The single and multiple dose pharmacokinetics of pranlukast in healthy volunteers

Objective: The pharmacokinetics of pranlukast, a leukotriene LTD₄ antagonist, were studied in 48 young, healthy subjects after single and repeated oral doses (given every 12 h) ranging from 112.5 to 675 mg. The doses were administered 30 minutes after a light breakfast. Results: Maximal drug concentrations generally occurred between 2 and 6 h after dosing, and there was some evidence of an absorption lag-time. Secondary peaks were observed in the plasma concentration vs. time profiles of many of the study subjects after both single and repeated doses, particularly during the period of maximum drug absorption. In general, after both single and repeated doses, there were related increases in the corresponding C_max and AUC with a rise in dose, although the increase was diminished at doses above 450 mg. With repeated dosing of pranlukast the mean AUC was generally higher (up to 1.6-fold), and the higher plasma concentrations allowed characterisation of a longer mean t_1/2 than after single dose administration. The mean steady-state trough plasma concentrations attained after evening doses were considerably higher (up to 14-fold) than those obtained after the morning dose. Conclusion: The data suggested that the pharmacokinetics of pranlukast are influenced by the time of dosing. Based on analysis of urinary 6β-hydroxycortisol excretion, there was no evidence that pranlukast modified the metabolic activity of cytochrome P-450 3A isoenzymes. Received: 6 November 1995/Accepted in revised form: 17 April 1996     

Factor VIII inhibitor by-passing activity (FEIBA) in the management of patients with factor VIII inhibitors

Three patients with high titre factor VIII inhibitors have been treated with factor VIII inhibitor by-pass activity (FEIBA). Successful management of spontaneous bleeding episodes was achieved in all three patients. In one patient dental surgery was performed three times without haemorrhagic complications and on each occasion the only treatment given was FEIBA and an antifibrinolytic agent. The only complication of FEIBA has been a significant increase in the factor VIII inhibitor concentration of one patient.Disseminated intravascular coagulation did not occur.     

Global Curriculum in Research Literacy for the Surgical Oncologist

Background

The ability to provide optimal care to cancer patients depends on awareness of current evidence-based practices emanating from research or involvement in research where circumstances permit. The significant global variations in cancer-related research activity and its correlation to cancer-specific outcomes may have an influence on the care provided to cancer patients and their outcomes. The aim of this project is to develop a global curriculum in research literacy for the surgical oncologist.

Materials and Methods

The leadership of the Society of Surgical Oncology and European Society of Surgical Oncology convened a global curriculum committee to develop a global curriculum in research literacy for the Surgical Oncologist.

Results

A global curriculum in research literacy is developed to incorporate the required domains considered to be essential to interpret the published research or become involved in research activity where circumstances permit. The purpose of this curriculum is to promote research literacy for the surgical oncologist, wherever they are based. It does not mandate direct research participation which may not be feasible due to restrictions within the local health-care delivery environment, socio-economic priorities and the educational environment of the individual institution where they work.

Conclusions

A global curriculum in research literacy is proposed which may promote research literacy or encourage involvement in research activity where circumstances permit. It is hoped that this will enhance cancer-related research activity, promote awareness of optimal evidence-based practices and improve outcomes for cancer patients globally.