期刊文献+
共找到744篇文章
< 1 2 38 >
每页显示 20 50 100
Protocol and statistical designs in classic clinical research—toripalimab series trial analysis
1
作者 Yingjian He Li Bian Zefei Jiang 《Cancer Biology & Medicine》 2026年第3期338-342,共5页
Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical d... Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical designs ensure the reliability of trial outcomes and improve the credibility of research findings.By reviewing the statistical approaches used in the TORCHLIGHT,NCC2167,and NeoTENNIS trials,this article illustrates the principles underlying large-sample confirmatory RCTs,small-sample exploratory adaptive designs,and single-arm two-stage designs.This discussion is aimed at helping researchers apply these design methods more effectively,to increase the likelihood of success in clinical studies. 展开更多
关键词 improve credibility evaluating efficacy safety medical interventionsrobust protocols statistical designs clinical research randomized controlled trials rcts statistical designs randomized controlled trials SAFETY EFFICACY
暂未订购
Design of Out-of-Band Protocols to Transmit UHDTV Contents in the CATV Network
2
作者 Sunsik Roh 《International Journal of Communications, Network and System Sciences》 2012年第5期253-262,共10页
The goal of an UHDTV is to broadcast digital video contents which is 16 times the pixel resolution of HDTV. As the resolution is increased, the UHDTV requires a transmission technology to support very high data transf... The goal of an UHDTV is to broadcast digital video contents which is 16 times the pixel resolution of HDTV. As the resolution is increased, the UHDTV requires a transmission technology to support very high data transfer rate. In this paper, we propose two out-of-band protocols to transmit UHDTV contents in a CATV network: an OOB-based protocol and a DSG-based protocol. The former may be a short term solution which is well suitable for a traditional CATV network and the letter may be a long term solution which is adoptable for a CATV network equipped with DOCSIS functionalities. In order to transfer 200 Mbps UHDTV contents, proposed protocols use a channel bonding mechanism which combines several QAM channels. We propose CATV network architectures to support an UHDTV service with a channel bonding mechanism, and design the format of messages to share the information of bonded channels between a headend and a STB. We develop an OPNET simulator and ascertain successful transmission of UHDTV contents. 展开更多
关键词 UHDTV (Ultra High DEFINITION TV) CATV Networks Control protocol Network Simulation protocol design
暂未订购
A Formal Approach to the Design of Network Protocol
3
作者 罗军舟 顾冠群 《Journal of Southeast University(English Edition)》 EI CAS 1996年第2期2-6,共5页
This paper presents the network service model and protocol model, and gives a brief introduction to a high level Petri net called EPr/TN net system, which serves as the formal specification tool for network protocol.... This paper presents the network service model and protocol model, and gives a brief introduction to a high level Petri net called EPr/TN net system, which serves as the formal specification tool for network protocol. Finally, the general methods for the 展开更多
关键词 protocol PETRI NET design
在线阅读 下载PDF
Cross-Layer Design Based Optimized Link State Routing Protocol for Wireless Mesh Networks
4
作者 Huai-Yu Wen Guang-Chun Luo 《Journal of Electronic Science and Technology》 CAS 2011年第4期368-372,共5页
A proactive routing protocol CL-OLSR (cross-layer based optimized link state routing) by using a brand-new routing metric CLM (cross-layer metric) is proposed. CL-OLSR takes into account four link quality impact f... A proactive routing protocol CL-OLSR (cross-layer based optimized link state routing) by using a brand-new routing metric CLM (cross-layer metric) is proposed. CL-OLSR takes into account four link quality impact factors in route calculation through the cross-layer operation mechanism: the node available bandwidth, the node load, the link delivery rate, and the link interference, and thus the effect of route selection is optimized greatly. The simulation results show that the proposed CL-OLSR protocol can not only improve the network throughput to a large extent, but also reduce the end-to-end delay, while achieving load balance route results. 展开更多
关键词 Cross-layer design proactive routing routing protocol wireless mesh network.
在线阅读 下载PDF
痛风急性期与间歇期中医药临床研究设计关键要素考量
5
作者 冷媛媛 于亚南 +2 位作者 明雨 刘骏 王忠 《中南药学》 2026年第3期315-321,共7页
目的构建符合患者需求的痛风急性期与间歇期中医药研究框架,推动证据转化与临床优化。方法基于国际指南与新药研发特点,结合以患者为中心理念,分析痛风临床常用疗效指标、现代治疗方案局限及中医药多靶点调控优势,提出临床设计关键要素... 目的构建符合患者需求的痛风急性期与间歇期中医药研究框架,推动证据转化与临床优化。方法基于国际指南与新药研发特点,结合以患者为中心理念,分析痛风临床常用疗效指标、现代治疗方案局限及中医药多靶点调控优势,提出临床设计关键要素包括明确差异化定位、采用复合终点评价、设置中药特色对照、贴合病程规划访视。结果确立了痛风急性期与间歇期中药临床试验的核心设计要素:在差异化定位上,明确急性期以快速镇痛消肿为核心,间歇期则聚焦于降低发作频率及改善代谢状态;在复合终点评价方面,建议构建涵盖疼痛评分(如VAS)、炎性标志物(如CRP、ESR)及生活质量(如SF-36)的多维度复合评价体系;在中药特色对照设计上,推荐采用安慰剂或西药基础上的叠加设计,以凸显中药增效减毒的优势;在疾病阶段匹配的随访上,强调急性期需采用短密集随访(按小时或天),间歇期采用长期随访,从而精准契合疾病特征与中药起效规律。结论整合结构化设计要素可为中医药研究提供科学框架,促进高质量证据生成与临床实践优化。 展开更多
关键词 痛风 中医药 临床研究 方案设计
原文传递
基于跨层链路质量感知的OLSR协议优化研究
6
作者 李翊嘉 刘玉涛 +2 位作者 刘倩楠 刘宪磊 李佳峰 《计算机测量与控制》 2026年第1期166-172,180,共8页
针对传统OLSR协议多点中继选择机制仅依赖拓扑覆盖而忽略链路动态质量的问题,提出了一种基于跨层设计的OLSR改进方案,对MPR选择机制进行优化;构建跨层综合状态因子,融合物理层误比特率、MAC层帧接收成功率、MAC层队列长度等多维指标,设... 针对传统OLSR协议多点中继选择机制仅依赖拓扑覆盖而忽略链路动态质量的问题,提出了一种基于跨层设计的OLSR改进方案,对MPR选择机制进行优化;构建跨层综合状态因子,融合物理层误比特率、MAC层帧接收成功率、MAC层队列长度等多维指标,设计拓展HELLO消息格式,新增CSE跨层字段,实现邻居节点状态的实时交互;设计新的MPR选择机制,将传统覆盖度优先策略优化为基于CSE加权的多目标决策模型,通过动态评分函数同时优化链路稳定性和负载均衡;仿真结果表明:CSE-OLSR在分组投递率、平均端到端时延等方面均优于传统OLSR,能够有效提高数据传输的稳定性和可靠性,适用于高动态、高负载的MANETs场景。 展开更多
关键词 移动自组网 OLSR协议 跨层设计 链路质量感知 路由优化
在线阅读 下载PDF
A Secure Blockchain-Based Vehicular Collision Avoidance Protocol: Detecting and Preventing Blackhole Attacks
7
作者 Mosab Manaseer Maram Bani Younes 《Computer Systems Science & Engineering》 2024年第6期1699-1721,共23页
This work aims to examine the vulnerabilities and threats in the applications of intelligent transport systems,especially collision avoidance protocols.It focuses on achieving the availability of network communication... This work aims to examine the vulnerabilities and threats in the applications of intelligent transport systems,especially collision avoidance protocols.It focuses on achieving the availability of network communication among traveling vehicles.Finally,it aims to find a secure solution to prevent blackhole attacks on vehicular network communications.The proposed solution relies on authenticating vehicles by joining a blockchain network.This technology provides identification information and receives cryptography keys.Moreover,the ad hoc on-demand distance vector(AODV)protocol is used for route discovery and ensuring reliable node communication.The system activates an adaptive mode for monitoring communications and continually adjusts trust scores based on packet delivery performance.From the experimental study,we can infer that the proposed protocol has successfully detected and prevented blackhole attacks for different numbers of simulated vehicles and at different traveling speeds.This reduces accident rates by 60%and increases the packet delivery ratio and the throughput of the connecting network by 40%and 20%,respectively.However,extra overheads in delay and memory are required to create and initialize the blockchain network. 展开更多
关键词 Vehicular networks blockchain collision avoidance protocol design security mechanisms
在线阅读 下载PDF
多协议融合的视频监控设备通信软件设计与实现
8
作者 刘洋 张明军 +2 位作者 雷宇 刘新宇 潘夏宁 《数字通信世界》 2026年第2期53-55,共3页
针对当前网络视频监控设备管理软件存在协议集成度低、操作烦琐、数据交互灵活性不足等问题,本文提出一种多协议融合的网络视频监控设备通信控制软件方案。软件采用客户端—服务器架构,客户端基于Windows系统QT5.15平台开发,包含登录、... 针对当前网络视频监控设备管理软件存在协议集成度低、操作烦琐、数据交互灵活性不足等问题,本文提出一种多协议融合的网络视频监控设备通信控制软件方案。软件采用客户端—服务器架构,客户端基于Windows系统QT5.15平台开发,包含登录、主界面、程序控制、网络摄像机查询、数据库查询、系统配置6大核心模块,通过ONVIF、FTP、JSON多协议协同,实现设备发现、指令执行、参数读写、文件传输等功能;服务器模块基于Ubuntu平台开发,独立部署于监控设备主机,负责与客户端数据交互并执行对应操作。测试验证表明,该软件可实现监控设备从出厂配置、运行维护到问题处理的全生命周期管理,操作便捷且功能全面,能有效提升运维效率、降低管理成本,适用于大规模监控设备集群管理场景。 展开更多
关键词 视频监控 通信协议 软件设计 服务器
在线阅读 下载PDF
CAN_TP软件的设计与实现
9
作者 赵文斌 肖兵 张镭耀 《自动化仪表》 2026年第1期85-89,94,共6页
为解决汽车悬架电控系统中应用层与数据链路层之间通信时数据长度不统一的问题,设计与实现了控制器局域网传输协议(CAN_TP)软件。CAN_TP软件设计以实现网络层为高层提供服务与网络层的内部操作为重点,对数据帧进行分类处理。设计了九种... 为解决汽车悬架电控系统中应用层与数据链路层之间通信时数据长度不统一的问题,设计与实现了控制器局域网传输协议(CAN_TP)软件。CAN_TP软件设计以实现网络层为高层提供服务与网络层的内部操作为重点,对数据帧进行分类处理。设计了九种状态标识符及对应函数,提出信息收发过程中的数据拆分与重组方法。采用先入先出(FIFO)队列缓存上、下层之间的传输数据,改善了网络传输层的性能。针对传输过程中可能出现的错误,设计了相应的错误处理机制,以保证传输信息的准确性。试验结果表明,CAN_TP软件能够实现对报文的实时、快速和准确处理。CAN_TP软件设计为汽车测量、标定与诊断(MCD)系统中信息的处理和传输方式提供了参考,在汽车电子领域具有一定的应用价值。 展开更多
关键词 控制器局域网传输协议 内部操作 软件设计 数据拆分与重组 错误处理机制 测量、标定与诊断
在线阅读 下载PDF
AI智能照明系统设计的探讨
10
作者 李响 《土木工程与绿色建筑》 2026年第2期151-155,共5页
随着AI技术的快速发展,智能照明系统正从自动化向智慧化转型。为适应新的设计需求,文章提出基于“感知-通信-决策-执行”四步集成设计框架的系统构建策略。从智能照明系统的物联网四层架构出发,分析传感器选型、通信协议对比及AI后端平... 随着AI技术的快速发展,智能照明系统正从自动化向智慧化转型。为适应新的设计需求,文章提出基于“感知-通信-决策-执行”四步集成设计框架的系统构建策略。从智能照明系统的物联网四层架构出发,分析传感器选型、通信协议对比及AI后端平台的功能,并结合建筑行业存量市场趋势,探讨传统总线系统的AI适配改造方案。通过典型设计案例,验证该设计框架的适用性。结果证明,四步设计框架可适用于新建和改造项目的 AI智能照明控制系统设计工作。该设计框架为AI赋能的智能照明系统提供了清晰的设计路径,有助于推动照明控制从被动模式向智慧化方向转型。 展开更多
关键词 AI智能照明系统 四步集成设计框架 传感器技术 通信协议 既有建筑改造
在线阅读 下载PDF
药物临床试验的设计创新和技术创新 被引量:4
11
作者 熊海燕 罗剑锋 王伟炳 《复旦学报(医学版)》 北大核心 2025年第1期153-158,共6页
药物临床试验是评估药物有效性和安全性的实验流行病学研究方法。本文介绍了药物临床试验设计创新的类型和设计思路,为相关研究提供方法学参考。适应性设计是一类复杂创新型临床试验设计方法,依据适应性的目的可以分为:成组序贯设计,样... 药物临床试验是评估药物有效性和安全性的实验流行病学研究方法。本文介绍了药物临床试验设计创新的类型和设计思路,为相关研究提供方法学参考。适应性设计是一类复杂创新型临床试验设计方法,依据适应性的目的可以分为:成组序贯设计,样本量重估计,无缝试验,富集设计,主方案设计(篮式试验、伞式试验、平台试验等)。适应性设计具备更大的调整灵活性,在一定程度上克服了常规临床试验的缺点,进而提高研究结果的有效性和论证强度。药物临床试验的设计创新与重塑将为实现精准医学目标提供更有力的循证证据。 展开更多
关键词 药物临床试验 适应性设计 主方案设计 人工智能
暂未订购
Toward a Multi-Hop, Multi-Path Fault-Tolerant and Load Balancing Hierarchical Routing Protocol for Wireless Sensor Network
12
作者 Mokhtar Beldjehem 《Wireless Sensor Network》 2013年第11期215-222,共8页
This paper describes a novel energy-aware multi-hop cluster-based fault-tolerant load balancing hierarchical routing protocol for a self-organizing wireless sensor network (WSN), which takes into account the broadcast... This paper describes a novel energy-aware multi-hop cluster-based fault-tolerant load balancing hierarchical routing protocol for a self-organizing wireless sensor network (WSN), which takes into account the broadcast nature of radio. The main idea is using hierarchical fuzzy soft clusters enabling non-exclusive overlapping clusters, thus allowing partial multiple membership of a node to more than one cluster, whereby for each cluster the clusterhead (CH) takes in charge intra-cluster issues of aggregating the information from nodes members, and then collaborate and coordinate with its related overlapping area heads (OAHs), which are elected heuristically to ensure inter-clusters communication. This communication is implemented using an extended version of time-division multiple access (TDMA) allowing the allocation of several slots for a given node, and alternating the role of the clusterhead and its associated overlapping area heads. Each cluster head relays information to overlapping area heads which in turn each relays it to other associated cluster heads in related clusters, thus the information propagates gradually until it reaches the sink in a multi-hop fashion. 展开更多
关键词 Wireless Sensor Network protocol design Hierarchical Soft Clustering SELF-ORGANIZATION FAULT-TOLERANCE Fault-Resilience ENERGY-EFFICIENCY Load Balancing Scalability Ambient Intelligence
在线阅读 下载PDF
电力行政通信系统中IMS核心网的设计与实现
13
作者 史浩伟 《通信电源技术》 2026年第5期31-33,共3页
面向电力行政通信系统网际互连协议(Internet Protocol,IP)化演进需求,构建IP多媒体子系统(IP Multimedia Subsystem,IMS)核心网架构,采用分层编址、动态路由、时间同步及地址迁移机制,提升网络结构稳定性与业务调度能力。通过部署BCG5... 面向电力行政通信系统网际互连协议(Internet Protocol,IP)化演进需求,构建IP多媒体子系统(IP Multimedia Subsystem,IMS)核心网架构,采用分层编址、动态路由、时间同步及地址迁移机制,提升网络结构稳定性与业务调度能力。通过部署BCG5000、IAD1224、TimeSync 3000等设备,完成控制面与媒体面解耦设计,建立安全同步链路与电话号码映射(E.164 Number Uniform resource identifier Mapping,ENUM)协议映射机制。测试结果表明,所设计的IMS核心网在呼叫建立、链路切换、实时传输协议(Real-time Transport Protocol,RTP)稳定性与同步精度等关键指标上均满足设计阈值,适用于电力行业多地协同通信系统。 展开更多
关键词 电力行政通信系统 网际互连协议多媒体子系统(IMS)核心网 时间同步 路由设计
在线阅读 下载PDF
嵌入式物联网融合通讯协议实践教学设计
14
作者 邓招奇 郝亚茹 《福建电脑》 2025年第1期99-102,共4页
为使学生能够融会贯通嵌入式物联网分散在各门专业课的知识,本文提出一个以通讯协议为纽带的综合实践课程设计方法。该方法应用Zigbee无线协议,串口协议和网络协议,整合现有的专业课知识。通过设计基于硬件和软件的实践项目,同时以嵌入... 为使学生能够融会贯通嵌入式物联网分散在各门专业课的知识,本文提出一个以通讯协议为纽带的综合实践课程设计方法。该方法应用Zigbee无线协议,串口协议和网络协议,整合现有的专业课知识。通过设计基于硬件和软件的实践项目,同时以嵌入式物联网的典型问题为导向,引导学生加深理解专业知识。实践的结果表明,采用该教学方法的嵌入式物联网综合实践课程能够在一定程度上提高学生对专业知识的综合理解和应用。 展开更多
关键词 嵌入式 物联网 通讯协议 教学设计
在线阅读 下载PDF
Special Topic on Digital Twin Online Channel Modeling for 6G and Beyond
15
作者 WANG Chengxiang HUANG Chen 《ZTE Communications》 2025年第2期1-2,共2页
Channel characterization and modeling are fundamental to communication system design,development,testing,and deployment.As the innate digital twins of wireless channels,channel models replicate real-world channel beha... Channel characterization and modeling are fundamental to communication system design,development,testing,and deployment.As the innate digital twins of wireless channels,channel models replicate real-world channel behaviors,e.g.,large-scale/small-scale fading,spatio-temporal-frequency non-stationarity,through mathematical and data-driven methods.This enables simulation-based validation across system development stages—from protocol design to network optimization-without costly physical testing. 展开更多
关键词 simulation G VALIDATION communication system channel modeling channel characterization digital twin protocol design
在线阅读 下载PDF
A Wireless Sensor Network Ad-Hoc Designed as Anti-Theft Alarm System for Photovoltaic Panels 被引量:3
16
作者 Silvano Bertoldo Oscar Rorato +1 位作者 Claudio Lucianaz Marco Allegretti 《Wireless Sensor Network》 2012年第4期107-112,共6页
Photovoltaic (PV) systems have attracted increasing attention in last years as well as Wireless Sensor Networks (WSNs), which have been used in many application fields. In PV plants, especially in ground installations... Photovoltaic (PV) systems have attracted increasing attention in last years as well as Wireless Sensor Networks (WSNs), which have been used in many application fields. In PV plants, especially in ground installations, a lot of thefts and damages occur due to the still high cost of the modules. A new experimental WSN ad-hoc has been designed to be an anti-theft alarm system. Each node of the network is directly installed under each PV string and it is equipped with an accelerometer sensor capable to detect a minimum displacement of the panel from its steady position. The WSN presents a star topology: a master node cyclically interrogates the slave nodes through RF link. It collects all the nodes responses and communicates though a RS-232 interface with a control PC checking the network status. When a slave node detects an alarm, continuous messages are sent to the control PC which turns on all the alarm signaling systems. The control PC is equipped with an open source operative system and software and provides for SMS, e-mail and sound-light signaling in case of alarm. It also communicates with a remote server where all the WSN information is stored. A first low cost experimental WSN has been already installed and it is working properly. 展开更多
关键词 WSN ALARM SYSTEM Photovoltaic SYSTEM Electronic BOARD AD-HOC designed BOARD Low Cost AD-HOC protocol
暂未订购
A Contention-Based MAC and Routing Protocol for Wireless Sensor Network
17
作者 Chung Yee Haw Azlan Awang Fawnizu Azmadi Hussin 《Wireless Sensor Network》 2023年第1期1-32,共32页
Advance development of wireless technologies and micro-sensor systems have enabled Wireless Sensor Network (WSN) to emerge as a leading solution in many crucial sensor-based applications. WSN deploys numerous resource... Advance development of wireless technologies and micro-sensor systems have enabled Wireless Sensor Network (WSN) to emerge as a leading solution in many crucial sensor-based applications. WSN deploys numerous resource-constrained sensor nodes which have limited power supply, memory and computation capability in a harsh environment. Inefficient routing strategy results in degraded network performance in terms of reliability, latency and energy efficiency. In this paper, a cross-layer design, Contention-based MAC and Routing protocol is proposed, termed Contention/SNIR-Based Forwarding (CSBF) protocol. CSBF utilizes the geographical information of sensor nodes to effectively guide the routing direction towards destination node, thereby enhancing reliability. Furthermore, Signal-to-Noise-plus-Interference Ratio (SNIR) metric is used as a routing parameter to guarantee high quality link for data transmission. A Contention-Winner Relay scheme is utilized to reduce the delays caused by the contention procedure. Energy efficiency is also improved by introducing sleep mode technique in CSBF. The simulation work is carried out via OMNeT++ network simulator. The performance of CSBF is compared with other existing routing protocols such as AODV and DSDV in terms of packet delivery ratio (PDR), average end-to-end (ETE) delay and energy consumption per packet. Simulation results highlight that CSBF outperforms AODV and DSDV protocols in respect of PDR and energy efficiency. CSBF also has the most consistent overall network performance. 展开更多
关键词 Wireless Sensor Network Inefficient Routing Strategy Cross-Layer design CSBF protocol Geographical Information SNIR Metric
在线阅读 下载PDF
Cross Layer Design for Cooperative Transmission in Wireless Sensor Networks
18
作者 Kanojia Sindhuben Babulal Rajiv Ranjan Tewari 《Wireless Sensor Network》 2011年第6期209-214,共6页
Several protocols and schemes have been proposed to reduce energy consumption in Wireless Sensor Net-works (WSNs). In this paper we employ farcoopt, a cross layer design approach with the concept of coop-eration among... Several protocols and schemes have been proposed to reduce energy consumption in Wireless Sensor Net-works (WSNs). In this paper we employ farcoopt, a cross layer design approach with the concept of coop-eration among the nodes with best farthest neighbor scheme to increase the Quality of Service (QoS), reduce energy consumption, increases performance and end-to-end throughput. We present cooperative transmission to connect previously disconnect parts of a network thus overcoming the separation problem of multi-hop network. We show that this approach improves connectivity over 50% compared to multi-hop approaches and reduces the number of nodes necessary to provide full coverage of an area up to 35%. Simulation results show that on increase of data rates i.e. packet the network life time increases in farcoopt as compared to tra-ditional multi hop approach. The result of this analysis is presented in this work. 展开更多
关键词 COOPERATIVE Network CROSS Layer design WIRELESS Sensor Networks Energy SAVING Communication protocol ROUTING
在线阅读 下载PDF
中成药治疗肺癌化疗后中性粒细胞减少的有效性与安全性临床试验方案设计探索——以双黄升白口服液Ⅱ期临床试验设计方案为例
19
作者 楚立园 田劭丹 +3 位作者 侯丽 王中奇 龚亚斌 陈信义 《药物评价研究》 北大核心 2025年第2期386-393,共8页
目的以双黄升白口服液Ⅱ期临床试验设计方案为例,探索中成药治疗肺癌化疗后中性粒细胞(ANC)减少的临床试验方案的设计,为治疗肿瘤化疗后出现ANC减少的中药新药研发提供参考。方法双黄升白口服液Ⅱ期临床试验设计方案:以晚期肺癌或肺癌... 目的以双黄升白口服液Ⅱ期临床试验设计方案为例,探索中成药治疗肺癌化疗后中性粒细胞(ANC)减少的临床试验方案的设计,为治疗肿瘤化疗后出现ANC减少的中药新药研发提供参考。方法双黄升白口服液Ⅱ期临床试验设计方案:以晚期肺癌或肺癌术后化疗导致1、2级ANC减少的精气两亏证患者为研究对象,采用随机、双盲、安慰剂平行对照、多中心的临床试验方法,将240例患者以1∶1比例分到试验组和对照组,试验组予双黄升白口服液、对照组予双黄升白口服液模拟剂,疗程为21 d。以ANC维持与复常为主要疗效指标;将ANC和白细胞(WBC)计数减少的发生率、ANC曲线下面积、粒细胞减少性发热(FN)的发生率、重组人粒细胞集落刺激因子(rhG-CSF)注射液使用量、中医证候疗效改变以及FACT-L量表评分变化作为次要疗效指标;以不良事件作为安全性指标。结果双黄升白口服液Ⅱ期临床试验设计方案将疾病共性规律与患者个体特征相结合,在方法学上病证结合评定疗效,客观评价药物的有效性与安全性,具备实用性和科学性。结论该方案既体现了中医学治疗思维和疗效优势,又适应了循证理念,成果具有外推性,为规范临床试验方法和推动中医药走向国际公认化做出了有益探索。 展开更多
关键词 肺癌 化疗 中性粒细胞减少 精气两亏证 双黄升白口服液 中医证候疗效 方案设计
原文传递
针对疫苗研发的临床试验创新设计
20
作者 赵丹妮 黄卓英 +2 位作者 田婕 张涛 王伟炳 《复旦学报(医学版)》 北大核心 2025年第2期311-316,共6页
对于一些突发的重大新发传染病流行,仅依靠传统疫苗临床试验不能及时得到有意义的研究结果。为了更好地应对疾病的暴发,需要一些新的试验设计,不仅能够加速或重组传统疫苗临床试验的3个阶段,同时依然严格遵守与候选药物安全性和有效性... 对于一些突发的重大新发传染病流行,仅依靠传统疫苗临床试验不能及时得到有意义的研究结果。为了更好地应对疾病的暴发,需要一些新的试验设计,不仅能够加速或重组传统疫苗临床试验的3个阶段,同时依然严格遵守与候选药物安全性和有效性评价相关的科学规律。本文归纳了目前疫苗临床试验的创新设计类型和思路,以及应用过程中需注意的要点,为相关研究提供方法学参考。适应性设计灵活性高,可根据中期分析结果动态调整试验参数,例如剂量选择、人群分层和样本量重估。贝叶斯设计允许纳入历史数据和先验信息,减少样本量需求。主方案设计可以在一个总体方案中评估多种治疗方法或目标人群,提高效率。真实世界数据(real-world data,RWD)的应用可以从非干预性环境中获取数据(如电子健康记录、接种记录、保险索赔数据),支持虚拟对照组的设立从而解决伦理问题。本文还介绍了基于随机对照试验和RWD的混合设计。这些试验设计的创新都优化了试验流程,从而加速疫苗研发和审批,为实现传染病防控目标提供了更有力的循证证据。 展开更多
关键词 疫苗临床试验 适应性设计 贝叶斯设计 主方案设计 真实世界数据(RWD)
暂未订购
上一页 1 2 38 下一页 到第
使用帮助 返回顶部