Clinical Observation On Effect Of Supplemented Huajian Erchen Decoction Combined With Aflibercept In Treating NAMD And Study On Serum TNF-α Expression

ObjectiveThe study aims to scientifically evaluate the clinical efficacy of Supplemented Huajian Erchen Decoction Combined with aflibercept in neovascular age-related macular degeneration(nAMD)and to investigate the mechanism of efficacy related to tumor necrosis factor-α(TNF-α).MethodA total of 60(68 eyes)cases of nAMD patients with phlegm and blood stasis were included in the study from the Department of Ophthalmology,People’s Hospital of Fujian University of Chinese Medicine ophthalmology department of Hospital.All patients were randomly divided into observation group(30 cases,34 eyes)and control group(30 cases,34eyes).The observation group was treated with Supplemented Huajian Erchen Decoction Combined with intravitreal aflibercept while the control group was treated with intravitreal aflibercept alone.We observed the aspects of two groups before and after treatment that best corrected visual acuity(BCVA),fundus hemorrhage,exudation area,fundus drusen area,central macular thickness(CMT),choroidal neovascularizatrion(CNV)area.We compared the differences in clinical efficacy,TCM syndrome scores,and the difference in serum TNF-αlevels after 61 days of treatment by statistical analysis.Result1.A total of 60 patients(68 eyes)were included in this study,whole patients completed all treatments and examinations without any shedding.There was no statistically significant difference between the two groups in terms of age distribution,gender difference,BCVA,CMT,TCM syndrome scores,and serum TNF-α level before treatment(P>0.05),and the data were comparable.2.BCVA: After treatment,BCVA in the observation group was 0.4(0.63),a decrease from 0.92(0.33)before treatment.The control group was 0.82(0.52),a decrease from0.96(0.33)before treatment.BCVA decreased significantly in the observation group compared with the control group(P<0.05).The efficacy of BCVA was better in the observation group(91.2%)than that of in the control group(82.4%)(P<0.05).3.CMT:After treatment,CMT in the observation group was 266.90(112.10)μ m,a decrease from 394.00(97.00)μm before treatment.The control group was 321.70(80.05)μm,a decrease from 357.80(149.60)μm before treatment.CMT decreased significantly in the observation group compared with the control group(P<0.05).The efficacy of CMT was better in the observation group(91.2%)than that of in the control group(82.4%)(P<0.05).4.Fundus hemorrhage,exudation area,fundus drusen area,CNV area: After treatment,The efficacy of fundus hemorrhage,exudation area was better in the observation group(94.1%)than in the control group(79.4%)(P < 0.05).The efficacy of fundus drusen area was better in the observation group(85.3%)than in the control group(82.4%)(P < 0.05).The efficacy of CNV area was better in the observation group(91.2%)than that of in the control group(82.4%)(P < 0.05).5.Clinical efficacy: After treatment,the clinical efficacy was better in the observation group(91.2%)than that of in the control group(82.4%)(P<0.05).6.TCM syndrome scores: After treatment,the TCM syndrome scores in the observation group was(9.23±2.96)points,a decrease from(18.60±4.12)points before treatment.The control group was(17.00 ± 4.53)points,a decrease from(19.13 ± 4.90)points before treatment.TCM syndrome scores decreased significantly in the observation group compared with the control group(P<0.05).The efficacy of the integral ratio was better in the observation group(93.3%)than that of in the control group(13.3%)(P<0.05).7.Serum TNF-α level: After treatment,serum TNF-α level in the observation group was(4.47±1.15)pg/ml,a decrease from(6.68±2.02)pg/ml before treatment.The control group was(5.57±1.81)pg/ml,a decrease from(6.31±2.11)pg/ml before treatment.Serum TNF-αlevel decreased significantly in the observation group compared with the control group(P<0.05).Conclusion1.After treatment,the clinical efficacy and TCM syndrome scores reduction of Supplemented Huajian Erchen Decoction combined with intravitreal aflibercept treatment on phlegm and blood stasis nAMD better than ntravitreal aflibercept alone.2.After treatment,the serum TNF-α level reduction of Supplemented Huajian Erchen Decoction combined with intravitreal aflibercept treatment on phlegm and blood stasis nAMD better than ntravitreal aflibercept alone.From this,we speculate that the efficacy advantage of Supplemented Huajian Erchen Decoction on nAMD with phlegm and blood stasis may be due to reducing serum TNF-α levels.