| Purpose:To evaluate the efficacy of recombinant bovine basic fibroblast growth factor(bFGF)eye-gel on mild to moderate dry eye.Method:In the randomized,double-blind,parallel-controlled clinical study,28 patients(56 eyes)with mild to moderate dry eye were randomly divided into bFGF group and stroma group,who were diagnosed in Xiamen Eye Center,from July 2015 to July 2016.14 patients(28 eyes)in bFGF group were treated with bFGF eye-gel,14 patients(28 eyes)in stroma group were treated with bFGF eye-gel stroma.The primary and secondary efficacy indicators were observed and recorded at pretherapy and 4 weeks after treatment.The primary efficacy indicators included Ocular Surface Disease Index(OSDI),visual acuity(VA),conjunctival hyperemia,tear film break-up time(TBUT),corneal fluorescein sodium staining(FL)and reflex Schirmer test(Schirmer I).The secondary efficacy indicators included conjunctival goblet cell density and squamous metaplasia of epithelial cells.Result:(1)There was no significant difference in all efficacy indicators between two groups at pretherapy(p>0.05).(2)Four weeks after treatment,There was significant improvement in OSDI scores,TBUT,FL,and conjunctival hyperemia in two groups compared with pretherapy(p<0.05),but no significant difference between two groups(p>0.05).The VA and Schirmer I in two groups showed no significant difference compared with pretherapy(p>0.05).(3)Four weeks after treatment,There was significant improvement in conjunctival goblet cell density and squamous metaplasia of epithelial cells in bFGF group compared with pretherapy(p<0.05).(4)No obvious adverse reactions and drug intolerance cases were found in the study.Conclusion:The bFGF eye-gel can safely and effectively improve eye discomfort,repair corneal epithelial damage,improve tear film stability,reduce inflammatory irritation,reduce conjunctival squamous metaplasia and increase conjunctival goblet cell on mild to moderate dry eye. |
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