Clinical Research Of Binghuang Antidotal Plaster In The Treatment Of Acute Ulcer And Sore Of YANG Syndrome (Carbuncle And Furuncle)

Objective:To evaluate the clinical efficacy and safety of Binghuang Antidotal Plaster in the treatment of acute ulcer and sore(Carbuncle and Furuncle with the syndrome of accumulated heat-type toxin).Methods:The respective 60 outpatients received during the period of March 2006 to December 2007 at the Surgery Department of Traditional Chinese Medicine of the First Hospital of Shanxi Medical University,whose syndromes accord with the diagnostic standard of the disease of Carbuncle and Furuncle,were selected as the clinical cases.These two types of eases were randomly divided into a treatment group and a control group again,30 cases in each group.The double-blinding and parallel positive-controlled methods were applied to the clinical observation EPIdata Software was used to build up database as data input and management.SAS 9.0 Software Package was used as the statistic analysis tool.Measurement data was analyzed by t-test and enumeration data by x²-test.Ordinal data analysis is wilcoxon rank sum test. Comparison between the means of measurement data of two groups was made by independent sample t-test and comparison before and after treatment by pair-matching t-test.Repetitive data was dealt with variance analysis for repetitive measurement design.Results:1.The differences of the patients in the treatment group and control group on the aspects of sex, age,status of marriage,course of diseases,state of illness,leucocyte enumeration,neutrophile granulocyte percentage are meaningless in statistics(P＞0.05).That shows the base data is balanced and comparable.2.Patients' syndrome scores of for Furuncle of two groups on the 4^th day show that the difference has significance in statistics(P＜0.05).It can be considered that efficacy is better in treatment group than in control group.The 7^th day,no significance in statistics(P＞0.05),but it can't be considered that there exists the difference of efficacy between two groups.Patients' syndrome scores of for Carbuncle of two groups on the 4^th day show that the differences has no significance in statistics(P=0.15),but it can't be considered that there exists the difference of efficacy between two groups.The 7^th day,significant in statistics(P=0.036).It can be considered that efficacy is better in treatment group than in control group. 3.Patients' syndrome scores of the groups have different changing trends on different time points by repeated measurement ANOVA,when different medicines are used.It shows the two medicines are both effective but different at the same time,and the medicine for treatment is superior to the medicine for control.4.The differences on the way of recovery for different groups have no significance in statistics (P＞0.05).It can't be considered that there is difference on the way of recovery for different groups.5.The difference of two groups for the case of furuncle on the period of treatment has significance in statistics(P＜0.05).It shows the period of treatment for treatment group is shorter. For the case of carbuncle,no significance in statistics(P=0.0845),it can't be considered that there is difference for two groups on the period of treatment.6.For the ease of furuncle,the difference for treatment group on WBC enumeration before and after treatment has no significance in statistics(P＞0.05).The difference on NEU percentage has significance in statistics(P＜0.05),but no significance in clinic.Both above two indexes have significance in statistics for control group(P＜0.05),but no significance in clinic.For the case of carbuncle,the difference for both treatment group and control group on both WBC enumeration and NEU percentage before and after treatment has significance in statistics (P＜0.05),and in clinic as well.It shows both of the medicines used to treatment and control are effective on the above two indexes.But for the two cases of furuncle and carbuncle,the difference between treatment group and control group after treatment on WBC enumeration and NEU percentage has no significance in statistics(P＞0.05),it can't be considered that there exists difference on the above indexes for treatment medicine and control medicine.7.There is no elimination and loss of cases during the whole process.There is no abnormality on safety index and situation of skin allergy.We can consider that both medicine for treatment and control are safe.Conclusion:1.The randomized double-blinding and parallel positive-controlled methods are applied to clinical research.These methods are scientific,advanced and reasonable in design.The results achieved are dependable.2.Binghuang Antidotal Plaster is safe and effective in the treatment of acute ulcer and sore (Carbuncle and Furuncle with the syndrome of accumulated heat-type toxin).It is superior to control medicine(Ruyi Jinhuang Plaster) on the aspect of syndrome relief and shortening the period of treatment.It demonstrates that the proper application of skin penetrating absorbent in Traditional Chinese Medicine can promote medicine absorbency by way of skin penetrating and improve the efficacy of the medicine for external use.