Role of vitamin D in the pathogenesis and treatment of atopic dermatitis

Atopic dermatitis (AD) is a highly prevalent allergic skin disease that affects children worldwide. Epidemiological, clinical and basic immunological studies have suggested an association between vitamin D (VD) deficiency and the development of AD and other allergic diseases. Low levels of VD, a pleiotropic hormone that has widespread effects on the immune system and skin integrity, appear to be inversely correlated with AD severity, and VD deficiency at birth is associated with higher risk of developing AD. Recent randomized trials have reported inconsistent, but still promising, results on whether VD supplementation may improve AD severity. The apparent differences are likely due to small samples, different regimens and different patient populations. The mechanisms underlying this potential improvement in AD severity remain under investigation.     

Environmental determinants of atopic eczema phenotypes in relation to asthma and atopic sensitization

BACKGROUND: There is still uncertainty about the determinants of atopic eczema (AE). To explain the heterogeneity of the disease, different phenotypes of AE have been suggested. METHODS: The cross-sectional PARSIFAL study included 14 893 school-age children of farmers or children attending Steiner schools and their respective reference groups. A detailed questionnaire was completed, and house dust was collected for the measurement of endotoxin and glucans. Atopic sensitization was defined by allergen-specific IgE levels in the serum. RESULTS: In multivariate analyses, helping with haying was the only variable related to a farming environment having a consistent inverse association with both current symptoms and a doctor's diagnosis of AE [aOR = 0.65 (95% CI: 0.46-0.93) and 0.73 (0.51-1.05)], respectively. Severe lower respiratory tract infections (LRTI) in the first 2 years of life and usage of antibiotics ever were found to be positively related only to asthma-associated AE, whereas the effect of LRTI on AE without asthma had an opposite effect. Levels of beta(1-->3)-glucans in mattress dust were inversely related to a doctor's diagnosis of asthma-associated AE [aOR = 0.75 (0.57-0.98)], and endotoxin levels to current symptoms of asthma-associated AE [aOR = 0.73 (0.57-0.94)]. CONCLUSIONS: The analyses of the PARSIFAL study revealed two different phenotypes of AE, depending on the association with asthma and wheezing ever. With regard to the hygiene hypothesis, help with haying, exposure to beta(1-->3)-glucans and endotoxin were found to be inversely associated with the AE phenotype associated with asthma and wheezing.     

Janus激酶1抑制剂PF-04965842

Janus激酶（JAKs）是一类细胞内非受体酪氨酸激酶,介导多种细胞因子和生长因子的信号传导,参与免疫、炎症和造血细胞的发育、分化成熟、凋亡和功能表达等过程。JAK1在JAK家族成员中具有最广泛的细胞因子信号转导途径,JAK1选择性抑制剂可以抑制参与炎症和免疫功能的许多细胞因子,同时避免因抑制其他JAKs所引起的不良反应。PF-04965842是辉瑞公司正在开发的JAK1抑制剂,用于炎症性疾病的治疗。目前PF-04965842在中重度特异性皮炎治疗中的作用及与其他药物相互作用的影响研究正处于Ⅰ、Ⅱ、Ⅲ期临床研究中,其有效性和安全性已经得到验证。     

卡介苗多糖核酸联合依匹斯汀治疗慢性湿疹58例疗效观察

目的探讨卡介苗多糖核酸联合依匹斯汀治疗慢性湿疹的临床疗效及不良反应情况。方法 116例慢性湿疹病例被随机分为观察组和对照组各58例,观察组肌注卡介苗多糖核酸隔日一次,连续4 w,每日口服依匹斯汀10 mg,联合外用丁酸氢化可的松软膏;对照组每日口服依匹斯汀10 mg联合外用丁酸氢化可的松软膏,涂于患处,每日早晚两次。观察两组患者的治疗效果及不良反应情况。结果观察组治愈26例、显效26例,有效6例,总有效率100%;对照组治愈13例、显效20例、有效20例,总有效率91.4%,差异具有统计学意义(P<0.05)。观察组复发3例(5.17%),对照组复发13例(22.4%),差异具有统计学意义(P<0.05)。两组患者均未观察到严重的不良反应。结论卡介苗多糖核酸联合依匹斯汀治疗慢性湿疹疗效确切,不良反应较轻,能显著降低患者的复发率。     

临床试验进展：大数据方法在临床试验中的应用

药物研发的复杂性与日俱增,而大数据时代的到来使得临床试验的进展大大加快。本期＂临床试验进展＂讨论了皮肤病学新创试验中面向数据的亮点,探讨了现实采用的大数据方法,剖析了对风险导向监察的新兴方法学。此外还汇总了银屑病和特应性皮炎新疗法的临床研究报告,揭示了这些疾病的影响以及Ⅱ期和Ⅲ期研究中已经取得成功的候选药。     

小儿湿疹局部用中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南,旨在推动儿科中药临床试验设计与评价水平的提高,并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的“共识会议法”和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则,国内全部18 个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11 个儿科常见病种指南的起草或多次提出修改建议,历经3 年反复完善,最终形成共识,并由中华中医药学会儿科分会于2013 年10 月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿湿疹中药新药临床试验的设计与评价技术要点,期望能为申办者与研究者在临床试验方案设计中提供指导。     

中药外用治疗婴儿湿疹的Meta分析

目的：用Meta分析的方法探讨中药外用治疗婴儿湿疹的治疗作用。方法：全面检索1982—2012年间公开发表在国内杂志上关于中药外用治疗婴儿湿疹的相关文献,收集文献所报道的关于中药外用治疗和西药治疗婴儿湿疹的总人数及有效人数。使用State11．0软件进行异质性检验,采用随机效应模型合并计算效应指标RR值,以比较中药外用治疗相对于西药治疗的优势。结果：合并计算中药外用治疗婴儿湿疹的总例数为2280例,有效2179例,有效率95．75％,显著优于西药治疗的有效率80．75％;中药外用治疗婴儿湿疹的优势是西药治疗的1．11倍（95％置信区间1．05—1．19）。结论：中药外用治疗可有效改善婴儿湿疹,较西药治疗效果更佳,值得在临床推广。