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PubMed1996

[Validation of a new interactive software monitoring a controlled-flow infusion pump for cisplatin dosage regimen adjustment].

Adaptive dosing of cisplatin (CDDP) results in reduced haematological and renal toxicity but it has never been clearly shown that it affects the tumoral response rate. Before undertaking a clinical randomized study of CDDP monitoring versus standard dose, a comparative study was performed between a new software dedicated to the interactive adjustments--the AJI software--and the APIS software for clinical pharmacokinetics which incorporates a bayesian procedure and a population information computed according to a three compartment model. CDDP was administered by continuous infusion at variable rates with a controlled flow pump during four days in order to reach the target of 1.3 mg/L at the end of the first day, and to maintain this level during the whole treatment. This study was carried out on two groups of patients. Group 1 (12 patients; 27 courses) received CDDP with sequential flow rates in order to obtain a population information to be used with AJI. For patients in group 2 (14 patients; 26 courses), doses (flows) were adapted in a prospective study using the AJI software two to three times the first day, then daily. They could have been adapted (retrospective study) after platin pharmacokinetic parameters identification by APIS. The dosage recommendations proposed by APIS the first day, from 12 hours to 24 hours, to reach the target of 1.3 mg/L at 24 hours, and then daily up to D4 (AAPT at Di) to maintain this level were compared to those which were really administered during the interactive treatment (DA at Di). There were no statistically significant difference for D2, D4 and for the total dose (118.7 +/- 20.1 mg and 118.5 +/- 45.1 mg). The difference was statistically significant for D1 and D3 (P < 0.05). The inter-individual variability was less important with AJI (CV = 16.9% for DA total) than with APIS (CV = 38.0% for ADAPT total). The platin pharmacokinetic parameters identified the first day by APIS were not statistically different from those identified from the whole treatment for clearance (5.92 and 5.63 l/d) and Vtotal 87.8 and 93.1 L); the difference was statistically significant for Vinitial (34.7 and 42.5 L; P < 0.05) and the terminal half-life (13.1 and 15.5 days; P < 0.05).

Adolescent↗
PubMed1976

Evaluation of a multitest microtechnique for yeast identification.

A new, multitest, microtechnique system, API 20C (Analytab Products Inc. Clinical Yeast System), was evaluated by comparing it to the U.S. Center for Disease Control (CDC) standard techniques for the identification of yeast. Forty-four yeast strains isolated from clinical specimens were tested by fermentation and assimilation. Six fermentation carbohydrates and ten assimilation carbohydrates were compared. API results were read after incubation of 24 and 48 hours while the standard CDC system was read after 48 hours and 14 days when needed. One hundred per cent agreement in identification was found between the two systems in the strains studied. Growth in the presence of actidione was tested by the API strip only and gave unreliable results with nine per cent of the strains tested. The API 20 Clinical Yeast System provides a reliable and rapid approach to yeast identification enabling the clinical laboratory to completely identify a yeast organism in 48 hours instead of the usual four to 14 days. A cost comparison showed the API system to be significantly more economical than the conventional method of identification.

Culture Media↗
PubMed1998

Epidemiology of HIV and AIDS among Asian and Pacific Islander Americans.

As of June 1997 the Centers for Disease Control and Prevention reported 4,370 AIDS cases among Asian and Pacific Islander Americans (APIs) in the U.S. It also reported that the rate of new AIDS cases among APIs men who have sex with men (MSM) per 100,000 population increased by 55% from 1989 (4.0) to 1995 (6.2). Focusing on the relatively low numbers of APIs with AIDS in the U.S. has resulted in complacency among API communities and government officials, despite reports of increased seroprevalence and exponential growth in diagnosed AIDS cases. However, because of the geographic and social isolation of many Asian and Pacific Islander American communities, the effect of HIV is magnified once it takes hold. The low numbers of reported AIDS cases among API and the perception of them as the "model minority" has reinforced their denial of AIDS as a threat. Data collection and surveillance tools must be modified to accurately capture the range of HIV-related and social issues that affect Asian/Pacific Islander communities in the United States. Notwithstanding sample limitations, ethnic-specific data are needed to identify HIV trends in each of the Asian Pacific Islander American communities, which can inform prevention and intervention programs.

Acquired Immunodeficiency Syndrome↗
PubMed1998

HIV seroprevalence, risk behaviors, and cognitive factors among Asian and Pacific Islander American men who have sex with men: a summary and critique of empirical studies and methodological issues.

The goals of this article are to (a) summarize and discuss published empirical studies addressing HIV seroprevalence rates and HIV-related behaviors and cognitive factors among Asian and Pacific Islander American (API) men who have sex with men (MSM) in the United States, (b) examine existing population-based research methodologies for studying HIV and AIDS prevention, (c) describe a conceptual framework to facilitate the identification of ecologically sound or culturally appropriate and competent methodologies for studying HIV prevention among API MSM, and (d) discuss methodological issues and recommend alternative methodologies to better understand this population in HIV prevention. A total of eight published empirical studies reported the HIV seroprevalence rates, HIV-risk behaviors, and attitudes toward HIV and AIDS among API MSM. Specifically, seven studies reported HIV seroprevalence rates that were based on either self-disclosure of HIV status or HIV test results among the study participants. Four studies also reported findings about the relationships between HIV-related behaviors and cognitive factors. There are five population-based databases on HIV and AIDS epidemiology and surveillance which have been managed by the Centers for Disease Control and Prevention. Findings from the seven studies indicate that API MSM are as likely to engage in HIV-risk behaviors as other groups. The present analysis reveals that conventional surveillance or epidemiological techniques (e.g., random digit telephone dialing), based on a singular model of populations, are not appropriate to address culturally, linguistically and racially/ethnically diverse groups of API MSM. To address the diversity of this group, ecologically sound or culturally appropriate and competent research methodologies are needed. Thus, a conceptual framework for such methodologies with examples was reviewed. Two alternative methodologies, network analysis and venue-based sampling, were briefly discussed.

Asian↗
PubMed2001

Inulin as a carrier for contrast agents in magnetic resonance imaging.

Magnetic resonance angiography (MRA) has put forth an impetus for the development of macromolecular GdIII complexes that have a prolonged lifetime in the vascular system. Herein, we report the synthesis and GdIII complexation of a new sugar conjugate based on inulin and the DO3A ligand (DO3A = 1,4,7,10-tetraazacyclododecan-1,4,7-triacetic acid). Two API-DO3ASQ conjugates (API = O-(aminopropyl)inulin, SQ = squaric acid = 3,4-dihydroxy-3-cyclobutene-1,2-dione) with different degrees of substitution (ds = 0.7 and ds = 1.5) were prepared from API by using the diethyl ester of squaric acid as a linking agent for the DO3A chelate. The efficacies of the resulting GdIII compounds were evaluated by investigation of their water 1H longitudinal-relaxation-rate enhancements at variable field (NMRD). A dramatic increase in relaxivity was observed in the more highly substituted conjugate (ds = 1.5); this prompted us to do a variable-temperature (17)O study in order to further characterize the relaxation parameters involved in this system. [Gd(API-DO3ASQ)] shows promising properties for application as a contrast agent for MRI.

Chelating Agents↗
PubMed1992

Arthritis problem indicator: preliminary report on a new tool for use in the primary care setting.

Improving the quality of life for people with rheumatic disease involves timely identification of problem areas and application of appropriate interventions. In response to a 1987 Commonwealth of Pennsylvania study, which reported a wide variety of unmet needs in arthritis patients and their families, the Arthritis Problem Indicator (API) was developed. It is a single-page, self-report, low-cost tool. A mixed rheumatology population (n = 50) and their primary care physicians participated in a pilot study. The study revealed that the seven most common areas of patient concern were pain, weight control, sleep, mobility/walking, activities of daily living, community access, and depression/anxiety. The physicians reported that the patient's answers on the API led them to initiate new treatment or referral for 32% of the patients. The physicians also stated that for 80% of the patients, the API was helpful in providing information about the patient. The API is easily interpreted by health professionals and designed to be an indicator of problem areas frequently associated with arthritis.

Adult↗
PubMed2005

Cancer incidence in the Hmong in California, 1988-2000.

The Hmong represent a unique new Southeast Asian immigrant group to the U.S. Approximately 169,000 Hmong reside in the U.S., primarily in California, Minnesota, and Wisconsin. Previous studies of cancer in this population have indicated that Hmong experience an elevated risk of gastric, hepatic, cervical, and nasopharyngeal cancers and experience a reduced risk of breast, prostate, lung, and colorectal cancers. Approximately 65,000 Hmong live in California, where there has been a population-based cancer registry since 1988, and the authors used these data to calculate age-adjusted cancer incidence rates and to examine disease stage and tumor grade at diagnosis. Changes in rates during the period studied also were evaluated. These rates and proportions were compared with rates among the non-Hispanic white (NHW) and Asian/Pacific Islander (API) populations of California. Between 1988 and 2000, a total of 749 Hmong in California were diagnosed with invasive cancer, and the age-adjusted rate of cancer for the Hmong was 284 per 100,000 population, compared with 362.6 and 478 per 100,000 in the API and NHW populations, respectively. The age-adjusted incidence rates of cancer in the Hmong were elevated for hepatic, gastric, cervical, and nasopharyngeal cancers and for leukemia and non-Hodgkin lymphoma (NHL). Rates were lower in the Hmong for colorectal, lung, breast, and prostate cancers. For gastric cancer and lung cancer, age-adjusted rates increased between 1988 and 2000 in the Hmong, although breast cancer incidence declined. Cervical cancer incidence increased, rates of NHL were declining, and rates for colorectal cancer remained steady between 1988 and 2000. The Hmong experienced later disease stage at diagnosis than other API and generally poorer grade of disease at diagnosis. Hmong experienced lower overall invasive cancer incidence rates than API or NHW populations in California. However, they experienced higher rates of hepatic, gastric, cervical, and nasopharyngeal cancers; and, for most types of cancer, they were diagnosed in a later disease stage.

Age Factors↗
PubMed2006

Particle size limits to meet USP content uniformity criteria for tablets and capsules.

Content uniformity (CU) of pharmaceutical dosage units can be affected by active pharmaceutical ingredient (API) particle size and size distribution. Previous authors have estimated this impact but use of different particle size descriptors led to confusion and difficulty in applying the theoretical models developed. We show that when the same descriptors for particle size and distribution are used (i.e., median diameter on a weight basis (d(50)) and geometric standard deviation (sigma(g))), previously published models are consistent. The approach of Yalkowsky and Bolton4 [Pharm Res 7:962-966, 1990] is modified to use these descriptors and updated for current USP28/NF23 CU criteria. A nomograph is provided to allow easy estimation of an acceptable d(50) for a given dose and sigma(g). To test the model's validity, tablets were manufactured over a wide range of doses and assayed for CU. As predicted, %relative standard deviation (RSD) increased as dose decreased. However, for APIs that deviate significantly from the assumed log-normal distribution, sigma(g) is more appropriately described by the upper region of the API size distribution, presumably because large particles have greatest influence on CU. At very low doses, CU values deviate significantly from normality, consistent with the presence of single large API particles causing super-potent dosage units.

Algorithms↗
PubMed2007

Biowaiver monographs for immediate release solid oral dosage forms: isoniazid.

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing isoniazid as the only active pharmaceutical ingredient (API) are reviewed. Isoniazid's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Isoniazid is "highly soluble" but data on its oral absorption and permeability are inconclusive, suggesting this API to be on the borderline of BCS Class I and III. For a number of excipients, an interaction with the permeability is extreme unlikely, but lactose and other deoxidizing saccharides can form condensation products with isoniazid, which may be less permeable than the free API. A biowaiver is recommended for IR solid oral drug products containing isoniazid as the sole API, provided that the test product meets the WHO requirements for "very rapidly dissolving" and contains only the excipients commonly used in isoniazid products, as listed in this article. Lactose and/or other deoxidizing saccharides containing formulations should be subjected to an in vivo BE study.

Biological Availability↗
PubMed1998

Short-term biomarkers of tumor promotion in mouse skin treated with petroleum middle distillates.

Topical application of certain petroleum middle distillates (PMD) to mice produces skin tumors after long latency, and initiation/promotion protocols indicate that this effect is associated with their tumor promoting activity. Since induction of sustained, potentiated epidermal hyperplasia is predictive of promoting activity, five compositionally distinct PMD [hydrodesulfurized kerosene (API 81-07); hydrodesulfurized PMD (API 81-10); odorless light petroleum hydrocarbons; severely hydrotreated light vacuum distillate (LVD); and lightly refined paraffinic oil (LRPO)] were assessed for their effects on epidermal hyperplasia. PMD were administered (2 x/week for 2 weeks) to skin of CD-1 mice. Four quantitative biomarkers of epidermal hyperplasia were evaluated: epidermal thickness, number of nucleated epidermal cells per unit length of basement membrane, labeling (BrdUrd) index of epidermal cells, and induction of epidermal ornithine decarboxylase (ODC) activity. As positive controls, 12-O-tetradecanoylphorbol-13-acetate (TPA) and n-dodecane were utilized. PMD-induced skin irritation was evaluated visually and/or histopathologically. All five PMD produced dose-dependent, skin irritation and epidermal hyperplasia. On a weight basis the magnitude of the maximal PMD-induced effects was similar to that produced by n-dodecane, but > 1000-fold less than that produced by TPA. Epidermal hyperplasia and subacute skin irritancy produced by the five PMD were similar. Of the four short-term markers of tumor promotion assessed, labeling index and epidermal ODC activity were predictive of the relative promoting activities of those PMD for which tumorigenicity bioassay data are available, i.e., API 81-07 > API 81-10 > LRPO. An apparent discrepancy to the predictability of epidermal ODC activity occurred with LRPO:toluene [1:1 (v/v)]. This mixture is nontumorigenic, yet significantly induced epidermal ODC activity. This mixture, however, produced severe epidermal toxicity that precluded any meaningful analysis of short-term biomarkers in relationship to biological activity.

Administration, Topical↗
PubMed1995

A simple and inexpensive method for the identification of Staphylococcus epidermidis and Staphylococcus hominis.

Eight hundred and ninety-two strains of Staphylococcus species were identified by means of desferrioxamine susceptibility and fermentation results of three carbohydrates, with the API Staph system (bioMérieux, France) as reference method. No identification could be obtained for 34 strains with API Staph. Of the remaining 858 strains, identical identification was obtained with 842 (98.1%). All 707 strains identified as Staphylococcus epidermidis or Staphylococcus hominis by the API Staph system were found to be desferrioxamine susceptible, and all but 5 (3.3%) of 151 strains identified as other staphylococcal species were found to be resistant, yielding an identification correlation of 99.4% for desferrioxamine. The five additional strains which were susceptible to desferrioxamine were identified as Staphylococcus capitis (2 strains), Staphylococcus lugdunensis (2 strains), and Staphylococcus warneri (1 strain) by API Staph, and as Staphylococcus epidermidis (1 strain), Staphylococcus hominis (3 strains), and one other staphylococcal species by the experimental system.

Deferoxamine↗
PubMed1996

Evaluation of the ability of a commercial system to identify Acinetobacter genomic species.

A collection of 130 Acinetobacter strains identified by DNA hybridization to 18 different genomic species was used to assess the ability of the API 20NE system (bioMérieux, France) to identify Acinetobacter genomic species and to determine its accuracy. Fifty-eight (87%) of the 67 strains of genomic species defined in the database (version 5.1) were identified to the appropriate genomic species. The Acinetobacter baumannii strains and the Acinetobacter haemolyticus strains were all identified correctly. Three of five Acinetobacter junii strains, three of eight Acinetobacter johnsonii strains, and 11 of 13 Acinetobacter lwoffii strains were also identified correctly. The 58 correctly identified strains represented 45% of the total 130 strains. Thirty-six of the 72 inappropriately identified strains were designated Acinetobacter baumannii. Thirty-one of these 36 strains belonged to genomic species 1 (Acinetobacter calcoaceticus), 3, or 13TU. Analysis of the profiles showed that the API system does not discriminate between genomic species 1, 2, 3, and 13TU. Lumping of these groups into the Acinetobacter calcoaceticus-Acinetobacter baumannii complex in the API 20NE database would make the system considerably more accurate. Incorporation of these data into the database may improve identification of the remaining genomic species, including some that are not defined. However, the discriminative power of the tests in the API galleries is insufficient for correct identification of all Acinetobacter genomic species.

Acinetobacter↗
PubMedDate not supplied

Biochemical profiles and serotypes of nosocomial Enterobacter cloacae strains in Northern Norway: biochemical identification problems with commercial test systems.

During a period of 2 years, 118 strains of Enterobacter cloacae were collected consecutively in connection with nosocomial infections in Northern Norway; identified by conventional methods and by the API 20E system. The API 20E profile 3305573 predominated and was present in 73 of 118 strains. Among 96 serotyped strains, 73 were serotypable, 20 nontypable and two polyagglutinable. Predominating serotypes were 3 (29 strains), 8 (21 strains) and 23 (nine strains). When the API 20E profiles of the 118 strains were read in the new ATB (automated computer-assisted) 20E data base system, 97 of 118 (82.2%) strains were identified as E. cloacae. The 118 strains were tested in the new ATB Rapid ID 32E and ATB ID 32E (ATB system, bioMérieux, France) systems. Only 69 of 118 (58.5%) strains were identified as E. cloacae in both systems. The ATB Rapid ID 32E identified 97 of 118 strains (82.2%), and the ATB ID 32E only 80 of 118 strains (67.8%). Among 73 serotypable strains, the ATB Rapid ID 32E identified 79.5% as E. cloacae, while the ATB ID 32E identified only 64.4%. Among 40 serotypable strains with API 20E profile 3305573, all 40 were identified as E. cloacae by the ATB Rapid ID 32E, while only 27 (67.5%) by the ATB ID 32E system. Further improvements may increase the value of biochemical identification of E. cloacae in diagnostic work.

Bacterial Typing Techniques↗
PubMed1990

Non-invasive assessment of the steal phenomenon following femoro-femoral bypass.

Clinical studies were performed on 42 patients who underwent femoro-femoral bypass and postoperative assessment of the ankle/brachial pressure index (API) and Doppler waveform for each limb was carried out. Patients who had poor runoff of the donor limb showed a significant decrease in API after ankle joint exercise (p less than 0.05), whereas no significant change was observed in patients who had poor runoff of the recipient limb. The response of pulsatility index was similar to that of API. Thirteen of the 42 patients underwent both pre- and postoperative assessments. Six of these patients underwent additional procedures such as thromboendarterectomy or profundaplasty on the anastomotic site of the donor limb, and the other 7 patients had no additional procedures performed. A decrease in API after exercise was prominent in the patients who had not undergone any additional procedures, in the postoperative stage (p less than 0.01). Thus, when performing femoro-femoral bypass, improving poor runoff in the donor limb by carrying out intraoperative additional procedures should be taken into consideration, as any imbalance of peripheral resistance must be kept to an absolute minimum.

Ankle↗
PubMed2005

Heat-balling wasps by honeybees.

Defensiveness of honeybee colonies of Apis cerana and Apis mellifera (actively balling the wasps but reduction of foraging) against predatory wasps, Vespa velutina, and false wasps was assessed. There were significantly more worker bees in balls of the former than latter. Core temperatures in a ball around a live wasp of A. cerana were significantly higher than those of A. mellifera, and also significantly more when exposed to false wasps. Core temperatures of bee balls exposed to false wasps were significantly lower than those exposed to V. velutina for both A. cerana and for A. mellifera. The lethal thermal limits for V. velutina, A. cerana and A. mellifera were significantly different, so that both species of honeybees have a thermal safety factor in heat-killing such wasp predators. During wasps attacks at the hives measured at 3, 6 and 12 min, the numbers of Apis cerana cerana and Apis cerana indica bees continuing to forage were significantly reduced with increased wasp attack time. Tropical lowland A. c. indica reduced foraging rates significantly more than the highland A. c. cerana bees; but, there was no significant effect on foraging by A. mellifera. The latency to recovery of honeybee foraging was significantly greater the longer the duration of wasp attacks. The results show remarkable thermal fine-tuning in a co-evolving predator-prey relationship.

Animals↗
PubMed2001

Physiological Diversity of Rhizoplane Diazotrophs of the Saltmeadow Cordgrass, Spartina patens: Implications for Host Specific Ecotypes.

Diazotrophic bacteria are important contributors to salt marsh productivity, but the biotic and abiotic factors that influence their distributions and function and the extent of their diversity cannot be understood in the absence of physiological information. Here we examine the physiological diversity and distribution patterns of diazotrophic bacteria associated with the rhizoplane of the saltmeadow cordgrass, Spartina patens, in comparison with diazotrophs from other intertidal grasses (tall and short form Spartina alterniflora and Juncus roemerianus) from the same salt marsh. S. patens plants were collected from two distinct habitats, and a total of 115 strains (111 Gram negative and 4 Gram positive strains) were isolated into pure culture by stab inoculating roots and rhizomes into combined nitrogen-free semisolid media. Most strains were microaerophilic and approximately one-half were motile. API test strips were used to eliminate redundancy within the culture collection, resulting in 21 physiologically different API groups (17 Gram negative and 4 Gram positive groups). A representative strain from each API group was selected for dot blot hybridization with a nifH specific probe and 16 strains (13 Gram negative and 3 Gram positive) were scored as positive. The nifH positive API group representative strains were characterized further using BIOLOG test plates. Substrate utilization potentials defined two S. patens strain clusters, and only one S. patens strain was physiologically similar to any other strain from a different host plant origin. No distinctions could be made based on the different S. patens habitats, suggesting that the host plant may have a greater impact than abiotic environmental conditions on the distributions of the rhizoplane diazotrophs recovered.

Journal Article↗
PubMed1998

Comparative evaluation of a commercial system for identification of gram-positive cocci.

The performance of a new commercial system for the identification of different groups of gram-positive cocci [BBL Crystal Gram-Positive (GP) Identification System; Becton Dickinson Microbiology Systems, Germany] was evaluated in comparison with two currently used commercial systems, the API Staph and the API Strep (bioMérieux Diagnostic, Germany). A total of 191 strains from seven different gram-positive genera comprising 32 different species were tested. For the BBL Crystal GP system, the correct identification rate without additional tests was 89.5% at the species level and 97.9% at the genus level. The findings suggest that the newly introduced BBL Crystal GP ID system provides an accurate method for the identification of gram-positive cocci, with an overall rate of correct species identification of about 90%, similar to that of the established API systems. Its major advantage is the extended spectrum of taxa included in a single test panel in contrast to the two different API test kits. Furthermore, the simplicity of use and the safe and rapid handling in a closed system conveniently accommodate existing laboratory workflow.

Bacteriological Techniques↗
PubMed2005

Gastric adenocarcinoma among Hmong in California, USA, 1988-2000.

BACKGROUND: This study examined gastric adenocarcinoma incidence, mortality, and tumor characteristics in the Hmong population of California, 1988-2000. Many Hmong relocated to the United States at the conclusion of the Vietnam War. Resettlement difficulties encountered by Hmong have included socioeconomic and healthcare issues. Hmong are wary of Western medicine and would resort to it as the last option, which may delay the diagnosis and treatment of diseases such as cancer. METHODS: Data from the California Cancer Registry were used to calculate incidence and mortality rates for Hmong, and were compared to these in Asian Pacific Islanders (API) and non-Hispanic whites (NHW). The population at risk was estimated through linear interpolation, using data from the 1990 and 2000 decennial censuses. RESULTS: Hmong experienced incidence and mortality rates of gastric adenocarcinoma several times higher than those of API and NHW. More than 97% of Hmong patients chose no treatment, compared to only 25.6% of API and 30.3% of NHW patients. Hmong were more likely to be diagnosed with cancer at later stages but at better histologic grades than API and NHW. CONCLUSIONS: Further investigations into Helicobacter pylori, Epstein-Barr virus, acid reflux, and dietary practices of Hmong living in the United States are needed before any firm conclusion can be made, as these risk factors may impact gastric cancer development. Hmong should also be encouraged to use traditional and Western medicines simultaneously, provided that traditional healthcare practices do not interfere with biomedicines.

Adenocarcinoma↗