Objective :
@EN To evaluate the eficaey, safety and pharmacokinetics of β-cyclodextrin-piroxicam in patients with osteoarthritis of knee.
@ES methods :
@EN Thirty patients with osteoarthritis(28 women, 2 men) were enrolled in the study. β-cyclodextrin-piroxicam 20mg was administered orally, once daily for 8 weeks. The indices of efficacy9evaluation of the pain, joint swelling, tenderness and
functional limitation) were evaluated at 0,2,4,8 weeks. Piroxicam plasma concentrations wee determined by HPLC over 24 hours in 4 healthy volunteers, and were compared with those of reference formulation.
@ES Results :
@EN There were statisticaly significant improvement in the indices of eficacy between entry and end of the study. The majority of side effects were related to the gastrointestinal tract, but the symptoms were mild except 1 drop-out case.
According to pharmacokinetic study, the bioavailability and absorption rate of prroxicam were improved in β-cyclodextrin-piroxicam group. Peak plasma piroxicam concentrations were higher in β-cyclodextrin-piroxicam group than were in reference
group.
@ES Conclusion :
@EN β-cyclodextrin-piroxicma is efficacious and well tolerated in patients with osteoarthritis. Because of its rapid absorption, good bioavailability and fewer gastrointestinal disturbance, it seems to be a useful drug for long-term management
of
osteoarthritis.
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