| Objective: To observe the auxiliary effect and safety of nonsteroidal anti-inflammatory drug Praprofen eye drops in the treatment of allergic conjunctivitis by comparing the changes in symptoms,signs,eosinophils,and dry eye related indicators of patients with seasonal and perennial allergic conjunctivitis in Anning District,Kunming,Yunnan Province before and after treatment.Methods: A prospective,randomized controlled trial was conducted in strict accordance with the inclusion and exclusion criteria.The patients who were diagnosed as seasonal allergic conjunctivitis or perennial allergic conjunctivitis with at least one eye of conjunctival scraping positive eosinophil test in the ophthalmology outpatient department of the First People’s Hospital of Anning District,Kunming,Yunnan Province,from August to December 2022,were selected as the study subjects.The subjects,a total of 240 patients(240 eyes),were divided into three groups with different treatments,according to the random number table: Group A(Group O+P)with 80 eyes of 80 patients received 0.1% Oiopatadine Hydrochloride eye drops(twice a day,1 drop/time)combined with 0.1% Pranoprofen eye drops(4 times a day,1 drop/time);Group B(Group O+H)with 80 eyes of 80 patients received 0.1%Oiopatadine Hydrochloride eye drops(twice a day,1 drop/time)combined with Sodium Hyaluronate eye drops(4 times a day,1 drop/time);Group C(Group O)with 80 eyes of 80 patients received 0.1% Oiopatadine Hydrochloride eye drops(twice a day,1 drop/time).The scores of allergy-related symptoms,signs,eosinophil counts(EOS),and the scores of dye eye-related first tear break-up time(BUT-f),average tear break-up time(BUT-av),Schirmer test(SIT),and tear meniscus height(TMH)were evaluated in the three groups before treatment,1 week and 2 weeks after treatment.The primary efficacy indicators included symptom score,sign score and the number of EOS,while the secondary efficacy indicators include BUT-f,BUT-av,SIT and TMH.The score decline indice of the three groups were calculated according to the scoring criteria for the above items,and then the cure rate,significant efficiency,effective rate,inefficient rate and total effective rate of the three groups of patients were calculated according to the score decline indice.The total effective rate of the three groups of patients was compared,and the adverse reactions of patients after medication were recorded and evaluated.Results: There were no significant differences in baseline population characteristics,symptoms,signs,eosinophil counts and dry eye-related index scores among the three groups of patients before treatment(P>0.05). The symptom scores in the three groups were: before treatment,Group A(12.30±1.51),Group B(12.22±1.45),and Group C(12.22±1.39);1 week after treatment,Group A(4.29±1.18),Group B(5.91±1.16)and Group C(6.85±0.92);2weeks after treatment,Group A(0.66±1.10),Group B(1.06±0.66)and Group C(1.78±1.01).All showed a significant reduction compared to the ones before the treatment(P<0.05,each group respectively).The sign scores in the three groups were:before treatment,Group A(9.96±1.87),Group B(10.00±1.74)and Group C(10.04±0.96);1 week after treatment,Group A(4.59±0.90),Group B(5.44±1.00)and Group C(6.49±1.19),2 weeks after treatment,Group A(0.89±0.93),Group B(1.61±1.97)and Group C(2.71±0.93).All showed a significant reduction compared to the ones before treatment(P<0.05,each group respectively).EOS in the three groups were: before treatment,Group A(24.24±14.71),Group B(24.09±12.06)and Group C(24.16±10.32);1 week after treatment,Group A(8.21±8.27),Group B(8.80±5.68),and Group C(12.30±7.99);2 weeks after treatment,Group A(1.31±2.57),Group B(2.31±2.77),and Group C(3.75±3.03).All showed a significant reduction compared to the ones before treatment(P<0.05,each group respectively).BUT-f in the three groups were: before treatment,Group A(5.08±2.07),Group B(4.80±1.54)and Group C(4.38±1.63);1 week after treatment,Group A(8.58±8.20),Group B(7.86±1.85),and Group C(6.72±1.81);2 weeks after treatment,Group A(11.88±2.36),Group B(10.78 ± 1.37)and Group C(9.03 ± 1.67).All showed a significant improvement compared to the ones before treatment(P <0.05,each group respectively).BUT-av in the three groups were: before treatment,Group A(7.30±1.98),Group B(6.74±1.85)and Group C(6.62±1.65);1 week after treatment,Group A(12.38±3.08),Group B(10.90±2.22)and Group C(9.57±2.43);2 weeks after treatment,Group A(14.67±2.59),Group B(13.65±1.88)and Group C(12.77±1.90).All showed a significant improvement compared to the ones before treatment(P<0.05,each group respectively).SIT in the three groups were: before treatment,Group A(10.18±1.50),Group B(10.34±1.57)and Group C(10.24±1.34);1 week after treatment,Group A(12.69±1.56),Group B(12.26±1.65),and Group C(11.34±1.32);2 weeks after treatment,Group A(13.84 ±1.56),Group B(13.56 ±1.70)and Group C(12.49 ±1.77).All showed a significant improvement compared to the ones before treatment(P<0.05,each group respectively).TMH in the three groups were: before the treatment,Group A(0.18±0.06),Group B(0.19±0.05)and Group C(0.18±0.05);1week after treatment,Group A(0.30±0.07),Group B(0.28±0.07),and Group C(0.23 ± 0.07);2 weeks after treatment,Group A(0.36 ± 0.08),Group B(0.34 ±0.07)and Group C(0.27±0.08).All showed a significant improvement compared to the ones before treatment(P<0.05,each group respectively). At one week after treatment,compared with Group B,symptom scores,sign scores and BUT-av in Group A were significantly improved(P<0.05),while EOS,BUT-f,SIT and TMH were improved respectively,although the difference was not statistically significant(P>0.05),the improvement trend in Group A was more obvious than Group B;compared with Group C,all the indicators in Group A showed significant improvement(P<0.05);compared with Group C,all the indicators in Group B also showed significant improvement(P<0.05). At two weeks after treatment,compared with Group B,symptom scores,sign scores,BUT-f and BUT-av in Group A were significantly improved(P<0.05),while EOS,SIT and TMH were improved respectively,although the difference was not statistically significant(P>0.05),the improvement trend in Group A was obvious than Group B;compared with Group C,all the indicators in Group A showed significant improvement(P<0.05).compared with Group C,all the indicators in Group B also showed significant improvement(P<0.05). The total effective rate at 2 weeks after treatment was 95.0% in Group A,72.5% in Group B and 50.0% in Group C,with significantly difference(P<0.001). No adverse events occurred during the treatment period,no patient had IOP exceeded the range of 10-21 mm Hg,and no patient reported general discomfort after medication.Only a few patients in the three groups at 1 week after treatment reported mild or moderate symptoms of eye irritation,with no statistically significant difference among groups(P>0.05).The stimulation symptoms disappeared after continuing medication,and no patient reported that the symptoms of eye irritation persisted after 2 weeks’ treatment.Conclusion: For seasonal allergic conjunctivitis and perennial allergic conjunctivitis,Pranoprofen eye drops combined with Oiopatadine Hydrochloride eye drops is more effective than Sodium Hyaluronate eye drops combined with Oiopatadine Hydrochloride eye drops or Oiopatadine Hydrochloride eye drops alone.Non-steroidal anti-inflammatory drug Pranoprofen eye drops can enhance the anti-allergic effect,stabilize tear film and improve the dry eye caused by allergic conjunctivitis.It has obvious auxiliary effect on the treatment of allergic conjunctivitis and high safety. |
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