Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.
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Biopharmaceutics↗
Biomedical subjects
Mei-Ling Chen
Publications and source records attributed to Mei-Ling Chen.
Effects of brief pain education on hospitalized cancer patients with moderate to severe pain.
The purpose of this randomized controlled study was to assess the effects of a structured pain education program on the pain experience of hospitalized cancer patients. Eligible cancer pain patients were randomly assigned to either an experimental group (receiving pain education 10-15 min per day for 5 days, n = 15) or a standard care control group (n = 15). The effects of the intervention on six pain-related variables were evaluated using three instruments. Pain intensity, pain interference with daily life, negative beliefs about opioids, beliefs about endurance of pain, pain catastrophizing (an individual's tendency to focus on and exaggerate the threat value of painful stimuli and negatively evaluate his or her own ability to deal with pain), and sense of control over pain were evaluated by the Brief Pain Inventory-Short Form Taiwanese version (BPI-T), Pain and Opioid Analgesic Beliefs Scale-Cancer (POABS-CA), and the Catastrophizing subscale and the sense of control over pain measure from the Coping Strategies Questionnaire (CSQ). The results indicated that, after completing treatment, patients who had received structured pain education had significantly less pain intensity on average, negative pain beliefs regarding opioids, pain endurance beliefs, and pain catastrophizing than patients in the control group. In addition, patients in the pain education group showed a significant increase in their sense of control over pain. These preliminary results strongly suggest that structured pain education can effectively improve the pain experience of hospitalized cancer patients and should be further implemented clinically.
Attitude to Health↗
Assuring quality and performance of sustained and controlled released parenterals.
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Animals↗
Physical symptom profiles of depressed and nondepressed patients with cancer.
Depression and symptom severity are predictive of survival in cancer patients, but are often correlated with each other. This paper compares the physical symptom profiles of depressed and nondepressed cancer patients and further examines the predictive ability of multiple symptoms on depressive status. Data were collected from 121 hospitalized patients with breast, oesophageal and head and neck cancer. Patients were categorized as depressed (n = 30) or nondepressed (n = 91) using the Hospital Anxiety and Depression Scale. Occurrence of symptoms was evaluated with the Patient Disease Symptom/Sign Assessment Scale. The most prevalent symptom in the total sample was insomnia (occurrence rate = 67%). Insomnia, pain, anorexia, fatigue, and wound or pressure sore occurred significantly more often in depressed patients, with no difference in occurrence rates of nausea/vomiting and dyspnoea. Significantly more symptoms were observed in depressed than in nondepressed patients (mean = 3.77 versus 2.52). Both groups showed similar rankings of symptom occurrence rates. Patients simultaneously experiencing insomnia, pain, anorexia and fatigue had a higher risk of depression (odds ratio = 5.03).
Adult↗
SARS in hospital emergency room.
Thirty-one cases of severe acute respiratory syndrome (SARS) occurred after exposure in the emergency room at the National Taiwan University Hospital. The index patient was linked to an outbreak at a nearby municipal hospital. Three clusters were identified over a 3-week period. The first cluster (5 patients) and the second cluster (14 patients) occurred among patients, family members, and nursing aids. The third cluster (12 patients) occurred exclusively among healthcare workers. Six healthcare workers had close contact with SARS patients. Six others, with different working patterns, indicated that they did not have contact with a SARS patient. Environmental surveys found 9 of 119 samples of inanimate objects to be positive for SARS coronavirus RNA. These observations indicate that although transmission by direct contact with known SARS patients was responsible for most cases, environmental contamination with the SARS coronavirus may have lead to infection among healthcare workers without documented contact with known hospitalized SARS patients.
Adult↗
Dwarfism, impaired skin development, skeletal muscle atrophy, delayed bone development, and impeded adipogenesis in mice lacking Akt1 and Akt2.
To elucidate the functions of the serine/threonine kinase Akt/PKB in vivo, we generated mice lacking both akt1 and akt2 genes. Akt1/Akt2 double-knockout (DKO) mice exhibit severe growth deficiency and die shortly after birth. These mice display impaired skin development because of a proliferation defect, severe skeletal muscle atrophy because of a marked decrease in individual muscle cell size, and impaired bone development. These defects are strikingly similar to the phenotypes of IGF-1 receptor-deficient mice and suggest that Akt may serve as the most critical downstream effector of the IGF-1 receptor during development. In addition, Akt1/Akt2 DKO mice display impeded adipogenesis. Specifically, Akt1 and Akt2 are required for the induced expression of PPARgamma, the master regulator of adipogenesis, establishing a new essential role for Akt in adipocyte differentiation. Overall, the combined deletion of Akt1 and Akt2 establishes in vivo roles for Akt in cell proliferation, growth, and differentiation. These functions of Akt were uncovered despite the observed lower level of Akt activity mediated by Akt3 in Akt1/Akt2 DKO cells, suggesting that a critical threshold level of Akt activity is required to maintain normal cell proliferation, growth, and differentiation.
Abnormalities, Multiple↗
Development and testing of the pain opioid analgesics beliefs scale in Taiwanese cancer patients.
The purpose of the study was to develop and preliminarily test the feasibility, validity, reliability, and factor structures of the Pain Opioid Analgesics Beliefs Scale-Cancer (POABS-CA) in hospitalized adults diagnosed with cancer in Taiwan. This scale was developed in three phases. In Phase I, item development was based on qualitative analysis as well as a review of the literature. Face validity, content validity, and feasibility were also evaluated. In Phase II, internal consistency reliability was further tested in 42 subjects with pain. In Phase III, test-retest reliability, internal consistency, and essential construct validity were further assessed in a sample of 361 hospitalized cancer patients with pain. The POABS-CA evolved from testing as a 10-item 5-point Likert-type instrument. Higher scores indicated more negative beliefs regarding opioids and their use in managing pain. Satisfactory face validity and content validity were found. The POABS-CA was also shown to be a reliable and stable pain belief scale, with Cronbach's alpha and test-retest reliability of 0.70 and 0.94, respectively. Two factors, namely pain endurance beliefs and negative effect beliefs, were extracted from the principal component factor analysis to support the construct validity. In conclusion, preliminary evidence indicates the POABS-CA is a reliable, stable, valid and easily applied scale for assessing beliefs regarding opioid use for cancer pain. Further studies should test this scale in different populations to increase its applications in cancer pain management.
Adult↗
Are nurses prepared to manage cancer pain? A national survey of nurses' knowledge about pain control in Taiwan.
Nurses play a crucial role in cancer pain control, but little is known about how well-prepared nurses are to manage cancer pain in Taiwan. The purpose of this study was to examine the level of knowledge about pain management among Taiwanese nurses with different background characteristics and to determine the predictor(s) of nurses' pain management knowledge. Nurse subjects were recruited by a cross-sectional nationwide survey with stratified sampling from nine hospitals distributed in the four major geographic regions of Taiwan. The Nurses' Knowledge and Attitudes Survey-Taiwanese version (NKAS-T) and a background information form were used to collect the data. Of 1900 surveys distributed, 1797 valid questionnaires (94.5%) were analyzed. The average correct response rate was 50.5%, with rates ranging from 7-86% for each survey question. Results from stepwise regression showed that nurses with higher mean correct answer scores had BS or higher degrees, had received pain education at professional conferences, had more prior hours of pain education, had longer clinical care experiences, and always worked with cancer patients. Nurses who worked in intensive care units, however, had significantly lower mean correct scores. The results strongly suggest an urgent need to strengthen pain education in Taiwan. The results also provide the direction for developing pain education.
Data Collection↗
Pain and hope in patients with cancer: a role for cognition.
The importance of hope in determining the adjustment of patients with cancer to their illness has been recognized. Stressful events such as pain and disease metastasis may have an impact on patients' hope levels. This study had three purposes: 1) to examine the effect of disease status on hope levels among patients with cancer who have pain; (2) to compare the level of hope between patients with cancer who have pain and those do not; and (3) to determine which dimensions of pain are associated with hope. Patients (n = 226) with various cancer diagnoses completed the Herth Hope Index. Disease status was measured by one objective indicator (disease stage) and one subjective indicator (perceived treatment effect). The Perceived Meanings of Cancer Pain Inventory was used to measure the cognitive dimension of pain, whereas pain intensity and relief were used to represent the sensory dimension of pain. The patients' disease stage did not affect their level of hope, but their perception of treatment effect was associated with this factor. No difference in level of hope was found between patients with pain and those without pain. For those with pain, the cognitive dimension of pain (meaning ascribed to pain) was significantly correlated with hope, whereas sensory dimensions (pain intensity and relief) showed no such correlation. The study results support the role of cognition in promoting the psychological well-being of patients with cancer.
Activities of Daily Living↗
Recombinant 56-kilodalton major outer membrane protein antigen of Orientia tsutsugamushi Shanxi and its antigenicity.
The gene encoding the 56-kDa protein of Orientia tsutsugamushi Shanxi was amplified by a nested PCR and cloned into the expression vector pQE30. The 56-kDa protein of O. tsutsugamushi Shanxi (Sxh56) was expressed as a fusion protein with the His(6)-binding protein of Escherichia coli by deleting the signal peptide-encoding sequence from the 5' end of the open reading frame. The recombinant protein formed inclusion bodies when expressed in E. coli M15. The recombinant protein was examined for reactivity with mouse sera against three antigenic prototypes of O. tsutsugamushi by an immunoblot assay. The recombinant Sxh56 reacted only to polyclonal antiserum to O. tsutsugamushi Gilliam in an enzyme-linked immunosorbent assay (ELISA) and in an immunoblot assay. Recombinant Sxh56 was purified by Ni-nitrilotriacetic acid affinity chromatography and injected into mice to evaluate its ability to stimulate immune responses. High levels of immunoglobulin G and T-cell proliferation appeared in mice immunized with the recombinant protein. The recombinant Sxh56 was used in an ELISA to evaluate the ability of the method to detect antibodies to O. tsutsugamushi in human and animal sera. Thirty sera from mice infected with O. tsutsugamushi Gilliam or Shanxi and 55 sera from normal mice were detected in the ELISA with recombinant Sxh56, and the sensitivity and specificity were 96.67 and 100%, respectively. One hundred fifty-one positive sera and 412 negative sera to O. tsutsugamushi Gilliam were detected in an indirect immunofluorescence assay with the recombinant protein, and the sensitivity and specificity were 96.36 and 88.08%, respectively. These results strongly suggest that the recombinant Sxh56 is a suitable type-specific immunodiagnostic antigen and vaccine candidate.
Animals↗
The generalizability of Caregiver Strain Index in family caregivers of cancer patients.
The purpose of this study was to estimate the variance components associated with individual differences and various sources of measurement error of Caregiver Strain Index (CSI). A two-facet (item and occasion) crossed design generalizability study (G study) was conducted using a sample of 14 caregivers of cancer patients. Based on the findings of the G study, alternative decision studies were then designed to search for optimal generalizability of CSI. The measurement of CSI was not reliable with a single test. Averaging two or more measurements would make CSI scores more generalizable for either relative or absolute assessment of caregiver strain.
Adult↗
Biopharmaceutics classification system: the scientific basis for biowaiver extensions.
The current BSC guidance issued by the FDA allows for biowaivers based on conservative criteria. Possible new criteria and class boundaries are proposed for additional biowaivers based on the underlying physiology of the gastrointestinal tract. The proposed changes in new class boundaries for solubility and permeability are as follows: 1. Narrow the required solubility pH range from 1.0-7.5 to 1.0-6.8. 2. Reduce the high permeability requirement from 90% to 85%. The following new criterion and potential biowaiver extension require more research: 1. Define a new intermediate permeability class boundary. 2. Allow biowaivers for highly soluble and intermediately permeable drugs in IR solid oral dosage forms with no less than 85% dissolved in 15 min in all physiologically relevant dissolution media, provided these IR products contain only known excipients that do not affect the oral drug absorption. The following areas require more extensive research: 1. Increase the dose volume for solubility classification to 500 mL. 2. Include bile salt in the solubility measurement. 3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing.
Biopharmaceutics↗
Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USP.
This is a summary report of the American Association of Pharmaceutical Scientists, the Food and Drug Administration, and the United States Pharmacopoeia cosponsored workshop on "Assuring Quality and Performance of Sustained and Controlled Release Parenterals." Experts from the pharmaceutical industry, the regulatory authorities, and academia participated in this workshop to review, discuss, and debate formulation, processing, and manufacture of sustained and controlled release parenterals and identify critical process parameters and their control. Areas were identified where research is needed to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops, meetings, and working groups in this area.
Delayed-Action Preparations↗
Equivalence approaches.
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Clinical Trials as Topic↗
Assuring quality and performance of sustained and controlled release parenterals: workshop report.
This is a summary report of the American Association of Pharmaceutical Scientists, the Food and Drug Administration and the United States Pharmacopoeia co-sponsored workshop on "Assuring Quality and Performance of Sustained and Controlled Release Parenterals." Experts from the pharmaceutical industry, the regulatory authorities and academia participated in this workshop to review, discuss and debate formulation, processing and manufacture of sustained and controlled release parenterals and identify critical process parameters and their control. Areas were identified where research is needed in order to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops, meetings and working groups in this area.
Biological Availability↗
Antimicrobial drug resistance in pathogens causing nosocomial infections at a university hospital in Taiwan, 1981-1999.
To determine the distribution and antimicrobial drug resistance in bacterial pathogens causing nosocomial infections, surveillance data on nosocomial infections documented from 1981 to 1999 at National Taiwan University Hospital were analyzed. During this period, 35,580 bacterial pathogens causing nosocomial infections were identified. Candida species increased considerably, ranking first by 1999 in the incidence of pathogens causing all nosocomial infections, followed by Staphylococcus aureus and Pseudomonas aeruginosa. Candida species also increased in importance as bloodstream infection isolates, from 1.0% in 1981-1986 to 16.2% in 1999. The most frequent isolates from urinary tract infections were Candida species (23.6%), followed by Escherichia coli (18.6%) and P. aeruginosa (11.0%). P. aeruginosa remained the most frequent isolates for respiratory tract and surgical site infections in the past 13 years. A remarkable increase in incidence was found in methicillin-resistant S. aureus (from 4.3% in 1981-1986 to 58.9% in 1993-1998), cefotaxime-resistant E. coli (from 0% in 1981-1986 to 6.1% in 1993-1998), and cefotaxime-resistant Klebsiella pneumoniae (from 4.0% in 1981-1986 to 25.8% in 1993-1998). Etiologic shifts in nosocomial infections and an upsurge of antimicrobial resistance among these pathogens, particularly those isolated from intensive care units, are impressive and alarming.
Anti-Bacterial Agents↗
[Food-grade gene expression systems for lactic acid bacteria].
Lactic acid bacteria (LAB) are important industrial microorganism used in the production and preservation of food-stuffs. Recently, considerable advances have been made in the genetics and molecular biology of LAB. These have resulted in the construction of food-grade gene expression systems for these bacteria. This paper aims to review the essential features for food-grade systems, food-grade selection markers, food-grade controlled gene expression and food-grade inducible signaling molecule, and recent developments on food-grade cloning and expression systems for LAB. These gene expression systems have great potential for studies on gene expression and regulation in LAB and a variety of bioprocessing application in industrial fermentations.
Food Industry↗
Acute pancreatitis complicated with periappendicitis.
Colonic complications of severe acute pancreatitis are quite uncommon and always occur in the transverse colon and splenic flexure. Here we report the case of a 47-year-old male with mild acute pancreatitis (Ranson's score 1) who suffered from acute right lower quadrant pain during hospitalization. After conservative treatment failed, he underwent open appendectomy under the impression of acute appendicitis. However, the pathology revealed only periappendicitis. Small bowel ileus was noted on plain film of the abdomen and a high ascitic lipase level was found during operation suggesting that the periappendicitis resulted from the spreading of the pancreatic inflammatory exudate via the small bowel mesentery route. This report suggests that although rare, periappendiceal involvement mimicking acute appendicitis remains possible in even mild acute pancreatitis.
Acute Disease↗