DRUGDEX DRUG EVALUATIONS数据库介绍

DRUGDEX DRUG EVALUATIONS数据库主要收录基于实时证据,针对药品临床使用信息编撰而成的独立专论。本文简要介绍DRUGDEX数据库的数据开发流程、专论内容及组织结构、检索方法和获取途径等,目的是为医药专业人员提供一个药品评价信息的参考资源。

A Few Specialized Issues That Should Be Focused on Anti-HIV Drug Evaluation In Vitro

Since the introduction of antiretroviral therapy (ART), the lifespan and quality of life of patients infected with HIV have been significantly improved. But treatment efficacy was compromised eventually by the development of resistance to antiretroviral drugs, and more new anti-HIV drugs with lower toxicity and higher activity were needed. Based on the experience and lessons learned from the treatment in the developed countries, US FDA suggested that more pharmacodynamical researches should be considered ahead of the clinical trials. To facilitate the anti-HIV drug research and development, we reviewed a few specialized issues that should be focused on drug evaluations in vitro, including: 1) Mechanism of action studies, demonstrating the candidate drug's efficacy to specifically inhibit viral replication or a virus-specific function and confirm the drug target. 2) Drug resistance studies, selecting the drug-resistant variants in vitro and determining the activities inhibiting HIV isolates resistant to approved antiretroviral drugs of the same class. 3) Antiviral activity in vitro in the presence of serum proteins, ascertaining whether an investigational product is significantly bound by serum proteins. 4) Combination activity analysis, evaluating in vitro antiviral activity of an investigational product in two-drug combinations with other drugs approved.

Drug utilization evaluation of medications used in the management of neurological disorders

Background and object:The burden of neurological disorders in India is expected to increase due to the rapid demographic and epidemiological transition,with irrational drug use,which is also a global concern.Thus,drug utilization evaluation is designed to ensure appropriate medicine use within the healthcare settings.The aim of the study was to assess the rate and pattern of drug utilization in the management of neurological disorders.Materials and methods:A hospital-based cross-sectional drug utilization evaluation study on neurological drugs was carried out at the Department of Neurology over a span of six months.All legible prescriptions consisting neurological medications irrespective of patient's gender,aged≥18 years were included for the study.The World Health Organization(WHO)core drug use indicators were used to assess the drug prescribing and utilization patterns.Results:A total of 310 prescriptions were reviewed,where male predominance was found to be 56.45%.Out of 310 prescriptions,drugs belonging to 26 neurological classes were prescribed for the management of various neurological disorders.The majority of patients were diagnosed with epilepsy and the most prescribed drugs per patient were phenytoin(14.8%)and valproic acid(6.45%).By following the WHO core drug prescribing indicators,65.47%of drugs prescribed from the India National List of Essential Medicines,2022,followed by 29.83%of drugs prescribed in generic name and 10.86%of prescriptions including injections.Conclusion:The study findings showed that the prescribing pattern in the Department of Neurology was in accordance with the WHO core prescribing indicators.But,the extent of polypharmacy prescriptions was very high.Therefore,interventions are very necessary to promote rational drug prescribing patterns and thus clinical pharmacists can contribute to assess and review the drug utilization pattern to optimize the drug therapy and improvement in patient safety.

The role of drug utilization evaluation in medical sciences

Background:Drug utilization evaluation(DUE)is defined by the World Health Organization(WHO)and focuses on the medical,social,and economic consequences of pharmaceutical marketing,distribution,prescribing,and usage in society.The WHO recommends a physician to every 1000 people.According to the recent data from the Health Ministry in 2019,in which 1.16 million doctors are of active population with just 80%,or 0.9 million,practicing.As a result,a ratio of 0.68 doctors for every 1000 people,which is much below as per the WHO reports.This article describes history,types,WHO guidelines,need and purpose of DUE.Objective:The main aim of this paper is to provide information about the rational use of medication in outpa­tient and inpatient department with special emphasis of DUEs.It also provides awareness directly to healthcare professionals,researchers,academicians,pharmacist and nurses to reduce the irrationality of medicines.Methods:The method used to compile this review information gathered from websites,Google scholar,PubMed,Research gate,and studies published on DUE from July 20 to Oct 22 were included as source of information.Results:We studied more than 35 published study on DUE,that reveals most of the physicians prescribed branded drugs not generic drugs,but WHO prescribing indicator allows to prescribe generic drugs in the hospital pharmacy to maintain better inventory control.It may also help to prevent pharmacist misunderstanding during dispensing.Conclusion:The use of generic prescription names avoids the possibility of medication product duplication and lowers patient costs.It is important to remember that incorrect medication prescriptions have impact on both patients and their family members.WHO indicators identify irrational prescribing behaviours to make therapy more rational and cost-effective.

Construction of Non-infectious SARS-CoV-2 Replicons and Their Application in Drug Evaluation

Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has caused a devastating pandemic worldwide.Vaccines and antiviral drugs are the most promising candidates for combating this global epidemic,and scientists all over the world have made great efforts to this end.However,manipulation of the SARS-CoV-2 should be performed in the biosafety level3 laboratory.This makes experiments complicated and time-consuming.Therefore,a safer system for working with this virus is urgently needed.Here,we report the construction of plasmid-based,non-infectious SARS-CoV-2 replicons with turbo-green fluorescent protein and/or firefly luciferase reporters by reverse genetics using transformation-associated recombination cloning in Saccharomyces cerevisiae.Replication of these replicons was achieved simply by direct transfection of cells with the replicon plasmids as evident by the expression of reporter genes.Using SARS-CoV-2 replicons,the inhibitory effects of E64-D and remdesivir on SARS-CoV-2 replication were confirmed,and the halfmaximal effective concentration(EC50)value of remdesivir and E64-D was estimated by different quantification methods respectively,indicating that these SARS-CoV-2 replicons are useful tools for antiviral drug evaluation.

Facile fabrication of drug-loaded PEGDA microcapsules for drug evaluation using droplet-based microchip

Droplet-based microfluidic technology can be utilized as a microreactor to prepare novel functional monodisperse microcapsules.In this study,a droplet-based microfluidic chip with surface modification,which allowed the one-step preparation of double emulsion microcapsules.An O/W/O double emulsion using polyethylene(glycol)diacrylate(PEGDA)solution as the intermediate water phase was prepared by regulating the hydrophilicity and hydrophobicity of the chip surface,with PEGDA microcapsules prepared using UV polymerization.And then anti-tumor drug paclitaxel and neurotoxin 6-OHDA were encapsulated in microcapsules for drug and toxicology evaluation,respectively.Compared to controls,drug-loaded mi-crocapsules caused a significant increase in the death rate of PC12 cells.This indicates that the obtained drug-loaded microcapsules could be used in drug evaluation and potentially in drug screening and deliv-ery.

Quantitative characterization of cell physiological state based on dynamical cell mechanics for drug efficacy indication

Cell mechanics is essential to cell development and function,and its dynamics evolution reflects the physiological state of cells.Here,we investigate the dynamical mechanical properties of single cells under various drug conditions,and present two mathematical approaches to quantitatively characterizing the cell physiological state.It is demonstrated that the cellular mechanical properties upon the drug action increase over time and tend to saturate,and can be mathematically characterized by a linear timeinvariant dynamical model.It is shown that the transition matrices of dynamical cell systems significantly improve the classification accuracies of the cells under different drug actions.Furthermore,it is revealed that there exists a positive linear correlation between the cytoskeleton density and the cellular mechanical properties,and the physiological state of a cell in terms of its cytoskeleton density can be predicted from its mechanical properties by a linear regression model.This study builds a relationship between the cellular mechanical properties and the cellular physiological state,adding information for evaluating drug efficacy.

<i>In Vitro</i>Evaluation of Anticancer Drugs with Kinetic and Static Alternating Cell Culture System

Variable bioreactors have been developed for the evaluation of anti-cancer drug efficacy. The Kinetic and Static Alternating Cell Culture System (KSACCS) combines the advantages of kinetic bioreactors and static cultures to improve cell growth by providing adequate metabolic support while minimizing shear-stress. In the current studies, the KSACCS in the ZYX Bioreactor could significantly increase the sensitivity of lung cancer cells (PLS008) and leukemia cells (HL60) to anticancer drugs Cisplatin and 5-FU by accelerating the apoptosis of cancer cells. It was also shown that excessive agitation of the cells could lead to severe cell damage, which resulted in a diminished sensitivity of anticancer drug evaluation, and co-culture systems tend to reduce the sensitivity of anticancer drug evaluation although it might better mimic in vivo conditions.

An Evaluation Synthesis of US AIDS Drug Assistance Program Policy

US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.

The Problems of the Safety Evaluation of Biotechnology Derived Drugs

Recent years have witnessed rapid advances in the toxicologic assessment of biotechproducts.Safety assessment of a biotech product is a complex and multiple process.This includes a knowledge of its pharmaco-biological characteristics,and identifyingthe target patient population and the proposed clinical application. To make a decision on the safe human application(the products are administering tohumans for therapeutic purposes),besides the identity and purity of the final product,

Evaluation and Risk Prevention and Control of Hepatic Injury by Traditional Drugs

My topic is the risk assessment of safety of Chinese materia medica.Next I will take drug-induced hepatic injury as an example.First of all,let us look back at what Chinese materia medica is.What are the real meanings of these 3 words? These 3 words Zi Hua Zi have been said more than BC 500."TCM practitioners are for treatment and medicines," what do you mean? Treatment means to find the cause of the disease and to find the law,while medicine is to find ways and means to cure diseases.

The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises

Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.

Clinical Observation and Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for Dermatosis

[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.

Advances on biological evaluation methods of programmed cell death protein-1/ligand-1 inhibitors

Immuno-oncology represents a groundbreaking and well-established field within cancer treatment.Among the various immuno-oncology targets,the exploration of programmed cell death-1/ligand-1 for drug discovery has proven to be one of the most successful endeavors.Remarkably,it took nearly 30 years from the initial target identification to the clinical approval of monoclonal antibodies.Providing suitable and reliable bioassays for drug candidate evaluation is of paramount importance throughout the early stages of drug discovery,from lead compound identification to in vivo efficacy testing.This assay review aims to shed light on diverse assays reported in the literature for testing antagonism activity and efficacy of programmed cell death-1/ligand-1 inhibitors.Each of these assays possesses inherent advantages and can be applied in different research scenarios.The insights presented in this summary can serve as a valuable resource for scientists in this field,aiding in the selection of appropriate assays for their specific investigations.

Requirements for Evaluation on Drug-medical Device

The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Administration of China(SFDA)is also illustrated.Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.

基于OBE理念的药物临床试验课程教学改革研究

首都医科大学将成果导向型教学(OBE)理念引入药物临床试验课程教学改革中。教师针对课程教学内容更新速度快、教学方式传统陈旧、考评模式较为单一等普遍存在的问题,以学生为中心组织和引导教学过程,优化教学大纲、改善教学方法、提升自身教学能力、完善学生评价体系,有效提升了教学产出和学生的创新性学习能力,可为相关课程教学改革提供借鉴。

Advances in the study of gastric organoids as disease models

Gastric organoids are models created in the laboratory using stem cells and sophisticated three-dimensional cell culture techniques.These models have shown great promise in providing valuable insights into gastric physiology and advanced disease research.This review comprehensively summarizes and analyzes the research advances in culture methods and techniques for adult stem cells and induced pluripotent stem cell-derived organoids,and patient-derived organoids.The potential value of gastric organoids in studying the pathogenesis of stomach-related diseases and facilitating drug screening is initially discussed.The construction of gastric organoids involves several key steps,including cell extraction and culture,three-dimensional structure formation,and functional expression.Simulating the structure and function of the human stomach by disease modeling with gastric organoids provides a platform to study the mechanism of gastric cancer induction by Helicobacter pylori.In addition,in drug screening and development,gastric organoids can be used as a key tool to evaluate drug efficacy and toxicity in preclinical trials.They can also be used for precision medicine according to the specific conditions of patients with gastric cancer,to assess drug resistance,and to predict the possibility of adverse reactions.However,despite the impressive progress in the field of gastric organoids,there are still many unknowns that need to be addressed,especially in the field of regenerative medicine.Meanwhile,the reproducibility and consistency of organoid cultures are major challenges that must be overcome.These challenges have had a significant impact on the development of gastric organoids.Nonetheless,as technology continues to advance,we can foresee more comprehensive research in the construction of gastric organoids.Such research will provide better solutions for the treatment of stomach-related diseases and personalized medicine.

从国家药品抽检角度分析已上市中成药需要关注的相关问题

药品抽检是药品监督和执法的重要技术支撑手段,通过分析抽检结果可有效发现上市后药品的质量风险,同时也可评价某类或一定区域内药品的质量。立足于历年国家药品抽检中发现的中成药品种质量问题和潜在安全风险,以与中成药质量相关的原料、生产工艺、辅料及包装材料等环节为切入点,分析已上市中成药需要关注的问题,以期为中成药质量的提升和监管工作的开展提供参考。

药品临床综合评价管理工作的核心环节及实现路径设计

目的 围绕我国药品临床综合评价管理工作中的核心环节设计其实现路径,为进一步优化和完善我国药品临床综合评价管理工作提供建议。方法 在借鉴国内外典型国家/地区药品评价管理工作相关经验的基础上,围绕资金来源、主题遴选、人员管理、信息化管理、数据管理、评价流程、完成质量考核七大核心环节展开探讨,并设计我国药品临床综合评价管理机制。结果与结论资金来源方面,可由财政部门给予经费保障或以绩效考核等其他可替代形式鼓励各方开展药品临床综合评价工作;主题遴选方面,可根据项目性质及实际情况确定“自上而下”或“自下而上”的遴选模式,同时形成“建立主题备选库-形成主题遴选清单-论证并发布主题清单”的遴选流程;人员管理方面,应精确匹配项目组成员的专业方向,并组建专家团队服务药品临床综合评价工作;信息化管理方面,可建立国家/省级药品临床综合评价基础信息平台,形成项目立项登记制度;数据管理方面,可组建区域性的健康数据共享平台,实行数据“申请-审核-使用”制度;评价流程方面,可实施以项目实施方案论证制度和项目结题评审制度为核心的评价流程;完成质量考核方面,则可建立“管理质量考核为先,技术质量考核为主”的项目完成质量考核及奖惩机制。基于七大核心环节规范实施的管理机制,将能在一定程度上规范我国药品临床综合评价工作的开展,有助于提高药品临床综合评价项目的质量。

国家医保谈判药品在我院遴选评价的转化应用探索

目的:积极推进国家医保谈判药品的常态化落地,提升国家医保谈判药品的供应保障水平及透明化程度,促进药品回归临床价值。方法:依据2022年5月河北省卫生健康委员会组织制定下发的《河北省三级公立医疗机构用药(化学药品)目录遴选评价表(试行)》中的评价体系,针对拟遴选入院的61个国家医保谈判药品,从有效性、药学特性、安全性、经济性、其他属性5个维度进行综合评价。结果:47个国家医保谈判西药中,29个药品前3项评分≥50分;34个药品前4项评分≥60分;39个药品总分≥60分;24个药品前3项评分≥50分、前4项评分≥60分、总分≥70分;7个药品前3项评分<50分、前4项评分<60分、总分<70分。14个国家医保谈判中药中,同时满足前3项评分≥50分、前4项评分≥60分、总分≥70分的药品数量与同时满足前3项评分<50分、前4项评分<60分、总分<70分的药品数量均为6个。结论:本研究运用量化评价体系对国家医保谈判药品的有效性、药学特性、安全性、经济性等指标进行全方位评价,赋予量化分值,构建满足医疗机构需求的国家医保谈判药品综合评价数据库,通过综合分数来提取出“优”的国家医保谈判药品,过程快速、科学、公正、透明。