Rufloxacin is a new long-acting, once-daily quinolone antibacterial agent. We evaluated inter-and intrasubject variations in pharmacokinetics of rufloxacin following oral administration of 400 mg (two capsules) under controlled conditions, at an interval of 2 weeks (periods I and II), to 12 healthy male subjects. Plasma and urine samples were collected up to 48 h after drug administration. Plasma drug levels determined by bioassay were higher than those measured by high-performance liquid chromatography, indicating that one or more active metabolites were formed. Individual high-performance liquid chromatography plasma rufloxacin concentrations were fitted with a one-compartment open model with first-order input. There were considerable variations in the plasma concentration-time profiles among subjects; for example, the elimination half-life in plasma varied from 14.6 to 95.5 h. However, pharmacokinetic parameters calculated for the two periods did not differ significantly. These results suggest that the intrasubject variation in the pharmacokinetics of rufloxacin is usually small in spite of the considerable intersubject variation.Rufloxacin (MF 934; Fig.
Pruritus was evaluated with respect to frequency, intensity, and prognostic significance in 360 patients with Hodgkin's disease. In order to discriminate severe from mild pruritus, the following criteria was used: (1) multiple excoriations; (2) ineffectiveness of local and systemic antipruritics; and (3) improvement with either radiotherapy or chemotherapy. Ninety of 360 patients had mild itching on admission and showed the same survival as the 249 nonitching cases; 21 patients presented with severe pruritus, which was also generalized, and showed a statistically shorter survival than that of mild and non‐itching cases. This comparison was carried out between patients homologous with respect to sex, age, stage, A or B category, and histotype. Analysis of the data pointed out that the third requirement, i.e., improvement with antineoplastic therapy, is not substantial; moreover, for staging purposes, it is preferably replaced by the requisite of generalized pruritus. The intrinsically poor prognosis related to severe pruritus may be important for treatment, when this symptom occurs in early stages or without other systemic symptoms. The inclusion of severe pruritus among the Ann Arbor criteria for definition of the B‐clinical category is proposed.
Serum albumin levels were measured by electrophoresis in 552 evaluable patients with Hodgkin's disease. Determinations were made on all patients at onset, on 224 after induction therapy and on 78 in relapse after remissions of variable length. At onset a discrete hypoalbuminemia was evident, inversely related to stage and more marked in symptomatic cases and elder patients. Little or no differences in albumin levels were found with relation to histologic subtypes, sex and presence of weight loss or hepatic damage. Posttherapeutic normalization of serum albumin occurred only after achievement of complete remission and failed after partial remission, while a new clear decrease became evident in relapse. On the basis of 799 albumin measurements during active disease and in remission, the albumin/α2‐globulin ratio demonstrated a clear and useful clinical advantage over either albumin or α2‐globulin fractions alone as indicator of active disease and relapse. If defective synthesis is the most accepted mechanism for hypoalbuminemia in Hodgkin's disease, these results suggest a casual factor somehow related to the tumoral mass.
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