| Objective:to scientifically evaluate the efficacy of mingmu xiaoyao granule in protecting optic nerve of glaucoma patients,and to lay a foundation for the development of new drugs.To establish a standardized clinical trial program for glaucoma optic nerve atrophy.To explore and sort out the new ideas of TCM in the treatment of glaucoma and the protection of optic nerve,and to enrich the theory of TCM in the treatment of eye diseases.The changes of scores of visual field injury of different types of glaucoma before and after treatment,the changes of scores of visual field injury of different stages of glaucoma before and after treatment.Research background:mingmu xiaoyao granules is a traditional Chinese medicine preparation for the treatment of optic neuropathy developed by professor Yuying Wei from the department of ophthalmology of Guanganmen hospital in the 1960s.This product prescription is composed of bupleurum,fuling,atractylodes macrocephala,angelica root,radix paeoniae alba,liquorice,chrysanthemum,medlar fruit,danpi,gardenia fruit,mint,acorus gramineus,which has the function of nourishing the liver,nourishing the blood,raising the Yang,Yuying Wei is used for the treatment of pediatric optic nerve atrophy and traumatic optic nerve atrophy and other eye diseases.In the past 30 years,with the change of disease spectrum,mingmu xiaoyao granule with the function of dredging the liver and nourishing the blood and promoting the Yang has been applied in our department to treat glaucoma optic nerve atrophy(syndrome of liver stagnation and blood deficiency)with good results.According to the preliminary statistics,the effective rate reached 80-90%.Methods:clinical trial protocols were designed and standardized according to the requirements of GCP.This study was a randomized,double-blind,placebo-controlled trial with 66 subjects.The treatment was set at 6 months,and all 66 cases in this study will be completed by guang ’anmen hospital,Chinese academy of traditional Chinese medicine.Patients with glaucoma were included,excluded and excluded according to the plan,and those who met the criteria were randomly divided into control group and experimental group,and were randomly stratified.The experimental group was treated with intraocular pressure control+taking mingmu xiaoyao granules twice a day,2 bags each time.The control group was treated with intraocular pressure+placebo,2 times a day,2 bags each time,6 months of treatment,mingmu xiaoyao granules and its placebo granules,all provided by the pharmacy room of guang’anmen hospital,each pack of 9 g.1.(1)demographic data:gender,age,height,weight,etc.;(2)general clinical data:family history,medical history,course of disease,treatment history,combined diseases and medication,etc.2.Safety indicators:(1)vital signs:such as body temperature,blood pressure,respiration,heart rate,etc.;(2)adverse events(keep detailed records at any time).3.Diagnostic indicators:visual acuity(international standard visual acuity chart),intraocular pressure(non-contact tonometer),atrial Angle(slit lamp),fundus examination(direct ophthalmoscope).The above indicators were tested once every 1 month before and after medication and at the end of the experiment,a total of 7 times.4.Curative index(1)main curative index:visual field test.The G 2 procedure was applied in the visibility meter of OCTOPUS and it was tested once before,3 months after and at the end of the experiment,with a total of 3 times.(1)visual field injury score(2)average loss of visual field sensitivity:referring to the MD value in the visual field report.Secondary efficacy index(1)(2)the optic nerve fiber layer tomography(HRT)-Ⅱ detection:before the medication,medication after March 1,test at the end of each test,a total of 3 times.A.Mean RNFL Thickness(Thickness of optic nerve fiber).B.Cup/Disk Ratio,the morphological index of optic nerve.5.TCM syndrome score:formulated according to the TCM industry standard of the People’s Republic of China "TCM disease and syndrome efficacy standard"(1994).Results:66 patients were included in this study,including 27 patients in the mingmu xiaoyao granules group,46 patients in the mingmu xiaoyao granules group,15 patients in the male group,and 31 patients in the female group.27 patients in the placebo group,46 patients in the male group,21 patients in the male group,and 25 patients in the female group.There was no significant difference in gender,age,visual field injury range,local visual field sensitivity loss,vision,intraocular pressure,MD value,MS value and LV value between the two groups through statistical analysis(P>0.05),which was comparable.1.Changes in scores of visual field injuries before and after treatment in the two groups.The mean difference of visual field injuries before and after treatment in the treatment group was 1.04,P=0.005<0.05,indicating significant results.The mean difference between the scores of visual field injuries in the control group before and after treatment was-0.18,P=0.559>0.05,indicating that the results were not significant.It can be considered that there was no significant difference between the scores of visual field injuries in the control group before and after treatment.2.Different types of glaucoma in the change of vision damage score before and after the treatment,in treatment group,the vision angle-closure glaucoma damage score before and after treatment of the mean difference of 1.48,P=0.019<0.05,explain the results significantly,can be thought of angle-closure glaucoma visual field damage score had significant difference before and after the treatment,and significantly than before treatment after treatment.However,the mean difference of visual field injury score of open-angle glaucoma before and after treatment was 0.61,P=0.139>0.05,indicating that there was no significant difference in visual field injury score of open-angle glaucoma before and after treatment.In the control group,the scores before and after treatment of primary open-angle glaucoma vision damage the mean difference of 0.27,P=0.599>0.05,primary open-angle glaucoma vision damage score there was no significant difference before and after the treatment,primary closed-angle glaucoma vision damage score before and after treatment of the mean difference of 0.08,P=0.802>0.05,angle-closure glaucoma vision damage score there was no significant difference before and after the treatment.3.Among the changes in scores of visual field injury before and after treatment in different stages of glaucoma,the mean difference of early glaucoma in the treatment group was 1.33,P=0.003<0.05,indicating that there was a significant difference before and after treatment in scores of early glaucoma visual field injury,and the difference before treatment was significantly greater than that after treatment.However,the mean difference value of glaucoma in the middle stage was 0.50,P=0.459>0.05,indicating that there was no significant difference before and after the scoring treatment for glaucoma in the middle stage.In the control group,the mean difference of early glaucoma was 0.28,P=0.459>0.05.indicating that there was no significant difference before and after the scoring treatment of early glaucoma visual field injury,while the mean difference of middle glaucoma was-0.94,P=0.053>0.05,indicating that there was no significant difference before and after the scoring treatment of middle glaucoma visual field injury.4.The changes of MD value,C/D and RNFL before and after treatment in the two groups were greater than 0.05 in all the comparison P values before and after treatment,suggesting that there was no significant difference between the treatment group and the control group in MD value,C/D and RNFL before and after treatment.It indicates that MD value,C/D,and RNFL are formed under various long-term effects,and the condition tends to be stable with little change.And the treatment time is too short to reflect the therapeutic effect of mingmu xiaoyao granules.5.Visual acuity changes before and after treatment in the two groups.In the control group,the P value before and after visual acuity treatment was less than 0.05,indicating significant results.There was no significant difference before and after visual acuity treatment in the treatment group.6.All P values before and after treatment were greater than 0.05,suggesting that there was no significant difference in iop values between the treatment group and the control group before and after treatment.7.Two groups of patients before and after treatment of TCM symptom scores,in treatment group and control group,the TCM symptom scores before and after treatment comparison of P value is less than 0.05,show the results significantly,can be thought of in treatment group and control group,the symptom scores have significant difference before and after the treatment of traditional Chinese medicine,according to the average difference shows that after treatment significantly greater than before.Conclusion:1.Mingmu xiaoyao granules can improve the visual field injury of glaucoma patients.2.Mingmu xiaoyao granule can reduce the score of visual field injury in glaucoma patients and improve their symptoms of TCM.3.The traditional Chinese medicine of relieving liver and nourishing blood and promoting Yang has better effect on protecting optic nerve of glaucoma. |
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