| Objective:To evaluate the improvement of eye symptoms and signs of patients with dry eye by atomization of tripterygium wilfordii,objectively evaluate the clinical efficacy and safety of tripterygium wilfordii,and observe its effect on inflammatory factors IL-1β,IL-6,IL-8,TNF-α in tears of patients with dry eye.The effect of the expression level,the anti-inflammatory effect and the mechanism of its function were studied,and we are trying to find a safe and effective Chinese medicine treatment method was provided for the treatment of dry eye.Method:This study is a prospective study.Under the guidance of clinical epidemiology,evidence-based medicine,and clinical trial research principles of drug clinical trial management standards,a randomized,controlled,double-blind,single-center study was used to evaluate the clinical efficacy and safety of tripterygium wilfordii combined with artificial tears in the treatment of dry eyes,and to study its regulatory role on inflammatory factors in tears of dry eye patients.40 dry eye patients(40 eyes)who met the standard of the study were included in the study.After being enrolled in the study,the patients were randomly divided into the test group and the control group according to the method of random number table.The test group was treated with tripterygium wilfordii(6g tripterygium wilfordii,6g menthol,200ml water decoction)atomization fumigation for 3 times/week,for 20 minutes/time,for 4 weeks;The control group was fumigated with placebo solution(diluted by 20:1 of the original prescription)for 3 times per week for 20 minutes per time for 4 weeks.Combined medication:patients in both groups were treated with 0.1%sodium hyaluronate eye drops for 3 times per day during the treatment period,and other eye drops and related treatments were stopped during the treatment period.Relevant examinations were carried out before and after treatment,and the main observation indicators included the following:in terms of eye symptoms,the severity of eye symptoms of dry eye patients and the improvement effect of treatment on eye symptoms were reflected according to the results of the Ocular Surface Disease Index(OSDI)scale;In terms of eye signs,the Schirmer I Test(SIT)and tear height were used to judge the tear secretion,the tear film break-up time(BUT)was used to evaluate the tear film stability,the eye red index and eye red score were used to show the degree of eye inflammatory reaction,and the corneal fluorescein staining(FLS)score was observed to evaluate the corneal epithelial damage of dry eye patients,The function of meibomian gland was judged by meibomian gland grading.At the cellular and molecular level,the inflammatory factors IL-1β,IL-6,IL-8 and TNF in the tears were detected by collecting the tears of two groups of patients before and after treatment-α To observe the effect of tripterygium wilfordii spray on ocular surface inflammation in patients with dry eye.Safety indicators:The drug delivery method in this study is local atomization,and the safety indicators mainly observe whether there is irritation reaction in the eyes.After each treatment,check the conjunctiva for congestion,corneal epithelium for damage,eyelid for erythema and rash with slit lamp.Result:1.Comparison of clinical efficacy:After treatment,the OSDI score,SIT,FLS score,FBUT,NIBUT,average BUT,eye red index,meibomian gland grade,and lacrimal river height of the test group were significantly improved compared with those before treatment.At the same time,the OSDI score,FBUT,NIBUT,average BUT,eye red index,and lacrimal river height of the control group were also improved to a certain extent compared with those before treatment,The results showed that there were statistical differences between the two groups,which showed that both groups had improved the OSDI score,FBUT,NIBUT,mean BUT,eye red index and tear river height of patients,but the efficacy of the test group was significantly better than that of the control group.The clinical efficacy of the two groups was evaluated by the effective rate of OSDI score improvement.The results showed that the total effective rate of the test group was 90%,and the total effective rate of the control group was 20%.The treatment effect of the test group was significantly better than that of the control group.2.Comparison of changes of inflammatory factors:after treatment,the levels of IL-1β,IL-6,IL-8 and TNF in tears of patients in the test group-α The expression level of IL-1β,IL-6,IL-8 and TNF in the control group was significantly lower than that before treatment,while the levels of the above inflammatory factors in the control group were not significantly changed-α There were significant differences in expression levels,indicating that Tripterygium wilfordii spray could effectively reduce the level of inflammatory factors in tears of dry eye patients,and inhibit the ocular surface inflammatory reaction.3.Safety observation:none of the patients participating in the test had eye irritation reaction,no allergy,skin erythema,corneal epithelial injury,conjunctival hyperemia,elevated intraocular pressure and other adverse reactions,and the safety was high.Conclusion:1.Tripterygium wilfordii spray combined with artificial tears is safe and effective in the treatment of dry eyes.It can significantly improve the clinical symptoms of patients with dry eyes,alleviate the discomfort of the eyes,promote the secretion of tears,significantly improve the stability of tear film,help restore the function of tarsal gland,and have a significant inhibitory effect on ocular surface inflammation.2.Tripterygium wilfordii can significantly reduce the inflammatory factors IL-1β,IL-6,IL-8 and TNF in tears of dry eye patients-α The mechanism of its treatment of dry eye may be related to the inhibition of ocular surface inflammation. |
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