| Purpose: To investigate the clinical effect and safety of 0.1% pranoprofen in the treatment of patients with mild and moderate dry eye disease.Methods: A randomized,open,parallel,controlled clinical trial was conducted.Total 113 patients(113 eyes)with dry eye were enrolled based on the same diagnosis criteria in Xiamen Ophthalmic Center from June 2015 to January 2016.The patients were randomly divided into 3 groups.Pranoprofen group had 40 patients(40 eyes).40 patients(40 eyes)participated in Fluorometholone group.Control group had 33 patients(33 eyes).All groups were given 0.1% Sodium hyaluronate eye drops as routine treatment,four times daily for 28 days.Pranoprofen group was given 0.1% pranoprofen eye drop,four times daily for 28 days.Fluorometholone groups were given 0.02% fluorometholone eye drops,three times daily for 28 days.Control group was not given any other drugs.Dry eye syndrome score,breakup time of tear film(BUT),corneal fluorescence staining scores,Schirmer I test(SIt),intraocular pressure(IOP),conjunctiva congestion and vision were observed before and 14,28 days after treatment,and prostaglandin E2 concentration in 3 groups in tears was detected by ELISA method.Results: The demography was matched between the three groups(P>0.05).Dry eye syndrome score,vision,conjunctiva congestion,corneal fluorescence staining score and BUT was considerably improved in Pranoprofen group compared with before treatment in post-treated 14 days(all at P<0.05);SIt in the group was elevated in comparison with before treatment in 14 days after treatment,which had not statistically significant(P>0.05).Dry eye syndrome score,conjunctiva congestion,corneal fluorescence staining score and BUT had significant improvements in Fluorometholone group compared with before treatment in 14 days(both at P<0.05).Vision and SIt were elevated in Fluorometholone group compared with before treatment in 14 days,but it had no statistically significant(P>0.05).Dry eye syndrome score were significantly lower in control group than before treatment in 14 days after treatment(P<0.05).All evaluated indexes in Pranoprofen group and Fluorometholone group became better than before treatment in 28 days after treatment(all at P<0.05).Dry eye syndrome score,conjunctiva congestion and vision in the control groups were reduced in comparison with before treatment in 28 days after treatment(P<0.05).Although BUT,corneal fluorescence staining score,Schirmer I test were better than before treatment in 28 days,it has not statistically significant(P>0.05).The corneal fluorescence staining score in Pranoprofer group were lower than the control group in 14 days after treatment;The BUT in the group was significantly delayed in 14 days after treatment in comparison with before treatment.BUT,corneal fluorescence staining score and conjunctiva congestion in Pranoprofer group were better compared with the control group in 28 days after treatment(both at P<0.05).Compared with the Fluorometholone groups,all evaluated indexes in Pranoprofer group had no significant difference in 14 and 28 days after treatment(P>0.05).During the treatment,there was no significant increase at intraocular pressure in the 3 groups.The PEG2 concentration in tear of patients with mild dry eye disease was decreased in the 3 groups in 28 days after treatment.The Pranoprofer eye drops had the best effect.The control group had the least improvement.For the patients with moderate dry eye disease,the PEG2 concentration in tear was improved in the control group in 28 days.At contrast,the PEG2 concentration in tear was decreased in the other two group.Fluorometholone group had the best improvement.Conclusions:Compared with separate use of artifical tears,the combination of pranoprofen eye drops with sodium hyaluronate eye drops can relieve dry eye symptoms and signs and reduce the content of PGE2 in tears more quickly and more effectively for mild and moderate dry eye.At present,pranoprofen and fluorometholone have the same effect. |