欧洲药物战略（2020）及其对中国医药领域的启示

在当前国际制药技术出现重大创新和变革、药品研发技术信息化和数字化程度不断发展，以及新型冠状病毒肺炎（COVID-19）疫情大流行的背景下，欧盟委员会为满足未竟临床需求、激励行业创新、增强监管系统应变能力、巩固欧盟药品监管体系国际地位，于2020年底发布了《欧洲药物战略》（Pharmaceutical Strategy for Europe，PSE）。PSE被视为欧洲未来5年卫生政策的“基石”，对欧洲制药领域发展和管理具有重要指导意义。通过对PSE制定背景及发展战略目标、具体举措等内容进行梳理分析，并结合中国COVID-19疫情防控与行业发展、药品科学监管与鼓励创新等实际工作提出政策建议。     

基于龋风险评估的龋病治疗计划

随着对龋病病因及发病机制的深入认识,龋病的治疗不应局限于对现有龋损的修复治疗,而应以龋病风险评估和龋损活跃性评估为基础,以患者为中心,制定个性化的治疗方案,恢复口腔微生态平衡,进而控制龋病进展和恢复患牙的结构与功能。     

EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

Fluorescence imaging of dental restorations using the VistaCam intra-oral camera

Optical fluorescence imaging methods have a range of forensic applications. The VistaCam system (Dürr Dental) is an existing intra-oral fluorescence camera, which was designed to aid detection of dental caries using 405 nm wavelength light generated by light emitting diodes (LEDs). This study assessed whether this fluorescence imaging device could also be used to recognize dental restorative materials, which is essential for accurate dental charting of deceased persons who are unidentified. The effect of body fluids (saliva and blood) on performance was also assessed. The VistaCam was used on the bench to assess 55 extracted human teeth with restorations, and samples of restorative materials. Readings were first taken in the moist state and then after the application of human saliva or venous blood. Fluorescence scores were compared using one-way ANOVA. Human enamel gave lower fluorescence than restorations. Different tooth-coloured restorative materials gave similar strong fluorescence scores, without statistically significant differences between them. Fluorescence scores were not affected by the presence of ambient fluids (saliva or blood). Using violet 405 nm light to elicit fluorescence may aid in the recognition of dental restorative materials.     

翻转课堂教学法在天然药物化学实验中的应用

目的利用翻转课堂教学法改进传统的天然药物化学实验课教学模式,提高该课程的教学效果。方法从实验教学的课程设计与开发,课前自主学习、课中内化及课后评估和讨论等环节进行了一系列的探讨与改革。结果翻转课堂教学模式为解决学生长期以来在天然药物化学实验课中缺乏主动参与性、探索性等问题提供一剂良方。结论在天然药物化学实验课教学中引入翻转课堂教学模式的初步探索为天然药物化学实验课的改革提供了依据和思路。     

我国中药材产地市场整合研究——以金银花、枸杞子、板蓝根和太子参为例

中药材专业市场交易量逐渐下降,产地市场交易成为趋势。研究产地市场整合程度有利于了解中药材市场的运行情况,对于合理规划中药材生产和提高市场效率具有重要意义。选取大宗中药材金银花、枸杞子、板蓝根和太子参研究中药材市场整合程度,利用2013—2019年价格指数,运用协整检验、误差修正模型和格兰杰因果检验进行实证分析。结果表明,我国中药材产地市场长期整合程度较高;中药材产地市场的短期整合程度远不及长期整合程度。为此提出4点政策建议:完善中药材价格信息平台、打造非道地产区中药材优质品牌、加快建成中药材质量追溯体系和建设中药材现代物流体系。     

In Vitro Comparison of Porcelain Fused to Metal Crown Retention after Endodontic Access and Subsequent Restoration: Composite,Amalgam, Amalgam with Composite Veneer,and Fiber Post with Composite

IntroductionThe aim of this study was to evaluate the effect of different access opening restorative materials on crown retention.MethodsThirty-eight extracted molars were mounted in resin and prepared for porcelain fused to metal (PFM) crowns. The crowns were fabricated and cemented with zinc phosphate, and the force to displace it was measured with a tensile-testing machine before and after endodontic access preparations. The endodontic access area, crown preparation axial wall, and preparation surface area were measured for comparison. The crowns were then recemented, and access openings were restored with either amalgam or composite before displacement force was remeasured. The restorative material was removed from each access opening; access area was measured and restored again (amalgam with composite or fiber post with composite) for displacement force to be remeasured. Paired t test was used to compare the means of displacement between groups. One-way analysis of variance was used to compare the mean outcome measure within the groups.ResultsStatistical analyses showed retention after unfilled access was significantly lower than intact crowns. Amalgam, composite, amalgam + composite, and fiber post + composite increased retention beyond the original value. There was no statistical difference among the different restorative protocols. Qualitative results indicate that the restorative material remains in the crown after displacement regardless of the material used to restore the access.ConclusionsThe results from this study suggest that an endodontic access cavity decreases retention of a PFM crown. However, subsequent restoration with amalgam, composite, amalgam + composite, or post + composite may increase the original retention of the crown.     

Current status and perspective of CAD/CAM-produced resin composite crowns: a review of clinical effectiveness

The purpose of the present review was to survey the available literature on computer-aided design/computer-aided manufacturing (CAD/CAM)-produced resin composite materials to provide clinicians with a current overview of the key components necessary for daily clinical use. An electronic search was conducted in the PubMed database. Peer-reviewed articles in English language on the use of resin composites in CAD/CAM dental crowns were included. A total of 122 full-text articles were identified, 15 of which were selected during the initial review. Two additional articles were also discovered through a manual search, to obtain a final total of 17 articles included in the present review. Of these, 16 were to in vitro studies, and one was an in vivo study. Findings from the in vitro studies indicate that resin composite block materials for CAD/CAM applications demonstrate excellent physical properties and are appropriate for the clinical restoration of premolars and molars. However, the in vivo study reported a low 3-year success rate, but high survival rate for resin composite CAD/CAM crowns placed in the premolar region. The key to ensuring the successful prognosis of a resin composite CAD/CAM crown is to ensure that all steps—such as proper case selection, abutment tooth preparation, occlusal adjustment, and bonding—are accurately performed.