| Objective:To study the clinical effects of an auto-invented Traditional Chinese medicine(TCM)herb tea,Jiang-Pi-Huo-Xue-Xiao-Shui-Tang,a kind of Chinese medicine on treating diabetic macular edema.And to observing its combination effects with conbercept on treating diabetic macular edema whether is superior to single medication,to provide more optimized treatment methods and ideas for clinical treatment on diabetic macular edema.Methods:Research object from September 2014 to September 2017 in our hospital,87 patients(90 eyes)who meet inclusion criteria with diabetic macular edema were randomly divided into three groups:29 cases in TCM group(30 eye s),29 cases in conbercept group with injection of conbercept in glass body cavity(30 eyes),29 cases in combination group which were treated with glass body cavity injection of conbercept combined with TCM(30 eyes).A daily dose of TCM in water decoction was drinked.Conbercept(chengdu kanghong biotechnology co.,LTD.)was injected with 0.5 mg in the glass body cavity,and the intraocular pressure was lowered by front room puncture.After the operation,theconjunctival sac was coated with the dexamethasone and sterile gauze paste.After 3 course of treatment,the patient was follow-up for 1~3 months.The best corrected vision acuity(BCVA),macular hemorrhage area,macular edema are a,central macular retinal thickness(CMT)and flash-electroretinogram(F-ERG)amplitude changes,the fundus fluorescence angiography(FFA)of vessels were evaluated as the curative effects after 3 months of the treatment.The comprehensive evaluation of curative effect in three groups was evaluated.The evaluation criteria were drawn up with reference to the standard of diagnosis and efficacy of TCM diseases.This study followed the Helsinki declaration,and all patients signed informed consent prior to surgery.Results:The gender,age,course and other general information of the patients in the three groups and the stage composition of DME had no significant difference(P>0.05).There were significant increasing in visual acuity in three groups after the treatment.The visual acuity in TCM group increased by 0.09 ± 0.04.In the conbercept group it was increased by 0.11 ± 0.05,and in the combined group it was increased by 0.25 ± 0.06.The comparison in three groups was significantly different with P<0.05.The efficiency and stability in combined group were better than that in single groups.The total effective rate of vision improvement is 70.00%,73.33%and 80.00%individually in TCM,conbercept and combination groups.In Comparison with fundus hemorrhage curative effect after treatment,the total effective rate was 73.33%in CMT or in conbercept group,and 90.00%in combination group.The comparison was significantly different between CMT or conbecept group(P<0.05).For the effectiveness of macular edema treat ment,the final evaluation was made according to the golden standard.In the TCM group,there were obvious effects in 9 eyes,mild effects in 14 eyes and no effects in 7 eyes.The total effective rate was 76.67%in the TCM group.In Conbercept group,there were obvious effects in 12 eyes,some effects in 12 eyes and no effects in 6 eyes.The total effective rate was 80.00%.While in TCM and Conbercept group,there were obvious effects in 21 eyes,some effects in 5eyes and no effects in4 eyes and the total effective rate was 86.67%.The clinical effectivness of single TCM and single Conbercept are nearly the same(P=0.474),while the combined group had much better clinical result(compared with TCM group,P=0.006,compared with Conbercept group,P=0.044).After treatment,the size of CMT were obvious decreased in three groups:The differnce value was 358.07 ± 107.14mm in TCM group,376.11 ± 116.13mm in conbercept group and 450.25 ± 137.11mm in combination group individually before and after treatment.The changes of ERG b wave in the combined group was significant compared with that in other single groups(P<0.05).The efficiency of ERG was76.67%in CMT group,80.00%in conbercept group and 83.33%in combination group.The comparison in three groups was significantly different with P<0.05,while the efficiency of ERG in combined group were better than that in single groups.Conclusion:The auto-invented Traditional Chinese medicine herb tea can reduce diabetic macular edema,improve patients’ eyesight,no severe ocular and systemic adverse reactions.TCM combines with conbercept is superior to single using of conberceptin or single using Traditional Chinese medicine herb tea in reducing diabetic macular edema and improving patients’ eyesight,which is worthy of clinical promotion. |
