| The First Part Clinical study on Quji Tongluo decoction in the treatment of macular edema in branch retinal vein occlusion[Objective]To evaluate the clinical efficacy of Quji Tongluo decoction combined with anti-VEGF drugs in the treatment of macular edema of the branch retinal artery occlusion(BRVO),and to detect the morphological changes of the macula correlated with visual function by optical coherence tomography Angiography(OCTA).[Method]Selecting 100 patients with newly diagnosed BRVO,CRT≥300um,and first-onset patients with a disease duration of less than 4 weeks,which randomly divided into control group and experimental group,50 cases in each group,the control group was treated with anti-VEGF(1+PRN),and the experimental group was treated with Quji Tongluo decoction combined with anti-VEGF(1+PRN).The duration of treatment was 6 months,and the number of ETDRS letters was recorded before treatment and at 1,3,and 6 months after treatment,the central retinal thickness was detected by Optical Coherence Tomography;the vascular density of Superficial Capillary Plexus(SCP),Deep Capillary Plexus(DCP)and SCP-FAZ(Fovea vascularzone)and DCP-FAZ were measured by OCTA.The number of injections in the two groups was recorded at 6 months of treatment.The patients were scored according to the criteria of TCM syndrome differentiation before and after treatment.[Result]At the end of the study,there are 6 cases falling off,including 2 cases in the experimental group and 4 cases in the control group.1 Analysis of TCM Syndrome Improvement:A total of 94 patients were scored by the TCM syndrome score standard before and after treatment,among them,the effective rate of TCM syndrome improvement of 46 patients in the control group was 52%.The total effective rate of TCM syndrome improvement of the 48 patients in the experimental group was 85%,compared with the two groups,theχ2 test was performed,χ2=5,76.the difference was statistically significant(P<0.05).2 ETDRS vision:Following up for 6 months,22 eyes(47.82%)of the 46 eyes in the control group were significantly effective in ETDRS vision;15 eyes(32.60%)were effective,and the total effective rate was 80.42%:there are 5 cases of macular edema aggravated,including One of those developed neovascular glaucoma.40 eyes(83.33%)of the 48 eyes in the experimental eroup were significantly effective in ETDRS vision,best corrected visual acuity was improved by≥20 letters;2 cases(4.17%)were invalid,and macular edema aggravated.and the total effective rate was 90.83%.Compared with both groups at 6 months,there was a statistically significant difference in ETDRS vision between the control group and the experimental group at 6 months after treatment(χ2=5.21,P<0.05).3 Central retinal thickness of the macula(CRT):CRT in both groups was significantly reduced after treatment,the changes at 1 month,3 months,and 6 months after treatment compared with before treatment in each group were statistically significant.There was no statistically significant difference between the two groups after 6 months of treatment.There was a statistically significant difference between the two groups at 1 month,3 months,and 6 months after treatment compared with before treatment.4 Shallow capillary plexus(SCP)vascular perfusion area:The SCP vascular perfusion area increased after treatment in both groups,the changes at 1 month,3 months,and 6 months after treatment in each group compared with before treatment were statistically significant.There was a statistically significant difference between the two groups at 1 months,3 months,and 6 months after treatment compared with before treatment.5 Deep capillary plexus(DCP)vascular perfusion area:The DCP vascular perfusion area increased after treatment in both groups,the control group at 1 month after treatment compared with before treatment was not statistically significant;the changes of at 1 month,3 months,and 6 months after treatment compared with before treatment in each group were statistically significant.There was a statistically significant difference between the two groups at 1 month,3 month,and 6 months after treatment compared with before treatment.6 SCP-FAZ and DCP-FAZ:SCP-FAZ and DCP-FAZ in both groups after treatment were significantly reduced,there was no statistically significant difference between SCP-FAZ and DCP-FAZ in both group at 1 month and 3 months after treatment;there was statistically significant difference in average value of SCP-FAZ and DCP-FAZ at 6 months after treatment;there were statistically significant differences between the two groups at 3 months and 6 months after treatment compared with the pre-treatment.7 Number of injections:The average number of injections in the control group was 4.35±0.24 at 6 months after treatment;the average number of injections in the experimental group was 3.23±0.08 at 6 months after treatment.There were statistically significant differences between two groups(P<0.05).8 Correlation analysis:Central retinal thickness(CRT)was negatively correlated with ETDRS at the corresponding time(r=-0.501,P<0.05).The better vascular perfusion of shallow capillary plexus(SCP)and deep capillary plexus(DCP)in the retinal macular area was significantly positively correlated with the number of EDTRS visual letters(r=0.695,P<0.01;r=0.863,P<0.001),in particular,the area of the blood vessel in the experimental group DCP is the most significant parameter associated with the number of EDTRS visual letters.However,SCP-FAZ and DCP-FAZ are negatively correlated with the number of ETDRS visual letters(r=-0.583,P<0.05;r=-0.621,P<0.05),the smaller the FAZ area is,the more the number of ETDRS letters increases.The SCP-FAZ and DCP-FAZ were statistically significant differences between the experimental group and the control group(P<0.05).[Conclusion]During the process of branch retinal vein occlusion with macular edema occurs,recurrent macular edema is closely related to macular microvascular injury,maintaining good retinal perfusion,especially in DCP,is critical for better visual function in BRVO.At increasing ETDRS letters、the Vascular perfusion area of SCP DCP and reducing CRT、the area size of SCP-FAZ and DCP-FAZ,Quji Tongluo decoction combined with anti-VEGF treatment group compared with the anti-VEGF treatment group,there are significantly statistical differences.And combined with traditional Chinese medicine treatment can significantly improve the TCM syndrome of patients,reduce the number of injections,reduce the economic burden of patients.The second part To study the mechanism of Quji Tongluo decoction in the treatment of retinal tissue in rats with retinal vein occlusion by regulating HIF1α/VEGF pathway[Objective]To explore the Quji Tongluo decoction can prevent the development of retinal vein occlusion disease by inhibiting the expression of HIF1α and VEGF in the retinal tissue of rat model of retinal Vein Occlusion[Method]The RVO rat model was established.The experimental components were high,medium and low doses of Quji Tongluo Formula.The negative control group was gavage with equal volume of normal saline.One group of positive control group was gavage with compound Xueshuantong capsule,and the other group of positive control group was intravitreal injection of anti-VEGF.Through the detection method of Immunofluorescence,RT-PCR,Western-Blot,the expressions of HIF1α,VEGF and VCAM-1 in the retina of RVO rat model before and after treatment with Quji Tongluo decoction were observed.[Result]1.Immunofluorescence semi-quantitative results show:Compared to normal group,the expression of HIF1α.VEGF and VCAM-1 protein in the retinal tissue of the model group were increased significantly.After 28 days of different intervention treatments,the three proteins all decreased,and the difference between each group and the model group was statistically significant(P<0.05).Among them,the high-dose Quji Tongluo group has the most obvious effect on inhibiting the expression of HIF1α.VEGF and VCAM-1 protein,compared with the anti-VEGF group.the two groups reduce the expression of HIF1α and VCAM-1 protein with statistical significance(p<0.05).but reduce the expression of VEGF protein.the high-dose Quji Tongluo group has no significant difference compared with the anti-VEGF group and the middle-dose group(p>0.05).2.RT-PCR results showed:HIF-1α and VEGFmRNA were slightly expressed in the normal control group.The expression level in the model group was significantly increased,and decreased after different interventions.The expression of HIF-lamRNA was not significantly different between the high dose group and the anti-VEGF group(p>0.05),but was significantly different between the other groups(p<0.05).The relative expression of VEGF mRNA was significantly different among the groups(P<0.05).3.Western-Blot results showed:The expression of HIF1α and VEGF protein in the retinal tissue of the blank control group were a small amount,the expression of HIF1αand VEGF protein in the retinal tissue of the model group were increased significantly,and the difference was statistically significant(P<0.05);after treatment for 28 days in each,compared with before treatment,the difference was statistically significant(P<0.05);there was no significant difference between the high-dose group of Quji Tongluo decoction and the anti-VEGF group,it showed that there was no statistically significant difference in the efficacy between the Quji Tongluo decoction group and the anti-VEGF group at 28 days after treatment,the results are consistent with the results of immunofluorescence staining.[Conclusion]1.Microvascular injury related factors HIF1α,VEGF,VCAM-1 play a key role in the occurrence of RVO disease.2.Quji Tongluo decoction can prevent the development of retinal vein occlusion disease by inhibiting the expression of HIF1a and VEGF in the retinal tissue of rat model of retinal Vein Occlusion.3.Quji Tongluo decoction regulating the HIF1α/EGF pathway is effected at the transcriptional level. |
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