Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

Equity in Access to Health Care Services in Italy

ObjectiveTo provide new evidence on whether and how patterns of health care utilization deviate from horizontal equity in a country with a universal and egalitarian public health care system: Italy.ConclusionsDespite its universal and egalitarian public health care system, Italy exhibits a significant degree of SES-related horizontal inequity in health services utilization.     

“知-信-行”一体化健康教育对高原涉核官兵健康素养的影响

目的:探讨"知-信-行"一体化健康教育对高原涉核官兵健康素养的影响;方法:方便抽样选取165名高原涉核官兵为研究对象,对其进行为期15天的"知-信-行"一体化健康教育,包括健康知识技能教授(健康教育评估、健康知识讲座、健康技能培训、健康资料宣传、健康知识查询机使用等)、健康信念支持、健康行为指导等定期和随机即时的健康教育,并应用高原涉核官兵健康素养调查问卷在教育前后对涉核官兵进行健康素养调查,观察教育前后官兵健康素养各维度得分及具备健康素养的人数和百分数的变化情况,以评价健康教育效果。结果:(1)"知-信-行"一体化健康教育后官兵在健康知识、健康技能、健康信念、健康行为4个维度得分均显著高于健康教育前(t=22.7814,21.7027,10.7039,10.9213;P0.01),差异有统计学意义;(2)"知-信-行"一体化健康教育后,165名官兵中具备健康素养的人数由之前的50人上升为122人,占比由30.30%升至73.94%,差异有统计学意义(t=65.3500,P0.01)。结论:"知-信-行"一体化健康教育可有效提高高原涉核官兵的健康素养;建议对高原涉核官兵进行长期的"知-信-行"一体化健康教育随访与指导。     

Community action for health in socioeconomically deprived neighbourhoods in Barcelona: Evaluating its effects on health and social class health inequalities

BackgroundThe aim of this study was to analyse trends in several health-related indicators in socioeconomically deprived neighbourhoods in Barcelona with strong community action for health (CA), and compare them to neighbourhoods without such community action. A secondary goal was to analyse trends in socioeconomic inequalities in health in both types of neighbourhood.MethodsWe performed a quasi-experimental pre-post study using data from the Barcelona Health Surveys of 2001 and 2011. Our dependent variables were self-perceived health, mental health, previous drug use, and smoking cessation. We used Poisson regression with robust variance to calculate prevalence ratios (PR) and 95% Confidence Intervals (95% CI).ResultsThe percentage of men who had ever used drugs decreased over time in neighbourhoods with strong CA (PR = 0.48; 95% CI:0.25–0.92, from 2001 to 2011), but not in neighbourhoods without CA (PR = 1.02; 95% CI:0.74–1.40). However, the prevalence of poor mental health among men increased more in neighbourhoods with strong CA than in neighbourhoods without CA (p-value = 0.025). Among women, social class inequalities in poor mental health and smoking cessation decreased over time in neighbourhoods with strong CA but not in neighbourhoods without CA.ConclusionsOur study shows promising results regarding the effect of community action on health, particularly in terms of inequalities. Our results highlight the importance of allocating resources to implement and continuously evaluate CA initiatives.     

年龄相关性黄斑变性的影像学研究进展

年龄相关性黄斑变性(age-related macular degeneration,AMD)是发达国家50岁以上人群致盲的首要原因.近年来,随着影像学技术在眼科的应用和发展,对该病的发病机制、诊断水平及疗效评价能力大大提高.本文将就近年来AMD的影像学研究进展予以综述.