| Objective:Observation the clinical curative effect of herbal internal and homemade mask for external use. Through the test of the skin character, the sebum excretion rate, SER, the level of testosterone and the level of the testosterone receptor discuss the possible treatment mechanism. By observation of the possible adverse events, evaluate its security.Method:Clinical research part1. According to the medical order, all acne patients were randomly assigned to the experiment group and the control group. At the same time the patients in the experiment group were divided into FeiJing FengRe group, FeiWei ShiRe group and TanYu HUJie group. There are395patients which were evaluated by statistics. There is304cases were divided into treatment group and91cases in control group.2. Therapeutic method:the120cases in FeiJing FengRe group were treated with NO.1recipel and herbal mask, the135cases in FeiWei ShiRe group were treated with NO.2recipel and herbal mask, the49cases in TanYu HuJie group with NO.3recipel and herbal mask. The91patients in the control group were treated with Danshentong capsule p.o and the0.3%viaminate cream for external use. The treatment cycle is about6weeks.3. Method of the observation:all the patients must fill in the observation form, record the quality and the number of the lesions, including the inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (white head acnes and black head acnes). Meanwhile we should ask the compliance of the patients and record the side effect during the experiment.4. Method of evaluation on clinical effect:reference to the efficacy criteria on "efficacy criteria and grading standard of acne vulgaris" instituted by Chinese Medical Association dermatology and cosmetology group Oct.1997, we evaluate the clinical effects after the treatment on2weeks,4weeks,6weeks observed point. Compare the alteration of the classification of acne according to the international PillSbury and improved international acne classification before and after the treatment.5. The security standard:observe the new symptoms, physical signs and diseases during the experiment. Through the observation of the possible adverse events, evaluate its security.The experiment part1. The research of the change about the quality of the skin:we detect the seborrhea, the size of the pore, skin elasticity, skin moisture on the same part of the304patients in experiment group. Firstly we use the sponge that can test the oil of the skin to press the facial T area (forehead and nose) and U area (on both sides of the cheek) respectively for about6seconds. Analyzed by the Skin diagnosis system, we record the data. Secondly the size of the pore was detected by the digital microscope on the5square centimeter area of the skin and the number and size of the pore were record. Thirdly the moisture content of the skin was tested by the moisture inductor. Then we use the computer to analyze the data.2. Test of the sebum excretion rateThe60patients are come from the treatment group randomly and the sebum was extracted by the organic solvent after wiping by the sponge. Test the SER by the Looking bill and Cunliffe improved determination method.①The clean measuring bottle and1cm×1cm×2cm size of the sponge were roasted by drying oven on60℃,they are removed and cooled to room temperature after3hours.②Every three sponge for one article group was put into a skim plastic bag. After30min in fixed temperature and humidity conditions (room temperature18to22℃, relative humidity10%-20%), test its weight and set to quality I③Using5%soap water cleaning the forehead of the patients about6cm×12cm size of the area, then the skin was dried by sterile gauze and brushed again with no water ethanol and normal hexane.④Ask patients sit and avoid touch the forehead by hand or other parts of the body. After1h, use the plastic film about4cm×10cm in the forehead part which is sterilized.⑤Every patient who was investigated was wiped forehead window skin for three times with sponge dip in the normal hexane. And then pack the sponge to the original plastic bags, waiting for the hexane is volatile.⑥The sponge is baked in the oven at60℃and cooled to room temperature after1h. After30min also fixed temperature and humidity conditions, measure the quality of sponge, set the result to quality Ⅱ. Calculate the SER according to the formula.3. The blood testosterone was detected by the Laboratory dept of XiYuan Hospital. The result is given by them.4. Serum levels of testosterone receptor detection:patients in the treatment group drawn venous blood3ml before and after the treatment. The male patients drown blood during6to7o’clock in the morning time, women drown the blood during5to7days after menstruation with heparin anticoagulation. We use the enzyme league immune analysis test kit to test the levels of testosterone receptor, according to the manual operation strictly.5. Statistic method:all the data was analyzed by spss19.0, according to the nature of the data.ResultClinical part1. The contrast of the clinical total effective rateAt two weeks Visit viewpoint, the total effective rate of the experiment group and control group is about29.1%and32%respectively, the curative effect is quite, no significant difference (X2=0.29, P>0.05). In four weeks after treatment, the effective rate is59.7%which is significantly higher than that of the control group the effective rate of which was49.6%(X2=5.10, P<0.05). At the6weeks visit viewpoint the total effective rate of.the two group is about83.7%and71.2%respectively, there is obvious difference (X2=6.63, P<0.05)2. The result of the contrast of the number of the lesions.①The inflammatory lesions, non-inflammatory lesions and the total lesions are all reduced after treatment in the FeiJing FengRe group(t=6.29,5.29and7.71, P<0.05).③The inflammatory lesions, non-inflammatory lesions and the total lesions are also all reduced after treatment in the FeiWei ShiRe group (t=7.00,3.82,6.42, P<0.05)③The inflammatory lesions, non-inflammatory lesions and the total lesions are also all reduced after treatment in the TanYu HuJie group (t=4.89,2.8,4.75, P<0.05)④All kinds of lesions were significant difference between the treatment group and control group before and after the treatment (t=2.71,4.08,4.04, P<0.05).3. Comparison of the acne classification:(1) Before treatment there is no obvious difference between the experiment group and control group (X2=4.37, P>0.05).(2) At the end of the experiment there is obvious difference between the two groups, the difference was statistically significant (X2=39.7, P<0.05).1. The result of contrast about the skin quality.①After2weeks the sebum of facial T area and U area, the size of the pore were significantly reduced, the difference was statistically significant (P<0.05). But the moisture and the elasticity of the skin were not changed significantly (P>0.05).②After4weeks the sebum of facial T area and U area, the size of the pore were significantly reduce (P<0.05). But the moisture and the elasticity of the skin were still not change significantly (P>0.05).③After6weeks the sebum of facial T area and U area, the size of the pore were significantly reduced (P<0.05). The moisture of the skin is still not changed significantly (P>0.05). But the elasticity of skin is obviously improved (P<0.05).2. The SER is not significantly reduced after treatment for about2weeks in the60patients of the experiment group (P>0.05). At forth week there is still no obvious difference (P>0.05).But six weeks later the SER is significantly reduced (P<0.05)3. The contrast of the blood testosteroneThe blood testosterone of male patients in the treatment three groups (FeiJing FengRe group, FeiWei ShiRe group and the TanYu HuJie group) is not obviously changed before and after treatment (P>0.05). But that of the female is significantly reduced (P<0.05).4. The contrast of the level of the testosterone recpter:The the level of the testosterone recpter in the experiment group is significantly decreased afer6weeks treatment with the Chinese medcines(P<0.05).Conclusion1. Traditional Chinese medicine combined with the herb mask is effective on the treatment of all kinds of lesions of acne.2. It can increase the efficience, improve the severity of the acne.3. It also can improve the skin’s quality, reduce the sebum of facical T area and U area of, refine pores.4. The combination therapy can reduce the SER, the blood level of testosterone, the level of the testosterone receptor that maybe the reason of the effect of the treatment. 5. Traditional Chinese medicine combined with the herb mask is a safely, effectively, worthly Spreading therapeutic schedule. |
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