精准医疗时代下制药行业的挑战和机遇

精准医疗是一种基于病人特定分子标志物的医疗模式,不同于目前针对一般病人的循证医学模式。简要介绍了精准医疗的发展历史和美国的精准医疗计划,提出对制药行业的挑战主要在于:新药产品研发的复杂程度加大、较小的市场容量下研发投入难以回报、配套政策的滞后,给制药行业带来的机会在于:疾病细分导致药物创新需求增加、老药和失败药物面临重生的机遇、中小企业竞争的优势上升、延伸产业发展空间巨大,并针对性地提出了发展策略和建议。     

运用德尔菲法构建上市中药企业竞争力评价指标体系

目的构建上市中药企业竞争力评价指标体系,为评价我国上市中药企业竞争力提供有效的技术和手段。方法通过文献研究初步得到指标库,然后采用德尔菲法进行咨询,请20名相关领域资深专家依据各指标重要性打分,筛选上市中药企业竞争力评价指标体系维度及指标池,经过2轮问卷咨询,最终形成指标体系。结果第1、2轮问卷咨询的专家积极系数分别为95%、100%,专家权威程度为0.713 2,专家协调系数分别为0.659、0.639,指标体系最终包含5个1级指标、26个2级指标。结论本次德尔菲法专家积极系数及权威程度均较高,第2轮咨询专家的意见已趋于一致,形成的上市中药企业竞争力评价指标体系结果可信。     

丹红注射液数字制药平台设计与建设

讨论丹红注射液数字化制药平台的设计与建设,建立制药过程数据采集与集成系统,集成原料、生产批次记录、质量检验、设备、人员等数据,实现丹红注射液从原料至成品生产全过程数字化管理。采用数据挖掘技术建立信息智能处理系统对丹红注射液制药过程产生的海量数据进行分析处理,建立丹红注射液统计质量监控模型,确保制药过程质量。将基于实时数据的质量控制与生产管理相结合,规范业务处理流程,实现生产过程高效、节能、环保和安全的全方位闭环管控。     

1例瑞舒伐他汀联用缬沙坦致梗阻性黄疸的药学监护

目的 探讨临床药师参与的1例冠心病患者联用瑞舒伐他汀和缬沙坦引起肝损害所致的梗阻性黄疸的药学监护。方法 介绍临床药师参与1例冠心病患者的治疗过程,从药理学角度分析他汀类药物引起的肝损害与剂量、代谢及其他药物相互作用的关系,并提供相关建议。结果 医师只考虑由他汀类药物引起,而临床药师利用专业知识,提出瑞舒伐他汀钙与缬沙坦胶囊的相互作用最大,建议同时停用缬沙坦胶囊。结论 通过医师与药师的合作,从而促进合理用药,保证患者用药的安全有效。同时,也为临床药师实施药学监护提供一种新的思维方式。     

Understanding of for whom,under what conditions and how the compulsory licensing of pharmaceuticals works in Brazil and Thailand: A realist synthesis

When pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implications for attempting CL relevant for middle-income countries in the era of high-cost medicines. CL is not only a politically well-devised measure to achieve universal health coverage, but also a tentative commitment, which is determined both at the country level and at the global level. At the country level, political will, with catalytic roles of civil activism, is important in order to guarantee the right to health. Through this will, the governments can achieve universal health coverage. In addition, electoral systems, political leaders, and a constitution are necessary to attempt CL. In addition, CL should operate along with other policy instruments, including a comprehensive essential medicines list, CL-friendly phrasing in patent law, and a competent pharmaceutical industry. At the global level, the balance of power between the WTO regime and the global justice movement is critical. This provides global-level context that can either encourage or prevent CL.     

Understanding Interactions Between Chinese Medicines and Pharmaceutical Drugs in Integrative Healthcare

In the 21 st century,the public are more informed,mainly via the Internet,about health and medical products and have become more knowledgeable about matters relating to their health conditions and well-being in curing and preventing illnesses.They often self-medicate themselves with various health products and over-the-counter(OTC) medicines apart from prescribed pharmaceutical drugs(PD).Some of those non-prescribed products may have doubtful quality control and contain harmful additives or unchecked ingredients;thus their usefulness is in doubt.The increasing popularity world-wide of using Chinese medicines(CM) and related OTC functional products has raised concerns over their concomitant use with PD and the consequential adverse effects.In most cases the alleged causes of adverse effects are linked with herbal sources,although the authorised information on the interactions between CM-PD is not plentiful in the literature.There is an urgent need for such a data base.The future professionals in health and medical care should be knowledgeable or aware of what their patients have been taking or given.In actual practice the patients may receive both treatments intentionally or unintentionally,with or without the awareness of the practitioner.In these situations a reliable database for interactions between CM-PD will be extremely useful for consultation when treatment problems appear or during emergency situations.Their combining of medications may be involved with possible outcomes of adverse reactions or beneficial effects.Such a database will be welcomed by both practitioners of herbal medicines and orthodox medicine practitioners in the emerging trend of integrative medicine.The author has been involved in various research projects of basic and clinical aspects in mainly CM among other herbal and PD.Examples will be given largely on those related to these disciplines as illustrations in this overview.