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.     

膝关节自体软骨细胞移植术后康复的研究进展

目的总结膝关节自体软骨细胞移植术（autologous chondrocyte implantation，ACI）术后康复的研究进展。方法查阅近年来国内外 ACI 术后康复相关的基础及临床研究，并进行总结分析。结果研究表明，ACI 术后移植物成熟分为 4 个阶段：增生期（术后 0～6 周）、过渡期（术后 6～12 周）、重塑期（术后 12～26 周）、成熟期（术后 26 周～2 年）。为了避免早期移植物损伤，适当刺激移植物和骨骼的整合过程，更快恢复关节功能，临床需针对术后不同阶段移植物的生物力学特性设计康复锻炼方案，主要体现在术后负重、运动范围、康复训练方式的过渡和调整。结论膝关节 ACI 术后应科学地逐步增加负重和运动范围，在不同阶段可借助相应的康复锻炼手段。但目前相关研究的证据等级较低，仍需更高质量、更大样本量的随机对照试验，进一步探讨完善康复方案。     

选择性修薄股前外侧皮瓣修复足跟及足跟后区缺损

目的探讨选择性修薄股前外侧皮瓣修复足跟及足跟后区缺损的疗效。方法2013 年 4 月—2015 年 8 月，收治 8 例不同原因导致的足跟及足跟后区缺损患者。男 6 例，女 2 例；年龄 15～49 岁，平均 31.2 岁。创面范围为 14 cm×10 cm～19 cm×14 cm。手术切取对侧股前外侧皮瓣，将拟覆盖足底非承重区和足跟后区部分行不同程度修薄。皮瓣切取范围为 14 cm×10 cm～19 cm×14 cm。供区游离植皮修复。结果术后皮瓣均顺利成活，创面 Ⅰ 期愈合。2 例发生供区局部皮片坏死，经换药后愈合；其余植皮均顺利成活。患者均获随访，随访时间 8～20 个月，平均 12.3 个月。患者恢复正常行走，其中 2 例皮瓣发生破损，经换药后自愈。7 例皮瓣外观无臃肿，不影响穿鞋；1 例于术后 1 年行二期皮瓣修薄术。结论选择性修薄股前外侧皮瓣修复足跟及足跟后区缺损，可获得较理想足部外观和功能。     

Evaluation of a policy to strengthen case management and quality of diabetes care in general practice in Denmark

ObjectivesTo evaluate the utilization of a policy for strengthening general practitioner's case management and quality of care of diabetes patients in Denmark incentivized by a novel payment mode. We also want to elucidate any geographical variation or variation on the basis of practice features such as solo- or group practice, size of practice and age of the GP.MethodsOn the basis registers encompassing reimbursement data from GPs and practice specific information about geographical location (region), type of practice (solo- or group-practice), size of practice (number of patients listed) and age of the GP were are able to determine differences in use of the policy in relation to the practice-specific information.ResultsAt the end of the study period (2007–2012) approximately 30% of practices have enrolled extending services to approximately 10% of the diabetes population. There is regional – as well as organizational differences between GPs who have enrolled and the national averages with enrolees being younger, from larger practices and with more patients listed.ConclusionsOur study documents an organizationally and regionally varied and limited utilization with the overall incentive structure defined in the policy not strong enough to move the majority of GPs to change their way of delivering and financing care for patients with diabetes within a period of more than 5 years.     

北京市新农合大病保险实施效果分析与评价

目的:测算分析北京市新农合大病保险对患者疾病经济负担的减轻作用,对制度实施效果进行评价。方法:按照经济发展水平和大病保险承办方式选取北京市三个区县,再从中选择大病患者较多的2~3个乡镇。通过与大病保险管理者进行访谈,了解其运行现状;对样本乡镇全部大病患者进行问卷调查了解患者主观感受,收到有效问卷497份。利用新农合管理中心信息平台测算患者疾病经济负担。对定量和定性资料分别采用统计分析与主题框架法进行分析。结果:经大病保险报销,三个区县大病患者平均自付费用明显减轻,实际补偿比均有不同程度的提高,但灾难性卫生支出情况无显著改善。结论:应通过提高大病保险起付线与报销比例,拓宽报销目录等举措提高其补偿水平,重点缓解极重患者疾病经济负担。     

医疗机构治理结构与内生绩效改善机制:以北京市某三级综合医院医师费制度为样本

以北京市属某三级综合医院为研究样本,旨在观察和分析医疗机构的主要绩效产出持续提升的有效机制。通过研究样本医疗机构绩效产出主体人员主诊医师的主要激励措施即医师费制度对绩效产出的促进机制,进而讨论机制的有效性与医院治理结构的内在关联。研究认为,组织治理和管理架构的有效设计促进产生了内生机制改善的持续动力——内生动力,内生动力保障了促进机制的持续和有效改善,而有效的促进机制保障了绩效产出的持续提升,进而实现组织发展的目标。     

公立医院PF医师费的年资积分模型设计

年资积分是PF医师费制度中体现医疗团队合作、实践经验传承的重要部分。作者以清华大学附属北京清华长庚医院为样本,以医师职业进阶路径为基础,结合培养年限,架构出公立医院年资积分设计的基本模型。该模型既体现尊师重教的基本职业伦理,又激励年轻医师追求卓越。     

新医改形势下药师参与住院药费控制成效分析

目的:通过对药师参与住院药费控制的成效分析,旨在为医改形式下药师参与药费控制提供参考借鉴。方法:在医院政策支持下,各部门密切协作,药师参与药费控制,采取系列措施:制定辅助用药目录与排他性药物目录、开展处方点评、利用信息手段实施事前干预、鼓励药师事前干预/在线干预、开展临床合理用药宣教等。统计分析药师参与住院药费控制前后西成药占比、医院自制药及中药占比、主要治疗药物及辅助用药占比、人均总费用及人均药费的变化。结果:住院西成药占比降低10.65%,达到医院预期目标。其中辅助用药下降幅度最大;零加成后主要治疗用药占比上升21.15%,医院自制药品及中药占比上升173.23%。人均药费及人均总费用较前减少不明显,符合医改总体目标。结论:新医改形式下药师参与住院药费控制成效显著,可发挥不可替代的职业价值。     

The free healthcare initiative in Sierra Leone: Evaluating a health system reform, 2010‐2015

This article presents the findings of a theory‐based evaluation of the Sierra Leone Free Health Care Initiative (FHCI), using mixed methods. Analytical approaches included time‐series analysis of national survey data to examine mortality and morbidity trends, as well as modelling of impact using the Lives Saved Tool and expenditure trend analysis. We find that the FHCI responded to a clear need in Sierra Leone, was well designed to bring about needed changes in the health system to deliver services to the target beneficiaries, and did indeed bring funds and momentum to produce important systemic reforms. However, its ambition was also a risk, and weaknesses in implementation have been evident in a number of core areas, such as drugs supply. We conclude that the FHCI was one important factor contributing to improvements in coverage and equity of coverage of essential services for mothers and children. Modelled cost‐effectiveness is high—in the region of US$ 420 to US$ 444 per life year saved. The findings suggest that even—or perhaps especially—in a weak health system, a reform‐like fee removal, if tackled in a systematic way, can bring about important health system gains that benefit vulnerable groups in particular.