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.     

疫情防控期间某医院开展临床医学课程在线教学的SWOT分析

利用SWOT理论分析疫情防控期间教学医院开展在线教学的内外部竞争环境和竞争条件。在综合性大学附属某医院开展临床医学课程在线教学，具有资源优势、组织优势和平台优势；但也存在临床医学专业的课程特殊性、临床教学医院的教师身份特殊性、疫情防控背景下在线教学的软硬件特殊性等劣势；为医院对标国家一流课程建设、发挥课程思政在教学阵地的主作用、营造主动型学习生态圈提供了发展基础；也对未来教学模式、教学管理模式、教学空间变革提出了挑战。基于此，提出推进医院医学教育信息化建设；全面提升教师信息素养；筑构适应于医院管理环境的教育信息化平台；搭建基于智慧教学空间的多元评价体系；基于多学科建设线上线下混合式课程体系等措施，以推进医院医学教育信息化建设和提升教学管理效率，促进“新医科”建设。     

基于Oncomine数据库分析PD-L1基因在头颈部癌中的表达及预后

目的:研究程序性死亡因子配体1(programmed death factor 1,PD-L1/CD274)在头颈部癌中的表达情况,并分析其与临床病理特征及预后的相关性。方法:挖掘Oncomine数据库中关于PD-L1基因在头颈部癌中的相关数据,进行PD-L1表达量与头颈部癌临床生物学特性的相关分析,并利用数据库中生存数据进行生存分析。结果:Oncom-ine数据库中有关PD-L1基因癌组织/正常组织表达量的分析共176项,其中高表达的癌种共4项,低表达2项;在头颈部癌组织中,显著高表达1项。Meta分析显示,PD-L1在头颈部癌中呈现高表达,显著高于正常组织。在人乳头瘤病毒(human papillomavirus,HPV)阳性的HNC患者中PD-L1的表达显著高于HPV阴性HNC患者(0.38 vs 0.16,P=0.018),有远处转移的患者显著高于无转移者(1.36 vs 0.55,P=0.004)。生存分析显示PD-L1表达量与生存期无显著相关。结论:PD-L1在头颈部癌中表达水平高,与人乳头瘤病毒状态及肿瘤转移相关,与生存期不相关。     

葡萄胎诊治的研究进展

葡萄胎是一种良性妊娠滋养细胞疾病，可分为完全性葡萄胎和部分性葡萄胎两类。新出现的葡萄胎染色体倍体分析、基于短串联重复序列的基因型检测、印记基因CDKN1C表达产物p57的免疫组化染色等辅助手段有助于其鉴别诊断。完全性葡萄胎多为孤雄二倍体，p57免疫组化染色阴性，但特殊的双亲来源完全性葡萄胎为双亲二倍体。部分性葡萄胎多为双雄三倍体，p57免疫组化染色阳性。葡萄胎的治疗以清宫术为主，特殊病例可行子宫切除术，通常不建议行预防性化疗。清宫术后应连续每周监测血清hCG直至降至正常水平。相比部分性葡萄胎，完全性葡萄胎后出现妊娠滋养细胞肿瘤的风险更高、连续2次完全性葡萄胎后继续发生葡萄胎的风险也更高。复发性葡萄胎患者中，有NLRP7或KHDC3L基因纯合突变者，妊娠失败风险极高。本文对葡萄胎诊断和治疗，尤其是对临床处理具有指导作用的主要研究进展进行综述。     

IKBKE enhances TMZ-chemoresistance through upregulation of MGMT expression in glioblastoma

Glioblastoma multiforme (GBM) is the most common and aggressive malignant type of brain tumor. Despite advances in diagnosis and therapy, the prognosis of     

Benzophenone-3 promotion of mammary tumorigenesis is diet-dependent

Benzophenone-3 is a putative endocrine disrupting chemical and common ingredient in sunscreens. The potential of endocrine disrupting chemicals to act as agonists or antagonists in critical hormonally regulated processes, such as mammary gland development and mammary tumorigenesis, demands evaluation of its potential in promoting breast cancer. This study identifies the effects of BP-3 on mammary tumorigenesis with high-fat diet during puberty versus adulthood in Trp53-null transplant BALB/c mice. Benzophenone-3 exposure yielded levels in urine similar to humans subjected to heavy topical sunscreen exposure. Benzophenone-3 was protective for epithelial tumorigenesis in mice fed lifelong low-fat diet, while promotional for epithelial tumorigenesis in mice fed adult high-fat diet. Benzophenone-3 increased tumor cell proliferation, decreased tumor cell apoptosis, and increased tumor vascularity dependent on specific dietary regimen and tumor histopathology. Even in instances of an ostensibly protective effect, other parameters suggest greater risk. Although benzophenone-3 seemed protective on low-fat diet, spindle cell tumors arising in these mice showed increased proliferation and decreased apoptosis. This points to a need for further studies of benzophenone-3 in both animal models and humans as a potential breast cancer risk factor, as well as a more general need to evaluate endocrine disrupting chemicals in varying dietary contexts.     

锥形束CT对儿童上颌前部埋伏多生牙定位的研究

目的评价锥形束CT(cone beam computed tomography,CBCT)及三维重建技术对儿童上颌前部埋伏多生牙定位的价值,为临床提供准确的治疗措施。方法选择2017年6月-2018年9月来本院就诊上颌骨内埋伏牙儿童患者263例行锥形束CT扫描,获取牙体表面三维立体图像及任意平面图像和任意曲面体层图像,从多个角度显示埋伏牙的形态、大小、萌出方向、唇腭侧位置及与邻牙位置的关系。结果263例患儿312颗上颌前部埋伏多生牙252颗位于腭侧,50颗位于唇侧,10颗位于牙槽骨中部;牙冠正向生长77颗,牙冠倒置生长154颗,牙冠横向生长81颗。所有患者顺利完成手术,术前诊断与术中结果完全一致,准确率为100%。结论锥形束CT是精确定位儿童上颌前部埋伏多生牙有效方法,可直接、准确地反映埋伏多生牙的位置,为临床诊断和治疗提供可靠信息。