In Japan, Oxycodone hydrochloride injection formulation has been approved in 2012. However, its pharmacokinetics has been poorly studied. The aim of this study is to evaluate the pharmacokinetics of oxycodone after intravenous and subcutaneous administration of oxycodone hydrochloride injection in Japanese patients with cancer pain. Noncompartmental analysis and population pharmacokinetic analysis were performed. We conducted a multicenter open-label study of oxycodone hydrochloride administered as constant infusion with the dose titrated individually according to the pain intensity in patients with cancer pain. Pharmacokinetic parameters for plasma oxycodone and its metabolites were estimated using pharmacokinetics of oxycodone was evaluated using a total of 344 plasma concentrations obtained from 89 patients. The estimated geometric mean clearance (CL) of oxycodone was 24.3 L per hour after constant intravenous infusion and 29.5 L per hour after constant subcutaneous infusion, respectively. Population pharmacokinetic analysis indicated that body surface area was the influencing factor on CL and there were no pharmacokinetic differences for CL between intravenous and subcutaneous infusion. These results provide important information for the clinical use of oxycodone injection.
BackgroundThe Pain Management Index (PMI) is widely used in the assessment of pain management, and negative scores are traditionally considered to indicate inadequate pain management. However, it is not known whether negative PMI scores are always problematic.MethodsIn this prospective observational study, we examined the data of 1156 patients with cancer and pain who were hospitalized in a cancer care hospital in Japan from July 2012 to January 2015 and compared the proportion of patients with PI across various PMI scores in this cohort. We further evaluated the predictive validity of PMI scores for PI using different cutoffs. This study aimed to examine the association between PMI scores and the proportion of patients whose pain interferes with their daily lives (i.e., pain interference [PI]).ResultsWe found that lower PMI scores were generally associated with a higher percentage of patients with PI. A smaller proportion of patients with PMI scores of − 1 (567/1550, 36.6%) reported PI compared with those with PMI scores of 0 (788/1505, 52.4%). The sensitivities of PMI scores < − 1 and < 0 for predicting PI were 0.16 and 0.37 and the corresponding specificities were 0.95 and 0.71, respectively.ConclusionsThese findings suggest that PMI scores are inversely associated with the proportion of patients with PI. However, PMI scores of − 1 do not always indicate inadequate pain management; pain management should therefore be evaluated from multiple perspectives.
The safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.
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