Introduction
Dry eye disease (DED) is a chronic ocular surface disease that seriously affects quality of life. Traditional Chinese medicine (TCM) has prominent advantages in the treatment of DED. This study investigated the efficacy and safety of Chinese medicine Zhangyanming tablets (ZYMT) combined with fluorometholone eye drops (FED) and human epidermal growth factor eye drops (HEGFED) in the treatment of DED.
Methods
This was a randomized controlled study. A total of 122 patients with DED were randomly divided into the intervention group (n = 61) and the control group (n = 61). The control group received FED and HEGFED treatment (one drop twice daily), while the intervention group was given ZYMT (0.84 g orally, three times daily) in addition to the control group’s treatment. Both groups underwent 8 weeks of treatment. The primary outcome was the efficacy rate. The secondary outcomes included the mean change from baseline in the OSDI score and its subscales, tear film breakup time (BUT) and Schirmer’s test.
Results
After 8 weeks of treatment, the efficacy rate was 75.9 % (44/58) in the intervention group versus 54.2 % (32/59) in the control group (absolute difference 21.6 %, 95 % CI, 4.3 %∼37.2 %; risk ratio 1.40). The mean change from baseline in the OSDI score in the intervention group were significantly greater than those in the control group in week 8 (absolute difference -6.25, 95 % CI, -9.08∼-3.42). The mean changes from baseline in BUT, Schirmer’s test were significantly greater in the intervention group than that of the control group in both week 4 (BUT: absolute difference 2.49 s, 95 % CI, 1.82∼3.15 s; Schirmer’s test: absolute difference 1.11 mm/5 min, 95 % CI, 0.28∼1.95 mm/5 min) and week 8 (BUT: absolute difference 2.93 s, 95 % CI, 2.37∼3.49 s; Schirmer’s test: absolute difference 4.36 mm/5 min, 95 % CI, 3.88∼4.84 mm/5 min). No significant difference was observed in the safety profiles in these two groups (P > 0.05).
Conclusion
Compared to using FED and HEGFED alone, combined intervention of ZYMT can effectively ameliorate the eye symptoms of DED patients, and improve the efficacy rate.
扫码关注我们
求助内容:
应助结果提醒方式:
