The orphan drug designation was granted in August 2019 for the treatment of myelodysplastic syndromes (including chronic myelomonocytic leukemia).Decitabine combined with cedazuridine was investigated in two open-label, randomized, crossover trials. Trial ASTX727-01-B (NCT02103478) included 80 adult participants with MDS (International Prognostic Scoring System [IPSS] Intermediate-1, Intermediate-2, or high-risk) or CMML and trial ASTX727-02 (NCT03306264) included 133 adult participants with MDS or CMML, including all French-American-British classification criteria and IPSS Intermediate-1, Intermediate-2, or high-risk prognostic scores. The trials were conducted at 51 sites in the United States and Canada.In both trials, participants were randomized 1:1 to receive decitabine combined with cedazuridine (35 mg decitabine and 100 mg cedazuridine) orally in cycle 1 and decitabine 20 mg/m2 intravenously in cycle 2 or the reverse sequence. Both decitabine combined with cedazuridine and intravenous decitabine were administered once daily on days 1 through 5 of a 28-day cycle. Starting with cycle 3, all participants received decitabine combined with cedazuridine orally once daily on days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity. Both trials provided comparison of exposure and safety in the first two cycles between oral decitabine combined with cedazuridine and intravenous decitabine and description of disease response with decitabine combined with cedazuridine.
For good results, the patient must have good palatal motion, as the occlusion of the nasal cavity is mainly carried out by muscles already existing and functioning. Complications
The most common complications of the posterior pharyngeal wall flap are hyponasality, nasal obstruction, snoring, and sleep apnea. Rarer complications include flap separation, sinusitis, postoperative bleeding, and aspiration pneumonia. Possible complications of the sphincter pharyngoplasty are snoring, nasal obstruction, difficulty blowing the nose. Some researches suggest that sphincter pharyngoplasty introduces less hyponasality and obstructive sleep symptoms than the posterior pharyngeal wall flap. Both surgeries have a favourable effect on the function of the Eustachian tube. See also
Rhinolalia clausa
Nasalization
Nasalance

References


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