| Objective:The purpose of this study is to collect and collate relevant Chinese and English literature and systematically evaluate the efficacy and safety of external treatment of diabetic foot with traditional Chinese medicine through evidence-based medicine methods,so as to provide evidence-based medical evidence for the application and promotion of the treatment of diabetic foot with traditional Chinese medicine.Methods:The literature related to the external treatment of diabetes foot with traditional Chinese medicine in major domestic and foreign databases(CNKI,Wan Fang,VIP,CBM,Pub Med,Cochrane Libra,Embase)was searched from January 1,2013 to December 31,2022,and then the literature was sorted through Note Express software.Two researchers independently completed the screening of literature according to the inclusion criteria,exclusion criteria,outcome indicators,etc.In case of disagreement,The third researcher was involved in the discussion and reached a consensus result to obtain the final document.Data extraction was performed on the final included literature,and quality evaluation was completed using the Cochrane Bias Risk Assessment tool.Meta analysis was performed using Review Manager5.4.Results:This study eventually included 49 literatures with a total sample size of 3926 patients,including 1976 patients in the experimental group and 1950 patients in the control group.The results of meta-analysis showed that:(1)In terms of effective rate:The therapeutic effect of external treatment with Chinese medicine on diabetic foot was higher than that of control group(OR=4.46,95%CI[3.66,5.44],Z=14.73,P<0.00001),the difference was statistically significant;Subgroup analyses were performed according to the duration of treatment.The results of subgroup analysis showed that,Compared with the control group,the experimental group with external treatment of traditional Chinese medicine can significantly improve the effective rate in different courses of treatment.The total combined effect size is that:OR=4.48,95%CI[3.65,5.49],Z=14.40,P<0.00001.(2)In terms of cure rates:Compared with the control group,The use of traditional Chinese medicine therapy group and control group than can significantly improve the cure rate,(OR=2.54,95%CI[2.14,3.03],Z=10.47,P<0.00001),the difference was statistically significant.(3)In terms of ulcer area:The treatment of diabetic foot ulcer with external treatment of traditional Chinese medicine can reduce the ulcer area,and the effect is more effective than that of the control group,(SMD=-3.03,95%CI[-4.24,-1.81],Z=4.87,P<0.00001),the difference was statistically significant.(4)In terms of healing time:The healing time between studies after external treatment with Chinese medicine was less than that of the control group,(MD=-10.49,95%CI[-12.97,-8.02],Z=8.31,P<0.00001),the difference was statistically significant.The subgroup analysis indicated that TCM external treatment could shorten the average healing time in different courses than control group,total combined effect size,MD=-10.49,95%CI[-12.97,-8.02],Z=8.31,P<0.00001.(5)In terms of the peroneal nerve conduction velocity:Motor conduction velocity of the common peroneal nerve:Using Chinese medicine external treatment of trial group of total nerve motor nerve conduction velocity improved effect is better than the control group,(MD=5.76,95%CI[4.96,6.56],Z=14.11,P < 0.00001),the difference was statistically significant;Sensory conduction velocity in the common peroneal:application of Chinese medicine external treatment of trial group of total nerve sensory nerve conduction velocity improved effect is better than the control group(MD=2.51,95%CI[1.89,3.13],Z=8.00,P<0.00001),the difference was statistically significant.(6)In terms of adverse reactions:Combined with the literature analysis of the reported adverse reactions and recurrence rate,there are no serious adverse reactions in the external treatment of diabetic foot with traditional Chinese medicine.Conclusions:(1)The external treatment of diabetes foot with traditional Chinese medicine has obvious advantages over the simple western medicine treatment group in terms of total effective rate,cure rate,shrinking ulcer area,shortening wound healing time,and common peroneal nerve conduction velocity.At the same time,there is no serious adverse reaction,with good safety and low recurrence rate,it is worth recommending.(2)The traditional Chinese medicine for the treatment of diabetic foot mainly focuses on promoting blood circulation,removing blood stasis,clearing heat and detoxing. |