Clinical Observation Of The Therapeutic Efficacy Of Zhongjing Lishui Decoction Orally Combined With Conbercept In The Treatment Of Diabetic Macular Edema With Yang Deficiency And Water Flooding Syndrome

Objective:To observe the clinical efficacy of Zhongjing Lishui Decoction orally combined with conbercept in the treatment of diabetic macular edema with Yang deficiency and water flooding syndrome.Methods:Fifty-six patients(56 eyes)meeting the inclusion criteria were selected and randomly divided into 28 patients(28 eyes)in the treatment group and 28 patients(28 eyes)in the control group according to the random number table method.In the treatment group,the patients who completed the first intravitreal injection were treated with Zhongjing Lishui Decoction orally and conbercept intravitreal injection(1+PRN),and on the same day,the patients started to take Zhongjing Lishui Decoction orally with evidence for 12 weeks,and the macular OCT was reexamined after the first month,the second month and the third month,respectively.If the CMT was<300 μm,the condition was observed without further intravitreal injection of Compazine;if the CMT was≥300μm,intravitreal inj ection of Compazine was administered.In the control group,the patients were treated with conbercept intravitreal injection once a month for 3 months(3+PRN).Both groups were treated with diabetic diet,hypoglycemia,hypotension,lipid regulation,and active prevention and treatment of complications.The best corrected visual acuity(BCVA),central macular concavity thickness(CMT),TCM evidence score and adverse effects were collected from the two groups at the screening enrollment period and at the post-treatment visit points of the first month,the second month and the third month,and the above results were statistically analyzed using noninferiority tests to compare the differences between the two groups.Results:The difference d=7.05%between the BCVA effective rate in the treatment group compared with the control group,calculated by the formula C_L=-19.82%,[-19.82%,∞)is completely within[-20%,∞),and the noninferiority test holds;the difference d=6.09%,calculated by the formula C_L=6.32%,[-6.32%,∞)is fully within the range of[-20%,∞),the non-inferiority test is established;the overall efficacy efficiency of the treatment group compared with the control group,the difference d=1.59%,calculated by the formula C_L=-16.96%,[-16.96%,∞)was completely within the range of[-20%,∞),and the non-inferiority test was established;the effective rate of improving TCM symptoms in the treatment group was 57.69%,while that in the control group was only 20.83%,and the treatment group was significantly better than the control group(P<0.05);and no adverse reaction situation occurred in both groups.Conclusion:The efficacy of Zhongjing Lishui Decoction orally combined with conbercept(1+PRN)in the treatment of DME is no less than that the treatment of intravitreal injection of conbercept(3+PRN),and can reduce the thickness of the central macular sulcus retina,improve the best corrected visual acuity of patients,effectively improve the systemic symptoms.There is smaller side effects and better economy,safer and more reliable,more easily accepted by patients than that the treatment of intravitreal injection of conbercept(3+PRN).It has certain clinical application value and significance,and provides a new idea and method for the combined treatment of DME by Chinese and Western medicine.