Multicenter Observation On The Effect Of BUJING YISHI PIAN On Improving The Visual Function Of Glaucoma After Intraocular Pressure Control

Objective: By observing the changes of vision,visual field,P-VEP,optic coherence tomography(OCT)of retinal nerve fiber layer and TCM syndrome score,the protective effect of BUJING YISHI PIAN on the visual function of glaucoma patients with stable intraocular pressure control was studied.Method: A randomized,positive drug control,parallel group design and open label multicenter clinical research method were used.Patients with glaucoma after intraocular pressure control were randomly divided into experimental group and control group.The experimental group took BUJING YISHI PIAN orally,and the control group took Mecobalamin tablet orally for 6 months,and reexamined once a month.Before treatment and at each follow-up visit,corrected vision,intraocular pressure and other routine ophthalmic examinations were carried out.Static visual field,OCT of retinal nerve fiber layer and P-VEP were examined before and after treatment.And TCM symptom scores were given.The curative effect of Western medicine was evaluated by observing the detection results of corrected vision,visual field,OCT of retinal nerve fiber layer and P-VEP,The curative effect of TCM is evaluated by observing symptom score,the protective effect of BUJING YISHI PIAN tablet on visual function of glaucoma patients after intraocular pressure control was observed.Result: In this study,216 cases were included,108 cases in the experimental group and 108 cases in the control group,38 cases in the shedding(loss of follow-up and nonstandard medication),18 cases in the experimental group and 20 cases in the control group,178 cases were included in the statistics,90 cases in the experimental group(177 eyes)and 88 cases in the control group(170 eyes).(1)There was no significant difference in age,vision,intraocular pressure,visual field,OCT,P-VEP and TCM syndrome between the two groups before treatment(P >0.05);(2)After treatment,curative effect of Western Medicine,the total effective rate was 75.14%,significant rate was 8.47%,effective rate was 25.99%,stable rate was40.68%;the total effective rate of the control group was 73.53%,significant rate was8.24%,effective rate was 25.53%,stable rate was 41.76%,the difference was not statistically significant(P > 0.05);curative effect of TCM,the total effective rate of the treatment group was 71.1%,significant rate was 33.3%,effective rate was37.8 %,The total effective rate of the control group was 56.8%,the significant rate was 20.5%,the effective rate was 36.3%,there was no significant difference(P >0.05).There was no significant difference in the curative effect of traditional Chinese medicine and Western medicine among the three centers(P > 0.05).(3)Static field of vision: Before and after treatment,MS in the experimental group and the control group was improved,the difference was statistically significant(P <0.05),but there was no statistical significance(P > 0.05)in MD and s LV,and there was no statistical significance between the two groups after treatment(P > 0.05).(4)OCT: Before and after treatment,the RNFL in G,N,NS,TI,T in the experimental group was improved,the difference was statistically significant(P <0.05).The RNFL in N,NS,NI,T in the control group was improved,the difference was statistically significant(P < 0.05),There was no significant difference between the two groups(P > 0.05).(5)P-VEP: the peak time of P100 in the experimental group was slightly shortened after treatment,the difference was not statistically significant(P > 0.05),the amplitude was significantly improved,the difference was statistically significant(P < 0.05);The peak time of P100 in the control group was slightly delayed,the difference was statistically significant(P < 0.05),the amplitude was slightly improved,and the difference was not statistically significant(P > 0.05).There was no significant difference between the two groups(P > 0.05).(6)The experimental group had significant effect in improving the unclear vision,eye distension,waist and knee tenderness(P < 0.05),The control group was effective in improving the vision and eye distension(P < 0.05).Compared with the controlgroup,the experimental group had a significant advantage in the symptom score of unclear vision and waist and knee tenderness(P < 0.05).Conclusion: BUJING YISHI PIAN and Mecobalamin can improve the visual function of glaucoma patients after intraocular pressure control,but the two drugs are almost equal in the evaluation of Western medicine.although there is no significant difference in the therapeutic effect of traditional Chinese medicine,BUJING YISHI PIAN is better than Mecobalamin tablet in improving the symptoms of traditional Chinese medicine,which is worthy of clinical promotion and further exploration of the mechanism of action.