1.中国中医科学院 中医临床基础医学研究所,北京 100700
2.中国中医科学院 西苑医院,北京 100091
3.中日友好医院,北京 100029
崔鑫,博士,主治医师,从事中医临床评价方法学研究,E-mail:xinroberttcm@hotmail. com
白彦萍,主任医师,博士生导师,从事皮肤科系统疾病研究,E-mail:zhi@tsinghua.edu.cn
谢雁鸣,主任医师,博士生导师,从事中药上市后评价研究,E-mail:ktzu2018@163.com; *
收稿:2025-08-30,
修回:2025-08-21,
录用:2025-11-20,
网络首发:2025-11-21,
纸质出版:2026-05-05
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崔鑫,宋坪,黎元元等.冰黄肤乐软膏临床应用专家共识[J].中国实验方剂学杂志,2026,32(09):163-170.
CUI Xin,SONG Ping,LI Yuanyuan,et al.Expert Consensus on Clinical Application of SkinPro Ointment[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(09):163-170.
崔鑫,宋坪,黎元元等.冰黄肤乐软膏临床应用专家共识[J].中国实验方剂学杂志,2026,32(09):163-170. DOI: 10.13422/j.cnki.syfjx.20260495.
CUI Xin,SONG Ping,LI Yuanyuan,et al.Expert Consensus on Clinical Application of SkinPro Ointment[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(09):163-170. DOI: 10.13422/j.cnki.syfjx.20260495.
冰黄肤乐软膏是源自藏医经验配方、结合现代技术制成的乳剂型软膏,为西藏海容唐果药业有限公司独家专利品种,被列入国家中药保护品种、《中华人民共和国药典》(2010年版至今)及国家医保乙类目录,具有清热燥湿、活血祛风、止痒消炎功效,临床用于湿热蕴结或血热风燥引起的皮肤瘙痒,以及神经性皮炎、湿疹、足癣、银屑病等瘙痒性皮肤病。为明确其临床应用规范,促进合理用药,全国34名皮肤科、循证医学及药学专家成立共识工作组,通过专家访谈、名义组法、问卷调查等确定15个临床问题,采用推荐意见的评估、制定与评价(GRADE)证据等级标准评估证据,形成《冰黄肤乐软膏临床应用专家共识》(以下简称《共识》)。本《共识》明确了冰黄肤乐软膏适用范围为各级医疗机构医师、药师,规范了临床应用的证候特点、剂量疗程、联合用药、注意事项及禁忌。针对15个临床问题形成推荐意见和共识建议,涵盖①适应证与证候:中医主治湿疮、白疕、摄领疮、脚湿气等,对应西医湿疹、银屑病、神经性皮炎、足癣等,中医证候为湿热蕴结或血热风燥证;②用法用量:外用涂搽患处,每日3次,用量参照指尖单位(FTU)薄涂,轻中度推荐疗程1~2周,重度遵医嘱;③联合用药:轻度可单独用药,中重度建议联合用药(参考相关指南);④安全性:常见皮疹、瘙痒、红斑等不良反应,禁用于患处破溃或有明显渗出者及对本品成分过敏者,避免接触眼、口腔等敏感部位。现代研究显示其在成人特应性皮炎、股癣、剥脱性角质松解症、寻常痤疮、马拉色菌毛囊炎等疾病中亦有一定疗效。该《共识》为促进临床合理使用冰黄肤乐软膏,提高疗效及降低用药风险提供了科学依据,后续将根据新的临床问题及循证证据动态修订。
SkinPro Ointment is an emulsion-based preparation derived from a traditional Tibetan medical empirical formula and developed using modern pharmaceutical technology. It is an exclusive patented product of Tibet Hairong Tangguo Pharmaceutical Co. Ltd. and has been listed as a National Protected Traditional Chinese Medicine Variety,
the Pharmacopoeia of the People's Republic of China
, and classified as a Category B product in the National Basic Medical Insurance Catalog. The ointment possesses the functions of clearing heat and drying dampness, activating blood circulation and dispelling wind, relieving itching and reducing inflammation. Clinically, it is used for skin pruritus caused by dampness-heat accumulation or blood-heat with wind-dryness, as well as pruritic skin diseases such as neurodermatitis, eczema, tinea pedis, and psoriasis. To clarify the standards for its clinical application and promote rational drug use, a consensus working group comprising 34 national experts in dermatology, evidence-based medicine, and pharmacy was established. Through expert interviews, the nominal group technique, and questionnaire surveys, 15 clinical issues were identified. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence grading system was employed to assess the quality of evidence, leading to the formulation of the
Expert Consensus on the Clinical Application of SkinPro Ointment
. This consensus specifies that the intended users are physicians and pharmacists in medical institutions at all levels. It standardizes the clinical application of the ointment, including syndrome characteristics, dosage and course of treatment, combination therapy, precautions, and contraindications. Recommendations and consensus suggestions were formed addressing the 15 clinical issues, covering the following key areas: ①Indications and TCM syndromes: In TCM, the ointment mainly treats conditions such as "damp sores" (Shichuang), "white scaling" (Baibi), "collar sores" (Shelingchuang), and "damp foot Qi" (Jiaoshiqi), corresponding to eczema, psoriasis, neurodermatitis, and tinea pedis in Western medicine. The relevant TCM syndromes are identified as dampness-heat accumulation or blood-heat with wind-dryness. ②Usage and dosage: For external use, apply to the affected area 3 times daily. The dosage should follow the fingertip unit (FTU) principle. A treatment course of 1-2 weeks is recommended for mild to moderate cases; for serious cases, the course should be followed as prescribed by a physician. ③Combined therapy: The ointment can be used as monotherapy for mild cases. For moderate to severe cases, combination therapy is recommended, with reference to relevant clinical guidelines. ④Safety: Common adverse reactions include skin rashes, pruritus, and erythema. The ointment is contraindicated in patients with broken skin or obvious exudation at the affected area, as well as in patients with known hypersensitivity to any of its components. Contact with sensitive areas such as the eyes and oral mucosa should be avoided. Modern research shows that the ointment also has potential efficacy in other dermatological conditions, such as adult atopic dermatitis, tinea cruris, exfoliative keratolysis, acne vulgaris, and Malassezia folliculitis. This consensus provides a scientific basis for promoting the rational clinical use of SkinPro Ointment, improving its therapeutic efficacy, and reducin
g medication risks. Future updates will be dynamically revised according to emerging clinical issues and new evidence.
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