EMA对草药产品申请上市许可或注册的非临床资料的要求

EMA于2017年8月发布了"公认和传统草药产品申请上市许可或注册的非临床文件的指导原则（草案）"。该指导原则指出传统和公认的草药物质或制剂,在获得人体充分而详实经验的情况下,单次给药和重复给药毒性、毒代动力学研究、免疫毒性以及局部耐受性试验是不必要的;而其生殖毒性、遗传毒性和致癌性,如果发表的文献不能用或不足,附加非临床试验是必要的。详细介绍该指导原则主要内容,以期对拟在欧盟上市的中草药产品有所帮助,也对我国草药监管有所启发。     

基于PC平台的扩展视野超声成像

扩展视野超声成像技术可以利用常规超声成像系统获得观察视野更大的图像,使得医生能够全面了解被成像部位的解剖结构,从而得出更客观和准确的诊断结果.本文给出一种基于PC平台的扩展视野超声成像系统及图像配准和拼接的快速算法.实验证明此算法不仅有较好的成像精度,并且有望实现实时成像.     

医学X线图像配准技术研究进展及其存在的问题

医学X线图像受到探测器面积大小的限制,成像范围有限,对较大器官的扫描无法一次完成.在观察病变部位时,医生需要结合多幅图像来进行诊断或治疗,因此需要对多张影像进行拼接处理.作为图像拼接技术的核心,图像配准技术已被广泛应用于医学成像中,将那些从扫描中获得的多类型信息进行配准从而得到更详细的信息.首先,本文重点综述了目前面向X线图像的比较主流和新兴的配准技术,如基于互信息的配准法,基于特征的配准法和基于变换域的配准法.其次,指出了X线图像配准中存在的影像漂移问题、拍摄角度的限制、非刚性配准仍未成熟、没有绝对的配准评价标准等问题.最后,总结了基于FPGA等硬件的医学图像配准、采用超分辨率重建技术以获取更高质量的待配准图像从而提高图像配准的精度和速度等发展趋势与研究前景.     

湖南省2012—2017年学生肺结核登记情况及流行特征

目的分析湖南省学生肺结核患者登记情况,了解流行特征,为完善全省学校结核防治策略提供依据。方法利用2012-2017年中国结核病信息管理系统中登记的资料,统计分析湖南省学生结核病患者登记率及其流行特征。结果2012-2017年湖南省发现学生肺结核患者7 940例,登记发病率为13.23/10万,涂阳肺结核患者2 203例,登记发病率为3.67/10万。2012-2017年学生活动性肺结核登记发病率比较,差异有统计学意义（χ2=80.079,P<0.001）;2012-2017年学生涂阳肺结核登记发病率比较,差异有统计学意义（χ2=112.213,P<0.001）。二季度学生肺结核登记人数最多（占32.2%）,以男性为主（占60.8%）,年龄以15～19岁为主（占61.8%）。2012-2017年各市州学生肺结核登记情况比较,差异有统计学意义（χ2=320.432,P<0.001）,累计登记总数居前三位的分别是长沙市、湘西州、衡阳市。2012-2017年登记学生肺结核患者来源以转诊为主（占38.8%）,99.8%患者接受抗结核治疗,诊断治疗以涂阴患者、非重症、非耐药、初治患者为主,分别占67.9%、95.2%、99.5%、99.3%。结论应加强学校结核病防治工作,加强对高中和大学入学新生的结核病筛查,定期开展学校结核病知识的宣传,提高学校结核病防治的意识。     

The lateral leeway in the habitual intercuspation: experimental studies and literature review

The habitual intercuspation is used ubiquitous for manufacturing small dental restorations. However, a little is known on its precision. The aim of the present study was therefore to investigate the unambiguity and accuracy of the habitual occlusion in mounted plaster casts from fully dentate persons. Eighty-one fully dentate volunteers, 36 women and 45 men aged 26.8 +/- 6.2 years (18-55 years), with minor fillings and no signs or symptoms of TMD took part in the experiments. Silicone impressions were taken, poured with stone plaster and the obtained casts mounted into Dentatus ARL(R)- articulators using an individual face bow transfer. Subsequently, the models were transferred to a custom-made measuring articulator where the lateral leeway and the accuracy of the hand-held habitual intercuspation were quantified in the condylar area. Measurements were repeated seven times with the upper cast pushed either to the maximum right or the maximum left intercuspation. The hand-held habitual intercuspation of upper and lower cast proved ambiguous in 57% of pairs of casts. The average lateral leeway of the habitual intercuspation in the condylar area was 0.10 +/- 0.05 mm (0-0.51 mm; median 0.07 mm) between the maximum right and left occlusal positions. The average accuracy of three repeated measurements was 0.22 +/- 0.09 mm (0.02-1.17 mm; median 0.16 mm). Natural occlusal surfaces in a full dentition do not guarantee an unambiguous habitual intercuspation of the plaster casts. The described leeway and technical limits might be possible causes for occlusal adjustments that are sometimes necessary when inserting restorations manufactured in habitual intercuspation.     

3D digital breast cancer models with multimodal fusion algorithms

Breast cancer image fusion consists of registering and visualizing different sets of a patient synchronized torso and radiological images into a 3D model. Breast spatial interpretation and visualization by the treating physician can be augmented with a patient-specific digital breast model that integrates radiological images. But the absence of a ground truth for a good correlation between surface and radiological information has impaired the development of potential clinical applications.A new image acquisition protocol was designed to acquire breast Magnetic Resonance Imaging (MRI) and 3D surface scan data with surface markers on the patient’s breasts and torso. A patient-specific digital breast model integrating the real breast torso and the tumor location was created and validated with a MRI/3D surface scan fusion algorithm in 16 breast cancer patients.This protocol was used to quantify breast shape differences between different modalities, and to measure the target registration error of several variants of the MRI/3D scan fusion algorithm. The fusion of single breasts without the biomechanical model of pose transformation had acceptable registration errors and accurate tumor locations. The performance of the fusion algorithm was not affected by breast volume. Further research and virtual clinical interfaces could lead to fast integration of this fusion technology into clinical practice.