中医药干预新型冠状病毒肺炎临床研究方案分析

对中医药防治新型冠状病毒肺炎临床研究方案注册情况进行分析,为提高相关研究设计质量提供参考和建议。检索中国临床试验注册中心网站(www.chictr.org.cn)以及美国临床试验注册中心网站(clinicaltrials.gov),以新型冠状病毒肺炎、2019-nCoV等为检索词,检索新型冠状病毒肺炎中医药相关临床研究方案。按照纳入排除标准筛选文献,并提取研究注册时间、研究目的、研究类型、申办单位、研究对象、样本量、干预措施、评价指标等数据,采用描述性分析方法。共纳入新型冠状病毒肺炎中医药相关研究方案49个,研究负责单位以湖北、北京、浙江等地医院或高等院校为主。研究具体实施单位属地集中在湖北、广东、浙江、河南等地医院。研究设计以干预性试验研究为主(共40个),其中随机平行对照研究30个,非随机对照试验7个,单臂研究2个,连续入组1个;观察性研究6个;卫生服务研究2个;预防性研究1个。总样本量30562例,单个研究样本量最大20000例,最小30例。49个方案的研究对象包括健康人群(3个)、隔离观察人群(1个)、疑似病例(10个)、确诊病例(31个)、康复期病例(4个)。31个拟纳入确诊病例的研究方案中,有16个研究未明确病情分级,3个研究明确排除危重症,4个研究纳入普通型,2个研究纳入轻型、普通型或重型,1个研究纳入轻型和普通型,1个研究纳入普通型或重型,3个研究纳入重型,1个研究纳入重症或危重症。评价的干预措施包括中成药(连花清瘟胶囊/颗粒、藿香正气滴丸/口服液、八宝丹、固表解毒灵、金蒿解热颗粒、复方鱼腥草合剂、金叶败毒颗粒、疏风解毒胶囊、双黄连口服液、痰热清注射液、血必净注射液、热毒宁注射液、喜炎平注射液)、汤药、太极拳疗法。主要疗效指标以退热时间、临床症状缓解、新型冠状病毒核酸转阴、重症转化率、胸部CT影像为主。结果表明中医药防治新冠肺炎的临床研究响应快速,当前注册方案涵盖了疾病预防、治疗和康复全过程。但存在人群定义不清,研究目标不明确,干预方案需要细化,疗效评价指标需要优化等问题;另外,需要考虑疫情救治的实际困难和工作负担,在符合医学伦理条件下,优化流程,提高研究方案的可操作性。     

医疗器械口咽通气道产品注册的常见问题及改进建议

近年来,医疗器械口咽通气道产品的注册数量日益增加,针对该产品的相关咨询也逐渐增多。但该产品暂无相关的注册技术审查指导原则,以致该产品的注册申报资料经常出现一些共性问题。现根据医疗器械口咽通气道产品相关法规和标准,对日常工作中遇到的常见问题进行归纳,分析该产品注册申报中的技术审评要求及共性问题,并给出对策或建议。     

Robust rigid registration of retinal angiograms through optimization

Retinal fundus photographs are employed as standard diagnostic tools in ophthalmology. Serial photographs of the flow of fluorescein and indocyanine green (ICG) dye are used to determine the areas of the retinal lesions. For objective measurements of features, the registration of the images is a necessity. In this paper, we employ optimization techniques for registration with the help of 2-parameter translational motion model of retinal angiograms, based on non-linear pre-processing (Wiener filtering and morphological gradient) and computation of the similarity criteria for the alignment of the two gradient images for any given rigid transformation. The optimization methods are effectively employed to minimize the similarity criterion.

The presence of noise, the variations in the background and the temporal variation of the fluorescence level pose serious problems in obtaining a robust registration of the retinal images. Moreover, local search strategies are not robust in the case of ICG angiograms, even if one uses a multiresolution approach.

The present work makes a systematic comparison of different optimization techniques, namely the minimization method derived from the optical flow formulation, the Nelder-Mead local search and the HCIAC ant colony metaheuristic, each optimizing a similarity criterion for the gradient images. The impact of the resolution and median filtering of gradient image is studied and the robustness of the approaches is tested through experimental studies, performed on macular fluorescein and ICG angiographies.

Our proposed optimization techniques have shown interesting results especially for high resolution difficult registration problems. Moreover, this approach seems promising for affine (6-parameter motion model) or elastical registrations.     

大面积堆场逐级增高下软土地基变形特性

通过历时2 a的现场监测,揭示了大面积堆场逐级增高情况下软土地基变形特性的规律,总结了固结沉降的规律,为软土地基的固结沉降分析计算提供依据.     

18F-FDG符合线路显像与同机CT融合在肿瘤诊断的应用

【目的】评价~(18)F-FDG符合线路显像及同机CT图像融合在肿瘤诊断中的价值。【方法】经病理确诊或临床确诊为恶性肿瘤的病人79例,良性肿块病人19例进行~(18)F-FDG符合线路显像及同机CT图像融合检查,经COSEM重建,结果与解剖显像比较。【结果】①~(18)F-FDG符合显像诊断恶性肿瘤的敏感性、特异性、准确率、阳性预测值和阴性预测值分别为92.4％、89.5％、91.8％、97.3％和73.9％,解剖显像分别为79.8％、63.2％、76.5％、90.0％和42.9％。②同部位显像比较中,~(18)F-FDG显像病灶探测数为302个,而解剖显像为286个。③同机CT融合明显提高对肺部近纵隔、膈缘及腹部等部位的定位诊断。【结论】~(18)F-FDG符合线路显像较解剖显像更好地对恶性肿瘤作出鉴别诊断,并且能探测到更多的恶性病灶,同机CT融合较大地提高定位诊断的准确性,具有重要的临床价值,值得临床广泛应用。     

基于Internet的遗传疾病登记、随访系统的设计与实现

本系统通过以Internet网为平台,将传统的医院/患者(咨询者)的遗传随访模式转为医院/Internet网/患者(咨询者)的新医疗模式,该系统会大大提高遗传随访的及时性和便利性;同时,会有利于遗传登记的开展,也有利于随访资料的保存。     

红细胞膜通道力学效应的探讨

在考察红细胞双凹碟形体形成的基础上,讨论了红细胞的输氧功能与红细胞变形的关系,揭示了红细胞膜通道的力学效应:当红细胞呈双凹碟形时,PiPo的地方,红细胞膜通道有释放出氧的现象,其氧的总流率为 J=Lo_2(Pio_2-Poo_2) Lp(Pi-Po) 式中Lo_2为O_2分压差引起的膜通道对氧的流导,PiO_2、Poo_2为膜内外的氧分压;Lp为由于压差引起的膜通道对氧的流导。     

The effect of mechanical deformation on magnetic properties and MRI artifacts of type 304 and type 316L stainless steel

The purpose of this study was to evaluate the influence of composition and deformation of biomedical stainless steels on mechanical properties, magnetic properties, and MRI artifacts. Type 304 and Type 316L samples were prepared using standard wire-drawing techniques. Mechanical properties were determined using standard test methods. The amount of ferromagnetic phase present was estimated using a Severn Gage and x-ray diffraction. Magnetic field attraction and artifacts were determined using previously described techniques. The strength of both steels increased significantly with increasing deformation. None of the type 316L wires transformed to the magnetic phase. The amount of magnetic phase in the type 304 wires increased with increasing deformation. There was no magnetic field attraction, and artifacts were minimal for all of type 316L wires and the undeformed type 304 wire. Deflection and artifacts were significant for the deformed type 304 stainless steel. These results provide guidance regarding the use of type 304 and type 316L stainless steels for bioimplants. In this regard, type 316L stainless steel seems to be a more acceptable material with respect to MR compatibility.     

基于薄板样条和形状内容的医学图像非刚性配准方法研究

目的 针对医学图像非刚性点配准的现状,给出一种基于点特征的非刚性配准方法.方法 利用一种新的相似度测量方法--形状内容来解决两幅图像中点的对应关系,并利用点对应关系来估计非刚性映射函数.结果 利用薄板样条实现了医学图像的快速准确非刚性配准.结论 实验结果表明,上述方法获得了很好的配准效果.