| Objective: To observe the clinical efficacy of Tongjing Huoluo Lotion for diabetic foot,discuss the potential mechanism of action,seek for effective traditional Chinese medicine(TCM)therapeutic measures and promote the recovery of diabetic foot.Methods:A total of 80 patients with diabetic foot who sought medical advices in our hospital from August 2015 to August 2017 were enrolled.All the patients met the inclusion criteria and exclusion criteria of the current study,and they were divided into control group and observation group by random number table method.The control group received non-TCM treatments,as well as blood glucose control,lipid anticoagulation,circulation improvement,etc.In addition to these treatments,the observation group was also treated with the self-prepared TCM foot bath prescription(Tongjing Huoluo Lotion)by our hospital.The two groups were compared in terms of the changes of various indexes and the effectiveness of clinical treatment,the examination results of the two groups were recorded for further statistical processing and analyses.Results:1.A total of 80 cases were enrolled,40 cases for each group.The data such as sex ratio,age,history of diabetic foot,BMI,Wagner classification and complications of the two groups were statistically analyzed.There were no statistically significant differences in patient data between the two groups,suggesting certain comparability(P>0.05).2.The levels of fasting blood-glucose(FBG)and 2 hour postprandial blood glucose were obviously reduced in both groups after glucose control treatment according to observation,showing statistically significant differences compared with those before treatment(P<0.05).However,the two groups showed no statistically significant differences(P>0.05);During the treatment process,the changes in the levels of cholesterol and triglyceride in the two groups before and after treatment were recorded and sorted out,and there were no statistically significant differences between the two groups(P>0.05),indicating that the treatment process has no obvious impact on their serum lipid indexes.3.Symptom rating.Chilly sensation and the cold limbs: In the control group,the score before treatment was 3.13±0.34 points,and that after treatment was 1.61±0.18 points;in the treatment group,the score before treatment was 3.06±0.33 points,and that after treatment was 0.77±0.09 points.Soreness and weakness of waist and knees: In the control group,the score before treatment was 2.96±0.32 points,and that after treatment was 1.55±0.17 points;in the treatment group,the score before treatment was 2.93±0.33 points,and that after treatment was 0.64±0.08 points.Numbness of the limbs: In the control group,the score before treatment was 3.09±0.32 points,and that after treatment was 1.63±0.18 points;in the treatment group,the score before treatment was 3.05±0.32 points,and that after treatment was 0.75±0.09 points.Pain of the limbs: In the control group,the score before treatment was 3.04±0.32 points,and that after treatment was 1.60±0.19 points;in the treatment group,the score before treatment was 3.01±0.33 points,and that after treatment was 0.72±0.08 points.The scores of blocked meridians symptom due to Spleen and Kidney Yang Deficiency Syndrome in the two groups were remarkably decreased(P<0.05).The score of blocked meridians symptom due to Spleen and Kidney Yang Deficiency Syndrome in the observation group was obviously lower than that of the control group(P<0.05),showing a statistically significant difference.4.Comparison of ankle brachial index(ABI)before treatment between the two groups: The ABIs of the control group and the observation group was 0.76±0.09 and 0.78±0.08 respectively,showing no statistically significant difference(P>0.05).After treatment,the ABIs of the two groups were obviously increased,and that of the control group 0.90±0.11 was obviously higher than that of the observation group 1.12±0.12,showing a statistically significant difference(P<0.05).5.Comparison of serum COX-2 and MCP-1 before and after treatment between the two groups: The two groups showed no statistically significant differences in serum COX-2 and MCP-1 before and after treatment;the levels of serum COX-2 and MCP-1 in the two groups were evidently decreased after treatment(P<0.05),and those of the observation group after treatment were obviously lower than those of the control group,showing statistically significant differences(P<0.05).6.In the control group,3 cases were cured,10 had evident treatment response,12 had a treatment response and 15 had no treatment response,with an overall response rate of 62.5%;in the observation group,6 were cured,14 were improved,14 had a treatment response and 6 had no treatment response,with an overall response rate of 85.0%.The curative efficacy of the observation group was much better than that of the control group,showing a statsticaly significant difference(P<0.05).7.The wound healing time of the control group was 40.0±4.7 days,apparently lower than that of the observation group was 35.1±4.0 days.There was a statistically significant differences between the two groups in wound healing time(P<0.01).8.Safety analysis: In the control group,2 cases(5.0%)had liver dysfunction,4(10.0%)had abnormalities in blood routine and urine routine,and 2(5.0%)had other conditions;in the observation group,1(2.5%)had liver dysfunction,3(7.5%)had abnormalities in blood routine and urine routine,and 3(7.5%)had other conditions.The two groups showed no statistically significant differences in terms of these data(P>0.05).Conclusion:For patients with diabetic foot,the combination of Tongjing Huoluo Lotion-based fumigation-washing therapy and conventional western medicine measures can be realized systemically and locally.It can not only effectively promote and speed up wound healing,but also improve patients' symptoms.Tongjing Huoluo Lotion has an obvious clinical efficacy for blocked meridians symptom due to Spleen and Kidney Yang Deficiency Syndrome and remarkably down-regulates the levels of COX-2 and MCP-1 in the bodies of patients with diabetic foot. |
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