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1.
Laryngoscope ; 2024 May 30.
Article in English | MEDLINE | ID: mdl-38813852

ABSTRACT

OBJECTIVES: This study aimed to evaluate the efficacy of as-needed pilocarpine for the management of radiation-induced xerostomia. Additionally, the study sought to assess the side effects associated with an as-needed regimen. METHODS: A randomized, double-blinded, placebo-controlled crossover study was conducted on patients who had undergone radiation therapy for head and neck cancers and developed xerostomia. Participants took pilocarpine or placebo as needed for symptom relief at 2 weeks per treatment, which included a one-week washout period. The primary outcome measure was the severity of dry mouth symptoms, quantified using the Xerostomia Inventory (XI). The primary outcome was the change in the XI score. RESULTS: Among the 20 participants who completed the crossover study, there was a significant reduction in XI scores during the treatment phase with pilocarpine compared to the scores during the placebo phase. The mean difference in XI scores was -18.05 (95% CI: -17.17, -6.13, p < 0.001), with a-49.77 ± 3.22% change (p < 0.001). Only one participant withdrew due to pilocarpine side effects. CONCLUSION: As-needed pilocarpine administration is effective in relieving symptoms of radiation-induced xerostomia, with fewer side effects and reduced treatment costs compared to fixed-dose regimens. This study guides the potential shift toward flexible dosing strategies in clinical practice, promoting enhanced patient-centered, tailored care and adherence. LEVEL OF EVIDENCE: Level 2. According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines Laryngoscope, 2024.

2.
Clin Pharmacol Drug Dev ; 12(1): 14-20, 2023 01.
Article in English | MEDLINE | ID: mdl-35877195

ABSTRACT

This study compared the pharmacokinetics and safety of favipiravir oral solution with those of tablet formulations, which were agents repurposed to treat nonsevere coronavirus disease 2019 in Thailand. In an open-label, single-dose, randomized, crossover study, 24 healthy subjects under fasting conditions were randomly assigned to a single dose of 200 mg of favipiravir, either as an oral solution of 200 mg/15 mL (test product) or a tablet (reference product), separated by a 7-day washout period. Fifteen plasma samples were collected over 12 hours after drug administration. Plasma favipiravir levels were quantified using in-house developed ultra-high-performance liquid chromatography-tandem mass spectrometry. The test/reference geometric mean ratio along with 90%CI for the maximum plasma concentration, area under the concentration-time curve (AUC) to the time of the last quantifiable concentration, and AUC after single-dose administration, extrapolated to infinity were 115.3% (90%CI, 107.7%-123.3%), 100.4% (90%CI, 96.9%-104.0%), and 100.4% (90%CI, 96.8%-104.2%), respectively. These results were within the predefined acceptance criteria for bioequivalence (80.0%-125.0%). No adverse events were observed in either group. The oral solution formulation could offer the advantage of easier swallowing in broader patient groups.


Subject(s)
COVID-19 , Southeast Asian People , Humans , Biological Availability , Cross-Over Studies , Healthy Volunteers , Thailand , Tablets
3.
Case Rep Oncol ; 15(2): 783-791, 2022.
Article in English | MEDLINE | ID: mdl-36157701

ABSTRACT

Rhabdomyosarcoma (RMS) exhibits varying degrees of clinical manifestations, and one of the determining factors is its primary site of origin. Ocular proptosis is an infrequent presentation of parameningeal RMS. The growing tumor in spacious environments such as air-filled sinuses can obscure its early detection, leading to late disease intervention. Among the four subtypes (embryonal, leiomyomatous, sclerosing and spindle cell, and alveolar), the predominant type of RMS in the paranasal sinuses is alveolar. The incidence in adult-onset RMS is relatively low compared with those of children. We herein present a rare case of a 23-year-old man with an unusual presentation of bilateral proptosis from alveolar RMS of the ethmoid sinus. In contrast to our patient, most reported cases of ocular involvement in RMS turned out to be unilateral and responded poorly to treatment. Despite the aggressive behavior of the adult-onset alveolar subtype in comparable reports, our case shows an excellent outcome. Negative FOXO1 fusion status has been recognized in recent studies as a molecular feature inclined toward a favorable outcome in alveolar RMS. The integration of molecular prognostic factors to risk stratification could be advantageous in determining different prognoses and proper management for an individual patient.

4.
IJID Reg ; 1: 1-2, 2021 Dec.
Article in English | MEDLINE | ID: mdl-35721778

ABSTRACT

Objective: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads through person-to-person contact via small droplet particles, especially in poorly ventilated indoor settings such as households, estimating at 16.6% of secondary attack rate. This study aimed to explore the secondary attack rate in Thai households during the new SARS-CoV-2 variant outbreak. Methods: We obtained a retrospective study of exposed members in households among 30 sets of patients with reverse transcriptase-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 infection (index cases) at Chulabhorn Hospital, Bangkok, Thailand, from May 1 to June 30, 2021. Characteristic of index cases and households were extracted from medical records and analyzed. Results: The 30 index cases were associated with 157 exposed household close contacts. Seventy-six were RT-PCR confirmed SARS-CoV-2 infections within 14 days after being exposed from an index case, with a secondary attack rate of 48%. However, there was no difference between secondary attack rates among the age of contact, household size, or SARS-CoV-2 variants. Conclusion: Our data show high transmissibility of SARS-CoV-2, which was notably exaggerated compared to previous studies. Therefore, developing preventive strategies such as post-exposure prophylaxis (PEP) in close contact with SARS-CoV-2 infection would be a novel supplement to the current standard of care.

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