Meta Analysis And Clinical Study Of TCM With Anti-VEGF Drugs In DME Treatment

With the prevalence of diabetes and the prolongation of life span,DME was an important factor in the decrease of visual acuity.The current treatment for DME includes anti-vascular Endothelial growth factor(VEGF)drug therapy,steroid therapy,laser photocoagulation,vitrectomy and so on.Although some progress has been made in the clinical treatment of DME,its long-term efficacy has not shown significant advantages and cannot satisfy patients.Traditional Chinese medicine has achieved good efficacy in the treatment of DME,and there are more and more theoretical studies on treatment,proprietary Chinese medicines and specialized prescription tests,which make traditional Chinese medicine have unique advantages in the treatment of DME,but there are few large-scale and standardized clinical studies reported.Based on the current situation,this study first conducted a meta-analysis on the treatment of DME with TCM combination therapy,followed by a clinical observation study on the treatment of DME with TCM combination therapy,so as to provide evidence-based and factual theoretical basis for the treatment of DME with TCM combination therapy,explore its mechanism of action,and provide more comprehensive data for clinical diagnosis and treatment.Objective1.To evaluate the clinical efficacy of traditional Chinese medicine combined with anti-VEGF drugs in the treatment of DME by Meta analysis.2.To observe the safety and efficacy of Xiaozhong Granule combined with Combocept in the treatment of DME,and to compare it with Combocept alone,so as to explore the clinical value of TCM combined therapy in the treatment of DME.Methods1.By searching CNKI,Wanfang,VIP,PubMed,Embace,Cochrane Library,Web of Science and other databases,All randomized controlled trials(RCTs)of DME treated with TCM combined with anti-vegf drugs were collected,and meta-analysis was conducted by Revman5.3 software.2.A total of 45 patients were enrolled in this study from January 2019 to September 2021.The patients were divided into two groups according to a randomized double-blind number table:23 eyes in the experimental group and 22 eyes in the control group.The experimental group was treated with Combocept+Detumescence granule,while the control group was treated with Combocept+placebo.BCVA,CMT,volume of macular edema,total effective rate and adverse reactions were observed before treatment,1 month,2 months,3 months and 6 months after treatment.Results1 Meta-analysis results showed that a total of 32 literatures were included,including 2331 patients and 2521 eyes.Compared with anti-VEGF drug therapy,TCM combined with anti-VEGF drug treatment of diabetic macular edema can significantly improve the best corrected visual acuity(BCVA),Visual acuity chart:MD=4.40,95%CI[2.23,6.57],Z=3.98,P=0.000;,LogMAR visual acuity chart:MD=-0.17,95%CI[-0.20,-0.14],Z=11.74,P=0.000;National standard vision chart:(MD=0.07,95%CI[0.06,0.08],Z=10.78,P=0.000),reduced the central macular thickness(CMT)(MD=-38.86,95%CI[-42.31,-35.42],Z=22.12,P=0.000),improving the total curative effect(OR=3.92,95%CI[2.74,5.60],Z=7.50,P=0.000),TCM syndrome score(MD=-2.68,95%CI[-2.90,-2.45],Z=23.56,P=0.000),Recurrence rate(OR=0.43,95%CI[0.28,0.68],Z=3.6,P=0.000).2 clinical study:(1)comparison of BCVA between the two groups.At 1,2 and 6 months after treatment,the increased VALUE of BCVA in experimental group was better than that in control group(P<0.05),which was statistically significant.After 1,2,3 and 6 months of treatment,BCVA in experimental groups was increased compared with that before treatment(P<0.05),with statistical significance;The visual acuity of the control group improved after 1 month of treatment(P<0.05),while the visual acuity after 2,3 and 6 months did not improve significantly compared with before treatment(P>0.05),which was not statistically significant.(2)Comparison of CMT between the two groups.After 1 month of treatment,there was no significant difference in CMT reduction between the two groups(P>0.05),which was not statistically significant.At 2,3 and 6 months after treatment,the reduction degree of CMT in the experimental group was better than that in the control group(P<0.05),which was statistically significant.CMT of the experimental group at 1,2,3 and 6 months after treatment was significantly lower than that before treatment(P<0.05),which was statistically significant.The CMT of the control group decreased significantly after 1 month of treatment,but showed no significant improvement after 2,3 and 6 months(P>0.05),which was not statistically significant.(3)Comparison of macular edema volume between the two groups.After 1 month of treatment,there was no significant difference in macular edema volume between the two groups(P>0.05),while at 2,3 and 6 months after treatment,the reduction degree of macular edema volume in the experimental group was better than that in the control group(P<0.05),which was statistically significant.The volume of macular edema in the experimental group at 1,2,3 and 6 months after treatment was significantly lower than that before treatment(P<0.05),with statistical significance.In the control group,the volume of macular edema decreased significantly after 1 month of treatment(P<0.05),while the volume of macular edema did not improve significantly after 2,3 and 6 months of treatment compared with before treatment(P>0.05),which was not statistically significant.(4)Comparison of the total effective rate between the two groups.The total effective rate of the experimental group at 1,2,3 and 6 months after treatment was 61.9%,68.4%,68.8%and 69.2%,respectively.In the control group,the total effective rate at 1,2,3 and 6 months after treatment was 50%,35.3%,21.4%and 40%,respectively.The total efficacy of the experimental group for DME patients was better than that of the control group(P<0.05),which was statistically significant.(5)Safety evaluation.There were no serious adverse events in 2 groups during treatment or follow-up.Conclusion:1 The combination of Traditional Chinese medicine and anti-VEGF drugs in DME is superior to the single anti-VEGF drugs in improving BCVA,reducing CMT,improving the total effective rate and reducing the recurrence rate.2(1)Xiaozhong Granule and Combocept showed certain efficacy in improving BCVA,reducing CMT and volume of macular edema in DME patients.(2)Xiaozang granule combined with Combocept was superior to combocept in improving BCVA and total efficacy,reducing CMT and volume of macular edema in DME patients.(3)From the perspective of safety,Xiaozhong granule combined with Combocept is safe in the treatment of DME;(4)Xiaozhong granule combined with Combocept can be used as a safe and effective treatment for DME in clinical practice.