Browsing by Author "Yanisorn Nanchaipruek"
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Publication Metadata only Bioequivalence Study of 100-mg Cilostazol Tablets in Healthy Thai Adult Volunteers(2019-01-01) Somruedee Chatsiricharoenkul; Yanisorn Nanchaipruek; Patcharaporn Manopinives; Suparat Atakulreka; Suvimol Niyomnaitham; Faculty of Medicine, Siriraj Hospital, Mahidol University© 2019 The Authors Background: Cilostazol is a vasodilator with anticoagulant effect for treatment of peripheral vascular disease. Cilostazol 100-mg tablet was shown to increase walking distance in this patient population. Objective: The aim of this study was to investigate and compare the pharmacokinetic profiles and safety of Bestazol 100-mg tablet (Berlin Pharmaceutical Industry Co Ltd, Bangkok, Thailand), which is a generic formulation of cilostazol, with the original brand Pletaal 100-mg tablet (Korea Otsuka Pharmaceutical Co Ltd, Seoul, South Korea) in healthy Thai adult volunteers. Methods: The pharmacokinetic profiles of Bestazol (test) and Pletaal (reference) 100-mg tablets were compared in a single-dose, open-label, 2-treatment, 2-period, 2-sequence, randomized crossover study in healthy Thai adult volunteers. This study was conducted at the Siriraj Clinical Research Center, Siriraj Hospital, Mahidol University, Bangkok, Thailand. Each volunteer was initially treated according to either the test–reference or the reference–test sequence, after which each volunteer was switched to the other study sequence after a 2-week washout period. Pharmacokinetic analysis was performed using log-transformed ratios for Cmax, AUC0–last, AUC0–∞, Tmax, t1/2, and λZ for both cilostazol and 3,4-dehydro-cilostazol (its active metabolite) with 90% CI. Physical examination, clinical laboratory data, vital signs, and adverse events were assessed in all participants. Findings: A total of 28 volunteers were included in the final analysis. The ratios of the geometric mean and the 90% CI compared test to reference of cilostazol formulations and were 101.86% (90% CI, 91.88%–112.92%), 107.78% (90% CI, 99.67%–116.56%), and 110.46% (90% CI, 102.68%–118.82%) for Cmax, AUC0–last, and AUC0–∞, respectively. The ratios of the geometric mean and the 90% CI compared test to reference of 3,4-dehydro-cilostazol and were 106.72% (95% CI, 95.31%–119.50%), 110.54% (95% CI, 101.92%–119.89%), and 107.37% (95% CI, 96.74%–119.16%) for Cmax, AUC0–last, and AUC0–∞, respectively. No significant difference was observed between formulations for Tmax. The most common adverse event was headache (51.85%), with no significant difference in incidence between the test and reference groups. No serious adverse events related to the studied drugs were reported. The findings of this study indicate these 2 cilostazol tablet formulations to be bioequivalent. Conclusions: Bestazol 100-mg tablet was bioequivalent to Pletaal 100-mg tablet. Thus, the formulations can be used interchangeably in clinical practice.Publication Metadata only The Cost-Effectiveness of Pulsed-Dye Laser Therapy Among Thai Patients with Facial Port-Wine Stain: A Retrospective Study and Economic Evaluation(2021-04-01) Rungsima Wanitphakdeedecha; Tatre Jantarakolica; Janice Natasha C. Ng; Chadakan Yan; Yanisorn Nanchaipruek; Nuttagarn Jantanapornchai; Woraphong Manuskiatti; Tatchalerm Sudhipongpracha; College of Interdisciplinary Studies, Thammasat University; Thammasat University; Faculty of Medicine Siriraj Hospital, Mahidol UniversityIntroduction: Port-wine stain (PWS) is a progressive capillary malformation that does not resolve spontaneously without treatment. Pulsed dye laser (PDL) is currently the gold standard treatment for PWS, although it is difficult to attain complete clearance and recurrences are common. This study determined the cost-effectiveness of PDL treatment among Thai patients with facial PWS. Methods: This was a retrospective chart review of 109 Thai patients with facial PWS and treated with PDL at Siriraj Hospital, Thailand from January 2008 to December 2017. The primary outcome of the study was the cost-effectiveness of PDL treatment in the clinical improvement of facial PWS. Results: Ten PDL treatment sessions will have an expected clinical improvement of 60%. At the 10th treatment, the marginal incremental improvement with respect to visit is approximately equal to one. The succeeding treatment sessions will only give an additional improvement of 5–10%. Conclusion: A total of 10 PDL treatment sessions was considered cost-effective as it can achieve 60% clinical improvement among Thai patients with facial PWS.Publication Metadata only Siliconoma successfully controlled with low-dose oral isotretinoin: A case report with histopathologic and ultrasonographic findings(2021-08-01) Siriwan Palawisuth; Janice Natasha C. Ng; Penvadee Pattanaprichakul; Yanisorn Nanchaipruek; Nuttagarn Jantanapornchai; Rungsima Wanitphakdeedecha; Sasima Eimpunth; Siriraj Hospital; Srinakharinwirot University