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PubMed1992

A comparison of imipenem to ceftazidime with or without amikacin as empiric therapy in febrile neutropenic patients.

BACKGROUND: Neutropenic patients with cancer are traditionally treated with empiric antibiotic combinations when they become febrile. The availability of broad-spectrum antibiotics such as ceftazidime and imipenem has made it possible to initiate therapy with a single agent (monotherapy). The objectives of this trial were to compare ceftazidime and imipenem as single agents for the therapy of febrile episodes in neutropenic patients and to ascertain whether the addition of an aminoglycoside (amikacin) to either of these agents would provide an advantage. METHODS: A prospective clinical trial was conducted in which eligible neutropenic patients with cancer were randomized to one of four treatment arms: ceftazidime alone; imipenem alone; ceftazidime plus amikacin; and imipenem plus amikacin. Efficacy analysis was done for 750 assessable episodes. A multivariate logistic-regression analysis was also performed to examine the unique contribution of various prognostic factors. RESULTS: The overall response rates were 76% with imipenem plus amikacin, 72% with imipenem, 71% with ceftazidime plus amikacin, and 59% with ceftazidime alone. Single-organism gram-positive infections occurred in 101 of 750 episodes. Without a change in antibiotics, the response rates were 50% with imipenem, 40% with imipenem plus amikacin, 39% with ceftazidime plus amikacin, and 38% with ceftazidime. Most responded to vancomycin or other antibiotics, and the mortality associated with gram-positive infections was only 5%. Regardless of the antibiotic regimen, the majority of uncomplicated gram-negative infections responded to therapy and the majority of complicated gram-negative infections failed to respond. Multivariate logistic-regression analysis showed that recovery of the neutrophil count was the most favorable prognostic factor in a patient's response to infection, whereas the presence of gram-positive infection, acute leukemia, pulmonary or enteric infection, and therapy with ceftazidime were unfavorable factors. CONCLUSIONS: Single-agent therapy with imipenem is as effective as more conventional combination antibiotic therapy for the empirical treatment of febrile episodes in neutropenic patients with cancer.

Adolescent↗
PubMed1992

Dose related acute irritant symptom responses to occupational exposure to sodium borate dusts.

A repeated measurement design was employed in the study of acute symptoms of eye and respiratory tract irritation resulting from occupational exposure to sodium borate dusts. The symptom assessment of the 79 exposed and 27 unexposed subjects comprised interviews before the shift began and then at regular hourly intervals for the next six hours of the shift, four days in a row. Exposures were monitored concurrently with a personal real time aerosol monitor. Two different exposure profiles, a daily average and short term (15 minute) average, were used in the analysis. Exposure-response relations were evaluated by linking incidence rates for each symptom with categories of exposure. Acute incidence rates for nasal, eye, and throat irritation, and coughing and breathlessness were found to be associated with increased exposure levels of both exposure indices. Steeper exposure-response slopes were seen when short term exposure concentrations were used. Results from multivariate logistic regression analysis suggest that current smokers tended to be less sensitive to the exposure to airborne sodium borate dust. There was no indication that anhydrous sodium borate was more potent than the other sodium borates in this work environment.

Adult↗
PubMed1988

HLA-DR2, a marker for class I antigen sensitization.

After analysis of 423 hemodialysis patients in a transfusion program and 461 cadaver-donor renal transplants, we found that HLA-DR2 frequency was significantly higher in the responder (36%) than in the nonresponder patient group (19%), according to the percentage of PRA (panel reactive antibodies). Among DR2+ patients, the percentage of hypersensitized patients was twice that of DR2- patients. Graft survival curves in cadaver-donor renal transplants indicated a significantly lower survival when recipients were DR2+, even in recipient-donor pairs identical for class II antigens but mismatched for class I antigens. The prognostic probability of low response to transfusions by a stepwise logistic regression analysis showed the influence of sex and DR2 phenotype. By multivariant discriminant analysis, we found that the DR2 phenotype was one of the most influential transfusion sensitization risk factors. Our preliminary conclusion is that DR2 can be related to immune responsiveness to class I antigens.

Antilymphocyte Serum↗
PubMed1988

Acute promyelocytic leukemia. Therapy results and prognostic factors.

From December 1976 to July 1986, 34 patients with acute promyelocytic leukemia (APL) were treated with daunorubicin (DNR) alone and simultaneous supportive therapy with low-dose heparin, platelet transfusions, and fresh frozen plasma. Two consecutive maintenance therapy regimens were employed in patients who achieved complete remission (CR): (1) a classical maintenance with methotrexate and 6-mercaptopurine, with DNR plus methyl-GAG re-inductions; (2) from 1982 an intensive sequential combination therapy regimen was administered. CR was achieved in 23 patients (68%). Only one patient had leukemic resistance. Other failures were a consequence of post-chemotherapy complications. A multivariate logistic regression analysis has been performed to evaluate the prognostic importance on response to remission induction of 25 patient and disease characteristics at diagnosis. The significant variables in decreasing order of significance were: serum albumin level, fever at diagnosis, serum creatinine level, and age. The median duration of remission and survival by Kaplan-Meier analysis were projected to be 24 and 25 months, respectively. Relapses occurred in 11 of 23 CR patients. Nine patients remained in the first remission from 5+ to 37+ months. Short-term (CR) and long-term results (duration of remission and survival) in APL treated for induction with DNR alone were similar to those obtained in other subtypes of acute myeloblastic leukemia by intensive combination chemotherapy.

Adolescent↗
PubMed1985

Prognostic value of B-cell mitogen-induced and spontaneous thymidine uptake in vitro in chronic B-lymphocytic leukaemia cells.

Blood lymphocytes from 50 patients with chronic B-lymphocytic leukaemia (B-CLL) were cultured in vitro with and without the polyclonal B-cell activators (PBA) dextran sulphate (DxS), lipopolysaccharide from E. coli (LPS), and Epstein Barr virus (EBV). Patients with blood lymphocytes that showed a high spontaneous or PBA-induced 3H-thymidine uptake in 4 d cultures had a significantly shorter therapy-free survival than patients whose lymphocytes showed a low thymidine uptake. The DxS-induced cellular thymidine uptake was the most powerful predictor of prognosis. Eighteen patients with leukaemic cells responding to DxS stimulation had a median therapy-free survival of 17 months and a probability of 5 year therapy-free survival of less than 0.1, whereas for 30 patients with DxS unresponsive cells the corresponding figures were greater than 120 months and greater than 0.7, respectively (log rank, P less than 0.0001). A multivariate Cox's regression analysis revealed that the DxS-induced leukaemic cell response was of greater prognostic importance than clinical features such as blood counts and staging according to Rai and Binet. Therefore PBA-induced leukaemic cell thymidine uptake seems valuable in the prediction of prognosis in B-CLL.

Adult↗
PubMedDate not supplied

Factors influencing the effectiveness of mailed health surveys.

The authors investigated sources of bias in health surveys by examining responses to their 1989 questionnaire mailed to 1,255 Massachusetts men who were eligible for dental care provided by the Department of Veterans Affairs. After a maximum of three mailings and one telephone call to nonrespondents, a total of 1,049 veterans had responded out of 1,228 finally determined to be eligible, a response rate of 85 percent. The investigators found that small differences in univariate estimates would have occurred had the field phase been terminated after the first mailing, which had a response rate of 61 percent. To evaluate multivariate distributions, they duplicated their previously published logistic regression model for sources of dental care, using only those who responded to the first and second mailings. Although model fits would have been substantively the same had the field phase been terminated after the first or the second mailings, analysis of parameter estimates and their statistical significances suggested bias that would have led to different substantive conclusions, in some instances. Another potential source of bias in surveys was found to be item omission. Fifty-eight percent of respondents answered all 46 survey questions, and 90 percent answered at least 91 percent of the questions. Fewer questions were answered by those whose responses were received last, but trends regarding missing data by age or education were not statistically significant. Although the survey using this methodology met all objectives, subject nonresponses, the ineligibility of potential respondents, item nonresponses, and skewed distributions of outcome variables combined to reduce the statistical power to detect differences among groups or to alter the analysis of the differences. These factors need to be planned for by investigators undertaking similar surveys.

Analysis of Variance↗
PubMed1989

Predicting local recurrence of carcinoma of the rectum after preoperative radiotherapy and surgery.

A prospective study of prognostic factors has been carried out in a group of 186 patients with tethered rectal carcinomas. Of these, 97 were randomized to surgery alone and 89 to receive preoperative radiotherapy (20 Gy in four fractions). DNA ploidy was determined by flow cytometry. DNA aneuploidy was detected in 60 patients (62 per cent) in the surgery only group, but in only 33 patients (37 per cent) after radiotherapy (P less than 0.01). There was a significant reduction in local recurrence in irradiated patients (P less than 0.0001). DNA diploid tumours were less likely to recur locally. This was more marked in the radiotherapy group (P = 0.01) than in the surgery only group (P = 0.06). After radiotherapy, only the surgeons' assessments of a 'curative' resection and DNA ploidy were independent predictors of local recurrence in multivariate regression analysis, whilst Dukes' classification was not. In conclusion, DNA ploidy may indicate response to radiotherapy and is an important predictor of subsequent local tumour progression.

Combined Modality Therapy↗
PubMed1975

A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival.

The presenting clinical features of 71 patients with multiple myeloma were correlated with myeloma cell mass (myeloma cells X 10(12)/m2 of body surface area) determined from measurements of monoclonal immunoglobulin (M-component) synthesis and metabolism. Bivariate correlation and multivariate regression analyses showed that myeloma cell mass could be accurately predicted from A) extent of bone lesions, B) hemoglobin level, C) serum calcium level, and D) M-component levels in serum and urine. Analyses of response to chemotherapy and survival indicated significant correlation with measured myeloma cell burden. The results were synthesized to produce a very reliable and useful clinical staging system with three tumor cell mass levels (Table 7). For clinical research purposes, multivariate regression equations were developed to predict optimally the exact myeloma cell mass. Thus, initial staging can be quantitatively related to followup using tumor cell mass changes calculated from changes in M-component production. Use of the clinical staging system sould provide better initial assessment and followup of individual patients, and should lead to improved study design and analysis in large clinical trials of therapy for multiple myeloma.

Adult↗
PubMed1992

A multivariate analysis of weight-loss behavior.

This study used a theoretical framework with multiple variables in multivariate analyses (factor, multiple regression, and path analyses) to investigate the sociopsychological predictors of weight loss. Responses from 309 participants of a comprehensive weight-loss program indicated that self-assurance was the most significant predictor of actual weight loss, followed by weeks completed. Other factors, such as program satisfaction and perceived importance, indirectly predicted weight loss through the intervening variables of self-assurance and weeks completed. Differences in the factors predicting weight loss were observed between completers and dropouts. The implications of these results for professionals concerned with weight control are discussed.

Adult↗
PubMed1991

Increased incidence of diabetes mellitus in relation to abdominal adiposity in older women.

The relationship between body fat distribution, measured by the ratio of waist-to-hip circumferences (WHR), and the 2 year incidence of diabetes mellitus was examined in a cohort of 41,837 women aged 55-69 years. The 399 women who reported the new onset of diabetes had a significantly greater mean body mass index (kg/m2) and WHR than non-cases. After adjustment for body mass index (BMI), age and education level using multivariate logistic regression, WHR was a significant independent predictor of diabetes in a dose-response fashion. Cases were 4.6 times (95% CI = 3.8, 5.6) more likely than non-cases to be in the upper tertile of WHR and 2.2 times (95% CI = 1.8, 2.7) more likely to be in the middle tertile. Women in the highest tertiles of both WHR and BMI had a 14.4-fold (95% CI = 9.5, 21.9) higher risk of diabetes than women in the lowest tertiles. These results demonstrate that increased abdominal adiposity is a significant independent risk factor for the development of diabetes mellitus in older women.

Aged↗
PubMed1975

[MASCA-model of the biochemical-pharmacological drug research. Part 3: Structure-activity relationships and KANORA (author's transl)].

The KANORA (multivariate regression and correlation analysis) leads to a combination with the multivariate structure-activity analysis which encloses the time-, dose-response and biological screening analysis. Drug-receptor interactions can be considered in connection with structure-action relationship. The importance of the analysis of "nonsense"-correlations (by using the partial correlation) and the model II of regression analysis is demonstrated.

Dose-Response Relationship, Drug↗
PubMed1991

[Left ventricular filling studied by echo-Doppler in hypertensive and normotensive subjects].

Purpose of the study was to evaluate the influence of different clinical and echocardiographic parameters on left ventricular diastolic filling in a group of 66 mild to moderate hypertensive subjects (mean age = 45.9 +/- 13.9 yrs) and in 49 normotensive controls (mean age = 44.2 +/- 15.9 yrs). All subjects underwent an echocardiographic study with pulsed Doppler evaluation of left ventricular filling. In the hypertensives, a noninvasive 24-hour blood pressure monitoring was performed. The ratio of early to atrial peak diastolic filling velocity (VmaxE/VmaxA) and the ratio between the respective velocity flow integral (Earea/Aarea) were significantly lower in the hypertensives compared to the normotensives (p less than 0.001). As within the hypertensives, office systolic blood pressure, average 24-hour mean blood pressure (24MBP), left atrial dimensions, and left ventricular mass index (MAXIND) were related both to age and diastolic filling. To study the relation between these parameters and diastolic filling a partial correlation test was used. The only variable related to diastolic filling, independently of age, was 24MBP (VmaxE/VmaxA vs 24MBP: r = -0.307, p less than 0.05, Earea/Aarea vs 24MBP: r = -0.261, p less than 0.05). Linear multivariate analysis using the method of stepwise regression established that age, 24MBP and heart rate were responsible for 75% of the VmaxE/VmaxA variance in the hypertensive group. To evaluate if the difference between the indexes of diastolic filling in the normotensives and the hypertensives varied according to age, we divided each group into two classes of subjects older and younger than 40 yrs. Under the age of 40 only VmaxE/VmaxA was significantly different in the two groups (p less than 0.05), while in the subjects older than 40 yrs both VmaxE/VmaxA and Earea/Aarea differed to a great level of statistical significance (p less than 0.001). The results of the present study allow the following conclusions: 1) age has the greatest influence on diastolic filling in both hypertensive and normotensive individuals. Diastolic filling is impaired in mild to moderate hypertension, when systolic function is still normal; 2) the worsening of diastolic filling determined by hypertension is more evident in the subjects greater than 40 yrs; 3) the only clinical variable that influences diastolic filling, independently of age, is 24MBP, while office blood pressure, MAXIND and left ventricular ejection fraction do not seem to be related to this clinical entity.

Adolescent↗
PubMed1992

Quantitative correlation of mutagenic and carcinogenic potencies for heterocyclic amines from cooked foods and additional aromatic amines.

Aromatic amines have long been recognized as animal and human carcinogens. Recently heterocyclic aromatic amines (thermic amines) have been found in small amounts in cooked foods, primarily meats, and have proven to be potent mutagens and rodent carcinogens. Availability of quantitative databases for mutagenic potency in Salmonella and for carcinogenic potency in rodents has made possible a study of ten heterocyclic thermic amines and 24 aromatic amines. Potencies on mutagenic and carcinogenic scales were significantly correlated. By multiple linear regression analysis and multivariate analysis of variance, two descriptive structural factors were found to modulate the two modes of biological response. These factors were number of rings and methyl substitution at carbon atoms. The quantitative correlation between mutagenic and carcinogenic potencies and the modulating structural factors suggest a significant similarity of molecular mechanisms and support the utility of the short-term bacterial assay in evaluating hazard levels.

Amines↗
PubMed1991

The influence of preoperative patient characteristics on early and late survival following cardiac transplantation.

In an attempt to identify the preoperative factors that influence survival following cardiac transplantation, we retrospectively analyzed multiple demographic, clinical, and hemodynamic data of 301 consecutive patients who underwent cardiac transplantation between December 1980 and July 1988 (cyclosporine era). Univariate and multivariate regression analyses revealed that the two most deleterious risk factors for premature death following transplantation were pulmonary hypertension not responsive to vasodilator challenge and preoperative requirement of hemodynamic support (intravenous inotropes or mechanical assistance). The combination of these two independent risk factors was an even stronger predictor of mortality (relative risk, 6:1; p less than 0.0001): the 3-month actuarial survival rate of the 20 patients with this combination was 30.3% versus 78.4% of the 47 patients with only pulmonary hypertension, 87.9% of the 42 patients with only the requirement of hemodynamic support, and 95.3% of the 172 patients with neither of these two risk factors. The difference in postoperative mortality between patients with versus those without these two risk factors is due to a higher rate of fatal infectious complications: six of 20 patients (30%) with both risk factors died from infection within 3 months after transplant compared with three deaths among 172 patients (1.7%) with neither of these risk factors. The majority of fatal infections were pulmonary. There were significantly more fatal and nonfatal infectious episodes in patients with one or both of these risk factors.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Age, cardiovascular risk factors and coronary heart disease as determinants of platelet function in men. A multivariate approach.

Older age, the cardiovascular risk factors and arteriosclerosis have been reported to be associated with stimulated platelet function. To evaluate the relative importance of these factors in determining platelet function, a cross-sectional multivariate study in 191 men, 113 healthy subjects and 78 patients with angiographically documented coronary heart disease, was performed. In healthy subjects, stepwise multiple linear regression identified age to be a major determinant of platelet aggregability. After induction with both ADP and collagen the platelet aggregatory response markedly increased with age. In the patients, platelet function was not age dependent. In multivariate analysis of variance, neither smoking status nor hypercholesterolemia (greater than or equal to 240 mg/dl) were determinants of platelet function in either group. An increase in systolic blood pressure was associated with slightly more inhibited ADP induced aggregation in both healthy subjects and patients with coronary heart disease. In patients compared to healthy subjects, aggregation after induction with ADP and collagen was markedly enhanced and the in vitro formation of thromboxane after collagen stimulation increased. Thus, by multivariate analysis, age and the presence or absence of coronary heart disease were found to be major determinants of platelet function. In contrast, the cardiovascular risk factors smoking, hypercholesterolemia and hypertension were associated with only minor or no alterations of platelet function.

Adult↗
PubMed1991

A multivariate analysis of risk factors for anterior atlantoaxial subluxation and an evaluation of the effect of glucocorticoid treatment on the upper rheumatoid cervical spine.

A cross-sectional, retrospective computerized analysis of risk factors for anterior atlantoaxial subluxation (AAS) was performed. Logistic regression performed on the clinical variables involved in 145 cases of rheumatoid arthritis (RA) disclosed a high joint score index and a low blood haemoglobin level as significant independent risk factors. This means that the development of anterior AAS is connected with widespread RA. Linear multiple regression analysis showed an association between the extent of anterior AAS in millimetres and the spread of erosions of the dens of axis and negative correlation with the severity of vertical atlantoaxial dislocation (VD). This suggests that whereas the presence of anterior AAS is connected with the severity of the systemic disease, its actual extent is associated with signs of local involvement, other than severe VD. The duration or cumulative dosage of glucocorticoids were not associated with the development or extent of anterior AAS, nor with the severity of vertical dislocation. This suggests that low dose glucocorticoid treatment is not involved with the development of rheumatoid changes in the upper cervical spine. It should be borne in mind, of course, that although no correlation was found, a causal relation cannot be excluded.

Arthritis, Rheumatoid↗
PubMed1991

Hormonal content of combined oral contraceptives in relation to the reduced risk of endometrial carcinoma. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

The relationship between the strength of the estrogenic and progestational components of combined oral contraceptives and risk of endometrial carcinoma was examined in a multinational hospital-based case-control study comparing 220 cases from 7 countries with 1,537 age- and hospital-matched controls. Oral contraceptives were classified according to their relative content of estrogen and progestin. The risk was not altered in women who used preparations containing high-dose estrogen/low-dose progestin compounds [odds ratio (OR) = 1.10, 95% CI = 0.13-9.96]. In contrast, the risk among users of low-dose estrogen/high-dose progestin oral contraceptives was greatly decreased (OR = 0, 95% CI = 0-1.08). Risks observed for users of high-dose estrogen/high-dose progestin (OR = 0.15, 95% CI = 0.045-0.50) and low-dose estrogen/low-dose progesterone (OR = 0.59, 95% CI = 0.26-1.30) preparations were intermediate between those for users of the 2 other types of preparation. A significantly lower risk was observed for high-dose progestin users than for low-dose users [ratio of odds ratios (ROR) = 0.21, 95% CI = 0.05-0.84]. Although the numbers are small, findings from this study suggest that combined oral contraceptives with varying strengths of estrogen and progestin have different effects on the risk of endometrial carcinoma.

Case-Control Studies↗