Purpose:To observe and evaluate the clinical efficacy and safety of Shengqingmingmu decoction combined with acupoint pressure eye protection patch in the treatment of dry eyes with meibomian gland dysfunction of spleen and stomach dampness-heat type.Method:A total of 120 MGD dry eye patients(240 eyes)with dampness-heat type of spleen and stomach who met the inclusion and exclusion criteria of this study were enrolled in the ophthalmic clinic of Dongzhimen Hospital of Beijing University of Chinese Medicine from May 2021 to December 2022 by randomized controlled observation.They were randomly divided into two groups,with 109 effective cases.There were 52 patients(104 eyes)in the experimental group and 57 patients(114 eyes)in the control group.Both groups received basic treatment of "hot compress,massage and cleaning",including warm water fumigation,meibomian gland massage extrusion and sodium hyaluronate eye drops.After meibomian gland massage treatment,levofloxacin,a broad-spectrum antibiotic,was routinely applied to suppress bacteria and relieve the temporary discomfort caused by the operation.On the basis of the control group,the experimental group was given Shengqingmingmu decoction oral administration after eye fumigation,and acupoint pressure eye protection patch treatment.The treatment cycle was 4 weeks.The subjective symptom score(including evaluation of dry eye degree and TCM clinical symptom score),tear film stability index(including FBUT,SIT and lacrimal river height),and indicators of palpebral margin and meibomian gland(including morphological changes of palpebral margin,degree of obstruction of meibomian gland mouth,meibomian gland discharge capacity,and meibomian gland secretion nature)before and after treatment were recorded in the two groups.SPSS Statistics 25 software was used to analyze and evaluate the data.First,the measurement data were tested for normality.For the data conforming to normal distribution,the homogeneity test of variance was performed.If the data were normal with homogeneity of variance,the data was expressed as mean plus or minus standard deviation(x±s).Treatments that fit the normal distribution but had uneven variances or did not fit the normal distribution were represented by the median(interquartile distance)M(P25,P75),using nonparametric tests.In this study,all tests were two-sided,α=0.05 was used as the test level,P<0.05 indicated statistical difference,P<0.01 was a significant mark of difference.Results:The gender,age,China Dry Eye Questionnaire score,subjective symptom score before treatment,tear film stability index,palpebral margin and meibomian gland indexes of the two groups were statistically analyzed,and there were no statistically significant differences in the above indexes between the two groups(P>0.05),which was comparable between the two groups and could be compared with each other.The clinical observation study confirmed that the total effective rate of the control group(basic treatment)was 68.42%,and the total effective rate of the experimental group(Shengqingmingmu decoction combined with acupoint pressure eye care patch treatment)was 96.15%.Both groups were suggested to be effective,and the statistical data showed that the experimental group was significantly superior to the control group(χ2=16.860,P=0.000<0.05).The subjective symptom score,tear film stability index,palpebral margin and meibomian gland index before and after treatment were compared between the two groups.The treatment in both groups could improve the subjective symptoms and the signs of MGD,and the tear film stability was improved(P=0.00<0.05).After treatment,the indexes of the two groups were compared,and there were significant differences(P=0.00<0.05),and the indexes of the experimental group were significantly better than the control group.No local and/or systemic adverse reactions occurred in the two groups during the treatment,which met the safety standards.Conclusion:Shengqingmingmu decoction combined with acupoint pressure eye care patch treatment based on basic conventional therapy can improve the subjective symptoms of patients,improve the stability of tear film,improve the signs of MGD,promote the secretion and excretion of blepharoester.Its curative effect is better than "hot compress,massage,clean" basic treatment.This study preliminarily confirmed the safety of this therapy,which is worthy of further clinical research to further explore. |