A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.     

大数据时代的药品安全主动监测:对照选择的挑战与机遇

电子医疗数据已成为大数据时代开展药品安全主动监测的重要资源。基于此确认药品与不良事件是否存在关联，要回归传统的流行病学研究设计，选取恰当的对照进行对比。本文主要阐述不同对照选取的原理、适用情形，介绍、评价并比较各种对照选取的思路与参数，引入对照选择批量化实现的进展性成果，以期为我国利用电子医疗数据开展上市后药品安全性监测提供方法学参考。     

认知行为干预在冠心病患者护理中的应用效果

目的观察认知行为干预在冠心病患者护理中的应用效果。方法选取本院2016年12月～2018年2月期间收治的53例冠心病患者,根据住院号奇偶性情况将其随机分为观察组(n=27)和对照组(n=26),对照组予以常规护理,观察组予以认知行为干预。比较两组患者控制态度评分、心理状况评分、生活质量改善情况及依从性。结果观察组控制态度评分、心理状况评分、生活质量改善情况及依从性与对照组比较,差异有统计学意义(P0.05)。结论在冠心病患者护理中给予认知行为干预应用效果极佳,可作为临床干预首选措施。     

超市连锁店熟食卤味销售的HACCP研究

应用HACCP的原理和方法,对超市连锁店熟食卤味销售进行了危害因素分析,找出了关键控制点(CCP),提出了控制措施,并建议超市连锁店销售非包装熟食卤味时使用密封低温冷藏展示柜。     

富含血管的听神经瘤

目的探讨富含血管的听神经瘤的手术治疗。方法复习20年（1975—1995）手术治疗单侧听神经瘤90例，其中4例为富含血管的听神经瘤（HAT），与86例非富含血管的听神经瘤（NHAT），做回顾性分析，据临床表现、放射学检查、手术所见做比较。结果HAT较NHAT年轻（28±10与54±17岁）（P〈0．01），MRI显示HAT为实质性，无肿瘤囊变，多数较NHAT为大（P〈0．05）；MRI示HAT有多个代表较大引流静脉的流空效应；经皮股动脉、椎动脉造影显示HAT有广泛的肿瘤着色及早期引流静脉的充盈，并证实由椎基动脉供血。过去文献报道认为以分期手术为宜。作者在控制性低血压麻醉下，成功地完成了4例HAT的切除术，未输血，术后无明显伤残。结论HAT是一种实质性大型肿瘤，出现于青年期，血管造影能够提供特征性发现。MRI能显示肿瘤表面的流空效应而确诊。采用控制性低血压麻醉有望能一期全切除肿瘤。     

高血压家系802人的高血压患病率、知晓率、治疗和控制状况调查

目的了解高血压家系人群高血压患病率、治疗率和控制率特点。方法用整群随机抽样调查的方法调查高血压家系高血压的流行和控制情况，分析比较相关指标的差异。结果家系成员高血压患病率为55．86％，存在危险因素聚集现象。高血压的知晓率、治疗率、控制率分别为79．46％、62．72％、19．64％。结论该地区高血压家系高血压患病率较高，遗传因素是重要原因。虽高血压控制水平较高，但需加强高血压的一级预防。     

儿童玩具噪声的影响及控制对策

本文对多种不同年龄组适宜的玩具进行声级监测，并根据其特点及声级特征归纳为７种类型，同时对有儿童家庭及其近邻进行了访问调查，绘出了玩具噪声对居民干扰程度图，通过对部分儿童的调查，给出了儿童对玩具噪声的主观反应情况；通过完成认知试验心理指标的测定，给出了经常使用电子游戏机学龄儿童与对照组ＬＭＴ和ＭＴＳ各项指标的比较，最后综合各项指标及结果提出了建议声级值，并对控制玩具噪声提出了可能的方法。     

医学生"网络成瘾症"产生的原因和对策

文章针对目前医学生“网络成瘾症”的现状进行了分析,并指出了产生的原因和解决问题的办法,以求达到标本兼治。最后提出三点预防医学生“网络成瘾症”的对策：一是高校及其附属医院要为医学生营造宽松愉快的学习、生活环境;二是呼吁家长关注医学生身心发展的特殊规律,建立良好的家庭环境;三是建立和完善与网络社会相应的法律法规,规范医学生的网上行为。     

Control of endemic methicillin-resistant Staphylococcus aureus—recent advances and future challenges

Although the exact burden of disease caused by methicillin-resistant Staphylococcus aureus (MRSA) remains largely unknown, most experts agree that MRSA infections are an important clinical and public health problem. Thousands of reports have been published during the last four decades concerning epidemiological and microbiological aspects of MRSA, but uncertainty remains about the best approach to prevent and control this worldwide plague, especially endemic MRSA. Epidemiological methods, e.g., risk scores for targeted screening upon admission, rapid molecular tests and pre-emptive isolation of high-risk patients, new decontamination regimens and restriction of certain antibiotic classes, are all promising approaches that may decrease MRSA cross-transmission; however, further evidence is needed before these strategies can be implemented on a wide scale. Control of community MRSA is an additional challenge for the future, requiring improved surveillance and contact tracing, as well as education and treatment of both infected cases and colonised contacts. This review summarises recent advances and studies that address these issues. Overall, it seems that there is no level of MRSA prevalence for which active control measures are no longer warranted.     

现代中医药发展战略思考

建国几十年来，由于党和政府的大力提倡和扶持，中医药得到了很大发展，但相对于西医的发展势头仍显不足。尤其是近10多年来，由于现代科技及现代管理学的有力推动，西医获得了突飞猛进的发展，然而，中医却由于种种原因发展相对缓慢。在这各行各业竞相发展的现代社会，中医要生存，就蓝须发展，中医要发展，就妊须总揽全局，从战略高度克服中医药发展的各种不利因素，充分发挥各方面的有利条件。