| Objective: Based on the concept of "combination of disease evidence",it aims to overcome the shortcomings of simple anti-VEGF treatment of diabetic macular edema(DME)and other deficiencies through the combination of traditional Chinese medicine and Western medicine,and comprehensively evaluate the efficacy and safety of Dahuang Zhechong capsule combined with anti-VEGF in the treatment of DME.Methods: 60 patients with DME who met the diagnostic and inclusion criteria were collected and randomly divided into the control group and the experimental group.The control group received intravitreal injection of ranibizumab in the "1 + PRN" scheme,the experimental group was treated combined with Dahuang Zhechong capsule for two months.The central macular thickness(CMT),best corrected visual acuity(BCVA),retinal crosssectional area(RCA),Amsler square table score,fundus quantitative score,traditional Chinese medicine syndrome score,systemic index and injection times of the two groups were recorded before and after treatment.After 2months of treatment,the two groups of patients were followed up for another3 months.The BCVA and CMT of the two groups were recorded at 1 month and3 months respectively.Comprehensive evaluation of the efficacy and safety of Dahuang Zhechong capsule combined with Anti-VEGF in the treatment of DME.Result:(1)Before treatment,the gender,age,duration of diabetes,admission,CMT,BCVA,RCA,Amsler integral and fundus quantification were analyzed.There was no significant statistical difference(P>0.05),which was comparable.(2)CMT comparison: The average CMT after treatment in the trial group was 293.53±103.56 was better than 488.73±170.00(P < 0.05)before treatment,and the average CMT after treatment in the control group was356.83±137.16 was better than 419.80±106.14(P<0.05)during treatment.CMT was better than the control group after treatment in the experimental group(P<0.05).The total effective rate of CMT in the experimental group was 83.33%,and the control group was 70.00%.The CMT in the experimental group was significantly reduced in the follow-up at one month and the follow-up at three months(P<0.05),and the difference was statistically significant,but there was no significant improvement in CMT during the follow-up period of the control group.(3)BCVA comparison: After treatment,BCVA in two groups was better than that before treatmen(P<0.05).The total effective rate of BCVA in the experimental group was 83.33% and 66.67% in the control group.The BCVA of the experimental group was significantly higher than that before treatment in the follow-up period of 1 month and 3 month(P<0.05).The BCVA of the control group was not significantly improved during the followup period.(4)Amsler score comparison: Analysis of the differences in groups according to the results showed that the experimental group after treatment was significantly better than that before treatment(P<0.05).There was no significant improvement in the control group.After the end of treatment,the experimental group was statistically significantly better than the control group(P<0.05).(5)RCA comparison: The RCA of two groups after treatment was better than that before treatment(P<0.05),and the RCA of the experimental group was better than that of the control group(P<0.05).(6)Comparison of quantitative scores of fundus:The quantitative score of fundus in the experimental group after treatment was significantly better than that before treatment(P<0.05),and better than that in the control group(P<0.05).There was no significant improvement in the fundus quantitative score in the control group.(7)Comparison of TCM Syndrome score: After treatment,both groups played a significant role in the symptoms of blurred vision,straight as curved and large as small(P<0.05),but there was no significant improvement in the shading of the main symptoms.All secondary symptoms in the experimental group were significantly improved.In the control group,there was significant improvement only in fatigue,dull complexion and purple lips.Comparison of two groups,the experimental group was significantly better than the control group in improving the five sub symptoms of dry eyes,dark lips,fatigue,lazy speech and dark complexion shortness of breath(P<0.05),the difference was statistically significant.At the end of treatment,the TCM syndrome scores of the two groups were significantly improved(P<0.05),The improvement of TCM syndrome score in the experimental group was significantly better than that in the control group(P<0.05).After treatment,the total effective rate of TCM syndrome integral reduction in the experimental group was 83.33%,in the control group was 33.33%.(8)Comparison of drug injection times: From the beginning of treatment to the end of follow-up,the average number of injections in the experimental group was 1.10 ± 0.31 and the average number of injections in the control group was 1.70 ± 0.65.The average number of injections in the experimental group was less than that in the control group,and the difference was statistically significant(P<0.05).(9)Comparison of blood glucose: The fasting blood glucose and glycosylated hemoglobin in the experimental group after treatment were better than those before treatment(P<0.05)and better than that in the control group(P<0.05),the difference was statistically significant.(10)In the two groups before and after the treatment the patient’s vital signs and laboratory tests not seen obvious abnormity,does not appear harmful response.Conclusion:1.Dahuang Zhechong capsule combined with anti-VEGF and single antiVEGF treatment can be effectively treated DME,reduce oedema.2.Under the guidance of the concept of "combination of disease and syndrome",the application of Dahuang Zhechong capsule combined with antiVEGF in the treatment of DME can give full play to the advantages of integration of traditional Chinese and Western medicine,significantly delay the recurrence of macular edema,reduce the number of injection times,improve visual acuity,improve visual function,achieve simultaneous treatment of symptoms and signs,improve the overall condition of patients and improve prognosis.3.All patients participating in the trial did not have any adverse reactions in the whole process.The treatment is worth clinical promotion. |
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