| Androgenetic alopecia (AGA) is a common and refractory disease. Male mainly has hair loss from two temples and gradually extend to the entire scalp, or from the top of the head and gradually extend to the forehead; Female’s symptoms usually lighter than male, performance as hair thinning, and gradually extend to temporal and occipital. Both men and women have more seborrhea.more vellus hair, increased dandruff, itching and other clinical symptoms. The number of AGA is increasing, as the disease has serious impact on patient’s appearance, AGA has been thought to have great psychological burden on patients. The mainly treatment is drug therapy. Topical medications are mainly applied to the hair follicles, aims at improving hair follicle’s microenvironment. And compared with oral medications, topical medications have fewer and milder adverse reactions. So when topical medications effect equivalent with oral medications, topical medications is a better choice. So it important to find safe and effective drug for external use.But now there is few drugs for AGA and western medicine have side effects. So this experiment uses a new traditional Chinese topical medicine to treat AGA:shengfa gel. Discuss it’s efficacy and safety in animal experiments and clinical therapeutic.This experiment have two parts:Part 1 is the literature review:Review 1 is mainly discusses the new progress on etiology and pathogenesis of AGA; Review 2 summarizes the external treatment of TCM and western medicine of AGA, and discusses the advantages of Chinese medicine on external treatment; Reviews 3 summarizes the commonly used AGA animal models, and discusses advantages and disadvantages of each model.Part 2 is the animal and clinical experiment:Objective:1. By using AGA rats model, use shengfa gel on the back of rats, to study it treatment effect on AGA.2. By using of hair tricoscopy, to study shengfa gel’s treatment effect on AGA.Methodology:1.43 male Wistar rats were randomly divided into blank group, model group, shengfa tincture group, shengfa gel grop and minoxidil group. Except the blank group rats, rest of the groups are injecting testosterone 5 mg/kg·d in accordance in the back for eight weeks in a row, to build AGA animal models, blank group injected the same amount of saline. From the second day, except the blank group and model group, the rest of the groups respectively use shengfa tincture, shengfa gel and minoxidil tincture on back. At the end of the experiment, kill the rats, using tricoscopy to check the fur on the back of the rats, and removal rats skin tissues to do HE staining, checking hair follicles under microscope, counts the total number of hair follicles, terminal hair number, vellus hair number, and terminal/vellus.2. Autologous bilateral control experiment method.35 male AGA patients with adopts bilateral control study for 3 months of clinical observation, during the treatment,the left side of scalp use shengfa gel, the right side scalp use the shengfa tincture. During the treatment, every patient have a visit monthly, fill the questionnaire and do the tricoscopy. At the end of experiment, through the symptoms satisfaction score to evaluate shengfa gel, ues the tricoscopy to count hair number and evaluate scalp symptoms to evaluate the efficacy of shengfa gel.Results:1.(1) building 3 weeks, back hair of rats gradually began to lose its luster, building after 8 weeks, except the blank group, the rest of the groups appear different degree of back hair loss. Rat skin tissue pathology in hair follicles show miniaturization, the total number of hair follicles, terminal hair and vellus hair number decreased significantly in the modle group, terminal/vellus decrease, AGA rats model building successfully. (2)8 weeks later, take the back skin tissue of rats HE staining, count the total number of hair follicles, terminal hair and vellus hair number and calculate terminal/vellus. We compare the each group data, and shengfa gel group compared with modle group, total number of hair follicle number, terminal hair, terminal/vellus were significantly increased (P<0.05), number of vellus hair without obvious difference; Compared with hair tincture and minoxidil group, the total number of hair follicles, the terminal hair, terminal/vellus had no obvious difference.2. (1) after 3 months of treatment, patients with hair microscopically signs have different degrees of ease. In the aspect of improving scalp inflammation shengfa gel is better than shengfa tincture (P<0.05). There is no difference in terms of improving the scalp grease. Other signs such as beely levy, dandruff, scalp folliculitis also have different degrees of improvement. According to the curative effect of this experiment index, use shengfa gel and shengfa tincture treatment after 3 months, none of the patients cured; Use shengfa gel 1 cases had marked effect, no marked efficacy by using the shengfa tincture cases; there are 3 patients effectively bu using shengfa gel and shengfa tincture; Use shengfa gel is invalid patients 28 people, using conveyance in 29 patients with tincture is invalid. (2) after 3 months treatment, patients with the subjective rating of scalp symptoms were falling. Shengfa gel side total score decline is superior to the germinal tincture side (P<0.05). The rest of the grading of the experiment, the scalp grease, scurf and scalp erythema ratings drop no difference on both sides. Itchy scalp and the decline in scalp folliculitis score difference on both sides, shengfa gel is better than that of shengfa tincture (P< 0.05), it should be associated with drugs improve on shengfa gel. According to the degree of satisfaction index, the overall satisfaction rate was 68.6% of shengfa gel, shegfa tincture of overall satisfaction rate was 46.9%, shengfa gel is better than that of shengfa tincture. (3) in the evaluation of the general character of shengfa gel, the majority of patients think gel’s color, smell, and viscosity of fair, and also easy to clean. The main adverse reactions of patients after using is erythema, itching, and desquamation, but after cleaning up the gel, the symptoms can reduce or disappear.Conclusion:1. In the animal experiments, AGA rats model build successfully, shengfa gel is effective for treatment of AGA in rats, and has a equal efficacy with shengfa tincture and minoxidil solution,no obvious adverse reactions.2. In the clinical trials, shengfa gel is better than shengfa tincture on AGA treatment, patients’satisfaction higher than shengfa tincture, shengfa gel adverse reactions is mild, shengfa gel is safe. |