| Objective: The aim of this study was to explore the clinical efficacy and safety of self-made Qingre qushi jiedu recipe in treating stasis dermatitis of humid heat and stasis-toxin syndrome.Method: According to the diagnostic criteria and case selection criteria,70 patients with stasis dermatitis of humid heat and stasis-toxin syndrome who were admitted to the first department of vascular therapy in Shijiazhuang City Hospital of Traditional Chinese medicine from January 2021 to January 2022 were selected to sign the informed consent form,using the method of randomized controlled study,according to the random number table,and the order of patients,70 patients were randomly divided into control group and treatment group,each group have 35 cases.The control group was given basic treatment,the treatment group on the basis of control group was treated with self-made Qingre Qushi Jiedu decoction orally.Four weeks for a course of treatment.Observed and recorded the two groups of patients before and after treatment of safety indicators and clinical efficacy indicators,compared the two groups of data,using SPSS26.0 data for statistical analysis,with P<0.05 for the difference was statistically significant,P<0.01 for the statistical difference was significant,to evaluate it’s clinical efficacy and safety.Results: In the study,total of 3 patients(1 in the treatment group and 2 in the control group)were excluded.Finally 67 cases were included in the statistical analysis,including 34 cases in the treatment group and 33 cases in the control group.1.Before treatment,there was no significant difference between the two groups in sex,age and course of disease(P>0.05).2.The total effective rate of the two groups was 91.18% in the treatment group and 60.61% in the control group(P<0.05).3.Skin temperature: The skin temperature of the two groups decreased after treatment,and the therapeutic effect of the treatment group was better than that of the control group(P<0.01).4.Transcutaneous partial pressure of oxygen: After treatment,transcutaneous partial pressure of oxygen increased in both groups,and the therapeutic effect of the treatment group was better than that of the control group(P<0.01).5.Skin lesion area score: After treatment,the area of skin lesion was improved,and the therapeutic effect of the treatment group was better than that of the control group(P<0.05).6.Clinical symptom score: The clinical symptom scores(including lower limb swelling,exudation,pruritus,desquamation and pigmentation)of the two groups were improved after treatment(P<0.01),and the improvement of erythema symptom was not obvious in the control group(P>0.05),the symptoms of erythema improved significantly in the treatment group(P<0.01).There was significant difference in the improvement of lower limb swelling,exudation,pruritus,erythema and pigmentation between the two groups(P<0.05).The therapeutic effect of the treatment group was better than that of the control group,the improvement of exudation and pigmentation in the treatment group was significantly different from that in the control group(P<0.01).7.Safety Evaluation: Blood routine examination,liver function and kidney function were not abnormal before and after treatment.The two groups of patients did not have significant adverse reactions during treatment,the two groups of drugs are relatively safe.Conclusion: Qingre Qushi Jiedu Recipe can improve the skin temperature,increase the oxygen content of local tissues,and promote the recovery of the area of skin lesion area score,obviously improve the clinical symptoms of patients with stasis dermatitis of humid heat and stasis-toxin syndrome.Compared with simple basic treatment,the addition of Qingre Qushi Jiedu Recipe can increase the cure rate of stasis dermatitis of humid heat and stasis-toxin syndrome,improve the overall curative effect,and prevent the further development of the disease,it is worthy of further application and popularization. |