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Comparison of Two Oral Morphine Formulations for Chronic Severe Pain of Malignant and Nonmalignant OriginKapanolTMvsMSTreg;

机译:Comparison of Two Oral Morphine Formulations for Chronic Severe Pain of Malignant and Nonmalignant OriginKapanolTMvsMSTreg;

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KapanolTMis a capsule formulation of morphine designed for 12- or 24-hourly administration. This multicentre, randomised, open-label, parallel study compared the efficacy and tolerability of 12-hourly KapanolTM1with morphine sulfate controlled-release tablets (MSTreg;2). Patients with severe chronic pain (n equals; 165) of various origins (73.5percnt; nonmalignant) were randomised and titrated to adequate analgesia with KapanolTMor MSTreg;, respectively. Once stabilised, patients started the 2-week study period. Rescue medication was available as necessary (immediate-release morphine 10mg tablets). Efficacy and tolerability were assessed by a final physician assessment, rescue medication requirement, pain scores, quality of sleep, and incidence of morphine-related adverse effects. Although 112 patients completed the study, 22 of 91 (24.2percnt;) patients on KapanolTMand 31 of 74 (41.9percnt;) patients on MSTreg;withdrew prematurely. Inadequate efficacy was the reason for premature termination in 5 patients in the KapanolTMgroup and 13 patients in the MSTreg;group. Patient demographics were similar in the two groups. KapanolTMwas shown to be significantly better than MSTreg;, based on final physician assessment (p equals; 0.02), quality of sleep (p equals; 0.05), and effect on mood (p 0.05). Morphine-specific adverse effects occurred with similar frequency in both groups.This study found that the continuous and sustained release of morphine achieved by the novel KapanolTMformulation was more effective than MSTreg;in managing severe chronic pain of both malignant and nonmalignant origin.

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