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Biomedical subjects

L Leone

Publications and source records attributed to L Leone.

At least 91 records · Page 5Linked to original sources

Pharmacokinetics of norfloxacin in healthy volunteers and patients with renal and hepatic damage.

The pharmacokinetics of norfloxacin were studied in six healthy volunteers, and three patients each with moderate renal and hepatic damage. A new specific and sensitive high performance liquid chromatography method was set up to measure plasma and urine concentrations of norfloxacin. The mean urinary concentrations after a single oral dose of 400 mg norfloxacin exceeded many times the MIC and MBC values of most of the bacterial strains responsible for urinary tract infections. Results in the patients with hepatic and renal damage indicated slight and not statistically significant differences in comparison with healthy volunteers.

Adult↗

Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study.

A randomized comparison of the relative efficacy and toxicity of daunorubicin (DNR) at 30 or 45 mg/sq m or adriamycin (ADM) at 30 mg/sq m, given on the first 3 days of a 7-day continuous infusion of cytosine arabinoside (ara-C) at 100 mg/sq m/day, shows the outcome to be dependent on anthracycline, dose, and patient age. DNR 45 is significantly better than DNR 30 or ADM 30 for inducing complete remissions (CR) in patients younger than 60 yr, (72%, 59%, 58% CRs, respectively). DNR 30 is better than DNR 45 or ADM 30 for inducing CR in patients older than 60 yr (47%, 31%, 35%, respectively). There was a corresponding shift in the induction mortality for the age, dose, and anthracycline groups. Adriamycin was significantly more toxic to the gastrointestinal tract than daunorubicin. The duration of complete remission, with cyclic courses of maintenance therapy, was independent of the patient's age, the dose, or choice of anthracycline used in induction, and of whether the maintenance courses were given every 4 wk or every 8 wk.

Adolescent↗

A new effective four-drug combination of CCNU (1-[2-chloroethyl]-3-cyclohexyl-1-nitrosourea) (NSC-79038), vinblastine, prednisone, and procarbazine for the treatment of advanced Hodgkin's disease.

Five hundred and sixty-six patients with either Stage III or IV Hodgkin's disease were prospectively randomized to test whether CCNU and/or vinblastine are more effective than mechlorethamine and/or vincristine with procarbazine and prednisone. The combination of CCNU, vinblastine, procarbazine, and prednisone (CVPP) was shown to be a highly effective program with a complete response frequency of 69%. The use of CCNU as part of the induction program was also shown to be the most significant determinant of prolonged remissions (P = .025). Reduced vomiting and neurotoxicity, as well as the oral administration, were the chief advantages of the CVPP as compared with MOPP. These factors resulted in improved patient and physician compliance. The MVPP regimen was also shown to be a highly effective regimen with a complete response frequency of 73% in patients without prior exposure to chemotherapy. However, the induction regimens containing vinblastine were associated with a significantly higher frequency of fatal hematopoietic toxicities than the induction regimens containing vincristine (P = .05). This higher frequency was almost exclusively seen in the elderly or in patients previously treated with both chemotherapy and radiotherapy. At this time, the remission durations maintained by vinblastine with periodic reinforcement are longer when compared with vinblastine maintenance alone (P = .06), but there is no corresponding increase in survival.

Adult↗

A randomized combined modality trial in small cell carcinoma of the lung: comparison of combination chemotherapy-radiation therapy versus cyclophosphamide-radiation therapy effects of maintenance chemotherapy and prophylactiv whole brain irradiation.

A randomized trial of combined modality therapy employing combination chemotherapy (cyclophosphamide (CTX) and methotrexate (MTX), CTX, MTX and Vincristine (VCR) and CTX, VCR and high-dose MTX with citrovorum rescue) and radiation therapy was compared to cyclophosphamide and radiation therapy in 258 patients with pulmonary small cell carcinoma. Patients were also rendomized: 1) to determine the effects of prophylactic whole brain irradiation; and 2) to establish the effects of maintenance chemotherapy. Survival, frequency of response and site of relapse were different in patients with limited disease (LD) (disease confined to lung, mediastinum and supraclavicular lymph nodes) when compared with disease spread beyond these sites (extensive disease) (ED). No survival advantage was seen in LD when combination chemotherapy was employed, although the frequency of complete remission was greater with three drugs than with one or two drugs (40% vs. 32%). In ED frequency of response was greater for three drugs than for one and two drugs (60% vs. 40%), but there was no survival advantage. The median survival time for complete responders was similar for limited or extensive disease (12.1 months), but 23.8% were alive at 24 months with LD compared to none with ED. Maintenance chemotherapy significantly prolonged survival by 16.8 months with 33% alive at 24 months compared to 9% who were unmaintained. Prophylactic while brain irradiation prevented brain metastases with only 4% developing this complication as compared to 18% of control subjects, but did not influence survival.

Antineoplastic Agents↗

Electrical wiring configurations and childhood leukemia in Rhode Island.

The study of the relationship between childhood leukemia and electric power line configurations in the greater Denver, Colorado, area by Wertheimer and Leeper (Am J Epidemiol 109:273-284, 1979) was repeated in Rhode Island, focusing on leukemia (age at onset, 0-20 years; year of onset, 1964-1978). The addresses of 119 leukemia patients and 240 controls were studied by mapping power lines within 50 yards (45.72 m) of each residence. The shortest distance between each power line and the point of the residence closest to it was found; the number and types of wires in each power line were noted. Exposure weights were assigned each type of wire using Wertheimer and Leeper's median field strength reading for each. Assuming that the strength of the field decreases with the square of the distance from its source, and that fields generated by different wires grouped in the same power line are simply additive, a summary value of relative exposure was calculated for each address. Quartile exposure values for controls were used to group patient exposures. Contrary to Wertheimer and Leeper's results, no relationship was found between leukemia and electric power line configurations.

Child↗

Antiepileptic drug therapy and plasma levels in 2500 patients from Northern Italy.

The antiepileptic drug therapy of 1912 patients coming from various neurological clinics of Northern Italy has been evaluated in a collaborative survey. The following epidemiological data have been analysed: incidence of the various seizures types, according to the International Classification (Gastaut, 1969), in relation to the age; drug choice and therapeutic schedules in relation to the seizure type and to the age; number of drugs administered in various age and seizure groups; side effects in relation to type, number and plasma concentrations of the administered drugs. The analysis of the drug plasma level determinations, carried out either with gas-chromatographic methods or with the EMIT system, was effected in order to evaluate the number of patients who were under, in or over the suggested therapeutic ranges, the influence of age on drug disposition and the modifications of the drug plasma levels due to drug interactions.

Adolescent↗

A comparative study of a BCNU containing 4-drug program versus MOPP versus 3-drug combinations in advanced Hodgkin's disease: a cooperative study by the Cancer and Leukemia Group B.

A prospective randomized trial by CALGB examined the relative value of four chemotherapy regimens in 537 patients with stage III B and IV Hodgkin's disease. A new combination BOPP, derived by substitution of BCNU for nitrogen mustard in the MOPP regimen, was compared to MOPP and to two 3-drug regimens, derived by removing the procarbazine in BOPP (BOP) or removing the alkylating agent (OPP). The 4-drug programs gave significantly higher frequency of complete remissions (BOPP 67%, MOPP 63%) than the 3-drug regimens (BOP 40%, OPP 42%), and significantly longer duration of remission and survival. BOPP had a therapeutic activity equal to MOPP, and was accompanied by less toxicity. After 6 cycles of induction chemotherapy, responding patients, both CR and PR, were continued on maintenance chemotherapy for 3 years. No significant difference in relapse rate was demonstrated following maintenance treatment with either vinblastine, chlorambucil, or chlorambucil plus monthly vincristine + prednisone doses. Nor could a reinforcement phase late in the maintenance program be shown to influence the relapse rate. The median survival for all patients entered on the 4-drug programs was 5 years, while the median has not yet been reached at 6 years for those patients, who obtained CR.

Adult↗

Improved remission rates and remission duration in young women with metastatic breast cancer following combined oophorectomy and chemotherapy: a study of Cancer and Leukemia Groupe B.

One hundred fifty-seven premenopausal women with metastatic breast cancer were prospectively randomized to treatment consisting of oophorectomy + vincristine, prednisone, cyclophosphamide, methotrexate, 5-fluorouracil (VPCMF) (Reg. I) or oophorectomy + cyclophosphamide (Reg. II) or oophorectomy followed by an observation period (Phase 1), followed by VPCMF (Phase 2) (Reg. III). Complete plus partial response rates were 72% on Reg. I, 65% on Reg. II, 18% on Reg. III, Phase 1 and 50% on Reg. III, Phase 2. Median duration of response for Reg. I was 17 months, for Reg. II 16 months, and for Phase 1 and Phase 2 of Reg. III, respectively, 5 months and 8 months. The response rate for patients treated with oophorectomy plus chemotherapy is significantly higher than the response rate achieved with oophorectomy alone as first treatment following the appearance of metastases in premenopausal women.

Adult↗

An ultrastructural and immunohistochemical study on the delta antigen associated with the hepatitis B virus.

Thirteen liver biopsies in which the delta antigen was detected by immunofluorescence were studied by electron microscopy and immune electron microscopy with peroxidase labelled IgG and F(ab1)2 fraction obtained from a human antiserum containing high-titre anti-delta antibodies. The findings were compared with those obtained in 11 HBcAg positive and in two HBsAg negative controls. Neither unique particulate morphology nor any HB virus ultrastructural component were visualised in the delta positive specimens; 20-23 nm naked core particles were observed in 10 of 11 biopsies displaying the HBcAg in immunofluorescence. Delta positive nuclei frequently contained dense round structures of diameter varying between 20 and 30 nm with a soft indistinct edge. These granules did not exhibit characteristic ultrastructural features which enabled them to be distinguished from other granular material observed occasionally in nuclei of normal and diseased livers. However, their association with the delta antigen has been proved by the deposition on identical structures of peroxidase labelled anti-delta antibody. These results suggest that the delta antigen is unrelated to the Dane particle, the putative HB virus. The granules observed in the delta positive nuclei are composed of an amorphous matrix, possibly insoluble aggregates of the delta antigen.

Cell Nucleus↗

A family study of unsocialized aggressive boys.

The psychiatric histories of relatives of 17 boys admitted to an inpatient unit with "unsocialized aggressive" behavior and of 19 boys admitted with other problems were investigated by means of structured interviews. The interviews were rated blind and diagnoses made on the respondents and relatives described in the family histories using research criteria. Fathers and combined parents of the probands qualified for the diagnosis of antisocial personality disorder more often than the fathers and combined parents of control boys. Uncles of probands and combined uncles and aunts more often had a history of marked antisocial behavior than the corresponding relatives of controls. Siblings of the probands more often had a history of behavior problems as children or adolescents than the siblings of controls. The data suggest an association between unsocialized aggressive reaction in boys and antisocial personality disorder in their adult relatives. Such an association is an interesting contrast to the relationship between hyperactivity in children and alcoholism in their adult relatives.

Adult↗