| Objective:The purpose of this study was to explore the clinical effectiveness of Zilong Ointment on damp-heat blocking syndrome of diabetic foot ulcer and the influence of PDGF expression through a controlled experiment,so as to provide clinical data and laboratory data support for the clinical treatment of Zilong Ointment on diabetic foot ulcer.Methods:Sixty patients diagnosed with damp-heat blocking syndrome of diabetic foot ulcer meeting the inclusion criteria of this study were selected.According to the order of admission,the patients were divided into control group and experimental group by random number table method,with 30 cases in each group.Based on conventional treatment,patients in both groups were given Si Miao Yong An Decoction plus or minus internally.The experimental group was given external dressing change with Zilong Ointment,while the control group was given external dressing change with MEBO.The dressing change frequency in both groups was twice a day,lasting for 4 weeks.VAS pain score,wound healing rate,positive rate of bacterial culture in wound secretions,and local wound scores were recorded on 0d,14 d and 28 d,respectively,to evaluate the clinical efficacy of the wound.At the same time,the expression level of PDGF in ulcer tissue was detected by immunohistochemistry(IHC).Based on the above clinical observation and laboratory research data,the system is discussed and analyzed,and the conclusion is drawn.Results:In this study,12 cases were lost or eliminated,including 5 cases in the experimental group,7 cases in the control group,25 cases in the experimental group and 23 cases in the control group.A total of 48 cases were included for experimental research and analysis.(1)There was no significant difference between the two groups in gender,age,course of disease,clinical observation indicators,laboratory detection indicators and other data before treatment(P>0.05),indicating comparability.(2)VAS pain score: There was no significant difference between the two groups after 14 and 28 days of treatment(P>0.05).Intra-group comparison showed that there was no significant difference between the two groups at 14 d and 0d(P>0.05),but there was statistical difference between the two groups at 28 d and 0d(P<0.05).(3)Wound healing rate: There was no statistical difference in the wound healing rate between the two groups after 14 and 28 days of treatment(P>0.05),indicating similar efficacy.Intra-group comparison showed that there was no significant difference between the two groups at 14 d and0d(P>0.05),but there was statistical difference between the two groups at 28 d and 0d(P<0.05).(4)Positive rate of bacterial culture in wound secretions: There was no statistical difference between the two groups at 14 days of treatment(P>0.05),and there was statistical difference at28 days of treatment,and the experimental group was lower than the control group(P<0.05).(5)Score of local wound condition: Among all scores,comparison between groups: The scores of wound depth,exudation volume,exudation character,granulation tissue filling rate and tissue type showed no statistical difference between the two groups after 14 and 28 days of treatment(P>0.05).The score of wound redness and swelling between the two groups showed no significant difference after 14 days of treatment(P>0.05),and the difference was statistically significant after 28 days of treatment.The score of experimental group was lower than that of control group(P<0.05).Intra-group comparison: There were no significant differences in wound depth,oozing fluid character,granulation tissue filling rate and tissue type between the two groups on 14 and 0d(P>0.05),but there were statistically significant differences between the two groups on 28 and 0d(P<0.05).In terms of oozing fluid volume score,There were statistical differences between the experimental group at 14 d and 0d,28 d and 0d,28 d and 14d(P<0.05),there were statistical differences between the control group at 14 d and 0d and 28d(P<0.05),there were no statistical differences between 28 d and 0d(P>0.05),the overall trend was first rising and then declining.However,the score of the control group was not significantly reduced after 28 days of treatment compared with before treatment.In the total score,there was no significant difference between the two groups after 14 and 28 days of treatment(P>0.05).Intra-group comparison showed that there were no significant differences between the two groups at 14 d and0d(P>0.05),but there were statistical differences between the two groups at 28 d and 0d(P<0.05).(6)The total effective rate of the experimental group was 84%,and the total effective rate of the control group was 86.96%.There was no significant difference in the therapeutic effect between the two groups(P>0.05).(7)Adverse reactions and safety: There were 2 cases in the experimental group,1 case in the control group,gastrointestinal discomfort such as abdominal distension and diarrhea,and 1 case in the experimental group,tingling pain in the wound cavity.The discomfort was relieved and did not appear again after standardized administration of traditional Chinese medicine,adjustment of the amount of drug yarn attachment and the position of packing,and there was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).No other serious adverse reactions or safety incidents occurred.(8)Laboratory IHC results: There was no significant difference in PDGF expression between the two groups at 14 d of treatment(P>0.05),but there was a statistical difference at 28 d of treatment(P<0.05),and the experimental group was higher than the control group.Intra-group comparison showed that there were statistical differences between the two groups at 14 d and 0d,28 d and 0d,28 d and 14d(P<0.05),the overall trend was first increased and then decreased,and the expression level of PDGF in the two groups after 14 d and 28 d was higher than that before treatment.Conclusion:In the treatment of diabetic foot ulcer(Damp-heat block syndrome),Zilong Ointment can effectively reduce wound pain,improve local wound conditions,and improve patients’ quality of life to a certain extent.By increasing the expression level of PDGF,Zilong Ointment can further play a role in promoting wound healing.Its efficacy is comparable to that of MEBO,which is clinically safe and feasible,but in improving local inflammation and bacterial infection,Zilong Ointment has more therapeutic advantages and can provide a new choice of clinical drugs for the treatment of diabetic foot ulcer. |
