| Objective:Purpose:With the prevalence of electronic products,the number of patients suffering from dry eye disease is increasing.Dry eye disease has a very high incidence in the population and is increasing year by year.Acupuncture is an effective method for treating dry eye disease.To demonstrate the superiority of acupuncture in treating dry eye disease and to preliminarily explore the potential mechanism of acupuncture in treating dry eye disease,56 dry eye patients were treated and analyzed for efficacy.Methods:Forty-eight dry eye patients who visited the ophthalmology clinic of the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine from September 2021 to June 2023 were randomly assigned to a control group and an experimental group using a random number table method after signing an informed consent form.Each group had 24 patients.The control group received treatment with sodium hyaluronate eye drops,and the experimental group received treatment with the "near-eye three-needle" acupuncture method combined with syndrome differentiation and acupoint selection and sodium hyaluronate.After 1 month of follow-up,the initial break-up time,average break-up time,tear film stability rating,tear meniscus height,ocular redness score,and OSDI scale score were recorded at three time points:initial diagnosis,5 acupuncture treatments,and 10 acupuncture treatments.Symptom scores,tear and meibomian gland infrared imaging,and corneal fluorescein sodium staining scores were collected before and after treatment.Safety,efficacy,and acceptability were evaluated after treatment.Graphical data were processed using ImageMagick 7.1.1 and imported into ImageJ 1.81 for analysis.Numeric data were imported into Graphpad Prism 9.3.1 for statistical analysis.Results:1.Baseline comparison:There were no significant differences in gender,course of disease,and OSDI scores between the two groups of patients before treatment,indicating comparability.2.OSDI score:There was a significant difference in OSDI scores between the treatment group and the control group at T3(P<0.01),and the difference in OSDI scores between T1 and T2 in both groups had extremely significant statistical significance(P<0.001).3.Symptom score:The symptom scores of both the treatment group(P<0.001)and the control group(P<0.001)decreased significantly after treatment,and the symptom score of the treatment group was lower than that of the control group after treatment(P<0.05).4.Tear film break-up time:The initial tear film break-up time at T3 in both the treatment group(P<0.001)and the control group(P<0.001)increased significantly compared to that at T1,and the tear film break-up time in the treatment group was significantly higher than that in the control group at T3(P<0.05).The difference in tear film break-up time between T2 and T3 was significant(P<0.01).The average tear film break-up time at T3 in both the treatment group(P<0.001)and the control group(P<0.001)was significantly higher than that at T1,and the tear film break-up time in the treatment group was significantly higher than that in the control group at T3(P<0.01).The difference in the average tear film break-up time between T2 and T3 was statistically significant(P<0.05).5.Tear film stability grade:The tear film stability grade at T3 in both the treatment group(P<0.001)and the control group(P<0.05)decreased significantly compared to that at T1.The difference in tear film stability grade between T2 and T3 in the treatment group was extremely significant(P<0.001),and the difference in tear film stability grade between T1 and T3 in both groups was significant(P<0.05).6.Tear meniscus height:There was an extremely significant difference in tear meniscus height between T1 and T2,and between T2 and T3 in the treatment group(P=0.001),and a significant difference between T1 and T3 in the control group(P<0.01).The tear meniscus height in the treatment group was significantly higher than that in the control group at T2(P<0.001).The difference in the change in tear meniscus height between T2 and T3(P<0.01)and between T1 and T3(P<0.05)in the treatment group was higher than that in the control group.7.Eye redness score:The eye redness score in both the treatment group(P<0.001)and the control group(P<0.01)decreased significantly at T3 compared to that at T1,but there was no significant difference between the two groups.8.Meibomian gland morphology analysis:The meibomian gland area in the control group decreased significantly after treatment(P<0.01),but there was no significant change in the meibomian gland area in the treatment group.The meibomian gland area in the treatment group was significantly higher than that in the control group at T3(P<0.05).In addition,the meibomian gland width in the treatment group was also higher than that in the control group(P<0.05)at the endpoint.9.Corneal fluorescein staining score:The corneal fluorescein staining score in the treatment group decreased significantly after treatment(P<0.05),but there was no significant difference between the treatment group and the control group before and after treatment(P>0.05).10.IL-1β content in tears:The IL-1β content in tears decreased significantly after treatment in both the treatment group(P<0.001)and the control group(P<0.001),and the IL-1β content in tears in the treatment group was significantly lower than that in the control group at the endpoint(P<0.001).11.Overall assessment:The treatment group(83.33%)had a significantly higher effectiveness rate than the control group(62.50%)with a statistically significant difference(P<0.05).The acceptability of the treatment group was significantly lower than that of the control group(P<0.01).There was no significant difference in safety evaluation between the treatment group and the control group.Conclusions:1.The combination of "Near-Eye Three-Needles" and the selection of acupoints based on differentiation of syndromes can quickly and effectively relieve the symptoms of dry eye patients in the early stage of treatment,and improve the stability of the tear film of dry eye patients in the later stage of treatment.2.The combination of "Near-Eye Three-Needles" and the selection of acupoints based on differentiation of syndromes can effectively delay the degenerative changes of the meibomian glands in dry eye patients and reduce the content of IL-1β in the tears of dry eye patients.3.The combination of "Near-Eye Three-Needles" and the selection of acupoints based on differentiation of syndromes cannot effectively improve the height of the tear meniscus and the signs of eye congestion in dry eye patients in the long term,nor can it effectively improve the corneal fluorescein staining score of dry eye patients.4.The combination of "J Near-Eye Three-Needles" and differential diagnosis for acupoint selection is safe and effective for treating dry eye,but the acceptance rate is relatively low. |