Biomedical subjects

M B Bear

Publications and source records attributed to M B Bear.

13 recordsLinked to original sources

PubMed2004

A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate.

OBJECTIVE: To assess the efficacy and safety of 100 mg daily anakinra (Kineret), a recombinant form of the naturally occurring interleukin 1 receptor antagonist, plus methotrexate (MTX) in reducing the signs and symptoms of rheumatoid arthritis (RA). METHODS: Patients with active RA (n = 506) despite current treatment with MTX were enrolled in this multicentre, double blind, randomised, placebo controlled study. Patients received subcutaneous injections of anakinra 100 mg/day or placebo. They were assessed monthly for 6 months for improvement in signs and symptoms of RA and for adverse events. The primary efficacy measure was the percentage of patients attaining ACR20 response at week 24. RESULTS: Significantly greater proportions of patients treated with anakinra compared with placebo achieved ACR20 (38% v 22%; p<0.001), ACR50 (17% v 8%; p<0.01), and ACR70 (6% v 2%; p<0.05) responses. The response to anakinra was rapid; the proportion of patients with an ACR20 response at the first study assessment (4 weeks) was twice as high with anakinra as with placebo (p<0.005). Clinically meaningful and statistically significant responses were also seen in individual components of the ACR response (for example, Health Assessment Questionnaire, pain, C reactive protein levels, and erythrocyte sedimentation rate). Anakinra was well tolerated, with a safety profile, similar to that of placebo with one exception: mild to moderate injection site reactions were more common with anakinra than with placebo (65% v 24%). CONCLUSIONS: This study confirms previous observations from a dose-ranging study showing that anakinra, in combination with MTX, is an effective and safe treatment for patients with RA who have inadequate responses to MTX alone.

Antirheumatic Agents↗

PubMed1997

Phase 1 safety trial of Filgrastim (r-metHuG-CSF) in non-neutropenic patients with severe community-acquired pneumonia.

The objectives of the present study were to: (1) evaluate the safety of Filgrastim therapy in non-neutropenic patients with severe community-acquired pneumonia; (2) determine the absolute neutrophil count (ANC) response to various dosages of Filgrastim in non-neutropenic patients with active infection; and (3) describe the impact of therapy with Filgrastim in combination with antibiotics on selected pneumonia-related clinical parameters. The study design was an open-label, dose-ranging, clinical trial, set in the General Clinical Research Unit of a large, public community hospital. The study population consisted of 30 patients who had presented to the Emergency Department with severe, community-acquired pneumonia. One of five dosages (75, 150, 300, 450 or 600 micrograms day-1) of Filgrastim (r-metHuG-CSF) was given subcutaneously daily for 10 days, until discharge or until the absolute neutrophil count > 75 x 10(9) l(-1), whichever was earlier. Vital signs, pulse oximetry, arterial blood gases, daily complete blood counts with differential, serum chemistries, coagulation profiles, electrocardiograms, chest radiographs, plasma G-CSF concentrations and duration of hospitalization were measured. There was no evidence of Filgrastim-related lung injury or evidence of extra-pulmonary toxicity. There was no apparent dose-response effect of Filgrastim on pneumonia-related clinical variables. Dosages of Filgrastim between 150 and 600 micrograms day-1 had similar effects on increasing the ANC. Filgrastim appeared to be safe in non-neutropenic patients with severe, community-acquired pneumonia when given in dosages of 75-600 micrograms day-1 in combination with appropriate antibiotic therapy. Further study is needed to determine the effect of Filgrastim on morbidity, mortality and duration of symptoms in this patient population.

Adult↗

PubMed1996

Time to resolution of morbidity: an endpoint for assessing the clinical cure of community-acquired pneumonia.

Clinical trials of new therapeutics for community-acquired pneumonia (CAP) have typically used a subjective endpoint of clinical response. However, as this endpoint is not quantitative, it is subject to observer bias and renders the conduct of multicenter trials difficult. For the purposes of conducting a clinical trial of filgrastim, as an adjunct to antibiotics for the treatment of CAP, a set of clinical criteria were developed prospectively to determine the time when a clinical cure was achieved, based on respiratory rate, temperature, oxygenation and roentgenographic findings, which was termed the time to resolution of morbidity (TRM). The TRM was evaluated on the first 100 patients entered in this clinical trial. As no clear reference standard exists, the predictive value for the duration of parenteral antibiotics (AB) and the length of hospital stay (LOS) was compared with that provided by a widely used classification system for severity of disease, APACHE II. The TRM was found to correlate significantly better with AB or LOS than APACHE II (P < 0.001). Furthermore, TRM offers the benefit over the endpoints of LOS and AB of being specifically designed to measure the patient's response to therapy, and, in fact, may aid physicians in determining the duration of parenteral antibiotic therapy. Hence, TRM is relevant to the clinician and is a useful tool to ensure uniformity in the assessment of the response to a new therapeutic in a multicenter clinical trial.

Adult↗

PubMed1994

The West Los Angeles Preterm Birth Prevention Project. I. Program impact on high-risk women.

OBJECTIVE: The primary objective of this prospective study was to test whether preterm birth prevention education plus increased clinic visits and selected prophylactic interventions reduce preterm birth. STUDY DESIGN: Eight West Los Angeles prenatal county clinics, comparable with respect to selected demographics, were randomized to be either experimental or control clinics. High-risk patients in all clinics were identified with a risk scoring system derived from a similar population. High-risk patients (N = 1774) in experimental clinics were offered a program of education and more frequent visits and were randomized to receive various secondary intervention protocols in addition to the basic interventions of education and more frequent visits. Control clinic patients (N = 880) received standard county care. RESULTS: Preterm birth rates were 19% lower among the experimental high-risk patients (7.4% vs 9.1%), and differences were significant (p < 0.05) when preterm risk was taken into account. There was no evidence to suggest that the secondary interventions provided added benefit over the primary intervention protocol of preterm birth prevention education and increased visits. CONCLUSION: The 19% reduction in preterm birth rate observed in the experimental clinics suggest an overall program benefit from a protocol that offered education, more frequent visits, and greater attention given to patients while the selected interventions were applied.

Adult↗

PubMed1993

Fetal echocardiography: factors that influence imaging of the fetal heart during the second trimester of pregnancy.

OBJECTIVE: The four-chamber view of the heart is an important component of the ultrasonographic examination of the fetus. However, during the second trimester of pregnancy the fetal heart cannot always be imaged in every patient. The purpose of this study was to ascertain the rate of successful imaging of the fetal heart during the second trimester and to determine factors that may influence imaging. METHODS: Seven hundred and nine second trimester fetuses were examined and an attempt was made to obtain the four-chamber and outflow tract views of the heart. Analysis included multiple logistic regression models of the main effects and interactions of ten candidate variables. RESULTS: The four chambers and outflow tracts were imaged in 643 fetuses (90.7%) and not imaged in 66 (9.3%). Fifty-two of 709 patients (7.3%) had had previous surgery. In the 52 patients with a history of previous surgery, the heart could not be imaged in 18 (34%). Six hundred and fifty-seven patients (92.7%) did not have previous surgery. Of this group, the fetal heart could not be imaged in 48 (7.3%). In only one fetus in which the heart could not be imaged was it because of fetal position. Three independent risk factors that influenced imaging of the fetal heart were gestational age, maternal adipose tissue thickness, and previous lower abdominal surgery. Increasing gestational age increased the probability of imaging the heart, whereas increasing adipose tissue thickness and a history of previous surgery decreased the probability of imaging the heart. COMMENTS: When the fetal heart cannot be imaged during the second trimester, these factors should be identified. Using data from this study, the gestational age at which the highest probability of imaging the heart can be determined if the thickness of the adipose tissue and a history of lower abdominal surgery are known.

Abdomen↗

PubMed1992

Nonstress test assessment of twins.

Twin pregnancies have higher perinatal morbidity and mortality rates than singleton pregnancies. Researchers have demonstrated that one major benefit of prenatal care in the twin gestation is reduced fetal death rate. This study to determine the relationship of nonstress tests (NSTs) to pregnancy outcome in twin gestations comprised 665 women who delivered at Los Angeles County-University of Southern California Women's Hospital from January 1985 to January 1989. These patients, all of whom had prenatal care (PNC), were subdivided into two groups: (1) PNC and NSTs and (2) PNC and no NSTs. The groups did not differ statistically with regard to gravidity, parity and abortions. NSTs were selectively done on twin gestations complicated by discordancy or other fetal/maternal complications. Ten pregnancies were complicated by fetal demise of one or both twins in patients who received prenatal care without NSTs. Among the NST group there was one fetal demise. Although the NST group had fewer fetal deaths, the reduction was not statistically significant (P = .062). Infant birth weight was identified as a confounder because the NST group had a statistically higher mean birth weight. Definitive proof of the ability of NSTs to reduce the fetal death rate in twin gestations complicated by discordancy or other pregnancy complications awaits a large, prospective, randomized trial.

Female↗

PubMed1990

Ultrasonographic estimation of fetal weight in the clinically macrosomic fetus.

The purpose of this study is to evaluate models for the prediction of birth weight in fetuses suspected of being macrosomic. A total of 141 patients with standard measurements of the head, abdomen, and femur were studied. Linear regressions were performed with single parameters, squares, and all possible cross products in the generation of models with log (birth weight) and birth weight as dependent variables. These models were then compared with a group of previously published equations. Clinically, all models performed poorly. However, two models were significantly less accurate in the prediction of birth weight (p less than or equal to 0.05). The best results were obtained by equations that used abdominal circumference and femur length measurements. There was no improvement in models that contained log (birth weight) or birth weight as dependent variables or models with complex variables such as squares or cross products of measured parameters. In conclusion, when evaluating patients at risk of macrosomia, the best estimates of fetal weight can be obtained by models that contain abdominal circumference and femur length.

Body Weight↗

PubMed1989

Barriers to screening for cancer of the cervix.

Despite the widespread availability and demonstrated efficacy of screening with the Papanicolaou smear, many women are screened irregularly or not at all. This study was designed to identify the barriers that prevent those women at risk for cervical cancer from being screened. Complete cervical cytology screening histories were taken during a population-based case-control study of invasive squamous cell carcinoma of the cervix involving 200 patients and their matched neighborhood controls. Smears taken during the previous 5 years were verified whenever possible. Ordinal logistic regression analysis was used to identify seven factors that significantly (P less than 0.05) and independently predicted regular recent screening among both cases and controls [failure to understand the importance and screening nature of cervical smears (-), expressed fears of embarrassment (-), having had a urogenital infection (+), number of pregnancies during the last 5 years (+), the number of pregnancies for which no prenatal care was sought (-), and knowledge of the recommended screening interval (+)], two variables that predicted screening among cases but not controls [age (-) and number of years of oral contraceptives use (+)], and one that predicted screening only among controls [years of living in the United States (+)]. Education, income, Latin heritage, being married, having a regular physician for one's medical care, and all other methods of birth control were significant predictors of screening in the univariate analyses, but were explained by the other more powerful predictors in the multivariate analysis.

Adult↗

PubMed1988

Studies of IgG, IgM and IgA antiphospholipid antibody isotypes in systemic lupus erythematosus.

We evaluated the clinical relevance of 6 antiphospholipid antibodies including cardiolipin and their IgG, IgM and IgA isotypes in 92 patients with systemic lupus erythematosus (SLE). Antiphospholipid antibodies generally had significant associations with thrombocytopenia and a history of false-positive syphilis serologies. In 4 of 6 antiphospholipid antibodies, an inverse association with renal disease was observed. Antiphospholipid antibodies may moderate or protect against renal disease, or this may reflect the high doses of corticosteroids and cytotoxic drugs received by this group. Further studies are needed to determine how many antibody families cause these activities and to elucidate whether certain SLE subgroups possess differing specificities for each of the phospholipids.

Adolescent↗

PubMed1987

Fetal head and abdominal circumferences: ellipse calculations versus planimetry.

One hundred twenty-two images of fetal heads and abdomens were obtained by ultrasound. The head and abdominal circumferences and their ratios were determined by planimetry and by the ellipse method utilizing four different equations. The accuracy of these equations was assessed by regressing the circumferences and ratios obtained by the equations against those measured by planimetry. All equations were found to be equally accurate in calculating head and abdominal circumferences and the head-to-abdomen circumference ratio. Compared to planimetry, the ellipse method is more accurate in calculating circumferences than when calculating their ratio.

Abdomen↗

PubMed1987

Fetal head and abdominal circumferences: effect of profile shape on the accuracy of ellipse equations.

Images of 122 fetal heads and abdomens were obtained with ultrasound for the determination of head and abdominal circumferences. The profile shapes were characterized by the cephalic or abdominal index (D1/D2 x 100), D1 and D2 being the shortest and longest diameters of either the head or abdomen. The mean of the cephalic index was 79.1% +/- 5.2%, and that of the abdominal index was 89.1% +/- 7.0%. All equations were equally accurate in calculating head and abdominal circumferences regardless of the profile shape. Therefore, the simplest equation, (D1 + D2) x 1.57, should be utilized when calculating circumferences except in situations of extreme dolichocephaly.

Abdomen↗

PubMed1987

Chorionic villus sampling is associated with normal fetal growth.

Seventy-eight singleton term neonates, delivered of women who were 35 years of age or older after chorionic villus sampling at 9 to 11 weeks' gestation, were compared with 1335 singleton control neonates delivered at term of mothers 35 years of age or older before the clinical application of chorionic villus sampling at our institution. No statistically significant differences were found in birth weight, crown-heel length, or ponderal index between control neonates and neonates delivered after chorionic villus sampling. The sample sizes necessary to detect a 5% difference in population means at an alpha error level of 0.05 and beta error level of 0.1 were calculated for the measured variables and achieved before analysis. This study suggests that patients undergoing chorionic villus sampling are not at increased risk for the development of decreased fetal growth or intrauterine growth retardation.

Adult↗

PubMed1986

A simplified risk-scoring system for prematurity.

Prematurity, the major cause of perinatal morbidity and mortality, results from a multifactorial interaction of medical, historic, and psychosocial conditions. Although the literature contains several reports of prematurity risk-scoring systems, the relative importance of specific risk factors may depend on the population studied. This report represents the first prematurity risk-scoring system designed specifically for a predominantly Hispanic population in the United States. Retrospective analysis of 8240 births occurring at Harbor/UCLA Medical Center from July, 1979 to December, 1982 identified maternal prenatal risk factors that were found to be statistically related to prematurity. A linear logistic regression model was then employed to derive a composite risk score. Using the logistic risk scores, we developed a simplified model for identifying women at risk for preterm birth. The methodology and analyses provide a system for the development of population-specific risk scoring.

Analysis of Variance↗