Sternicka Julia, Nowicki Roman J, Bieniaszewski Leszek, Purzycka-Bohdan Dorota
Department of Dermatology, Venereology and Allergology, Medical University of Gdańsk, University Clinical Centre, 80-214 Gdańsk, Poland.
Clinical Physiology Unit, Medical Simulation Centre, Medical University of Gdańsk, 80-204 Gdańsk, Poland.
J Clin Med. 2025 Mar 30;14(7):2376. doi: 10.3390/jcm14072376.
Off-label treatment is the use of a drug approved for marketing, outside the registration in terms of indication, age group, dose or route of administration. Despite the constant appearance of new preparations on the market, treatment outside the SmPCs guidelines is a current clinical problem. It is believed that it is based on the needs of patients unmet by classical therapy methods. This work focuses on off-label treatment in inflammatory dermatoses such as atopic dermatitis, psoriasis, acne vulgaris and rosacea. Publications on this subject, available on PubMed, Google Scholar and the Cochrane Library, were analyzed in the form of a review, taking into account the mechanisms of action, efficacy and safety of preparations. Based on the literature analysis, it can be concluded that the use of drugs outside the SmPC indications is a common situation in dermatology. However, it is difficult to determine its exact frequency-there is a lack of data on the prevalence of off-label appliances in inflammatory dermatoses from a European perspective. Publications demonstrate varying effectiveness and safety of this form of therapy, depending on the specific preparation. Off-label treatment in dermatology remains an important and current clinical issue that should be explored in further research.
超说明书用药是指使用已获上市批准的药物,但在适应证、年龄组、剂量或给药途径方面超出了注册范围。尽管市场上不断有新制剂出现,但超出产品特性总结(SmPC)指南的治疗仍是当前的临床问题。人们认为,这是基于传统治疗方法无法满足的患者需求。这项工作聚焦于炎症性皮肤病如特应性皮炎、银屑病、寻常痤疮和玫瑰痤疮的超说明书用药。以综述的形式分析了在PubMed、谷歌学术和考克兰图书馆上可获取的关于该主题的出版物,同时考虑了制剂的作用机制、疗效和安全性。基于文献分析,可以得出结论,在皮肤病学中超出SmPC适应证使用药物是一种常见情况。然而,很难确定其确切频率——从欧洲角度来看,缺乏关于炎症性皮肤病中超说明书用药器具患病率的数据。出版物表明,这种治疗形式的有效性和安全性各不相同,具体取决于特定制剂。皮肤病学中的超说明书用药仍然是一个重要的当前临床问题,应在进一步研究中加以探讨。