Abstract: Objective To explore the efficacy of oral bromhexine hydrochloride tablets combined with sodium hyaluronate on ocular symptoms and inflammation in patients with dry eye. Design Prospective case series. Participants 120 patients with different types of dry eye who were treated in Department of Ophthalmology, Affiliated Hospital of Southeast University, Jiangbei Hospital from June to December 2018 were selected. Methods patients were divided into observation group and control group by random number table, 60 in each group. The control group was treated with sodium hyaluronate eye drops. The observation group was combined with bromhexine hydrochloride tablets on the basis of the control group, orally 1 tablet each time, 3 times/day, the course of treatment was 4 weeks. After 4 weeks of treatment, the clinical effect, Ocular Surface Disease Index (OSDI) score, tear film rupture time (BUT), tear secretion test (SIt), inflammatory factors [interleukin-6 (IL-6), IL-8, IL-1β)] levels and adverse reactions were compared between the two groups. Main Outcome Measures OSDI score, BUT, SIt, iIL-6, IL-8, IL-1β levels in tears and adverse reactions. Results The total effective rate in the observation group was significantly higher than that in the control group（95% vs. 85%, χ2=6.667, P=0.010）; at 4 weeks after treatment, BUT and SIt in the two groups were significantly higher than those before treatment （all P=0.000）, and BUT and SIt in the observation group were significantly higher than those in the control group （t=9.506，8.767, all P=0.000）, OSDI scores in the two groups were significantly lower than those before treatment （all P=0.000）, and OSDI scores in the observation group were significantly lower than those in the control group （18.84±5.33 vs. 32.21±6.76, t=-17.014, P=0.000）. The levels of IL-6, IL-8 and IL-1β in the two groups were significantly lower than those before treatment （all P=0.000）, and the levels of IL-6, IL-8 and IL-1β in the observation group were significantly lower than those in the control group （t=-19.033, -13.904, -6.212, all P=0.000）; there was no significant difference in adverse reactions between the two groups （3.33% vs. 3.33%, χ2=0.000, P=1.000）. Conclusion Oral bromhexine hydrochloride tablets for 4 weeks has a good clinical effects for the patients with dry eye, which can effectively improve the patients' ocular symptoms, reduce the level of inflammatory factors in the patients' tears, and has good safety. (Ophthalmol CHN, 2021, 30: 195-198)

Key words: bromhexine hydrochloride, dry eye