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KMID : 0378019950380010080
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New Medical Journal
1995 Volume.38 No. 1 p.80 ~ p.87
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Clinical trial of β-cyclodextrin-piroxicam in patients with rheumatoid arthritis
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Abstract
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We conducted a clinical study to evaluate the efficacy and safety of newly-developed P-cyclodex-trin-piroxicam for the treatment of rheumatoid arthritis. We measured clinical activity of joint inflammation and laboratory parameters of disease activity before and after oral administration of F-cyclodextrin-piroxicam to eleven patients with rheumatoid arthritis. As a control, piroxicam was given to 14 patients with rheumatoid arthritis that matched for age, sex, and drug history with fl-cyclodextrin-piroxicam group. Total period of administration was three months for each group. Following results were obtained.
1. After twelve weeks of P-cyclodextrin-piroxicam or piroxicam, we observed statistically significant improvement in visual analogue pain scale(VAPS), duration of morning stiffness, and joint tenderness counts in both groups.
2. The improvement of pain, swelling, duration of morning stiffness, joint tenderness and functional capacity after treatment with P-cyclodextrin-piroxicam was not different from those observed in piroxicam-treated group.
3. Adverse drug reactions were observed in 4 cases in P-cyclodextrin-piroxicam group and 7 cases with piroxicam group. Adverse drug reactions were mild and improved with discontinuation or reduction of dose of the drugs. Epigastric pain was noted in 1 of 11 P-cyclodextrin-piroxicam group and 3 of 14 piroxicam treated group. There was no case whose stool occult blood test converted positively in both group.
4. There was no significant changes of clinical laboratory findings observed in both groups.
5. Overall efficacy observed by patient and physician after treatment was marked improvement or
improvement in 72% of the P-cyclodextrin-piroxicam group and in 71% of the piroxicam treated group respectively.
In conclusion, ft-cyclodextrin-piroxicam and piroxicam are equally effective, and F-cyclodextrin.
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