本文選題：臨床研究 + 馬拉色菌�。� 參考：《北京中醫(yī)藥大學(xué)》2016年博士論文

【摘要】：1目的通過(guò)臨床觀察客觀評(píng)價(jià)香柏酊對(duì)頭部脂溢性皮炎(濕熱證)的臨床療效,確立頭部脂溢性皮炎(濕熱證)外用藥治療的研究規(guī)范；通過(guò)動(dòng)物實(shí)驗(yàn)及藥敏實(shí)驗(yàn)探討香柏酊對(duì)脂溢性皮炎治療的作用機(jī)理。通過(guò)測(cè)定香柏酊有效成分含量進(jìn)行質(zhì)量監(jiān)控。為外用中藥制劑治療脂溢性皮炎的研發(fā)和推廣奠定基礎(chǔ)。2方法臨床研究部分：采用完全隨機(jī)平行對(duì)照單盲的方法對(duì)符合頭部脂溢性皮炎(濕熱證)入選標(biāo)準(zhǔn)的患者90例隨機(jī)分為治療組36例、陽(yáng)性對(duì)照組36例以及陰性對(duì)照組18例。三組分別外用香柏酊、聯(lián)苯芐唑溶液以及安慰劑,治療期間均使用統(tǒng)一發(fā)放的洗發(fā)液,隔日洗頭1次,每組均每日早晚各涂藥1次,療程為4周。治療期間,患者均需保證規(guī)律作息,飲食清淡。分別于用藥0天、14±3天、28-1-3天,痊愈者停藥后28±3天進(jìn)行訪視,對(duì)訪視節(jié)點(diǎn)中患者的靶皮損拍照,并且記錄紅斑程度、靶皮損面積、鱗屑程度、瘙癢程度以及脂溢程度積分,評(píng)價(jià)各組療效。并于用藥第28-1-3天進(jìn)行靶皮損真菌學(xué)鏡檢或培養(yǎng),評(píng)價(jià)真菌學(xué)療效。實(shí)驗(yàn)研究部分：①抗炎實(shí)驗(yàn)：取30只小鼠,隨機(jī)分成三組,每組各10只,在右耳外耳廓分別外涂香柏酊、哈西奈德以及生理鹽水,采用二甲苯外涂建立右耳外耳廓炎性腫脹模型,通過(guò)觀察耳片腫脹度(.兩只耳片重量差值),.評(píng)價(jià)各組抗炎療效：②止癢實(shí)驗(yàn)：取30只小鼠,隨機(jī)分成三組,每組各1 0只,各組將右后腿剃毛后外涂香柏酊、苯海拉明以及生理鹽水,將剃毛處擦傷后以濃度遞增的方式外涂磷酸組織胺,建立小鼠瘙癢模型,以小鼠舔右后腿時(shí)磷酸組織胺總量為致癢閾,觀察各組的止癢療效；③抑菌實(shí)驗(yàn)：動(dòng)物實(shí)驗(yàn)：取豚鼠30只,采用連續(xù)7天涂菌法建立豚鼠皮膚馬拉色菌感染模型,后采用自身對(duì)照法將藥物外涂于感染馬拉色菌的豚鼠背部皮膚,實(shí)驗(yàn)共分為4組,即治療組(采用香柏酊外用)、陽(yáng)性對(duì)照組(聯(lián)苯芐唑溶液外用)、陰性對(duì)照組(生理鹽水外用)以及空白對(duì)照組(不外用藥物),分別觀察連續(xù)用藥4天與連續(xù)用藥7天時(shí)(隨機(jī)分組,每組15只),各組的培養(yǎng)菌落數(shù)和真菌學(xué)治愈率。體外藥敏實(shí)驗(yàn)；采用濃度稀釋法分別檢測(cè)香柏酊及聯(lián)苯芐唑溶液的最小抑菌濃度(MIC值)。④通過(guò)高效液相色譜儀測(cè)定香柏酊有效成分槲皮苷及α-香附酮的含量,從而進(jìn)行藥物質(zhì)控。3結(jié)果臨床研究部分：符合方案集中各組治療4周后,香柏酊組36例,痊愈5例,顯效11例,有效16例,無(wú)效4例,愈顯率44.44%,總有效率為88.89%；聯(lián)苯芐唑組35例,痊愈2例,顯效5例,有效17例,無(wú)效11例,愈顯率20.0%,總有效率68.57%：安慰劑組16例,痊愈0例,顯效1例,有效3例,無(wú)效12例,愈顯率6.25%,總有效率25.0%。經(jīng)統(tǒng)計(jì)學(xué)比較,三組總有效率有顯著差異,各組間療效均具有統(tǒng)計(jì)學(xué)差異(P均0.05),療效比較：香柏酊組聯(lián)苯芐唑組安慰劑組。治療4周后,各組癥狀積分(靶皮損面積、紅斑、鱗屑、脂溢以及瘙瘁)均較治療前有一定改善,差異有統(tǒng)計(jì)學(xué)意義(P0.05),在鱗屑及瘙癢方面的改善程度,香柏酊組明顯優(yōu)于聯(lián)苯芐唑組(P0.05),其余各癥狀兩組改善程度無(wú)明顯差異(P0.05)。各組在治療期間均無(wú)嚴(yán)重不良事件發(fā)生,證明香柏酊和聯(lián)苯芐唑溶液的治療均是安全有效的。在真菌清除率方面,三組療效差異顯著(P0.01),香柏酊組和聯(lián)苯芐唑組差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),香柏酊組=聯(lián)苯芐唑組安慰劑組。實(shí)驗(yàn)研究部分：在小鼠耳廓炎性腫脹實(shí)驗(yàn)中證實(shí),香柏酊具有較好的抗炎作用,其作用與哈西奈德溶液相當(dāng)(P0.05)；在小鼠致癢實(shí)驗(yàn)中證實(shí),香柏酊具有較好的止癢作用,其作用與苯海拉明溶液相當(dāng)(P0.05)；馬拉色菌感染豚鼠抑菌實(shí)驗(yàn)證實(shí),香柏酊具有較好的抑菌作用,連續(xù)用藥7天療效明顯優(yōu)于4天,但療效不及聯(lián)苯芐唑(P0.05),香柏酊連續(xù)用藥4天真菌學(xué)治愈率為26.67%,連續(xù)用藥7天真菌學(xué)治愈率為60%,而聯(lián)苯芐唑的這一數(shù)據(jù)分別為53.33%和93.33%；香柏酊的最小抑菌濃度為70mg/ml,聯(lián)苯芐唑溶液的最小抑菌濃度為78.125 μg/ml。經(jīng)測(cè)定,香柏酊中有效成分槲皮苷的含量為0.1050mg/ml, α-香附酮的含量為0.0147mg/ml。4結(jié)論香柏酊治療頭部脂溢性皮炎總療效優(yōu)于聯(lián)苯芐唑溶液,在抑制鱗屑及緩解瘙癢等方面效果均優(yōu)于聯(lián)苯芐唑。香柏酊具有較強(qiáng)的抗炎作用和止癢效果,抗炎作用與哈西奈德溶液相當(dāng),止癢療效與苯海拉明相當(dāng),對(duì)糠秕馬拉色菌具有良好的抑菌療效。
[Abstract]:1 Objective To evaluate the clinical effect of Xiang Bai Tincture on seborrheic dermatitis (damp and heat syndrome) in the head and establish the study standard for the treatment of seborrheic dermatitis (damp heat syndrome) for head, and explore the mechanism of the effect of Xiang Bai Tincture on seborrheic dermatitis by animal experiment and drug sensitivity test. The clinical research part of the basic.2 method for the development and promotion of seborrheic dermatitis by external use of traditional Chinese medicine preparation: 90 cases of patients with head seborrheic dermatitis (damp heat syndrome) were randomly divided into 36 cases, 36 cases of positive control group and 18 negative control group by the complete random parallel control single blind method. In the three groups, the three groups were treated with cedar tincture, Bifonazole Solution and placebo respectively. During the treatment, the unified shampoo was used and the shampoo was washed 1 times every other day. Each group had 1 times each day and evening. The treatment period was 4 weeks. The patients were required to ensure regular rest and light diet. The drugs were used for 0 days, 14 + 3 days, and 28 + 3 after the cure was stopped. The target skin lesions in the visiting nodes were photographed, and the degree of erythema, target lesion area, scale, itching degree and the degree of seborrhea were recorded, and the efficacy of each group was evaluated. The target derma microscopic examination or culture was carried out on day 28-1-3 of the drug use. The experimental study part: (1) anti-inflammatory experiment: 30 Only mice were divided into three groups, each group was divided into three groups. 10 rats in each group were coated with cedar tincture in the right ear auricle, Hasi Ned and normal saline. The inflammatory swelling of the ear auricle outside the right ear was established by using dimethylbenzene and the swelling degree of the ears (the difference of the weight of two ears). The anti inflammatory effect of each group was evaluated: 30 mice were taken randomly. It was divided into three groups, each group was 10. After shaving, the right hind legs were shaved with cedar tincture, diphenhydramine and physiological saline. After the shaving was bruised, the phosphoric acid histamine was coated in a concentration increasing manner, and the mouse pruritus model was established. The mice were licking the right hind leg and the total amount of phosphate histamine was the pruritic threshold, and the antipruritic effect of each group was observed. Animal experiments: 30 guinea pigs were taken from the guinea pig. The guinea pig model of Malassezia infection was established by 7 days of smear method, and then the drugs were applied to the back skin of the guinea pigs infected with Malassezia by self control. The experimental group was divided into 4 groups, that is, the treatment group (using the tincture of cedar tincture), the positive control group (Bifonazole Solution external use) and the negative control group. The normal saline external use) and the blank control group (no external use medicine) were observed for 4 days of continuous medication and 7 days of continuous medication (random group, 15 in each group). The number of colonies and the cure rate of mycology in each group, in vitro drug sensitivity test, and the concentration dilution method were used to detect the minimum inhibitory concentration (MIC) of Bifonazole Solution tincture and the minimum inhibitory concentration (value). The content of quercetin and alpha - peronone in fragrant cypress tincture was determined by HPLC, and the clinical study of drug quality control.3 was carried out. After 4 weeks of treatment, 36 cases of Xiang Bai tincture group were cured, 5 cases were cured, 11 cases were markedly effective, 16 cases were effective, 4 cases were invalid, the healing rate was 44.44%, the total effective rate was 88.89%, and benzyzazole group 3 was 3. 5 cases were cured, 2 cases were cured, 5 cases were effective, 17 were effective, 11 cases were invalid, the more effective rate was 20%, the total effective rate was 68.57%: 16 cases in placebo group, 0 cases, 1 cases, 3 effective and invalid 12 cases, the total effective rate of 25.0%. was statistically significant difference between the groups (P), the curative effect was compared. After 4 weeks of treatment, the symptom scores (target lesion area, erythema, scaly, seborrhea and Sao) were improved after 4 weeks of treatment. The difference was statistically significant (P0.05), the improvement of scalar and pruritus was better than that of benzopazole group (P0.05), and the other two groups of symptoms were changed. There was no significant difference in the degree of good (P0.05). Each group had no serious adverse events during the treatment. It was proved that the treatment of cypress tincture and Bifonazole Solution were safe and effective. In the area of fungal clearance, the difference between the three groups was significant (P0.01), and the difference between the fragrant cypress tincture group and benzyzazole group was not statistically significant (P0.05), and the fragrant cypress tincture = bibenzazole group was in the group of fragrant cypress tincture = bibenzazole group. In the placebo group. Experimental study: in the mouse ear inflammatory swelling test, the fragrant cypress tincture has a good anti-inflammatory effect, its effect is similar to that of Halcinonide Solution (P0.05); in the itching experiment of mice, it is proved that the fragrant cypress tincture has a better antipruritic effect and the effect is equivalent to that of the benzhydramine solution (P0.05); Malassezia infection of guinea pigs The bacteriostasis experiment proved that the fragrant cypress tincture had better bacteriostasis effect, and the curative effect of 7 day continuous medication was obviously superior to 4 days, but the curative effect was less than P0.05, the cure rate of 4 naive bacteriology was 26.67%, the cure rate of 7 naive bacteriology was 60%, while the data of benzyzazole were 53.33% and 93.33% respectively, and the smallest cypress tincture was the smallest. The bacteriostasis concentration was 70mg/ml, the minimum inhibitory concentration of Bifonazole Solution was 78.125 g/ml., the content of quercetin in fragrant cypress tincture was 0.1050mg/ml, and the content of alpha - peronone was 0.0147mg/ml.4 conclusion the total curative effect of fragrant cypress Tincture on seborrheic dermatitis in head was better than that of Bifonazole Solution, in inhibiting the scales and alleviating pruritus. The effect is better than benzyzazole. The fragrant cypress tincture has strong anti-inflammatory and antipruritic effect. The anti-inflammatory effect is equal to that of Halcinonide Solution. The antipruritic effect is equivalent to that of diphenhydramine. It has good bacteriostasis effect for Malassezia chaff.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2016
【分類號(hào)】：R275

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