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PubMed2001

[Introduction of ancient Bencao works stored overseas yet not included in Quanguo Zhongyi Tushu Lianhe Mulu (National Coalition Catalogue of TCM Works)].

This paper briefly introduces 14 ancient Bencao works stored overseas yet not included in Quanguo Zhongyi Tushu Lianhe Mulu, with the information, including the authors, accomplish date, number of volume, categories, quantity of drugs, characteristics of content, store sites, and the condition of returned duplicated edition in China, and etc. Among the 14 works, 2 were accomplished in the Yuan dynasty, 9 in the Ming dynasty and 3 in the Qing dynasty.

Books↗
PubMed2006

Global mapping of pharmacological space.

We present the global mapping of pharmacological space by the integration of several vast sources of medicinal chemistry structure-activity relationships (SAR) data. Our comprehensive mapping of pharmacological space enables us to identify confidently the human targets for which chemical tools and drugs have been discovered to date. The integration of SAR data from diverse sources by unique canonical chemical structure, protein sequence and disease indication enables the construction of a ligand-target matrix to explore the global relationships between chemical structure and biological targets. Using the data matrix, we are able to catalog the links between proteins in chemical space as a polypharmacology interaction network. We demonstrate that probabilistic models can be used to predict pharmacology from a large knowledge base. The relationships between proteins, chemical structures and drug-like properties provide a framework for developing a probabilistic approach to drug discovery that can be exploited to increase research productivity.

Computational Biology↗
PubMed1997

Migraine prophylactic drugs: proof of efficacy, utilization and cost.

OBJECTIVES: In order to understand the pattern of utilization of migraine prophylactic drugs by US physicians, we reviewed the scientific rigor of published trials of anti-migraine medications, assessed their cost, and tested the correlation, if any, between utilization, scientific rigor and cost. MATERIALS AND METHODS: Scientific rigor of published reports. We identified all placebo-controlled, randomized, double-blind trials of migraine prophylactic agents through Medline search, major Headache textbooks and proceedings of major scientific meetings where headache-related topics are discussed. We excluded trials that did not include placebo treatment during the active phase of the study. The trials were reviewed and rated for scientific rigor using a 5-point scale (scientific score [ss]; 1 = low, 5 = good), blinded to the physicians' utilization data and cost of the drugs. Studies that did not show benefit of the active drug over placebo were scored -1 to -5, thus allowing for the reverse logic of negative studies. US physicians utilization. Neurologists and primary care physicians (PCP) completed phone-mail-phone questionnaires which inquired about first and second choices of migraine prophylaxis. These choices were averaged to obtain a weighted average percent usage of each drug. Cost. The average wholesale price (AWP) of each drug was obtained from data published by Adelman and Von Seggern, and from the Amerisource (7/9/96) catalog. STATISTICAL ANALYSIS: Spearman's correlation coefficient was used to assess the relationship between the average ss, physician use, and cost of each drug. RESULTS: Propranolol (ss = 1.44), amitriptyline (ss = 2.33) and verapamil (ss = 1.00) were the three preferred migraine prophylactic drugs by both neurologists and PCPs. Approximately 10% of neurologists said that divalproex (ss = 3.75) would be their first or second choice. The selective serotonin reuptake blockers were favored by 13.21% of PCPs. All other prophylactic drugs were felt to be first or second line of treatment by less than 10% of either neurologists or PCPs. Except for one study (ss = 1) that showed that propranolol reduced the migraine frequency by 76% over placebo, trials of the three most preferred medications failed to demonstrate that the active drug is > 50% better than placebo, i.e. the difference in headache frequency when on placebo vs active drug is > 50%. Of the drugs available in the United States, flurbiprofen and metoprolol achieved the best ss (5.00 and 4.33, respectively) but their efficacy over placebo (23% and 14-33%, respectively) and cost ($67.2 and $65.6) were unfavorable. Neurologists and PCPs chose migraine prophylaxis on the basis of scientific merit (r = 0.644, p = 0.018; r = 0.576, p = 0.05, respectively) but not cost (r = -0.254, p = 0.45; r = -0.255, p = 0.455). CONCLUSION: The three most commonly chosen migraine prophylactic agents have not been shown irrefutably to prevent migraine. Furthermore, their benefit, if any, does not exceed 50% over placebo. The well-conducted recent trials that demonstrated the efficacy of divalproex in migraine prevention are steps in the right direction of finding the "ideal migraine preventative agent". Until that drug is discovered, it is difficult to argue that one migraine prophylactic medication is superior to another and accordingly should be used as a first line of treatment.

Adult↗
PubMed1990

The biologic actions of extracellular adenosine triphosphate.

The study of the biologic effects of extracellular ATP is rapidly progressing from cataloging the integrated biologic responses of isolated tissues to characterizing the biochemical basis of signal transduction in isolated cells. Clearly, many fundamental issues remain; these include the classification of receptor subtypes, identification of defined or new signal-transduction pathways, generation of specific high-affinity ligands for the various ATP receptor subtypes, and ultimately, the development of protocols for the identification, isolation, cloning, and physicochemical characterization of the receptor moities per se. Such work will be essential for developing selective ATP-receptor antagonists. Such antagonists, in turn, will facilitate evaluation of the role of these receptors in physiological and/or pathological processes. A possible therapeutic role for drugs selective for these receptors is suggested by the critical pathophysiological roles of the human cell types (phagocytic leukocytes, vascular endothelial cells) known to express such receptors. The earlier, seminal work on the biologic actions of extracellular ATP was largely performed by smooth-muscle physiologists and pharmacologists. With the expanding range of, and interest in, this topic, recent studies have been carried out largely by diverse groups of pharmacologists, neurobiologists, physiologists, and biochemists. Not surprisingly, these various scientists often investigate certain aspects of extracellular ATP action from different perspectives, using the specialized tools and methods of their respective disciplines. Hopefully, by integrating these interdisciplinary perspectives on the biologic actions of extracellular ATP, there will be rapid progress in this field during the next few years.

Adenosine Triphosphate↗
PubMed1993

The exclusion of pregnant, pregnable, and once-pregnable people (a.k.a. women) from biomedical research.

The barriers to women's participation as subjects in biomedical research are currently being challenged as a matter of legislative policy, medicine, and law. This Article catalogs the ways in which women have been disadvantaged by their exclusion and recent developments to redress them, and goes on to dissect the underlying rationales for excluding women from clinical trials. The author reveals the 'fundamental misconception' behind exclusionary rationales, and argues that research sponsors in fact have more to fear in the way of potential liability from the exclusion of women, even pregnant women and women of child-bearing capacity, than from their inclusion. Finally, the Article suggests strategies for achieving reform of these exclusionary practices.

Abnormalities, Drug-Induced↗
PubMed1994

Investigational drug tracking: phases I-III and NDA submissions--Part II.

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. Part I of this article appeared in the September issue of Hospital Pharmacy. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I concludes with the remaining alphabetical listing by generic/chemical name or investigational drug number.

Clinical Trials, Phase I as Topic↗
PubMed2001

Transgenic and knockout databases: behavioral profiles of mouse mutants.

Genetically engineered strains of mice, modified by transgenesis or gene targeting ("knockouts") are being generated at an impressive rate and used, among other areas, as premiere research tools in deciphering the genetic basis of behavior. As behavioral phenotyping strategies continue to evolve, characterization of these "designer" mice will provide models to evaluate the efficacy of new pharmacological and gene therapy treatments in human hereditary diseases. Reported behavioral profiles include aberrant social, reproductive, and parental behaviors, learning and memory deficits, feeding disorders, aggression, anxiety-related behaviors, pain/analgesia, and altered responses to antidepressants, antipsychotics, ethanol, and psychostimulant drugs of abuse. The Induced Mutant Resource (IMR) at The Jackson Laboratory (TJL, Bar Harbor, ME, USA) imports, cryopreserves, develops, maintains, and distributes biomedically important stocks of transgenic and targeted mutant mice to the research community. Information on neurological/behavioral strains--including behavioral performance, husbandry requirements, strain availability, and genetic typing protocols--is provided through the IMR database (http://www.jax.org/resources/documents/imr/). A catalog of available strains is readily accessible via the JAX Mice website at http://jaxmice.jax.org/index.shtml. In addition, TJL is now host to TBASE (http://tbase.jax.org/), a comprehensive, public-domain database with primary emphasis on mouse knockouts. TBASE contains an exhaustive list of knockout-related citations and provides an extensive phenotypic characterization of numerous behavioral mutants that is extracted directly from the literature. Present efforts to merge the two resources into a novel, schematically enhanced database, provisionally named Transgenic and Targeted Mutation Database (TTMD), will be briefly discussed.

Animals↗
PubMed2003

The phase III trial in the era of targeted therapy: unraveling the "go or no go" decision.

PURPOSE: To review characteristics of contemporary phase III oncology trials and create an explicit framework to help clinical researchers prioritize novel therapies for phase III testing. METHODS: We searched the MEDLINE and EMBASE databases for all reviews of phase III trials; cataloged all phase III trials in two national clinical trial databases; and reviewed approval criteria of recently approved oncology drugs from public data provided by the US Food and Drug Administration. Industry data not available elsewhere in the medical literature were obtained from a sourcebook published by a large contract research organization. RESULTS: Phase III oncology trials are the most expensive and time-consuming aspect of the drug development process. The results of these trials continue to exert the greatest influence on the treatment decision of oncologists and remain pivotal to the granting of drug approval. Making optimal decisions about which agents to advance to phase III testing may decrease the overall cost of cancer drug development and limit the number of patients exposed to ineffective drugs. A conceptual decision model for prioritizing novel therapies for phase III testing is presented. CONCLUSION: Cancer drug development has become more complex and expensive, whereas overall clinical progress remains slow. The transition from phase II to phase III requires a strategic decision that is based on new considerations. A greater investment in phase I and II drug trials may be required to provide the information necessary for phase III planning.

Antineoplastic Agents↗
PubMedDate not supplied

Comparison of the NCI open database with seven large chemical structural databases.

Eight large chemical databases have been analyzed and compared to each other. Central to this comparison is the open National Cancer Institute (NCI) database, consisting of approximately 250 000 structures. The other databases analyzed are the Available Chemicals Directory ("ACD," from MDL, release 1.99, 3D-version); the ChemACX ("ACX," from CamSoft, Version 4.5); the Maybridge Catalog and the Asinex database (both as distributed by CamSoft as part of ChemInfo 4.5); the Sigma-Aldrich Catalog (CD-ROM, 1999 Version); the World Drug Index ("WDI," Derwent, version 1999.03); and the organic part of the Cambridge Crystallographic Database ("CSD," from Cambridge Crystallographic Data Center, 1999 Version 5.18). The database properties analyzed are internal duplication rates; compounds unique to each database; cumulative occurrence of compounds in an increasing number of databases; overlap of identical compounds between two databases; similarity overlap; diversity; and others. The crystallographic database CSD and the WDI show somewhat less overlap with the other databases than those with each other. In particular the collections of commercial compounds and compilations of vendor catalogs have a substantial degree of overlap among each other. Still, no database is completely a subset of any other, and each appears to have its own niche and thus "raison d'être". The NCI database has by far the highest number of compounds that are unique to it. Approximately 200 000 of the NCI structures were not found in any of the other analyzed databases.

Cluster Analysis↗
PubMed2005

International Union of Pharmacology. XLVI. G protein-coupled receptor list.

NC-IUPHAR (International Union of Pharmacology Committee on Receptor Nomenclature and Drug Classification) and its subcommittees provide authoritative reports on the nomenclature and pharmacology of G protein-coupled receptors (GPCRs) that summarize their structure, pharmacology, and roles in physiology and pathology. These reports are published in Pharmacological Reviews (http://www.iuphar.org/nciuphar_arti.html) and through the International Union of Pharmacology (IUPHAR) Receptor Database web site (http://www.iuphar-db.org/iuphar-rd). The essentially complete sequencing of the human genome has allowed the cataloging of all of the human gene sequences potentially encoding GPCRs. The IUPHAR Receptor List (http://www.iuphar-db.org/iuphar-rd/list/index.htm) presents this catalog giving IUPHAR-approved nomenclature (where available), known ligands, and gene names for all of these potential receptors (excluding sensory receptors and pseudogenes) together with links to curated sequence, descriptive information, and additional links in the Entrez Gene database (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gene). This list is a major new initiative of NC-IUPHAR that, through continuing curation, defines the target of our ongoing receptor classification and invites further input from the scientific community.

Animals↗
PubMed1998

Medication errors analysis is an opportunity to improve practice.

The United States Pharmacopeia (USP) Medication Errors Reporting (MER) Program collected and cataloged 2,213 reports between October 1991 and November 1996. Medication errors occur in all health care facilities, involve health care practitioners from all disciplines, and involve drugs from all categories, including neuromuscular blocking agents (38 out of 2,213). This class of drugs is discussed as an example of the program, and we trust will serve the reader as an educational guide about medication errors that occur with drugs in any class. When used inappropriately, they represent a higher morbidity and mortality than many other drug classes analyzed. Reports indicate various causes for the errors, such as similar-appearing products, and include suggestions by practitioners to prevent recurrence of the error. The USP Advisory Panel on Medication Errors has developed recommendations for facilities that are intended to prevent errors with neuromuscular blocking agents (NMB). The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices (ISMP).

Adverse Drug Reaction Reporting Systems↗
PubMed2007

Reporting adverse events in randomized controlled trials.

PURPOSE: How randomized controlled trial results are reported may minimize concerns and detection of adverse side effects. We aimed to describe the methods of reporting adverse events in these published trials. METHODS: Five frequently cited journals were investigated: Annals of Internal Medicine, British Medical Journal, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, all randomized controlled trials conducted on the use of a medication were selected from January 2000 through June 2003. All issues of each journal were reviewed manually. Information retrieved included any mention of adverse events in the abstract, methods, results, or discussion section of the article; or inclusion of adverse events data in tables or figures. We also cataloged whether there was a separate subheading in the results section for reporting adverse events. Reports of trials that referred to methods described in a previous report were excluded. RESULTS: There were 521 eligible articles. Explicit mention of adverse events was in 328 (63%) of abstracts (range 47-66%), 380 (73%) of methods (range 51-81%), 464 (89%) of results (range 80-95%), and 250 (48%) of tables (range 31-49%). There was a separate subheading for adverse events in 240 (46%) (range 22-64%) of the eligible articles. CONCLUSION: There is variation among authors and journals as to the location of reporting adverse events and the means by which it is done. Authors and editors should include specific information on adverse events when reporting the results of randomized controlled trials. It would be ideal if there was more consistency among authors and journals as to how these adverse events are described.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Collaborative study for establishment of a global standard for the potency assay of human anti-D immunoglobulin.

An international collaborative study aimed at establishing a global standard for the potency assay of anti-D immunoglobulin was started in 2002. 25 laboratories participated in this study run under the common aegis of the World Health Organization, the United States Food and Drug Administration (US-FDA) and the European Directorate for the Quality of Medicines (EDQM). The potencies of three candidate materials and the US-FDA standard (lot 3) included for comparison were evaluated using AutoAnalyzer, competitive enzyme-linked immunoassay (competitive EIA), flow cytometric methods or own "in-house" methods. Critical reagent, standardised procedures and standardised assay design were provided for either method, where appropriate. Central statistical evaluation of the potency data submitted by the participants was performed using a parallel line model. Agreement between laboratories and assay methods for all samples was observed. Intra-laboratory variability was lowest for laboratories performing flow cytometry and highest for laboratories that performed their in-house methods. Inter-laboratory variability was acceptable for all samples when assayed by AutoAnalyzer, competitive (EIA) and flow cytometric methods. It was concluded that sample A is most suitable to serve as a global standard and that sample C could serve as a reserve European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch provided that suitable stability is demonstrated. Sample A was adopted by the Ph. Eur. Commission at its 115th session (March 2003) as the first Ph. Eur. BRP (available from the EDQM: catalog number Y0000219) with the assigned potency of 285 IU/ampoule.

Chromatography, High Pressure Liquid↗
PubMed2001

Catalog of 46 single-nucleotide polymorphisms (SNPs) in the microsomal glutathione S-transferase 1 (MGST1) gene.

A major goal in our laboratory is to understand the role of common genetic variations among individual patients as regards susceptibility to common diseases and differences in therapeutic efficacy and/or side effects of drugs. As an addition to the high-density SNP (single-nucleotide polymorphism) maps of 12 glutathione S-transferase and related genes reported earlier, we provide here an SNP map of the microsomal glutathione S-transferase 1 (MGST1) gene. Among 48 healthy Japanese volunteers examined. we identified a total of 46 SNPs at this locus, 36 of which had not been reported before: 4 in the promoter region, 34 in introns, 3 in the 3' untranslated region, and 5 in the 3' flanking region. No SNP was found in 5'untranslated or coding regions. The ratio of transition to transversion was approximately 1.2:1. Among the 13 insertion-deletion polymorphisms was a 2-bp deletion in the coding region of MGST1 in DNA from one of the volunteers, which resulted in a frame-shift mutation. Since the gene product encoded by this mutant allele would lack the C-terminal half including the MAPEG (membrane-associated proteins in eicosanoid and glutathione metabolism) domain, MGST1 activity is likely to be reduced in the carrier's cells. The SNP map presented here adds to the archive of tools for studying complex genetic diseases, population migration patterns, and a variety of pharmacogenetic possibilities.

3' Untranslated Regions↗
PubMed1998

Providing patients with written medication information.

OBJECTIVE: To review the literature and provide recommendations for the development and dissemination of written medication information to patients and their care providers. DATA SOURCES: A MEDLINE search (1966-1997) of the English-language literature was performed to identify articles pertaining to the development or use of written medication information. A search of the Internet was conducted by using Yahoo as the guide and "medication information" as the search term. Additional resources were obtained through texts, bibliographies, and catalogs from medical publishers. DATA EXTRACTION: Reports documenting the creation and use of written medication information systems were reviewed, as well as studies of readability and reading skills assessment. Examples of materials available for purchase by laypeople and healthcare providers were also examined. DATA SYNTHESIS: Current statistics support the widespread availability of written medication information for patients and care providers. The goal set forth by the Food and Drug Administration of having 75% of patients receive written information by the year 2000 appears achievable. However, there are still many issues to address. Content is not standardized, and materials are frequently written at reading levels higher than that of the average patient. The development and use of resources requiring only minimal reading skills and an increase in the availability of materials written in Spanish are needed. CONCLUSIONS: Written medication information provides a useful addition to counseling by healthcare professionals. A wide variety of prepared materials is available, as well as resources for those interested in developing tools for a specific patient, population, or setting. Healthcare professionals should be aware of the limitations of some resources. Content and readability must be appropriate for the intended audience for these tools to serve a useful role in patient education.

Counseling↗
PubMedDate not supplied

Framework for pharmacy services quality improvement--a bridge to cross the quality chasm. Part I. The opportunity and the tool.

OBJECTIVE: To review the literature on the subject of quality improvement principles and methods applied to pharmacy services and to describe a framework for current and future efforts in pharmacy services quality improvement and effective drug therapy management. BACKGROUND: The Academy of Managed Care Pharmacy produced the Catalog of Pharmacy Quality Indicators in 1997, followed by the Summary of National Pharmacy Quality Measures in February 1999. In April 2002, AMCP introduced Pharmacy's Framework for Drug Therapy Management in the 21st Century. The Framework documents include a self-assessment tool that details more than 250 specific "components" that describe tasks, behaviors, skills, functions, duties, and responsibilities that contribute to meeting customer expectations for effective drug therapy management. FINDINGS: There are many opportunities for quality improvement in clinical, service, and cost outcomes related to drug therapy management. These may include patient safety; incidence of medical errors; adverse drug events; patient adherence to therapy; attainment of target goals of blood pressure, glucose, and lipid levels; risk reduction for adverse cardiac events and osteoporotic-related fractures; patient satisfaction; risk of hospitalization or mortality; and cost of care. Health care practitioners can measure improvements in health care quality in several ways including (a) a better patient outcome at the same cost, (b) the same patient outcome at lower cost, (c) a better patient outcome at lower cost, or (d) a significantly better patient outcome at moderately higher cost. Measurement makes effective management possible. A framework of component factors (e.g., tasks) is necessary to facilitate changes in the key processes and critical factors that will help individual practitioners and health care systems meet customer expectations in regard to drug therapy, thus improving these outcomes. CONCLUSIONS: Quality improvement in health care services in the United States will be made in incremental changes that rely on a structure-process-outcome model. The structure is provided by evidence created from controlled randomized trials and other studies of care and system outcomes that are based on the scientific method. The process portion is created by the application of evidence in the form of clinical practice guidelines, clinical practice models, and self-assessment tools such as Pharmacy's Framework for Drug Therapy Management. Incremental changes in structure and process will result in the desirable outcome of meeting customer needs for more effective drug therapy and disease management.

Guidelines as Topic↗
PubMedDate not supplied

Defibrillator/monitor/pacemakers.

Combined defibrillator/monitors enable the operator to assess and monitor the ECG and rapidly deliver a defibrillating countershock to patients suffering from ventricular fibrillation during a cardiac arrest. In addition, these units provide synchronized cardioversion for treating other arrhythmias, such as ventricular tachycardia, and most now offer external noninvasive pacemaker capability for treating patients with ventricular bradycardia or asystole. Defibrillator/monitors are critical resuscitation instruments and must perform effectively to avoid the otherwise preventable death of a cardiac arrest patient. However, both ECRI and the Food and Drug Administration (FDA) continue to receive a large number of problem reports on these devices each year. Device failures can occur for such reasons as operator error, depleted or defective batteries, or component failures. We evaluated eight units--three intended for crash-cart use and four intended for portable use, all with noninvasive pacemaker capability either standard or as an option, as well as one portable physiologic patient monitor to which a defibrillator (with or without a pacing option) can be attached--from six manufacturers.* We also evaluated one stand-alone noninvasive pacemaker. Although we did not include automated external defibrillators (AEDs) in our study, two of the evaluated units have options that allow them to function as AEDs. We rated the seven crash-cart and portable defibrillator/monitor/pacemakers according to three primary applications: (1) general crash-cart use, (2) prehospital (emergency medical service [EMS]) use, and (3) in-hospital transport. They are rated either Acceptable or Acceptable--Not Recommended for these applications, based primarily on technical performance (including battery operation, which is especially important in portable units), characteristics (such as line-powered operation and portability), features (such as automatic documentation), and human factors design (especially ease of use); some are inappropriate for specific uses because of their respective limitations in these applications. The portable physiologic patient monitor is not rated, but is discussed.** All of the pacemakers available as components of the evaluated units are acceptable for use; however, in most cases, purchasing decisions should be made according to defibrillator/monitor needs. The stand-alone pacemaker is rated Unacceptable because of its numerous performance, safety, and human factors disadvantages and because, other than its being a stand-alone unit, it offers no advantages over the other evaluated pacemakers; see "The Zoll NTP-1000 Stand-alone Noninvasive Pacemaker." Readers are cautioned not to base purchasing decisions on our ratings and rankings alone, but on a thorough understanding of the issues surrounding defibrillator/monitors and noninvasive pacemakers, which can be gained only by reading this study in its entirety.(ABSTRACT TRUNCATED AT 400 WORDS)

Catalogs, Commercial as Topic↗