Suggestions on Improving China’s Breakthrough Therapy Designation System

Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.

Development of a Decision Aid for Family Surrogate Decision Makers of Critically Ill Patients Requiring Renal Replacement Therapy in ICU:A User-Centered Design for Rapid Prototyping

Objectives Renal replacement therapy(RRT)is increasingly adopted for critically ill patients diagnosed with acute kidney injury,but the optimal time for initiation remains unclear and prognosis is uncertain,leading to medical complexity,ethical conflicts,and decision dilemmas in intensive care unit(ICU)settings.This study aimed to develop a decision aid(DA)for the family surrogate of critically ill patients to support their engagement in shared decision-making process with clinicians.Methods Development of DA employed a systematic process with user-centered design(UCD)principle,which included:(i)competitive analysis:searched,screened,and assessed the existing DAs to gather insights for design strategies,developmental techniques,and functionalities;(ii)user needs assessment:interviewed family surrogates in our hospital to explore target user group's decision-making experience and identify their unmet needs;(iii)evidence syntheses:integrate latest clinical evidence and pertinent information to inform the content development of DA.Results The competitive analysis included 16 relevant DAs,from which we derived valuable insights using existing resources.User decision needs were explored among a cohort of 15 family surrogates,revealing four thematic issues in decision-making,including stuck into dilemmas,sense of uncertainty,limited capacity,and delayed decision confirmation.A total of 27 articles were included for evidence syntheses.Relevant decision making knowledge on disease and treatment,as delineated in the literature sourced from decision support system or clinical guidelines,were formatted as the foundational knowledge base.Twenty-one items of evidence were extracted and integrated into the content panels of benefits and risks of RRT,possible outcomes,and reasons to choose.The DA was drafted into a web-based phototype using the elements of UCD.This platform could guide users in their preparation of decision-making through a sequential four-step process:identifying treatment options,weighing the benefits and risks,clarifying personal preferences and values,and formulating a schedule for formal shared decision-making with clinicians.Conclusions We developed a rapid prototype of DA tailored for family surrogate decision makers of critically ill patients in need of RRT in ICU setting.Future studies are needed to evaluate its usability,feasibility,and clinical effects of this intervention.

Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Infection after Vascular Surgery with Inguinal Incisions: Rationale and Design of a Randomized Controlled Trial (INVIPS-Trial)

Background/Aims: Inguinal incisions are a common route of access in vascular surgery. Due to anatomical challenges and a diverse bacterial flora in this area, surgical site infections (SSI) represent a common, debilitating and sometimes life-threatening complication. The INVIPS-Trial evaluates the role of Negative Pressure Wound Therapy (NPWT) on closed inguinal incisions in elective vascular surgery to prevent SSI and other wound complications. Methods: This randomized controlled trial (RCT) registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO, Smith & Nephew, UK) and the center’s standard wound dressing (Vitri Pad, ViTri Medical, Sweden) on postoperative wound complications, especially SSI. The study includes two distinct vascular procedures with different SSI risk profiles: endovascular aortic repair (EVAR) and open surgical approaches involving the common femoral artery (OPEN). Results: Four hundred ninety-five groin incisions in both treatment arms are anticipated to be included in the EVAR group and 147 inguinal incisions in both treatment arms in the OPEN group. Since a large percentage of inguinal vascular procedures in both groups but especially in the EVAR group are performed bilaterally, many patients can serve as their own control by randomly receiving NPWT on one and the standard dressing on the contralateral inguinal incision. Conclusions: This ongoing RCT attempts to elucidate the potential benefit of NPWT on closed inguinal incisions after different vascular procedures. Outcome and conclusions of this trial could have implications on postoperative wound care of patients in both vascular surgery and other surgical specialties.

Landscape Preference Evaluation for Hospital Environmental Design

This paper examined users’ preferences for landscape design of grounds and spaces surrounding hospitals, in order to assess how they perceived the landscape facilities so as to make future open spaces of hospitals suitable to users’ needs. The method of the research was based on quantifying a questionnaire survey of a representative sample of personnel (doctors, nurses, administrative staff and medical students) by using the stratified sample research programme that was carried out in March 2007 at the University Hospital of the city of Alexandroupolis, situated in northeastern Greece. The results of study show that users of hospital cared about footpaths, resting areas, social and public spaces, personal spaces, water features and a dominant, limited range of colors in landscaping. They also require environment that supports the principles and specifications of Therapeutic Hospital Gardens. Based on the results of this research, (a) interventions have been proposed (e.g., footpaths, resting areas, social and public spaces, personal spaces, water features and a dominant, limited range of colors in landscaping), and (b) the principles and specifications for the landscape design of Therapeutic Hospital Gardens have also been evaluated and have been redefined in the light of the study findings. These results also provide the opportunity for health care decision makers to apply and to incorporate user considerations into overall landscape design for current and future health care programs.

Intermittent androgen deprivation therapy in patients with prostate cancer: Connecting the dots

Intermittent androgen deprivation therapy(IADT)is now being increasingly opted by the treating physicians and patients with prostate cancer.The most common reason driving this is the availability of an off-treatment period to the patients that provides some relief from treatment-related side-effects,and reduced treatment costs.IADT may also delay the progression to castration-resistant prostate cancer.However,the use of IADT in the setting of prostate cancer has not been strongly substantiated by data from clinical trials.Multiple factors seem to contribute towards this inadequacy of supportive data for the use of IADT in patients with prostate cancer,e.g.,population characteristics(both demographic and clinical),study design,treatment regimen,on-and off-treatment criteria,duration of active treatment,endpoints,and analysis.The present review article focuses on seven clinical trials that evaluated the efficacy of IADT vs.continuous androgen deprivation therapy for the treatment of prostate cancer.The results from these clinical trials have been discussed in light of the factors that may impact the treatment outcomes,especially the disease(tumor)burden.Based on evidence,potential candidate population for IADT has been suggested along with recommendations for the use of IADT in patients with prostate cancer.

基于正交设计的穴位埋线治疗脑卒中后便秘方案优选研究

目的基于正交设计对脑卒中后便秘穴位埋线进行初步方案优选。方法选取脑卒中后便秘患者80例,以每周完全自主排便次数为观察指标,应用正交设计法,观察间隔时间(A,2周、间隔4周)、埋线深度(B,25~40 mm、50~60 mm)、取穴(C,天枢、天枢+大肠俞)、线体(D,胶原蛋白线、PDO线)4因素两水平间的不同搭配组合对脑卒中后便秘的疗效,初步确定优选方案。结果治疗后,各组周完全自主排便(CSBM)次数较治疗前均有明显改善(P<0.05),直观分析:两水平差值之差(R)(B)>R(C)>R(A)>R(D),R(B)、R(C)明显大于R(A)、R(D),可知B、C是影响效果的主要因素,而A、D则是次要因素。结论间隔2周、埋线深度40~50 mm、PDO线体、天枢+大肠俞,为较优治疗方案。

基于整合疗法的认知障碍防治产品设计

目的 针对老年痴呆的防治问题,为弥补单方面药物治疗的局限性,从设计康护的角度出发,探索性地提出整合疗法轻度认知障碍防治产品的创新设计策略。方法 首先,对整合疗法理论进行溯源分析与价值挖掘,思考整合疗法中设计介入的方式,探究整合疗法认知行为训练产品设计策略及原则;其次,采用SPSS数据分析软件进行量表数据处理和分析,对患者记忆、定向力、语言等关键指标进行量化比对,形成患者状态评价与病症考量依据,结合非药物治疗干预和药物治疗,协调患者兴趣及产品交互体验难度之间的平衡,围绕“养植养智”进行轻度认知障碍预防及治疗产品设计实证;最后对患者进行实验测试,采用CDR、MMSE量表积分对比,进行产品干预效度评估。结论 整合疗法理念的融入能够协调患者在认知康复训练过程中难度与兴趣之间的平衡,可有效改善认知训练产品设计的效度,使患者既不产生抵触,又可在体验种植乐趣中实现养智。此设计为认知障碍防治产品设计提供了一个新的切入点。

肿瘤治疗电场在肿瘤治疗中的应用和机制研究进展

[背景]肿瘤治疗领域缺乏高效、安全的非侵入式治疗方法.近年来,肿瘤治疗电场(tumor treating fields,TTFields)作为一种新兴的非侵入性物理治疗技术,通过释放中频、低强度的交变电场有效抑制肿瘤生长,引发的副作用较小.[进展]目前TTFields已被广泛应用于各类肿瘤治疗的临床研究中,包括脑胶质瘤、间皮质瘤、非小细胞肺癌、胰腺癌、卵巢癌、肝癌及胃癌等.TTFields通过向生物分子施加生物物理力,扰乱肿瘤细胞的生物学功能从而抑制其生长,但具体分子机制尚不明确.为研究TTFields在肿瘤治疗中的分子机制,研究人员通过设计和搭建不同电极和交变电场发生平台,在体外研究TTFields对肿瘤细胞的作用机制.研究发现TTFields干扰细胞分裂、DNA修复、自噬、细胞迁移和细胞膜通透性等生物学过程,也影响血脑屏障、血管生成和肿瘤免疫等肿瘤微环境.[展望]本文回顾了近年来TTFields在肿瘤治疗中的应用、用于体外研究的电极设计和电场发生平台,及其潜在的抗肿瘤机制.然而,TTFields抑制肿瘤生长的分子机制仍需深入研究,评估其对能够自我更新的非肿瘤细胞和终端分化细胞的影响,以减少可能的副作用.这些研究将有助于提升TTFields的治疗潜力,为更多恶性肿瘤的治疗开辟新的可能性.

自动驾驶汽车与中医理疗融合创新:移动中医理疗车设计研究

为缓解用户在生活时间与医疗服务时间上的冲突,将自动驾驶汽车与中医理疗服务融合,提出一种创新的解决方案。通过深入调研和分析,发现用户对便捷、隐私保护和个性化中医理疗有强烈需求,据此设计了一款集预约、检测、理疗为一体的移动中医理疗车,为用户提供一站式服务。这一创新服务模式能够提高中医理疗普及率,降低用户时间成本,为中医理疗现代化提供新思路。该设计也为未来医疗服务创新提供参考,推动医疗服务向更加便捷、个性化的方向迈进。

基于五感疗法的养老机构户外健康景观设计研究——以武汉楠山康养基地为例

人口老龄化的加剧导致国内老龄化环境建设越发紧迫,营造养老机构户外健康景观已成为创造宜居养老环境的重要组成部分。文章以五感疗法理念为切入点,结合武汉楠山康养基地的设计实践,在对老年人群的生理、心理、行为特征及其空间使用需求分析的基础上,以构建适合老年人的户外认知景观环境、户外感知景观环境及户外安全性景观环境为目标,在空间营造、感官要素等方面提出养老机构户外健康景观的设计优化策略,以期为养老社区户外景观环境建设与发展提供一些启示与参考。

Rationally designed approaches to augment CAR-T therapy for solid tumor treatment

Chimeric antigen receptor T cell denoted as CAR-T therapy has realized incredible therapeutic advancements for B cell malignancy treatment.However,its therapeutic validity has yet to be successfully achieved in solid tumors.Different from hematological cancers,solid tumors are characterized by dysregulated blood vessels,dense extracellular matrix,and filled with immunosuppressive signals,which together result in CAR-T cells’insufficient infiltration and rapid dysfunction.The insufficient recognition of tumor cells and tumor heterogeneity eventually causes cancer reoccurrences.In addition,CAR-T therapy also raises safety concerns,including potential cytokine release storm,on-target/off-tumor toxicities,and neuro-system side effects.Here we comprehensively review various targeting aspects,including CAR-T cell design,tumor modulation,and delivery strategy.We believe it is essential to rationally design a combinatory CAR-T therapy via constructing optimized CAR-T cells,directly manipulating tumor tissue microenvironments,and selecting the most suitable delivery strategy to achieve the optimal outcome in both safety and efficacy.

全健康(One Health)视角下绿色健康社区景观设计体系构建

以全健康(OneHealth)视角为出发点,保障人、环境和动物的健康对于社区健康环境规划与设计具有重要意义。在现有健康社区景观设计体系中,人、环境、物种三者关系虽被提及,但未被系统探究,健康社区建设实践也需要系统性的景观设计体系支持。基于全健康理念中人、环境和物种的相互关系,结合生态系统服务功能、康复景观理论和园艺疗法,进一步探讨人、环境、物种健康之间的关联途径。通过对全健康理念视角下的3个层次进行演绎发展,归纳总结了人的健康、环境健康和物种健康的组成要素及内容,构建了以人的健康需求为导向的社区健康设计框架,提出了以人与人际、人与环境和人与物种为三大圈层的健康社区景观设计体系。全健康视角为社区健康环境设计提供了一个系统性、整合性且具有操作性的框架,未来应重视健康社区体系中各类疗愈空间的设计与使用,以增进社区居民共享的健康福祉。

BNCT02真空设计及仿真

BNCT02由两套加速器和5个治疗端组成,可实现2组癌症患者同时治疗。目前开工建设的是其中一套装置,由一台ECR离子源,一条低能传输线(LEBT),一台2.8 MeV射频四极加速器(RFQ),两条高能传输线(HEBT)、两个治疗端和一条临时调束线组成。文章首先介绍了BNCT02真空设计,利用Molflow软件计算了RFQ及HEBT不同状态下的压力分布,并与实测情况进行比对。然后,对HEBT区段异型真空盒形变、水冷真空盒温升进行模拟计算,并优化对应真空盒设计。目前整个装置已经稳定运行,真空系统满足设计要求。

数字化口腔定位支架在头颈部肿瘤放射治疗中的应用现状

在放射治疗中,由于射线不可避免地对正常细胞产生辐射作用,头颈部肿瘤患者常会发生严重的口腔并发症,例如:放射治疗诱发性口腔黏膜炎、张口困难、吞咽困难、放射性颌骨坏死和放射性龋病等。这些并发症会影响甚至中断放射治疗的进行,对放射治疗后患者的生活质量造成难以估量的影响。为减小放射治疗带来不利影响,近年来,国内外学者对口腔定位支架(OPS)开展了广泛的研究,其中传统型OPS对一些口腔并发症的预防起到明显的作用,但其在设计制作以及推广应用上存在一些不足,数字化OPS的研究应运而生。本文主要对数字化OPS的设计制作方法、口腔并发症的预防以及放射治疗摆位的影响进行总结分析,对其应用前景进行了展望。

符合人体工学的环境改造方案在办公室慢性腰痛患者治疗中的应用效果

目的 探讨符合人体工学的环境改造方案在办公室慢性腰痛患者治疗中的应用效果。方法 选取2019年9月至2022年10月在广州中医药大学第一附属医院重庆医院(重庆市北碚区中医院)康复科就诊的办公室腰痛患者70例作为受试者。采用随机数字表法将受试者分为对照组和试验组,各35例。对照组采用单纯工作环境下的自我牵伸训练,试验组在对照组基础上由康复治疗师针对患者工作姿势、座椅、键盘及其他键入设备、显示器、工作区域空间、工作附件等各个因素给出合适的改造方案。比较两组临床疗效,两组干预前和干预后1、3个月Oswestry功能障碍指数(ODI)和视觉模拟评分法(VAS)评分。结果 试验组临床疗效优于对照组(P<0.05)。整体分析发现:两组ODI、VAS评分组间、时间点比较及交互作用差异均有统计学意义(P<0.05)。进一步两两比较:干预后1、3个月,两组ODI、VAS评分均低于干预前;干预后3个月,试验组ODI、VAS评分低于对照组(P<0.05)。结论 符合人体工学的环境改造方案可以有效缓解工作者腰痛症状,有助于预防腰痛的发生。

虚拟现实在恐高症辅助治疗产品设计中的应用

随着虚拟现实技术的发展,虚拟现实暴露疗法逐渐成为恐高症治疗的主流方法。为解决目前虚拟现实恐高症治疗场景单一化、缺乏情感化设计的问题,文章以恐高症辅助治疗产品为研究对象,探讨虚拟现实在恐高症治疗产品设计中的应用思路。从虚拟现实多风格场景设计、物理引擎设计、人机交互设计等方面,设计并制作了虚拟现实恐高症辅助治疗原型系统。以期提高用户的沉浸性和交互性,满足恐高症患者的使用需求,为促进虚拟现实恐高症治疗提供新思路。

面向大学生焦虑情绪干预的心理类产品交互设计研究

为促进大学生身心健康、全面发展,针对大学生的焦虑情绪进行干预式交互产品设计。通过文献调研,从遗传、环境、生活方式和心理4个方面探究大学生焦虑情绪产生的原因。通过对情绪干预类交互产品市场调研,发现面向大学生这一群体针对性的交互产品缺失。通过访谈目标用户总结需求,并从认知行为疗法入手,分别从认知、行为两个层面实施设计介入,从正确认识焦虑情绪、改变不良行为方式两方面着手对大学生的焦虑情绪进行调节和引导。通过对信息架构、流程图、低保真的设计,梳理了交互产品的功能结构和使用流程,并展示了相应的界面设计方案,为相关心理类产品的交互设计提供参考。

《儿童神经疾病与发育障碍物理治疗》课程思政建设探索

专业课程思政建设是打造思想政治教育的立体化育人体系的重要方式。文章在课程思政的背景下,从调查康复治疗学专业教学中课程思政融合的现状,阐述康复治疗学专业课程思政的重要性。以《儿童神经疾病与发育障碍物理治疗》课程为例,结合课程教学内容和特点进行教学设计,建设了聚焦于爱国情怀、社会责任感等方面的课程思政目标,并采用了思政元素直接导入课堂教学、思政专题嵌入课程知识点等多元化教学方法,为康复治疗学专业课教学构建了多维度的课程思政建设质量评价体系和团队合作机制,也为思想政治教育融入康复治疗学专业课程教学体系的建设提供了宝贵探索经验和实践基础。

基于学情分析的教学设计在神经系统体格检查教学中的应用

目的探讨基于学情分析的教学设计在神经系统体格检查(neurologic examination,NE)教学中的应用效果。方法2021年10—12月,选取重庆医科大学同一年级康复治疗学专业63名学生作为研究对象。按照学号排序分为为2组:A组31名,B组32名。A组采用NE的优化教学方案进行教学,而B组则采用NE的传统教学方案进行教学。通过课后现场考核方式,对比2组不同的教学方式,以评估学生在NE运用方面的表现。结果A组的考核得分[(95.355±1.199分)]高于B组的考核得分[(94.219±2.882)分],差异有统计学意义(P=0.046)。结论基于学情分析的教学设计可提升NE的教学效果,因此,教师在NE教学设计过程中应当注重学情分析。

龙氏治脊疗法结合放血疗法治疗40例神经根型颈椎病

目的:观察龙氏治脊疗法联合放血疗法对神经根型颈椎病患者症状的影响。方法:将164例神经根型颈椎病患者随机分为对照组、龙氏治脊组、放血组、联合组,每组各41例。对照组给予常规药物治疗,龙氏治脊组在对照组基础上应用龙氏治脊疗法治疗,放血组在对照组基础上应用放血疗法,联合组在对照组基础上应用放血疗法和龙氏治脊疗法。1周为1个疗程,共治疗2个疗程。治疗前、治疗1个疗程后、治疗2个疗程后分别用视觉模拟评分法(VAS)疼痛评分、VAS麻木评分、田中靖久颈椎病症状量表评分、颈椎功能障碍指数进行比较。同时评价治疗2个疗程后的临床疗效。结果:放血组剔除2例,联合组剔除1例,4组共161例完成研究。治疗2个疗程后,对照组、龙氏治脊组、放血组、联合组的VAS疼痛评分、VAS麻木评分、田中靖久颈椎病症状量表评分、颈椎功能障碍指数均较治疗前提高(P<0.01),且龙氏治脊组、放血组、联合组治疗2个疗程后VAS疼痛评分、VAS麻木评分、田中靖久颈椎病症状评分、颈椎功能障碍指数与对照组比较,差异均有统计学意义(P<0.05)。在治疗2个疗程后,联合组、对照组、龙氏治脊组、放血组总显效率分别为87.5%(35/40)、43.9%(18/41)、68.3%(28/41)、69.2%(27/39);联合组总显效率高于对照组、龙氏治脊组、放血组(P<0.05);龙氏治脊组和放血组总显效率均高于对照组(P<0.05);龙氏治脊组与放血组比较,差异无统计学意义(P>0.05)。龙氏治脊疗法和放血疗法两者无交互作用(P>0.05)。VAS疼痛评分、VAS麻木评分、颈椎功能障碍指数各评分的时间因素和分组因素都存在交互效应(P<0.01),4组下降趋势不一致,联合组下降幅度最大。田中靖久症状量表评分的时间因素和分组因素存在交互效应(P<0.01),4组增长幅度不一致,联合组增长幅度最大。结论:龙氏治脊疗法联合放血疗法可有效缓解神经根型颈椎病症状,使患者更快地回归正常生活。