| ObjectiveTo evaluate the efficacy,safety,efficacy analysis in the treatment of chloasma with Traditional Chinese Medicine Therapy.And study its possible mechanism furtherly.MethodsClinical research part1.Method of the research:The method of random parallel control was used in this clinical trial.All patients with chloasma were randomly assigned to the experiment group and the control group.Using a sealed envelope method,reference randomly arranged in accordance with the2:1to generate the experiment group and the control group.There are165patients which were evaluated by statistics.There are112cases were divided into experiment group and53cases in control group.2.Therapeutic method:The test group included112cases.GanYu XueZhi group were treated with NO.1recipel、herbal mask and ear pressure beans. ShenXu group were treated with NO.2recipel、herbal mask and ear pressure beans.The53patients in the control group were treated with the tablet of vitamin C and soft capsule of vitamin E orally,at the same time used0.1dimensional A emulsifiable paste externally. The treatment cycle is12weeks.3.Method of the observation:All patients must record the lesion area,color of skin lesions,skin lesions severity score on preliminary diagnosis(before treatment),4,8,12weeks after treatment.And detection of security index of blood and urine routine,hepatic and renal function were performed in all patients before treatment and at the end of12weeks treatments.Meanwhile we should ask the compliance of patients,record the combined medication and side reactions during the experiment. The cured patients were followed up for3months,most patients can use other methods to treat.4.Method of evaluation on clinical effect:Scoring methods and standards of melasma lesions:According to the standard developed by the skin venereal learn pigmented Diseases Branch of Chinese and Western Medicine in2003. Measurement formula:The treatment rate=(pre-treatment score-post-treatment score)/pre-treatment score×100%5.Safety evaluationThe patients’routine blood examination, routine urine examination, ALT, Cr and BUN were measured before and after treatment.The adverse events during the treatment were recorded.The experiment partl.The research object are40cases in the second part;the control group are10healthy cases.2.Extracted fasting peripheral venous blood5ml from the subjects and healthy volunteers before treatment,after treatment.Injected the blood into the test tube, learned from the upper serum and injected into the EP tube after centrifugal (2000/min,10min),plugged,at-87℃refrigeratory quarantine,avoided repeated freezing and thawing.3.We use the enzyme league immune analysis test kit to test the levels of SOD and MDA,according to the manual operation strictly.Statistical analysisStatistical analyses were performed by SAS8.1Test of t and X2statistical methods were used to evaluate the difference between the two groups. The significance was determined as P<0.05.Results1.The result of the contrast of improving symptoms:The total score and decrease index about lesions of two group patients have significant difference(P<0.05).2.The contrast of clinical efficacy:At the12weeks visit viewpoint the total effective rate of the two group is about87.50%and66.04%respectively,there is obvious difference(P<0.05).3. The contrast of saefty:There is no significant difference of safety between the two groups(P>0.05).4.Changes of serum SOD and MDA before and after treatment about test group:The serum SOD level is increased and the serum MDA level is decreased after treatment,the difference is statistically significant(P<0.05).ConclusionsTraditional Chinese Medicine Therapy in the treatment of chloasma is effective and safe. At the same time, the antioxidant mechanism maybe the reason of the effect of the treatment.Traditional Chinese medicine combined with herb mask and ear pressure beans is a safely,effectively,worthy spreading therapeutic schedule. |
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