中医药“内外合治”痤疮的疗效观察及对皮脂分泌影响的研究
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摘要
目的：观察中药内服加自制消痘面膜外用治疗痤疮的临床疗效；通过检测其对皮肤性状、皮脂溢出率、睾酮及睾酮受体水平的影响,探讨其可能的治疗机制；通过观察其可能出现的不良事件,对其安全性做出评价。
方法：
临床部分
1.按入选病例的先后顺序,将痤疮患者随机分配到试验组和对照组,同时根据辨证标准不同将试验组分为肺经风热证组、肺胃湿热证组和痰瘀互结证组。除去脱落和剔除的病人,最后总计395例病人进行统计学分析,其中试验组304例,对照组91例。
2.治疗方法：试验Ⅰ组(肺经风热证组)120例,给予粉刺1号方加中药消痘而膜治疗；试验Ⅱ组(肺胃湿热证组)135例,给予粉刺2号方加中药消痘面膜治疗和试验Ⅲ组(痰瘀互结证组)49例,给予粉刺3号方加中药消痘面膜治疗。对照组91例,采用丹参酮胶囊口服加加0.3%维胺酯乳膏外用,所有患者均治疗6周。
3.观察方法：所有患者在初诊、治疗2周、4周、6周后分别填写观察表格,记录皮疹的性质及数目,如炎症性皮损(丘疹,脓疱,结节)和非炎症性皮疹(白头粉刺和黑头粉刺。同时要询问用药的依从性,记录出现的不良反应。
4.临床疗效评价方法：参照1997年10月中华医学会美学与美容分会皮肤美容学组制定的《寻常痤疮严重程度分级和疗效判定标准》进行疗效评价。根据治疗2周、4周、6周前后痤疮患者皮损的数目来计算疗效指数；根据综合疗效评价标准评价临床疗效。观察治疗组、对照组炎症性皮损和非炎症性皮损的变化,每2周进行一次皮损的比较。参照PillSbury及国际改良痤疮分级法进行临床轻重分级,比较治疗前后痤疮分级的变化。
5.安全性指标：根据与入组时比较,试验过程中患者新出现或加重的症状、体征和疾病,通过观察其可能出现的不良事件,对其安全性做出评价。
实验部分
1.皮肤性状变化的研究：试验组304例患者在其面部同样的部位检测皮脂的分泌、毛孔大小、皮肤弹力度及水分含量。①用油份测定海绵分别在面部T型区(额头及鼻周)及U型区(两侧面颊)的部位轻轻按压6秒钟吸取油脂,经皮肤分析仪测试后,记录数据。②毛孔大小的检测：用数码显微镜射口,以观察窗内5cm2面积为测试区,记录可视的毛孔的大小及数量。③皮肤含水量的测定：用水分感应器测定患者靶部位皮肤的水分数据,将数值输入电脑系统内分析。④皮肤弹性的测定：将皮肤分析仪的探头对准靶部位的皮肤进行测定并记录数据。
2.皮脂溢出率(the sebum excretion rate, SER)(?)勺检测：对象为从试验组随机抽取的60例患者,利用海绵擦试,用有机溶剂提取收集皮脂：应用Looking bill及Cunliffe改良测定法测定SER。①将洗净的称量瓶及1cm×1cm×2cm大小的海绵条放入60℃干燥箱内烤3h,取出后冷却至室温。②每3块海绵条为1组,装入一个经脱脂处理过的塑料袋里。30min后在固定的温度和湿度条件(室温18～22℃,相对湿度10%～20%)下称量其重量,设为质量Ⅰ。③用5%肥皂水清洗受试者前额的皮肤大约6cm×12cm大小的面积,用消毒纱布擦干,再用无水乙醇和正己烷各擦一遍。④嘱被检测的患者静坐,避免用手或其他物品触及前额。1h后用4cm×10cm开窗的塑料膜贴于额头部位原来消毒过的皮肤上。⑤每例被检者各用1组海绵条蘸取正己烷,擦拭前额开窗内皮肤3遍,然后装回原塑料袋,等待正己烷挥发完毕。⑥将海绵条置于60℃干燥箱烤,1h后取出冷却至室温。30min后于同样固定温度和湿度条件下,同法测出海绵质量,设置为质量Ⅱ。⑦根据公式计算SER。
3.血睾酮的检测对象为试验组304例患者,由西苑医院检验科生化室进行检测并提供化验结果。
4.血清睾酮受体的检测：试验组患者于治疗前和治疗结束后分别抽取静脉血3ml,其中男性患者采血时间为早晨6～7时,女性患者采血.时间为月经后5～7天,肝素抗凝,采用酶联免疫分析试剂盒检测,严格按照说明书操作。统计学方法：临床与实验部分计量数据以平均数±标准差(X±S)表示,采用SPSS for windows19.0软件包进行统计学处理。对各组数据进行正态性检验和方差齐性检验。治疗前后比较用配对资料的t检验,计量资料组间比较用F检验、两组间比较采用独立样本t检验,计数资料采用x2检验,等级资料采用秩和检验。
结果
临床部分
1.临床有效率的比较：在治疗2周的观察点时,试验组和对照组的总有效率分别为29.1%和32%,两组疗效相当,无明显差异(X2=0.29,P>0.05)。在治疗4周后,试验组的有效率59.7%高于对照组的有效率49.6%,差别有统计学意义(X2=5.10,P<0.05)。在治疗6周后,试验组的有效率为83.7%明显高于对照组71.2%(X2=6.63,P<0.05)。试验三组治疗6周后的有效率分别为85%、83.7%、80%均明最高于对照组71.2%(P<0.05)。
2.皮损计数的比较结果：①肺经风热证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=6.29、5.29、7.71,P<0.05)。②肺胃湿热证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=7.00、3.82、6.42,P<0.05)。③痰瘀互结证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=4.89、2.8、4.75,P<0.05)。④治疗后试验组和对照组相比,各种皮损均有明显差异(t=2.71、4.08、4.04,P<0.05)。
3.痤疮分级的比较：①治疗前试验组和对照组分级无明显差异(X2=4.37,P>0.05)。②治疗结束时试验组与对照组痤疮的分级存在明显差异,差异有统计学意义(X2=39.7,P<0.05)。
实验部分
1.皮肤性状的比较结果：①试验组治疗前及治疗2周后皮肤状况的比较,治疗2周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显减少,差异有统计学意义(P<0.05),而皮肤水分和皮肤弹性变化不明显(P>0.05)。②治疗4周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显变小(P<0.05),而皮肤水分和皮肤弹性变化不明显(P>0.05)。③治疗6周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显减少,差异有统计学意义(P<0.05),皮肤水分仍然变化不明显(P>0.05),而皮肤的弹性得到了明显改善(P<0.05)。
2.SER：试验组中60例患者治疗2周后SER无明显变化(P>0.05),治疗4周后SER变化仍旧不明显(P>0.05),治疗6周后SER显著减少(P<0.05)。
3.血睾酮比较结果：试验组的三组(肺经风热组、肺胃湿热组、痰瘀互结组)男性患者在治疗前后睾酮的变化不明显(P>0.05),而对于女性患者睾酮的量明显降低了(P<0.05)。
4.血清中睾酮受体检测结果比较：试验组患者治疗6周后血清中睾酮受体明显下降(P<0.05)。
结论：
1.中药联合消痘面膜对痤疮患者各种皮损均有良好的治疗作用。
2.可提高有效率,改善痤疮患者病变的严重程度。
3.改善皮肤的性状,减少T型区及U型区皮脂量,缩小毛孔。
4.可能通过降低SER、女性患者血睾酮的水平以及睾酮受体的水平来达到治疗作用。
5.中药联合消痘面膜治疗痤疮是一种安全有效的值得推广的治疗方案。
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 part
1. 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 part
1. 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 rate
The60patients 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 I
③Using5%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.
Result
Clinical part
1. The contrast of the clinical total effective rate
At 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 testosterone
The 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).
Conclusion
1. 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.
方法：
临床部分
1.按入选病例的先后顺序,将痤疮患者随机分配到试验组和对照组,同时根据辨证标准不同将试验组分为肺经风热证组、肺胃湿热证组和痰瘀互结证组。除去脱落和剔除的病人,最后总计395例病人进行统计学分析,其中试验组304例,对照组91例。
2.治疗方法：试验Ⅰ组(肺经风热证组)120例,给予粉刺1号方加中药消痘而膜治疗；试验Ⅱ组(肺胃湿热证组)135例,给予粉刺2号方加中药消痘面膜治疗和试验Ⅲ组(痰瘀互结证组)49例,给予粉刺3号方加中药消痘面膜治疗。对照组91例,采用丹参酮胶囊口服加加0.3%维胺酯乳膏外用,所有患者均治疗6周。
3.观察方法：所有患者在初诊、治疗2周、4周、6周后分别填写观察表格,记录皮疹的性质及数目,如炎症性皮损(丘疹,脓疱,结节)和非炎症性皮疹(白头粉刺和黑头粉刺。同时要询问用药的依从性,记录出现的不良反应。
4.临床疗效评价方法：参照1997年10月中华医学会美学与美容分会皮肤美容学组制定的《寻常痤疮严重程度分级和疗效判定标准》进行疗效评价。根据治疗2周、4周、6周前后痤疮患者皮损的数目来计算疗效指数；根据综合疗效评价标准评价临床疗效。观察治疗组、对照组炎症性皮损和非炎症性皮损的变化,每2周进行一次皮损的比较。参照PillSbury及国际改良痤疮分级法进行临床轻重分级,比较治疗前后痤疮分级的变化。
5.安全性指标：根据与入组时比较,试验过程中患者新出现或加重的症状、体征和疾病,通过观察其可能出现的不良事件,对其安全性做出评价。
实验部分
1.皮肤性状变化的研究：试验组304例患者在其面部同样的部位检测皮脂的分泌、毛孔大小、皮肤弹力度及水分含量。①用油份测定海绵分别在面部T型区(额头及鼻周)及U型区(两侧面颊)的部位轻轻按压6秒钟吸取油脂,经皮肤分析仪测试后,记录数据。②毛孔大小的检测：用数码显微镜射口,以观察窗内5cm2面积为测试区,记录可视的毛孔的大小及数量。③皮肤含水量的测定：用水分感应器测定患者靶部位皮肤的水分数据,将数值输入电脑系统内分析。④皮肤弹性的测定：将皮肤分析仪的探头对准靶部位的皮肤进行测定并记录数据。
2.皮脂溢出率(the sebum excretion rate, SER)(?)勺检测：对象为从试验组随机抽取的60例患者,利用海绵擦试,用有机溶剂提取收集皮脂：应用Looking bill及Cunliffe改良测定法测定SER。①将洗净的称量瓶及1cm×1cm×2cm大小的海绵条放入60℃干燥箱内烤3h,取出后冷却至室温。②每3块海绵条为1组,装入一个经脱脂处理过的塑料袋里。30min后在固定的温度和湿度条件(室温18～22℃,相对湿度10%～20%)下称量其重量,设为质量Ⅰ。③用5%肥皂水清洗受试者前额的皮肤大约6cm×12cm大小的面积,用消毒纱布擦干,再用无水乙醇和正己烷各擦一遍。④嘱被检测的患者静坐,避免用手或其他物品触及前额。1h后用4cm×10cm开窗的塑料膜贴于额头部位原来消毒过的皮肤上。⑤每例被检者各用1组海绵条蘸取正己烷,擦拭前额开窗内皮肤3遍,然后装回原塑料袋,等待正己烷挥发完毕。⑥将海绵条置于60℃干燥箱烤,1h后取出冷却至室温。30min后于同样固定温度和湿度条件下,同法测出海绵质量,设置为质量Ⅱ。⑦根据公式计算SER。
3.血睾酮的检测对象为试验组304例患者,由西苑医院检验科生化室进行检测并提供化验结果。
4.血清睾酮受体的检测：试验组患者于治疗前和治疗结束后分别抽取静脉血3ml,其中男性患者采血时间为早晨6～7时,女性患者采血.时间为月经后5～7天,肝素抗凝,采用酶联免疫分析试剂盒检测,严格按照说明书操作。统计学方法：临床与实验部分计量数据以平均数±标准差(X±S)表示,采用SPSS for windows19.0软件包进行统计学处理。对各组数据进行正态性检验和方差齐性检验。治疗前后比较用配对资料的t检验,计量资料组间比较用F检验、两组间比较采用独立样本t检验,计数资料采用x2检验,等级资料采用秩和检验。
结果
临床部分
1.临床有效率的比较：在治疗2周的观察点时,试验组和对照组的总有效率分别为29.1%和32%,两组疗效相当,无明显差异(X2=0.29,P>0.05)。在治疗4周后,试验组的有效率59.7%高于对照组的有效率49.6%,差别有统计学意义(X2=5.10,P<0.05)。在治疗6周后,试验组的有效率为83.7%明显高于对照组71.2%(X2=6.63,P<0.05)。试验三组治疗6周后的有效率分别为85%、83.7%、80%均明最高于对照组71.2%(P<0.05)。
2.皮损计数的比较结果：①肺经风热证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=6.29、5.29、7.71,P<0.05)。②肺胃湿热证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=7.00、3.82、6.42,P<0.05)。③痰瘀互结证组治疗后炎症性皮损,非炎症性皮损数及总皮损数均比治疗前减少(t=4.89、2.8、4.75,P<0.05)。④治疗后试验组和对照组相比,各种皮损均有明显差异(t=2.71、4.08、4.04,P<0.05)。
3.痤疮分级的比较：①治疗前试验组和对照组分级无明显差异(X2=4.37,P>0.05)。②治疗结束时试验组与对照组痤疮的分级存在明显差异,差异有统计学意义(X2=39.7,P<0.05)。
实验部分
1.皮肤性状的比较结果：①试验组治疗前及治疗2周后皮肤状况的比较,治疗2周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显减少,差异有统计学意义(P<0.05),而皮肤水分和皮肤弹性变化不明显(P>0.05)。②治疗4周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显变小(P<0.05),而皮肤水分和皮肤弹性变化不明显(P>0.05)。③治疗6周后,T型区皮脂量、U型区皮脂量和皮肤毛孔大小均明显减少,差异有统计学意义(P<0.05),皮肤水分仍然变化不明显(P>0.05),而皮肤的弹性得到了明显改善(P<0.05)。
2.SER：试验组中60例患者治疗2周后SER无明显变化(P>0.05),治疗4周后SER变化仍旧不明显(P>0.05),治疗6周后SER显著减少(P<0.05)。
3.血睾酮比较结果：试验组的三组(肺经风热组、肺胃湿热组、痰瘀互结组)男性患者在治疗前后睾酮的变化不明显(P>0.05),而对于女性患者睾酮的量明显降低了(P<0.05)。
4.血清中睾酮受体检测结果比较：试验组患者治疗6周后血清中睾酮受体明显下降(P<0.05)。
结论：
1.中药联合消痘面膜对痤疮患者各种皮损均有良好的治疗作用。
2.可提高有效率,改善痤疮患者病变的严重程度。
3.改善皮肤的性状,减少T型区及U型区皮脂量,缩小毛孔。
4.可能通过降低SER、女性患者血睾酮的水平以及睾酮受体的水平来达到治疗作用。
5.中药联合消痘面膜治疗痤疮是一种安全有效的值得推广的治疗方案。
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 part
1. 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 part
1. 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 rate
The60patients 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 I
③Using5%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.
Result
Clinical part
1. The contrast of the clinical total effective rate
At 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 testosterone
The 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).
Conclusion
1. 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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