heating steam eye mask was established through TLC and HPLC, and good heating behavior of the herbal self-heating steam eye mask was ascertained heating temperature （43±5）℃; heating duration （≥20 min）, meeting requirements of the product quality control. After treatment for 6 weeks, FBUT was increased, while TCM syndrome score and the Chinese dry eye questionnaire score were both decreased in the study group （P<0.001）. Besides, compared with the control group, TCM syndrome score and the Chinese dry eye questionnaire score were much lower, while the FBUT were higher in the study group （P<0.001）. Moreover, the overall response rate in the study group （81.7%） was much better than that in the control group （25.9%）. Conclusion The combination of sodium hyaluronate （0.3%） eye drops with herbal self-heating steam eye mask could be applied to the clinical treatment of dry eye disease due to its good clinical effects on relieving dry eye symptoms.
