| Objective In the first part literature research,we aim at teasing the current TCM and western medicine treatment of diabetic microangiopathy.In the second part clinical research,We chose the early diabetic microangiopathy which were classified to Qi Yin deficiency and blood stasis Syndrome,to assess the clinical effects and safety together with health economic evaluation in the treatment of diabetic microangiopathy by Yiqi Yangyin Huoxue method,and then to provide references of methodology and evidences of evidence-based medicine for the treatment of diabetic microangiopathy by TCM.Methods In the first part literature research,we do the work of sorting,analysis and induction of the literature by using the metod of computer retrieval combined with artificial retrieval.In the second part clinical research,through the multicenter,randomized,controlled,single blind study methods,we selected from 6 cooperation units with 122 cases of early diabetic retinopathy and diabetic nephropathy which were classified to Qi Yin deficiency and blood stasis Syndrome,then we randomly divided them into two groups,the control group which contained 55 cases was provided with the foundation treatment schemes,while the experimental group which contained 67 cases was offered with the plan that combined both foundation and TCM treatment.We observed the curative effects and safety indexes before and after 12 weeks of treatments.(Primary effective values:TCM syndrome,quantitative of ptoteinuria in 24 hours,Ccr,visual acuity,fundus examination;Secondary outcome measures:FPG,HbA1c,TC,TG,HDL-C,LDL-C,SBP,DBP,evaluation of quality of life.)83 cases were randomly chose to keep a 36 weeks follow up,then the changes of the curative effects and safety indexes were collected.Finally,we handled the test data by statistical method.Results the current western medicine treatment of diabetic microangiopathy:(1)related to diabetes treatment:control of blood glucose,blood pressure control and regulate blood lipid;(2)drug therapy:aldose reductase inhibitor?antioxidant?protein kinase c inhibitor?hexosamine way inhibitor?AGEs antagonist,etc.(3)non-drug therapy:laserphotocoagulation?vitrectomy?control of protein intake?dialysis and kidney transplantation.the current TCM treatment of diabetic microangiopathy:(1)single chinese herb and chinese herb extracts;(2)compound traditional chinese medicine chinese patent medicine.After 12 weeks of treatment,the primary effective values got some changes as follows:compared with the control group,experimental group obviously improved TCM symptoms,TCM syndrome integral,TCM syndrome total effective rate,level of quantitative of ptoteinuria in 24 hours(P<0.01);but there was no significant difference between the two groups in tongue image,pulse condition,visual acuity,fundus examination and Ccr(P>0.05);in terms of secondary outcome measures,there was also no significant difference between the two groups in FPG,HbAlc,TC,TG,HDL-C,LDL-C,SBP,DBP,evaluation of quality of life.After 36 weeks of treatment,the primary effective values changed as follows:compared,with the control group,experimental group distinctly ameliorated the level of quantitative of ptoteinuria in 24 hours(P<0.01),but there was no significant difference between the two groups in Ccr,visual acuity,fundus examination(P>0.05);and also there was no significant difference in terms of secondary outcome measures between the two groups(P>0.05).There were 4 cases of mild form of gastrointestinal discomfort reaction such as anorexia and diarrhea in the experimental group,when we reduced doses of DaHunag,the discomfort reaction disappeared,meanwhile,there was no apparent gastrointestinal uncomfortable reaction in the control group.Health economic evaluation showed that TCM intervention needed to spend an extra of 38.62 yuan for every increase unit of total effective rate of TCM syndromes,and there was 1 efficient when 2.59 patients attended the treatment.Conclusions1.There was no record of cure of diabetic microangiopathy for TCM and western medicine,the early comprehensive intervention must be the future research direction,and it will also be highlighting the features and advantages of chinese medicine.2.It was effective and safe when Yiqi Yangyin Huoxue method was used to remedy the early diabetic nephropathy which classified to Qi Yin deficiency and blood stasis syndrome.3.The method of Yiqi Yangyin Huoxue could safely improve TCM syndromes of early diabetic microangiopathy such as early diabetic retinopathy and diabetic nephropathy which classified to Qi Yin deficiency and blood stasis syndrome.4.It showed no eye effects when the method of Yiqi Yangyin Huoxue was used to remedy early diabetic retinopathy which classified to Qi Yin deficiency and blood stasis syndrome.5.Health economic evaluation showed that TCM intervention needed to spend an extra of 38.62 yuan for every increase unit of total effective rate of TCM syndromes,and there was 1 efficient when 2.59 patients attended the treatment. |
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