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Ulcerative colitis (UC) is a chronic recurring inflammation that affects the colon and there is no cure.
Current treatments include abstinent drugs (metharamin, corticosteroids, immunosuppressants), biological drugs (Inflixi monoanti, adamo, golimu monoanti, Vido bead monoanti) and oral immunomodulants (tofatini).
Many patients are unresponsive or insatiable with these therapies, and UC patients need specific, better-to-resistant drugs, and the oral small molecule disgrysterase 4 (PDE4) inhibitor Apremilast works in cells to regulate the effects of inflammation.
may therefore be used for UC treatment, this study explores the effects of unresponsive or insatiable ulcerative colitis (UC) patients receiving Premiste.
researchers conducted two-blind, Phase 2 clinical drug trials on adult patients with active UC for three months or more, who had never received biotherapy or failed to undergo traditional therapies and were unable to withstand or had a precontinence.
patients were randomly divided into two groups, taking Prist 30 mg (n s 57), Prist 40 mg (n s 55) or a placebo (n s 58) for 12 consecutive weeks, and then randomly divided the patient into a group of 30 or 40 mg Pristedt twice a day for another 40 weeks.
endoscopy and collect biopsies at weeks 12 and 52.
main observational endpoint was clinical remission in week 12.
results showed that 31.6 percent of patients in the 30 mg Prest group who had achieved clinical remission at the 12th week and 12.1 percent in the placebo group (P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
, however, only 21.8% of patients in the 40 mg Prest group achieved clinical remission in week 12 (P=0.27).
differences between the prested groups of 30 mg and 40 mg were associated with differences in endoscopic improvement.
Mayo score components (stool frequency score, rectal bleeding score, doctor's overall assessment) in both groups were similarly improved from baseline.
in the Prested group of 30 weeks and 40 mg, the median decrease in C-reactive protein and fecal calcitonin was higher by the 12th week than in the placebo group.
at week 52, 40.4% of patients initially assigned to the Prest 30 mg group achieved clinical remission, and 32.7% of patients initially assigned to the Prested 40 mg group achieved clinical remission.
UC patients treated with 30 mg or 40 mg prestete were significantly improved in clinical and endoscopy, as well as in inflammation indicators, the researchers said.
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