【目的】 观察基于中医芳香疗法的丹丝方（海艾汤加减）洗发液外治湿热上蒸型雄激素性脱发（AGA）的临床疗效和安全 性。【方法】 选取 2023年 1月至 2023年 12月在湖南中医药大学第二附属医院皮肤科门诊就诊的 60例湿热上蒸型 AGA患者为 研究对象，采用随机数字表法将患者随机分为治疗组和对照组，每组各30例。治疗组给予丹丝方洗发液外洗治疗，对照组 给予2%酮康唑洗剂（采乐）外洗治疗，每次5 ~ 10 mL，每周2次，连续使用12周。观察2组患者治疗前后临床症状评分、皮 肤病生活质量指数（DLQI）评分、毛发镜下相关指标的变化情况，评估 2组患者的临床疗效和用药安全性。【结果】（1）脱落、 剔除情况方面，治疗组脱落2例，共纳入28例；对照组剔除1例，共纳入29例。（2）疗效方面，治疗12周后，治疗组的总有 效率为82.14%（23/28），对照组为51.72%（15/29），组间比较，治疗组的临床疗效明显优于对照组（P＜0.05）。（3）临床症状评 分方面，治疗后，2组患者的脱发、瘙痒、油腻、鳞屑、新生头发等临床症状评分及总积分均较治疗前降低（P＜0.05或P＜ 0.01）；组间比较，治疗组对新生头发评分的改善作用明显优于对照组（P＜0.01），对照组对油腻评分的改善作用明显优于治 疗组（P＜0.05），而 2组治疗后的脱发、瘙痒、鳞屑评分及总积分比较，差异均无统计学意义（P＞0.05）。（4）生活质量方面， 治疗后，2组患者的DLQI评分均较治疗前降低（P＜0.01），且治疗组的降低作用明显优于对照组（P＜0.05）。（5）毛发镜下相关 指标方面，治疗后，2组患者各部位（包括左额角、百会穴、发旋处）毛发直径变异率及头皮炎症评分均较治疗前显著降低 （P＜0.05或P＜0.01），治疗组各部位毛发数量均较治疗前显著增多（P＜0.05），而对照组各部位毛发数量均较治疗前无明显 改善（P＞0.05）；治疗后组间比较，治疗组对各部位毛发变异率及发旋处毛发数量的改善作用均明显优于对照组（P＜0.05）。 （6）安全性方面，治疗期间，治疗组的不良反应发生率为7.14%（2/28），对照组为6.90%（2/29），组间比较，差异无统计学意 义（P＞0.05）。【结论】 丹丝方洗发液外洗治疗湿热上蒸型AGA患者疗效确切，可有效提高毛发数量，缓解瘙痒、鳞屑增多等 症状，改善患者生活质量，且具有较高的安全性。

Objective To observe the clinical efficacy and safety of Dansi Formula Shampoo（modified Hai’ai Decoction） topically applied， based on traditional Chinese medicine （TCM） aromatherapy， in treating androgenetic alopecia （AGA） with damp-heat upward steaming syndrome. Methods Sixty AGA patients with damp-heat upward steaming syndrome who visited the dermatology outpatient clinic of the Second Affiliated Hospital of Hunan University of Chinese Medicine from January to December 2023 were selected as the studying subjects. Patients were randomly divided into a treatment group and a control group using a random number table， with 30 cases in each group. The treatment group received topical washing with Dansi Formula Shampoo，while the control group received topical washing with 2% Ketoconazole Lotion. The dosage was 5-10 mL each time，twice a week，for a continuous period of 12 weeks. Changes in clinical symptom scores，Dermatology Life Quality Index （DLQI） scores，and trichoscopy-related indicators were observed before and after treatment. The clinical efficacy and medication safety of the two groups were evaluated. Results （1） Regarding study attrition and exclusions， 2 cases dropped out in the treatment group，resulting in 28 cases included，while 1 case was excluded in the control group， resulting in 29 cases included.（2） Regarding efficacy， after 12 weeks of treatment， the total effective rate was 82.14% （23/28） in the treatment group，significantly higher than 51.72% （15/29） in the control group. Intergroup comparison showed that the clinical efficacy of the treatment group was significantly superior to that of the control group （P＜0.05）.（3）Regarding clinical symptom scores，after treatment，scores for hair loss， pruritus，greasiness，scaling，new hair growth，and the total score decreased in both groups compared to those before treatment （P＜0.05 or P＜0.01）. Intergroup comparison revealed that the improvement in the new hair growth score was significantly greater in the treatment group than in the control group （P＜0.01）， while the improvement in the greasiness score was significantly greater in the control group （P＜0.05）. There were no statistically significant differences between the two groups in the scores for hair loss，pruritus，scaling，or the total score after treatment （P＞0.05）.（4）Regarding quality of life， after treatment， DLQI scores decreased in both groups compared to those before treatment （P＜0.01）， and the reduction was significantly greater in the treatment group than in the control group （P＜0.05）. （5） Regarding trichoscopy-related indicators， after treatment，the hair diameter variation rates at all measured sites [including the left frontal angle，Baihui（GV20） point，and hair whorl area] and the scalp inflammation scores decreased significantly in both groups compared to those before treatment （P＜0.05 or P＜0.01）. The hair count at all sites significantly increased in the treatment group （P＜0.05）， while no significant improvement was observed in the control group （P＞0.05）. Intergroup comparison showed that the improvements in hair diameter variation rates at all sites and hair count at the hair whorl area after treatment were significantly greater in the treatment group than in the control group （P＜0.05）. （6）Regarding safety， the incidence of adverse reactions during treatment was 7.14% （2/28） in the treatment group and 6.90% （2/29） in the control group，with no statistically significant difference between the groups （P＞ 0.05）. Conclusion Dansi Formula Shampoo exerts certain effect in treating AGA patients with damp-heat upward steaming syndrome. It can effectively increase hair count， alleviate symptoms such as pruritus and scaling， improve patients’ quality of life，and exhibits a favorable safety profile.

R275.9

国家自然科学基金面上项目（编号：82174375）；湖南省中医药管理局重点课题（编号：A2024034）；湖南省“十四五”卫生健康 高层次人才项目（湘中医药[2022]4号）；湖南省卫生健康高层次人才项目（湘卫函[2019]196号）