| Objective:Evaluation of the effects of Modified Siwu Wuzi Decoction on optic disc blood flow in primary open angle glaucoma(POAG)caused by liver and kidney deficiency combined with blood stasis using Optical Coherence Tomography(OCTA).The effect would provide a new clinical basis for treating glaucoma optic nerve protection with integrated Chinese and Western medicine.Methods:This prospective randomized controlled study included 50 patients(50 eyes)who were screened and diagnosed as POAG with stable target intraocular pressure by the Hospital of China Academy of Chinese Medical Sciences,and met the Western diagnostic criteria,traditional Chinese medicine(TCM)syndrome differentiation criteria,inclusion criteria and exclusion criteria of POAG with liver and kidney deficiency combined with blood stasis.There were 25 patients(25 eyes)in each group.The TCM group was treated with Modified Siwu Wuzi Decoction combined with intraocular pressure-lowering drugs for 4 weeks,and the control group was treated with intraocular pressure lowering medications for 12 weeks.The main observational indicators were vessel density(VD)in the optic disc,best corrected visual acuity(BCVA)and visual field.The VD in optic disc was divided into whole image,inside disk,peripapillary area according to scanning location.The peripapillary capillary area can be subdivided into the following areas:superior,inferior,nasal,and temporal.Visual field correlation indexes include mean deviation(MD),pattern standard deviation(PSD),visual field index(VFI).Secondary observation indicators were retinal nerve fiber layer(RNFL)thickness,TCM syndrome score and intraocular pressure.RNFL thickness can be divided into the whole image,the superior area,the inferior area,the nasal area and the temporal area according to the scanning site.The visual field and TCM syndrome score were observed twice at baseline and 12 weeks after treatment,and the other observation indicators were observed three times at baseline,4 weeks,and 12 weeks after treatment.Results:1.The data at baselineA total of 50 patients(50 eyes)with POAG were included in this study,including 25 patients(25 eyes)in the TCM group and 25 patients(25 eyes)in the control group.The baseline data between the two groups showed no significant difference in terms of sex,eye type,age,and cup-to-disc area ratio(all at P>0.05),which were comparable.2.VD in the optic discWhen the VD in the whole image,peripapillary capillary area,nasal area,and temporal area were compared between the TCM group and the control group at baseline,there was no statistical significance(all at P>0.05).At 4 weeks and 12 weeks after treatment,the VD in the whole image,peripapillary capillary area,nasal area,and temporal area in the TCM group was significantly higher than that in the control group,and the difference was statistically significant(all at P<0.05).There was no statistical significance in VD inside disk,superior and inferior area between the TCM group and the control group at baseline(all at P>0.05),which were comparable.The VD in inside disk,superior and inferior area in the TCM group were similar to that in the control group at 4 weeks and 12 weeks after treatment,and the difference was not statistically significant(all at P>0.05).In the TCM group,VD in the whole image,peripapillary capillary area,nasal area and temporal area was significantly increased at 4 weeks and 12 weeks after treatment compared with baseline,and the difference was statistically significant(all at P<0.05).When compared 12 weeks after treatment with 4 weeks after treatment in the TCM group,VD in the whole image,peripapillary capillary area,nasal area,and temporal area was similar,and the difference was not statistically significant(all at P>0.05).In the TCM group,the VD in inside disk,superior and inferior area was similar at 4 weeks and 12 weeks after treatment compared with baseline.and the difference was not statistically significant(all at P>0.05).When compared 12 weeks after treatment with 4 weeks after treatment,VD in inside disk,superior and inferior area was similar,and the difference was not statistically significant(all at P>0.05).In the control group,the VD in the whole image,inside disk,peripapillary capillary area,superior area,inferior area,nasal area and temporal area was similar at 4 weeks after treatment and 12 weeks after treatment compared with baseline.The difference was not statistically significant(all at P>0.05)when compared 12 weeks after treatment with 4 weeks after treatment.3.BCVABCVA was comparable between the two groups at baseline,4 weeks,and 12 weeks after treatment,and the difference was not statistically significant(all at P>0.05).The BCVA was comparable when compared at different follow-up time points in both groups,and there was no statistical significance between 4 weeks after treatment and baseline,12 weeks after treatment and baseline,and 12 weeks after treatment and 4 weeks after treatment(all at P>0.05).4.Visual fieldVisual field MD,PSD and VFI were compared between the two groups at baseline and 12 weeks after treatment,and there was no statistical significance(all at P>0.05).When compared the baseline with 12 weeks after treatment in the TCM group,the visual field MD,PSD and VFI were no significant difference(all at P>0.05).When comparing the baseline with 12 weeks after treatment in control group,there was no significant difference in the visual field MD,PSD and VFI as well(all at P>0.05).5.RNFL thicknessThe RNFL thickness of the whole image,the superior area,the inferior area,the nasal area and the temporal area was comparable between the two groups at baseline,4 weeks after treatment and 12 weeks after treatment,and the difference was not statistically significant(all at P>0.05).The RNFL thickness of the whole image,the superior area,the inferior area,the nasal area and the temporal area was comparable when compared at different follow-up time points in both groups,and there was no statistical significance between 4 weeks after treatment and baseline,12 weeks after treatment and baseline,and 12 weeks after treatment and 4 weeks after treatment(all at P>0.05).6.TCM syndrome scoreAfter treatment,the total scores of TCM syndromes in the TCM group were lower than baseline,and difference was statistically significant(P<0.05).The total scores of TCM syndromes at 12 weeks after treatment in the control group were similar to those at baseline,and the results showed no statistical difference(P>0.05).There was no significant difference between TCM group and control group at baseline(all at P>0.05),which was comparable.The scores of the TCM group and the control group were compared at 12 weeks after treatment.The scores of the TCM group in the aspects of waist and knee weakness,fatigue,dizziness,headache and insomnia as well as the total scores of TCM syndrome were lower than those of the control group,and the differences were statistically significant(all at P<0.05).The syndrome scores of the TCM group were similar to those of the control group in the aspects of blurred vision,narrowed visual field,distension and discomfort,dark complexion,dry eyes,pale tongue,dark and white moss,side ecchymosis and thin and astringent pulse,and the differences were not statistically significant(all at P>0.05).At 12 weeks after treatment,the syndrome scores of lumbar and knee weakness,fatigue,dizziness,headache and insomnia in the TCM group were lower than the baseline,and the differences were statistically significant(all at P<0.05),but the symptom scores of blurred vision,narrowed visual field,distension and discomfort,dark complexion,dry eyes,pale tongue,dark and white moss,ecchymosis on the side and thin and astringent pulse were similar to those before treatment,and the differences were not statistically significant(all at P>0.05).There were no statistical differences in the scores of the above syndrome in the control group when compared after 12 weeks of treatment and the baseline(all at P>0.05).7.Intraocular pressureIntraocular pressure between the two groups was comparable at baseline,4 weeks,and 12 weeks after treatment,and the difference was not statistically significant(all at P>0.05).The intraocular pressure was comparable when compared at different followup time points in both groups,and there was no statistical significance between 4 weeks after treatment and baseline,12 weeks after treatment and baseline,and 12 weeks after treatment and 4 weeks after treatment(all at P>0.05).Conclusion:Modified Siwu Wuzi Decoction can improve the VD in the whole image,peripapillary capillary area,nasal area,and temporal area in POAG patients with stable target intraocular pressure and improve the general discomfort symptoms of patients.This provides a new clinical basis for TCM to protect the visual function of POAG patients by improving the blood supply of the optic nerve. |
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