Efficacy Observation of Heying Lishui Decoction in Treating Macular Edema Second-ary to Retinal Vein Occlusion
OBJECTIVE To observe the clinical efficacy of Heying Lishui Formula in treating macular edema secondary to retinal vein occlusion(RVO-ME).METHODS A total of 110 patients(110 eyes)with RVO-ME treated at Longhua Hospital,affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to June 2023 were included.The patients were randomly divided into a treatment group and a control group,leaving 54 patients(54 eyes)in the treatment group and 49 patients(49 eyes)in the control group for final analysis.The control group received intravitreal injections of Aflibercept,while the treatment group received oral Heying Lishui Formula in addition to the control group's treatment.before treatment and at one,three,six and 12 months post-treatment,best corrected visual acuity(BCVA)was measured.Optical coherence tomography angiography(OCTA)was used to detect macular foveal thickness(CMT),superficial retinal capillary plexus blood flow density(SCP),deep retinal capillary plexus blood flow density(DCP),foveal avascular area(FAZ),non-roundness index(AI),and FAZ range 300 μm Blood flow density(FD-300).RESULTS(1)BCVA:BCVA at all time points after treatment improved compared to before treatment,with statistically significant differences(t1 mon=34.093,t3 mon=57.481,t6 mon=59.741,t12 mon=46.442,all P=0.000).In the control group,BCVA at all time points after treatment also improved compared to before treatment,with statistically significant differences(t1 mon=29.606,t3 mon=49.027,t6 mon=48.711,t12 mon=30.826,all P=0.000).When comparing the two groups after treatment,the treatment group had significantly better BCVA at all time points compared to the control group(t1 mon=3.646,t3 mon=5.068,t6 mon=6.758,t12 mon=11.549,all P=0.000).(2)CMT:In the treatment group,CMT at all time points after treatment decreased compared to before treatment,with statistically significant differences(t1 mon=34.702,t3 mon=52.204,t6 mon=51.470,t12 mon=41.842,all P=0.000).In the control group,CMT at all time points after treatment also decreased compared to before treatment,with statistically significant differences(t1 mon=34.950,t3 mon=42.529,t6 mon=46.152,t12 mon=43.355,all P=0.000).When comparing the two groups after treatment,the treatment group had significantly lower CMT at all time points compared to the control group(t1 mon=2.438,P=0.017;t3 mon=6.649,t6 mon=3.776,t12 mon=6.138,all P=0.000).(3)SCP:In the treatment group,there was no statistically significant difference in SCP at one month after treatment compared to before treatment(P>0.05).SCP increased significantly at three,six,and 12 months after treatment(t3 mon=17.613,t6 mon=13.095,t12 mon=4.640,all P=0.000).In the control group,SCP decreased significantly at one month after treatment compared to before treatment(t=12.963,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher SCP at all time points compared to the control group(t1 mon=16.639,t3 mon=16.125,t6 mon=11.443,all P=0.000;t12 mon=2.975,P=0.004).(4)DCP:In the treatment group,there was no statistically significant difference in DCP at one month after treatment compared to before treatment(P>0.05).DCP increased significantly at three,six,and 12 months after treatment(t3 mon=9.261,t6 mon=6.833,t12 mon=4.749,all P=0.000).In the control group,DCP decreased significantly at one,three,and six months after treatment compared to before treatment(t1 mon=26.876,t3 mon=10.916,all P=0.000;t6 mon=3.486,P=0.001),with no significant changes at 12 months(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher DCP at all time points compared to the control group(t1 mon=23.077,t3 mon=17.558,t6 mon=10.694,t12 mon=7.299,all P=0.000).(5)FAZ:In the treatment group,there was no statistically significant difference in FAZ at one month after treatment compared to before treatment(P>0.05).FAZ decreased significantly at other time points(t3 mon=20.915,t6 mon=16.959,t12 mon=9.167,all P=0.000).In the control group,FAZ increased significantly at one month after treatment compared to before treatment(t=22.974,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly lower FAZ at all time points compared to the control group(t1 mon=21.963,t3 mon=16.895,t6 mon=12.043,t12 mon=6.758,all P=0.000).(6)AI:In the treatment group,AI decreased significantly at 3 and 6 months after treatment compared to before treatment(t3 mon=5.654,t6 mon=3.934,both P=0.000),with no significant changes at other time points(P>0.05).In the control group,AI increased significantly at one month after treatment compared to before treatment(t=7.797,P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly lower AI at one,three,and 12 months compared to the control group(t1 mon=8.029,P=0.000;t3 mon=3.379,P=0.001;t12 mon=2.305,P=0.023),with no significant difference at six months(P>0.05).(7)FD-300:In the treatment group,FD-300 increased significantly at three and six months after treatment compared to before treatment(t3 mon=6.022,t6 mon=5.020,both P=0.000),with no significant changes at other time points(P>0.05).In the control group,FD-300 decreased significantly at one and three months after treatment compared to before treatment(t1 mon=12.729,t3 mon=4.391,both P=0.000),with no significant changes at other time points(P>0.05).When comparing the two groups after treatment,the treatment group had significantly higher FD-300 at one,three,and 6 months compared to the control group(t1 mon=7.324,t3 mon=8.912,t6 mon=5.158,all P=0.000),with no significant difference at 12 months(P>0.05).(8)Injection frequency:The average number of injections in the treatment group was(4.83±0.38),lower than that in the control group(5.17±0.46),and the difference was statistically significant(t=4.104,P=0.000).CONCLUSIONS Heying Lishui Formula can improve the retinal capillary plexus blood flow density of RVO-ME patients and requires fewer injections,making it worthy of clinical promotion.