《中国临床药理学杂志》发展概况

本文对《中国临床药理学杂志》从1985年创刊至今的报道内容进行了概述。本文折射出我国临床药理学的发展，也反应了我国新药政策在管理执行中对我国临床药理学科和中国临床药理学杂志发展的促进作用。     

加强大学生素质教育的有效途径

如何加强大学生素质教育，培养具有创新精神和实践能力的复合型人才，是一项具有深远意义的重大课题。本文论述了在新形势下加强大学生素质教育，需要树立全员“育人”思想，深化教学改革，提高教师素质，培养学生自我教育意识，突出思想政治教育和健康教育，营造良好的校园文化氛围，发挥团学组织的积极作用。     

关于小儿腹泻防治的临床分析

目的探讨中西医结合治疗方法对腹泻患儿的临床治疗效果。方法选取2009年7月至2010年9月惠州市中心人民医院79例小儿腹泻住院患儿,将患儿随机分为两组,观察组与对照组,38例观察组患儿应用中西医结合治疗方法,41例对照组患儿采用临床西医治疗方法,对比分析观察组与对照组两组患儿的临床治疗效果。结果 38例观察组患儿当中,显效25例,临床显效率约为65.79%;有效12例,临床有效率约为31.58%;无效1例,临床无效率约为2.63%;观察组患儿总有效37例,临床总有效率约为97.37%;在41例对照组患儿当中,显效17例,临床显效率约为41.46%;有效15例,临床有效率约为36.59%;无效9例,临床无效率约为21.95%;对照组患儿总有效32例,临床总有效率约为78.05%。在临床治疗效果方面,观察组患儿均优于对照组患儿,观察组与对照组之间比较差异性显著(P<0.01),具有统计学意义。结论应用中西医结合治疗方法对腹泻患儿进行治疗,可以更好的将中医与西医的治疗特色进行合理有效的结合,相对于单独应用西医治疗方法而言,中西医结合治疗方法对腹泻患儿有着更好的临床治疗效果,值得临床借鉴应用。     

Model-Based Drug Development: The Road to Quantitative Pharmacology

High development costs and low success rates in bringing new medicines to the market demand more efficient and effective approaches. Identified by the FDA as a valuable prognostic tool for fulfilling such a demand, model-based drug development is a mathematical and statistical approach that constructs, validates, and utilizes disease models, drug exposure-response models, and pharmacometric models to facilitate drug development. Quantitative pharmacology is a discipline that learns and confirms the key characteristics of new molecular entities in a quantitative manner, with goal of providing explicit, reproducible, and predictive evidence for optimizing drug development plans and enabling critical decision making. Model-based drug development serves as an integral part of quantitative pharmacology. This work reviews the general concept, basic elements, and evolving role of model-based drug development in quantitative pharmacology. Two case studies are presented to illustrate how the model-based drug development approach can facilitate knowledge management and decision making during drug development. The case studies also highlight the organizational learning that comes through implementation of quantitative pharmacology as a discipline. Finally, the prospects of quantitative pharmacology as an emerging discipline are discussed. Advances in this discipline will require continued collaboration between academia, industry and regulatory agencies.     

Preceptor Development: Providing Effective Feedback

Feedback plays a significant role in precepting and is indispensable in residency training. As described by the Accreditation Council for Graduate Medical Education, the goal of any postgraduate residency program is to prepare individual trainees to function as qualified practitioners. Although feedback and evaluations have traditionally been synonymous, our goal is to differentiate the two and describe the role of each within resident performance. The goal of this article is to provide preceptors with the tools to provide timely, effective, and quality feedback to residents on a regular basis. Although the focus of this article is on residency training, these concepts can be utilized in student rotations as well.     

我国“药理学与毒理学”学科发展现状

该文通过分析ESI、InCites数据库中"药理学与毒理学"学科数据,详细解读了中国"药理学与毒理学"学科的发展现状。分析"药理学与毒理学"学科发文量、被引频次、发文期刊、高被引论文等数据信息,概况总结中国"药理学与毒理学"学科在全球所处的水平,并重点分析全球排名前100名的中国高校该学科的相关数据。     

Quantitative Systems Pharmacology for Rare Disease Drug Development

Though hundreds of drugs have been approved by the US Food and Drug Administration (FDA) for treating various rare diseases, most rare diseases still lack FDA-approved therapeutics. To identify the opportunities for developing therapies for these diseases, the challenges of demonstrating the efficacy and safety of a drug for treating a rare disease are highlighted herein. Quantitative systems pharmacology (QSP) has increasingly been used to inform drug development; our analysis of QSP submissions received by FDA showed that there were 121 submissions as of 2022, for informing rare disease drug development across development phases and therapeutic areas. Examples of published models for inborn errors of metabolism, non-malignant hematological disorders, and hematological malignancies were briefly reviewed to shed light on use of QSP in drug discovery and development for rare diseases. Advances in biomedical research and computational technologies can potentially enable QSP simulation of the natural history of a rare disease in the context of its clinical presentation and genetic heterogeneity. With this function, QSP may be used to conduct in-silico trials to overcome some of the challenges in rare disease drug development. QSP may play an increasingly important role in facilitating development of safe and effective drugs for treating rare diseases with unmet medical needs.     

Botulinum Toxin: An Update on Pharmacology and Newer Products in Development

Since its introduction as a treatment for strabismus, botulinum toxin (BoNT) has had a phenomenal journey and is now recommended as first-line treatment for focal dystonia, despite short-term clinical benefits and the risks of adverse effects. To cater for the high demand across various medical specialties, at least six US Food and Drug Administration (FDA)-approved formulations of BoNT are currently available for diverse labelled indications. The toxo-pharmacological properties of these formulations are not uniform and thus should not be used interchangeably. Synthetic BoNTs and BoNTs from non-clostridial sources are not far from clinical use. Moreover, the study of mutations in naturally occurring toxins has led to modulation in the toxo-pharmacokinetic properties of BoNTs, including the duration and potency. We present an overview of the toxo-pharmacology of conventional and novel BoNT preparations, including those awaiting imminent translation from the laboratory to the clinic.     

Pharmacology: Paper alert

A selection of interesting papers that were published in the two months before our press date in major journals most likely to report significant results in pharmacology.     

Preceptor Development: Providing Effective Feedback,Part 2

An integral part of providing effective feedback to pharmacy residents occurs during the evaluation process. Residency evaluation involves measuring and documenting performance as it relates to standardized residency outcomes, goals, and learning objectives. Evaluations may be formative or summative and include the preceptor’s evaluation of the resident’s performance, the resident’s self-assessments, and the resident’s evaluation of the preceptor and learning experience. Evaluations are more structured than feedback, and they involve documentation of the verbal feedback that was provided throughout the learning experience. This article will focus on the preceptor’s role in providing effective resident evaluations based on specific learning activities.Key Words: evaluation, feedback, formative, learning activities, residency precepting, self-assessment, summativeMany factors impact preceptors’ ability to provide quality feedback.¹ In verbal feedback and written evaluation, communication is critical. Effective communication is a key component to a successful pharmacy practice,² and much of the residency year involves training residents to develop communication proficiency in multiple practice situations. Because the intention in residency training is for learners to model the preceptors’ skills, attitudes, and behaviors, the way that preceptors communicate in evaluations is important in the residents’ overall development.Along with communication, professionalism, role-modeling, coaching, and evaluation skills have been identified as key elements of effective pharmacy precepting.^3,4 Colleagues in medicine and nursing have also identified preceptor characteristics associated with proficiency in providing feedback.^5–7 These include completing preceptor training, showing empathy for learners, establishing mutually agreed upon learning goals, challenging learners, managing conflict, and documenting and reviewing professional goals annually. Imparting these skills to residents, including the skills needed for effective evaluation, is not only important for individual resident growth, but is also important for the profession’s growth as new and future residency graduates will need to be confident and competent preceptors to advance residency training.⁸     

Application of Quantitative Pharmacology in Development of Therapeutic Monoclonal Antibodies

The advancement of therapeutic monoclonal antibodies during various stages of the drug development process can be effectively streamlined when appropriate translational strategies are applied. Design of successful translational strategies for development of monoclonal antibodies should allow for understanding of the dose– and concentration–response relationships with respect to both beneficial and toxic effects from early phases of drug development. Evaluation of relevant biomarkers during early stages of drug development should facilitate the successful design of safe and effective dosing strategies. Moreover, application of quantitative pharmacology is critical for translation of exposure–response relationships early on.     

Neuroimmune Pharmacology: An Emerging Discipline for the Italian Society of Pharmacology

This issue of the Journal of Neuroimmune Pharmacology is dedicated, in part, to the proceedings of the First Insubria Autumn School on Neuroimmunopharmacology, organized by Marco Cosentino, Georges J.M. Maestroni, Franca Marino (University of Insubria, Varese, Italy), Manfred Schedlowsky (University of Duisburg-Essen, Germany) and Rainer H. Straub (University of Regensburg, Germany), which took place in November 2011 in Varese, Italy. The School was attended by 50 graduate students and postdoctoral fellows in medical and biological disciplines from 16 european universities and 25 faculties/departments.     

Advancing monosaccharides as biomarkers: part I. Development of fluorophore-assisted carbohydrate-electrophoresis in Chironomus riparius

Fluorophore-assisted carbohydrate-electrophoresis (FACE) was developed as a bioassay for environmental stressors in larval Chironomus riparius. This quantitative technique involved acid hydrolysis and 2-aminoacridone labeling of monosaccharides followed by carbohydrate gel electrophoresis. Methods for carbohydrate isolation from whole tissue homogenates as well as migration distances for 23 different monosaccharides and 4 disaccharides were established. Sensitivity of the technique (5 microg/ml saccharide) exceeded those of other detection methods. Results showed seven distinct bands in larvae. Four migrated distances similar to those of ribose, glucose, galactose, and fructose. Three proved to be alternative reaction products (ARP). Experiments determined that two of the ARPs were primarily from glucose and one was from glycogen. FACE allowed different saccharides from multiple larval samples to be analyzed in parallel. Effects of toxicants and diet on bioenergetics could be studied using this technique.     

去纤核苷酸的生化药理研究进展

综述了有关去纤核苷酸的多种药理学作用：抗血栓；溶血栓；纤维蛋白溶解；抗局部组织缺血损伤；细胞保护作用及与其它药物的协同作用，以及它的作用机理