| Objective:To observe the curative effect and related indexes of the optimized treatment protocol of integrated TCM and WM in treating DF and compare with the protocol of 2006, then provide a reasonable optimization plan for treating DF.Method:60 patients were randomly divided into two groups by a random number table.Study group(30 patients,1 patient dropped out) was treated by the optimized protocol; Control group(30 patients,2 patients dropped out)was treated by the protocol of 2006.We observed overall curative effect,wound curative effect and changes of hemorheology,blood lipids,ABI,TcPO2 before and after treatment. Meanwhile,we observed changes of safety indexes including general physical examination items,3 routine tests(Blood Routine Test, Urine Routine Test,Stool Routine Test),Hepatic and Renal Function,electrocardiogram before and after treatment and evaluated adverse reactions of treatment.Result:After 1 month's treatment,effective rates of overall curative effect of study group and control group are 100.00% and 82.14% respectively,study group is better than control group(p<0.05).Effective rates of wound curative effect of study group and control group are 96.55% and 78.57% respectively,study group is better than control group(P<0.05). Hemorheology,blood lipids,ABI,TcPO2 are improved significantly(p<0.001 or P<0.05), there're no obvious differences in blood lipids between 2 groups(P>0.05),study group is better than control group in other indexes(P<0.05).The safety indexes demonstrated no evident abnormalities before and after the treatment,and no obvious adverse reactions were reported.Conclusion:1.The optimized treatment protocol of integrated TCM and WM has remarkable overall curative effect and wound curative effect in treating DF.It can obviously improve patients'hemorheology,ABI,TcPO2 and is better than the protocol of 2006.2.Two protocols can improve patients'TC,TG and LDL-C,but have no obvious differences.3.They all have no obvious adverse reactions and are safe and effective for clinical application. |