How is safety of dermatology drugs assessed: trials,registries, and spontaneous reporting

ABSTRACT

Introduction: Skin conditions are common and highly varied in their etiology; therefore, a diverse array of therapeutics are utilized. Drug safety studies in dermatology can be challenging as there are over 3000 diagnoses to consider. As a result, dermatologists rely on data from multiple sources including clinical trials and real-world evidence.

Areas covered: In this review, we cover the main sources of safety data available, their strengths and weaknesses and how dermatologists should utilize such data. We use real-world examples of the different types of adverse events reported and how they are best captured by either randomized controlled trials or post-marketing pharmacovigilance methods. With multiple new therapies in dermatology, such as dupilumab for atopic dermatitis and janus-kinase inhibitors for alopecia areata the specialty is awash with evolving high-level evidence for their use. It is important to understand the optimal way to assess safety from trials but also appreciate the need for ongoing capture of safety data in clinical practice.

Expert opinion: In dermatology, there is a plethora of conditions to treat and clinical trials, post-marketing surveillance, such as drug registries and spontaneous reporting, all enable dermatologists to gain a more comprehensive understanding of the safety profiles of drugs being used.     

温针灸联合放血疗法对痤疮患者皮损程度、DLQI评分及复发率的影响

目的观察温针灸联合放血疗法对痤疮患者皮损程度、皮肤病生活质量指数(dermatology life quality index,DLQI)评分及复发率的影响。方法 120例湿热型痤疮患者随机分为观察组和对照组,每组60例。对照组采用放血疗法,观察组在对照组基础上联合温针灸治疗。观察两组患者治疗前后皮损程度、DLQI评分、中医症候评分变化,比较两组的临床疗效、不良反应发生率及复发率。结果观察组总有效率显著高于对照组(P<0.05)。两组治疗后皮损个数显著减少(P<0.05),且观察组皮损个数少于对照组(P<0.05),皮损减少率大于对照组(P<0.05)。治疗后两组DLQI评分、中医症候评分均显著降低(P<0.05),且观察组低于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。治疗组复发率显著低于对照组(P<0.05)。结论温针灸联合放血疗法治疗湿热型痤疮疗效佳,不良反应率低,复发率低,疗效稳定。     

细胞力学在皮肤科的研究进展

【摘要】 细胞力学是一门新兴的交叉学科，以研究细胞的力学特性与细胞生命活动以及组织、器官、机体生理过程的关系为主。通过对力学信号的感受和响应机制，细胞参与皮肤、骨、眼等多器官组织的生理活动以及疾病的发生发展，包括皮肤组织再生、重建、适应性变化和多种皮肤病的发病，因此成为近年皮肤病研究的热点。本文综述近年来细胞力学的基础研究和其在瘢痕、压疮、白癜风、皮肤肿瘤、毛发疾病等方面的研究和应用进展，为皮肤病治疗提供可能的方法和策略。     

Disseminated tuberculosis associated with reactive arthritis of Poncet in an immunocompetent patient

Cutaneous tuberculosis is a rare extrapulmonary manifestation of tuberculosis which, like disseminated tuberculosis, commonly occurs in immunocompromised patients. Poncet reactive arthritis is a seronegative arthritis affecting patients with extrapulmonary tuberculosis, which is uncommon even in endemic countries. We report a previously healthy 23-year-old male patient with watery diarrhea associated with erythematous ulcers on the lower limbs and oligoarthritis of the hands. Histopathological examination of the skin showed epithelioid granulomatous process with palisade granulomas and central caseous necrosis. AFB screening by Ziehl–Neelsen staining showed intact bacilli, the culture was positive for Mycobacterium tuberculosis, and colonoscopy revealed multiple shallow ulcers. Disseminated tuberculosis associated with reactive Poncet arthritis was diagnosed, with an improvement of the clinical and skin condition after appropriate treatment.