| Objective: The objective of this study was to assess the therapeutic efficacy of a traditional Chinese medicine treatment protocol(Sanren Decoction plus or minus oral administration+Houttuynia cordata Thunb eye drops ultrasonic atomization)combined with(tarsal gland massage+polyvinyl alcohol eye drops+Beifushu eye gel)for tarsal gland dysfunction of spleen stomach damp heat type.The study aimed to analyze the effectiveness and safety of this protocol and explore new clinical treatment options for this condition.Methods: From January 2022 to December 2022,70 patients(140 eyes)diagnosed with meibomian gland dysfunction(MGD)of spleen stomach damp heat type were selected from the ophthalmic clinic of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine.The study was conducted as a randomized controlled clinical trial.A treatment group and a control group were established.The treatment group received modified Sanren Decoction,oral administration,ultrasonic atomization of Houttuynia cordata eye drops,meibomian gland massage,polyvinyl alcohol eye drops,and Beifushu eye gel,while the control group received tarsal gland massage+polyvinyl alcohol eye drops+Befloxacin eye gel for 2consecutive courses(4 weeks).Before treatment,at 2 weeks,4 weeks,and 4 weeks after the end of the course,the patient’s ocular surface disease index(OSDI),tear secretion volume(Schirmer I test,SLt),tear film rupture time(BUT)Fluorescein(FL)staining,the opening of meibomian gland,the characteristics of meibomian gland secretion,and the proportion of meibomian gland loss were used to evaluate the effectiveness of the two treatment schemes and the clinical efficacy of each group.SPSS26.0 software was used to perform statistical analysis on the data obtained from this clinical observation.In terms of safety,the study evaluated the safety of drug use,and in case of adverse reactions,active treatment was administered,and the decision of whether to continue participation in the study was re-evaluated.Results: 1.At the end of the trial,64 patients(128 eyes)completed the traditional Chinese medicine treatment for a total of 4 weeks,and all subjects were followed up 4 weeks after treatment.The baseline data analysis of the two groups of patients before treatment showed that there was no statistical difference in gender,age,course of disease,OSDI score,meibomian gland opening,characteristics of meibomian gland secretion,proportion of meibomian gland loss,BUT,SLt and FL scores,which were comparable(P>0.05).2.Intra-group comparison after treatment: After 2 weeks of treatment,the treatment group exhibited significant improvement in OSDI,meibomian gland opening,meibomian gland secretion,BUT and FL compared to pre-treatment(P<0.05);After4 weeks of treatment,the proportion of meibomian gland loss and SLt were significantly relieved in the treatment group compared to pre-treatment(P<0.05).Both the control group and the treatment group demonstrated improvement in subjective symptoms and objective signs after treatment compared to pre-treatment(P<0.05).The difference between the two groups in the proportion of tarsal gland loss and SLt after 4 weeks of treatment and before treatment was statistically significant(P<0.05).3.Comparison of data between groups after treatment: After 2 weeks of treatment,there was statistically significant difference in OSDI score,meibomian gland opening,BUT and FL(P<0.01);After 4 weeks of treatment,the therapeutic effect of the treatment group was superior to that of the control group(P<0.01).It shows that the treatment group has a better effect on the improvement of symptoms and signs of MGD of damp-heat type of spleen and stomach,while the treatment group has a significant improvement on the characteristics of secretion of tarsal gland,OSDI,BUT and SLt.4.At the 4-week follow-up after the treatment,it was found that the comparison between the two groups was statistically significant(P<0.05).5.Safety results: no adverse reactions occurred.Conclusion:1.The characteristic treatment of traditional Chinese medicine is effective for the treatment of spleen stomach damp heat MGD,and more effective than the simple use of polyvinyl alcohol eye drops,Beifushu eye gel eye drops and tarsal gland massage;2.The characteristic treatment of traditional Chinese medicine can improve OSDI,the opening of the meibomian gland,the characteristics of the secretion of the meibomian gland,BUT,FL;The proportion of meibomian gland loss and SLt,especially for OSDI,meibomian gland opening,BUT and SLt,have significant effects;3.The long-term curative effect of traditional Chinese medicine treatment is better than that of PVA eye drops alone,Beifushu eye gel combined with meibomian gland massage;4.The characteristic treatment scheme of traditional Chinese medicine has fewer adverse reactions and higher safety. |
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