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PubMed2026

Clinical pharmacokinetics of afatinib: A systematic review.

BACKGROUND: Afatinib is commonly used in the treatment of non-small cell lung cancer (NSCLC). This systematic review summarizes clinical pharmacokinetics (PK) evidence focusing on the effect of disease state and drug interactions on afatinib exposure. METHODS: Google Scholar, Science Direct, PubMed, and the Cochrane library were searched for human studies reporting the clinical PK of afatinib. The search yielded 24 articles that met the predefined inclusion criteria. RESULTS: Afatinib exposure increased slightly more than dose proportionally, with higher doses producing greater AUC0-24 and Cmax values. The apparent oral clearance reported after administration of the oral solution was lower than that observed following tablet administration. The Cmax of afatinib increases by 38.5% after coadministration with ritonavir and exposure decreases 34.3% with rifampicin. The Cmax decreases 31.45% when given with pemetrexed. Both the AUC0-24 and Cmax increase in NSCLC and tumor state. The AUC0-24 of afatinib is 2.61 folds higher following multiple oral doses among patients with solid tumors. Afatinib exposure is 22.1 % higher in renal impaired patients than in healthy controls. In grade 2 diarrhea, the AUC0-24 of afatinib is 83.93% higher as than in grade 0-1 diarrhea in solid tumor patients. CONCLUSION: This systematic review provides an updated synthesis of clinical PK evidence on afatinib. Afatinib exposure is influenced by dose, repeated administration, renal impairment, diarrhea associated toxicity, and P-glycoprotein mediated drug interactions. These findings may support individualized dosing, toxicity-guided dose adjustment, and future development of PK models for afatinib.

Humans↗
PubMed2003

Why an ICNP? Links among quality, information and policy.

Work has been underway for over a decade to develop and use the International Classification for Nursing Practice (ICNP). The International Council of Nurses has released ICNP Alpha and Beta versions. This article is an adaptation of the presentation given at the International Council of Nurses Congress on June 12th, 2001, in Copenhagen, Denmark. When the ICNP was originally drafted, many uses were envisioned. Key among these were that the information generated would be used by clinicians, researchers, administrators and policy makers. This article introduces examples of these uses.

Evidence-Based Medicine↗
PubMed2000

Epitope mapping of human anti-adeno-associated virus type 2 neutralizing antibodies: implications for gene therapy and virus structure.

Recombinant adeno-associated virus type 2 (AAV) is a common vector used in human gene therapy protocols. We characterized the humoral immune response to AAV and observed that 80% of normal human subjects have anti-AAV antibodies and that 18% have neutralizing antibodies. To analyze the effect of neutralizing antibodies on AAV readministration, we attempted to deliver recombinant AAV expressing human factor IX (AAV-hFIX) intraportally into the livers of mice which had been preexposed to AAV and shown to harbor a neutralizing antibody response. While all naive control mice expressed hFIX following administration of AAV-hFIX, none of the mice with preexisting immunity expressed hFIX, even after transient immunosuppression at the time of the second administration with anti-CD4 or anti-CD40L antibodies. This suggests that preexisting immunity to AAV, as measured by a neutralizing antibody response, may limit AAV-mediated gene delivery. Using human sera in an enzyme-linked immunosorbent assay for AAV and a capsid peptide scan library to block antibody binding, we mapped seven regions of the AAV capsid containing immunogenic epitopes. Using pools of these peptides to inhibit the binding of neutralizing antibodies, we have identified a subset of six peptides which potentially reconstitute a single neutralizing epitope. This information may allow the design of reverse genetic approaches to circumvent the preexisting immunity that can be encountered in some individuals.

Amino Acid Sequence↗
PubMed2002

Premenstrual dysphoric disorder: current status of treatment.

OBJECTIVE: Premenstrual dysphoric disorder (PMDD), also referred to as premenstrual syndrome (PMS), is a recurrent luteal-phase condition involving regular occurrence, prior to the onset of menstrual bleeding, of a cluster of symptoms of sufficient severity to result in the deterioration of interpersonal relationships and normal activity. Several treatment options for PMDD with varying degrees of efficacy have been proposed. The literature is reviewed and treatments of proven efficacy are reported. STUDY DESIGN AND METHODS: A MEDLINE/Cochrane Library search for all studies on PMS and PMDD published between 1983 and 2001 was performed. Only randomised trials were included. RESULTS: Several treatments appear to be effective. Among these are increased physical activity, dietary change, mineral salt supplementation and ovulation inhibitors. The most effective seems to be administration of selective inhibitors of serotonin reuptake (SSRIs). CONCLUSION: Therapy should begin with nonmedicated approaches and pharmacological treatment should only be envisaged if symptoms persist.

Female↗
PubMed1967

The Medical Library Association in retrospect, 1937-1967.

The medical librarian of 1967 lives in a period of changing concepts, dramatic new methods, everwidening scientific horizons. In looking toward the immediate past he may think of the medical librarian of thirty years ago as a complacent follower of accepted procedures, not as a pioneer in a brave new world. Yet the corps of trained medical librarians today and the resources of our collections and their management are dependent upon the efforts of those who were then pioneers in medical librarianship. Training, standards, recruitment, literature control, international relations, all had continuing attention at a time when financial assistance through government funds, support by administrators, concern by scientists was almost nonexistent. In these years the day of the devoted amateur passed; the trained medical librarian came into being and matured.This, the first Janet Doe Lecture, is named for one who illustrates the best in medical librarianship, serving with scholarly distinction. It is a brief survey pointing to some of the Association's significant achievements during the years of Miss Doe's greatest activity when she and her colleagues met their "Challenge of Change."

History, 20th Century↗
PubMed1998

The Medical Library Association in retrospect, 1937-1967.

The medical librarian of 1967 lives in a period of changing concepts, dramatic new methods, everwidening scientific horizons. In looking toward the immediate past he may think of the medical librarian of thirty years ago as a complacent follower of accepted procedures, not as a pioneer in a brave new world. Yet the corps of trained medical librarians today and the resources of our collections and their management are dependent upon the efforts of those who were then pioneers in medical librarianship. Training, standards, recruitment, literature control, international relations, all had continuing attention at a time when financial assistance through government funds, support by administrators, concern by scientists was almost nonexistent. In these years the day of the devoted amateur passed; the trained medical librarian came into being and matured. This, the first Janet Doe Lecture, is named for one who illustrates the best in medical librarianship, serving with scholarly distinction. It is a brief survey pointing to some of the Association's significant achievements during the years of Miss Doe's greatest activity when she and her colleagues met their "Challenge of Change".

History, 20th Century↗
PubMed1989

Estrogen regulation of tissue-specific expression of complement C3.

The administration of estradiol to immature rats results in the increased synthesis and secretion of a 180-kDa protein, composed of 115- and 65-kDa subunits, by the uterine luminal epithelial cells. A monoclonal antibody against the 180-kDa protein was utilized to isolate the corresponding cDNA (LE-1) from a rat uterine luminal epithelial cell cDNA lambda gt11 expression library. This LE-1 cDNA was sequenced and shown to be homologous to complement component C3. The sequence was approximately 81 and 90% homologous to human and mouse C3, respectively. The LE-1 cDNA sequence was homologous with the 3' portion of the C3 mRNA containing the alpha subunit (115 kDa). Uterine mRNA isolated from immature rats treated with 1 microgram of estradiol for 24 h demonstrated a 25-fold increase in the concentration of a 6.0-kilobase mRNA by Northern hybridization with either LE-1 or authentic human C3 cDNA probes. To further examine the possibility that the estradiol-regulated secretory protein was C3, an aliquot of radiolabeled media protein from control and estradiol-stimulated rat uteri was incubated with goat anti-rat C3 antibody. The immunoprecipitated radiolabeled protein from estradiol-treated animals was increased significantly (p less than 0.01) compared to media from control animals. Analysis of the immunoprecipitated proteins on nonreducing sodium dodecyl sulfate-polyacrylamide gel electrophoresis revealed a single protein of 180 kDa from estradiol-stimulated uterine media, whereas no detectable proteins were immunoprecipitated from media obtained from control uteri. Also, when the immunoprecipitated protein was reduced (20 mM dithiothreitol) it dissociated into two subunits of 115 and 65 kDa. Immunohistochemical studies demonstrated the presence of C3 only in the epithelial cells of estrogen-stimulated rat uteri. In addition, the estradiol-stimulated mRNA was only detectable in uterine epithelial cell RNA. Analysis of liver RNA demonstrated a 6.0-kilobase mRNA, as in the uterus, when hybridized with LE-1. However, unlike the uterus, its concentration was not influenced by estrogen administration with up to three daily injections of 100 micrograms of diethylstilbestrol. Based on biophysical, DNA sequence, and antibody data we conclude that rat uterine epithelial cells produce C3 in response to estradiol whereas the expression in the liver was not modulated by estrogens.

Animals↗
PubMed1998

Peroxisome proliferator-activated receptor gamma1 (PPAR-gamma1) as a major PPAR in a tissue in which estrogen induces peroxisome proliferation.

Estradiol administration induces peroxisome proliferation and the production of 3-hydroxy fatty acid pheromones in the uropygial glands of the duck, but not in the goose gland, which does not produce such pheromones. We isolated a peroxisome proliferator-activated receptor (PPAR)gamma1 cDNA from a duck uropygial gland cDNA library. Northern blots revealed two transcripts, PPAR gamma1 and gamma2, and showed that PPAR gamma was expressed at higher levels than PPAR alpha in the uropygial gland of the duck. Although PPAR gamma2 was expressed in both duck and goose uropygial gland, PPAR gamma1 was expressed only in the duck gland, which responds to estrogen by peroxisome proliferation. In NIH 3T3 transfected cells, PPAR gamma1 was activated by peroxisome proliferators such as Wy-14643, clofibric acid and Ly-171883 causing induction of the target marker gene. By cotransfection with a plasmid containing alpha-cis-retinoic acid receptor RXR alpha, the induction increased up to 9-fold. These results suggest that PPAR gamma1 may be involved in peroxisome proliferation while PPAR gamma2 may be involved in lipid metabolism.

3T3 Cells↗
PubMed2000

Human anti-CD30 recombinant antibodies by guided phage antibody selection using cell panning.

In various clinical studies, Hodgkin's patients have been treated with anti-CD30 immunotherapeutic agents and have shown promising responses. One of the problems that appeared from these studies is the development of an immune response against the nonhuman therapeutics, which limits repeated administration and reduces efficacy. We have set out to make a recombinant, human anti-CD30 single-chain variable fragment (scFv) antibody, which may serve as a targeting moiety with reduced immunogenicity and more rapid tumour penetration in similar clinical applications. Rather than selecting a naive phage antibody library on recombinant CD30 antigen, we used guided selection of a murine antibody in combination with panning on the CD30-positive cell line L540. The murine monoclonal antibody Ki-4 was chosen as starting antibody, because it inhibits the shedding of the extracellular part of the CD30 antigen. This makes the antibody better suited for CD30-targeting than most other anti-CD30 antibodies. We have previously isolated the murine Ki-4 scFv by selecting a mini-library of hybridoma-derived phage scFv-antibodies via panning on L540 cells. Here, we report that phage display technology was successfully used to obtain a human Ki-4 scFv version by guided selection. The murine variable heavy (VH) and light (VL) chain genes of the Ki-4 scFv were sequentially replaced by human V gene repertoires, while retaining only the major determinant for epitope-specificity: the heavy-chain complementarity determining region 3 (CDR3) of murine Ki-4. After two rounds of chain shuffling and selection by panning on L540 cells, a fully human anti-CD30 scFv was selected. It competes with the parental monoclonal antibody Ki-4 for binding to CD30, inhibits the shedding of the extracellular part of the CD30 receptor from L540 cells and is thus a promising candidate for the generation of anti-CD30 immunotherapeutics.

Amino Acid Sequence↗
PubMed2003

Peptide decoys selected by phage display block in vitro and in vivo activity of a human anti-FVIII inhibitor.

Hemophilia A is a life-threatening, hemorrhagic, X-linked recessive disorder resulting in deficient factor VIII (FVIII) activity. After the infusion of therapeutic FVIII, 25% of patients develop anti-FVIII antibodies that inhibit FVIII procoagulant activity, thus precluding further administration of FVIII. Here we report a novel approach aimed at neutralizing the activity of FVIII inhibitors by peptide epitope surrogates. To illustrate our concept, we chose the human anti-FVIII monoclonal antibody, Bo2C11, as a representative of anti-FVIII antibodies and a phage-displayed peptide library approach to obtain surrogate peptides. We selected a series of constrained dodecapeptides with the core sequence W-NR, which specifically interacts with the combining site of Bo2C11. The peptides mimic the epitope recognized by Bo2C11 and are able to inhibit specifically and in a dose-dependent manner the binding of Bo2C11 to FVIII. Peptide 107, in particular, neutralized the activity of Bo2C11 in vitro and restored normal hemostasis in hemophilic mice. Thus, the use of peptide decoys may be a promising new approach for the neutralization of pathologic antibodies.

Amino Acid Sequence↗
PubMed2004

Issues surrounding the administration of a credit course for medical students: survey of US academic health sciences librarians.

OBJECTIVES: For librarians developing a credit course for medical students, the process often involves trial and error. This project identified issues surrounding the administration of a credit course, so that librarians nationally can rely more upon shared knowledge of common practices and less upon trial and error. METHODS: A questionnaire was sent to the education services librarian at each medical school listed in the 2000 AAMC Data Book. A second questionnaire was sent to those librarians who did not return the first one. RESULTS: Of the 125 librarians surveyed, 82 returned the questionnaire. Of those 82, only 11 offered a credit course for medical students, though 19 more were in the process of developing one. Data were gathered on the following aspects of course administration: credit course offerings, course listing, information learned to administer the course, costs associated with the course, relationships with other departments on campus, preparation for teaching and grading, and evaluation of the course. CONCLUSIONS: Because of small number of respondents offering a credit course and institutional variations, making generalizations about issues surrounding the administration of a credit course is difficult. The article closes with a list of recommendations for librarians planning to develop a course.

Curriculum↗
PubMed1995

Molecular cloning and functional characterization of a novel member of the C-C chemokine family.

Chemokines play an important role in immune and inflammatory responses by inducing migration and adhesion of leukocytes. We have isolated a novel chemokine cDNA, designated CCF18, from a cDNA library of an IL-3-dependent murine pro-B cell line, Ba/F3. The cDNA encodes a protein structurally related to the C-C chemokine members. Among this family, C10 shows the highest homology to CCF18, and MIP-1 alpha also has a significant homology but to a lesser extent. CCF18 produced from COS cells induced chemotaxis and Ca2+ flux in CD4+ T cell clones. Moreover, prior administration of MIP-1 alpha desensitized the cells to CCF18. The CCF18 gene (Scya10) was mapped to a middle region of murine chromosome 11, where other genes for several C-C chemokine members are localized. These results clearly indicate that CCF18 is a new member of the C-C chemokine family. Since a high level of CCF18 mRNA is constitutively expressed in macrophage and myeloid cell lines, CCF18 may play a role in inflammatory processes.

Amino Acid Sequence↗
PubMed2004

The Heidelberg Ion Therapy Center.

The ion beam therapy facility presently under construction at the Department of Clinical Radiology, University of Heidelberg, Germany, will be the first dedicated and hospital-based irradiation facility for protons and heavier ions in Europe. A capacity of more than 1000 patient treatments per year is planned. The facility comprises two horizontally-fixed beamlines for patient treatments plus a fixed-beam experimental area. In addition, the world-wide first scanning ion gantry is under construction. The facility fully relies on an active beam delivery method, the intensity-controlled rasterscan technique. The availability of different ion species ranging from protons to oxygen under identical conditions optimally supports clinical trials aiming to clarify the question of which particle species is best suited for the individual indications. A linac-synchrotron combination will deliver libraries of energy-, focus- and intensity-variable pencil-beams for each ion species to the dose-delivering scanning systems at each treatment station. The available energies correspond to water-equivalent ranges from 2 cm to 30 cm. The intensity-controlled rasterscan technique allows for the administration of inversely planned and biologically optimized dose distributions having utmost precision. The facility will be equipped with state-of-the-art imaging modalities as well as an in-situ Positron-Emission-Tomography (PET). The commissioning of the different sections is scheduled for 2006. The pre-clinical operation will start early in 2007 followed by the routine patient treatment.

Heavy Ion Radiotherapy↗
PubMed1982

Isolation and structure of the gene for the progesterone-inducible protein uteroglobin.

Uteroglobin is a small steroid-binding protein that is differentially regulated by steroid hormones in several tissues of the rabbit. In endometrium, the levels of uteroglobin mRNA increase after progesterone administration due to an enhanced rate of transcription of the uteroglobin gene. As a prerequisite for understanding the molecular mechanisms that modulate uteroglobin gene expression, we have isolated and characterized the uteroglobin gene. We first synthesized, cloned, and sequenced a uteroglobin cDNA that was used to screen a rabbit gene library and to show that the uteroglobin gene is not reiterated in the rabbit genome. We obtained three recombinant phages containing uteroglobin gene sequences and covering 35 kilobases of the rabbit genome. The uteroglobin gene is 3 kilobases long and is composed of three short exons separated by a long and a short intron. The complete coding sequence, the short intron, part of the large intron, and the flanking sequences have been subjected to sequence analysis. The salient features of the nucleotide sequence, including the absence of a canonical "T-A-T-A box," are discussed. A possible relationship is considered between the exon-intron structure of the gene and the known structure and function of uteroglobin.

Amino Acid Sequence↗
PubMed2005

Origin and development of forensic medicine in India.

CONTEXT: : The medical profession is one of great antiquity in India. However, the history of medicine and, in particular, the role of medicine in the administration of justice in India has not been discussed very much. The present paper attempts to fill in this lacuna and traces the medicolegal practice from ancient times to British India. SOURCE: : This paper is based on archival materials collected from the Tamilnadu State Archives, Chennai, and Madras Medical College Library, Chennai, and University of Madras Library, Chennai. MAIN OBSERVATIONS: : The medical men in ancient India were considered as men of wisdom, and one of the ancient Tamil hymns equates the doctor-patient relationship to that of the dedicated love of a devotee to God. Kautilya's Arthashastra gives a list forensic evidence for establishing the cause of death and describes the necessity of autopsy in establishing the cause of death. In British India, the early incidence of custodial death and its certification by medical practitioners, issuance of medical certificate and wound certificate, and medicolegal autopsy are documented. The most outstanding contribution of India to legal medicine during this period is modern dactylography. It is recorded that there was a high ratio of homicidal poisonings in India.

Forensic Medicine↗
PubMed2003

Barriers to evidence-based decision making among Polish healthcare managers.

The 1999 reform of the Polish healthcare system revealed deficiencies in the research base and a lack of organized systems of information provision. Professionals who most need effective information systems are policymakers and healthcare managers. The main aim of the described study was to obtain data describing the needs, preferences and limitations of healthcare managers as information users, and to identify environmental factors influencing their information behaviour. A national postal survey was conducted and supplemented with information collected during focus groups, semi-structured interviews and through analysis of relevant policy documents. The target population included hospital chief executives, medical directors, head nurses and directors of the institutions responsible for health services planning and purchasing. Target institutions were drawn systematically from official lists, stratified by regions of the country and hospital reference level. The interviews were conducted with primary care unit managers and with Ministry of Health officials. National health strategy and directives, cost-effectiveness analyses of interventions and clinical practice guidelines emerged as information of primary importance to respondents. The main barriers to effective information behaviour were found to be: attitudes towards research activity, lack of appropriately processed data, lack of skills enabling information seeking and appraisal, inappropriate format of publications, ineffective dissemination of information and absence of services facilitating access to evidence. The current information environment of healthcare managers, together with their attitude towards information and deficiencies in information skills, appear to serve as a barrier to evidence-based practice in the Polish healthcare system.

Administrative Personnel↗
PubMed1987

Isolation and characterization of a complementary DNA (galanin) clone from estrogen-induced pituitary tumor messenger RNA.

The administration of high levels of estrogen is a well established method for producing prolactin-secreting pituitary tumors in rodents but the mechanism of tumor induction is not clear. In this paper we describe a cDNA clone (pEIC) which has been isolated from an estrogen-induced pituitary tumor cDNA library. The mRNA transcript corresponding to the pEIC clone is 0.9 kilobase in length and is not detectable in normal pituitaries but is expressed as early as 3 h after estrogen stimulation. Nucleotide sequence analysis of two 700-base pair recombinant clones shows that they encode a 124-amino acid protein which is 70% identical to the porcine galanin precursor. The sequence of 29 amino acid residues coded for by the pEIC cDNA clone is 88% identical with porcine galanin with only three amino acid substitutions near the C terminus. This extensive homology suggests that the pEIC cDNA clone codes for rat galanin or a protein belonging to the galanin gene family. These results provide the first evidence of a physiological regulator (estrogen) of the expression of the galanin gene. They also imply that galanin is secreted by prolactin-secreting tumors. Because intracerebroventricular injection of galanin can stimulate prolactin secretion and galanin inhibits hypothalamic dopamine release, it is conceivable that galanin may play a role in the induction of prolactin-secreting tumors.

Amino Acid Sequence↗
PubMed2001

Molecular cloning and sequence of Sparus aurata skeletal myosin light chains expressed in white muscle: developmental expression and thyroid regulation.

Two full-length cDNA clones encoding the skeletal myosin light chain 2 (MLC2; 1452bp) and myosin light chain 3 (MLC3; 972bp) were isolated from a cDNA library prepared from gilthead sea bream Sparus aurata larvae. The MLC2 cDNA encoded a predicted protein of 170 residues that was 79% identical to rabbit MLC2 over the entire length and 87% identical within the Ca(2+)-binding region. The deduced amino acid sequence of MLC3 was 153 residues in length and was 91% and 69% identical to the zebrafish and rabbit MLC3, respectively. Northern blot analysis revealed that in adults both transcripts were expressed in fast white muscle only. MLC2 appeared earlier in development: MLC2 transcripts were detectable from the beginning of segmentation, whereas MLC3 transcripts did not appear until 27h post-fertilisation. At this developmental stage, a second MLC2 transcript of 0.89 kilobase-pairs was present. MLCs exhibited a different age-related pattern of response to varied thyroidal states, which were experimentally induced by the administration of 1 microg g(-1)body mass of thyroxine (T4) or triiodothyronine (T3), or 5 ng g(-1)body mass of the hypothyroidal compound thiourea; MLC3 expression was not significantly affected, whereas levels of MLC2 transcripts were significantly elevated in the white muscle only of juvenile sea bream after administration of T4. Although the mechanism of thyroidal regulation of MLC expression remains unknown, the present results suggest that different regulatory mechanisms exist for different MLCs.

Amino Acid Sequence↗