【目的】 探讨清热祛湿方（由蒲公英、白花蛇舌草、苍耳草、苦参等中药组成）治疗特应性皮炎湿热浸淫证的疗效及其 对辅助性T细胞 17（Th17）/调节性T细胞（Treg）免疫稳态的影响。【方法】 采用随机对照研究方法，选取2024年4月至2025年 4月上海中医药大学附属曙光医院皮肤科收治的110例特应性皮炎湿热浸淫证患者，采用随机数字表法将患者随机分为对照 组和研究组，每组各55例。2组患者均给予常规西医治疗（包括氯雷他定片口服和艾洛松乳膏外涂），在此基础上，研究组给 予清热祛湿方口服治疗，对照组给予中药安慰剂治疗，2组疗程均为4周。评估2组患者的临床疗效，观察2组患者治疗前后 中医证候积分、特应性皮炎积分指数（SCORAD）评分、瘙痒程度视觉模拟量表（VAS）评分、湿疹面积与严重性指数（EASI）评 分、皮损处皮肤屏障功能指标以及血中Th17、Treg细胞百分比和Th17/Treg比值的变化情况，比较2组患者治疗期间不良反 应发生情况。【结果】（1）疗效方面，治疗 4 周后，研究组的 EASI 50（EASI 评分改善 50%）、EASI 70（EASI 评分改善 70%）达 标率分别为 81.82%（45/55）、54.55%（30/55），均显著高于对照组的60.00%（30/55）、23.64%（13/55），组间比较（χ2 检验），差 异均有统计学意义（P＜0.05或P＜0.01）。（2）中医证候积分方面，治疗后，2组患者的中医证候积分均较治疗前明显降低（P＜ 0.01），且研究组的降低幅度明显优于对照组（P＜0.01）。（3）病情严重程度方面，治疗后，2组患者的SCORAD评分、瘙痒程 度 VAS评分和 EASI评分均较治疗前明显降低（P＜0.05），且研究组的降低幅度均明显优于对照组（P＜0.01）。（4）皮肤屏障功 能方面，治疗后，2组患者的皮损处皮肤皮脂含量、角质层含水量均较治疗前升高（P＜0.05），经皮水分散失量（TEWL）均较 治疗前降低（P＜0.05）；且研究组对皮损处皮肤皮脂含量、角质层含水量的升高幅度及对 TEWI的降低幅度均明显优于对照 组（P＜0.01）。（5）Th17/Treg 免疫稳态方面，治疗后，2 组患者 Th17 细胞百分比和 Th17/Treg 比值均较治疗前降低（P＜0.05）， Treg细胞百分比均较治疗前升高（P＜0.05）；且研究组对Th17细胞百分比和Th17/Treg比值的降低幅度及对Treg细胞百分比的 升高幅度均明显优于对照组（P＜0.01）。（6）安全性方面，治疗期间，研究组的不良反应发生率为 9.09%（5/55），对照组为 3.64%（2/55），2组患者的不良反应发生率比较，差异无统计学意义（P＞0.05）。【结论】 在常规西医治疗基础上联合清热祛湿 方治疗特应性皮炎湿热浸淫证患者具有显著疗效，能有效减轻瘙痒症状，改善皮损状态及Th17/Treg免疫失衡状态，且具有 较高的安全性。

Objective To investigate the efficacy of Qingre Qushi Formula （composed of Chinese medicinals such as Taraxaci Herba， Hedyotis Diffusae Herba， Xanthii Herba， Sophorae Flavescentis Radix， etc.） in treating atopic dermatitis （AD） with damp-heat immersion syndrome，and to observe its impact on T helper 17（Th17）/ regulatory T cell （Treg） immune homeostasis. Methods Using a randomized controlled study design， 110 AD patients with damp-heat immersion syndrome admitted to the Department of Dermatology， Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from April 2024 to April 2025 were selected. Patients were randomly divided into a control group and a study group using a random number table， with 55 patients in each group. Both groups received conventional western medicine treatment （including oral administration of Loratadine Tablets and topical use of Mometasone Furoate Cream）. Moreover，the study group was additionally received Qingre Qushi Formula，and control group received treatment with a placebo of Chinese medicine. The treatment course for both groups was 4 weeks. The clinical efficacy was evaluated. Changes in traditional Chinese medicine （TCM） syndrome scores， Scoring Atopic Dermatitis （SCORAD） scores， pruritus Visual Analogue Scale（VAS） scores， Eczema Area and Severity Index （EASI） scores， skin barrier function indicators of the lesions，percentages of Th17 and Treg cells in blood，and the Th17/Treg ratio were observed before and after treatment. The incidence of adverse reactions during treatment was compared between the two groups. Results （1）Regarding efficacy，after 4 weeks of treatment，the achievement rates for EASI 50（≥50% improvement in EASI score） and EASI 70（≥70% improvement in EASI score） in the study group were 81.82% （45/55） and 54.55% （30/55），respectively，which were significantly higher than 60.00% （30/55） and 23.64% （13/55） in the control group. Intergroup comparison （by chi-square test） showed statistically significant differences （P＜0.05 or P＜0.01）.（2）Regarding TCM syndrome scores，after treatment，TCM syndrome scores were significantly decreased in both groups compared to those before treatment （P＜0.01），and the reduction was significantly greater in the study group than in the control group （P＜0.01）.（3） Regarding disease severity，after treatment，SCORAD scores，pruritus VAS scores，and EASI scores were significantly decreased in both groups compared to those before treatment （P＜0.05），and the reductions were significantly greater in the study group than in the control group （P＜0.01）.（4） Regarding skin barrier function，after treatment，sebum content and stratum corneum hydration at the lesion sites were increased in both groups compared to those before treatment （P＜ 0.05），while transepidermal water loss （TEWL） was decreased （P＜0.05）. The improvements in sebum content and stratum corneum hydration increases and the reduction in TEWL were significantly greater in the study group than in the control group （P＜0.01）. （5） Regarding Th17/Treg immune homeostasis， after treatment， the percentage of Th17 cells and the Th17/Treg ratio decreased in both groups compared to those before treatment （P＜ 0.05），while the percentage of Treg cells increased （P＜0.05）. The reductions in Th17 cell percentage and Th17/ Treg ratio and the increase in Treg cell percentage were significantly greater in the study group than in the control group （P＜0.01）.（6） Regarding safety，the incidence of adverse reactions during treatment was 9.09% （5/55） in the study group and 3.64% （2/55） in the control group. There was no statistically significant difference in the incidence of adverse reactions between the two groups （P＞0.05）. Conclusion The combination of Qingre Qushi Formula with conventional western medicine treatment demonstrates significant efficacy in treating AD patients with damp-heat immersion syndrome. The formula effectively alleviates pruritus，improves skin lesion condition and the Th17/Treg immune imbalance，with a favorable safety profile.

R275.9

国家自然科学基金资助项目（编号：8210151267，8197150577）