Data mining is critical for signal detection in pharmacovigilance systems. In this study, we compared signals between spontaneous reporting data and health insurance claims data for a socially issued drug, methylphenidate. We implemented data-mining tools for signal detection in both databases: Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Chi-squared test, and Information Component (IC), in addition to a Relative Risk (RR) tool in the claims database. The claims database generated 15, 15, 36, 1, and 1 adverse drug reactions (ADRs) by ROR, PRR, chi-square, IC, and RR, respectively. The World Health Organization (WHO) spontaneous database generated 91, 91, 137, and 96 ADRs by ROR, PRR, chi-square, and IC, respectively. We found seven potential matching associations from the claims and WHO databases, but only one of them was present in the Korean spontaneous reporting database. In Korea, spontaneous reporting is still underreported and there is a small amount of data for Koreans. Signal comparison between the claims and WHO databases can provide additional regulatory insight.
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http://dx.doi.org/10.1016/j.yrtph.2011.03.015 | DOI Listing |
Cureus
January 2025
Obstetrics and Gynecology, Al Thagher General Hospital, Jeddah, SAU.
Heterotopic pregnancy is defined as the concurrent presence of both an intrauterine pregnancy and an extrauterine (typically ectopic) pregnancy. This report presents the case of a 36-year-old female patient who presented to the emergency department with lower abdominal pain. A comprehensive evaluation, including transabdominal and transvaginal ultrasound imaging, revealed a heterotopic pregnancy at an estimated gestational age of six weeks and two days.
View Article and Find Full Text PDFCureus
December 2024
Department of Neurosurgery, Osaka University Graduate School of Medicine, Suita, JPN.
Traumatic cerebrospinal fluid (CSF) leakage from skull base fractures increases the risk of bacterial meningitis, which is associated with a high mortality rate in adults, and commonly results in severe neurological outcomes. While most cases of CSF leakage occur within three months post-injury and generally resolve spontaneously, delayed-onset meningitis remains a challenging complication. Herein, we report a rare case of severe bacterial meningitis with an intraventricular abscess one year following a frontal skull base fracture, despite no CSF leak.
View Article and Find Full Text PDFThe guide extension-facilitated ostial stenting (GEST) technique uses a guide extension catheter (GEC) to improve stent delivery during primary coronary angioplasty (PCI). GECs are used for stent delivery into the coronary arteries of patients with difficult anatomy due to tortuosity, calcification, or chronic total occlusion (CTO) vessels. Stent and balloon placement has become challenging in patients with increasing lesion complexity due to tortuosity, vessel morphology, length of the lesion, and respiratory movements.
View Article and Find Full Text PDFClin Case Rep
January 2025
Breastfeeding Research Center Family Health Research Institute, Tehran University of Medical Sciences Tehran Iran.
A rare spontaneous triplet heterotopic pregnancy occurred in a patient using emergency contraception. This highlights the need to consider heterotopic pregnancy in differential diagnoses for patients presenting with abdominal pain or vaginal bleeding, even with detected intrauterine pregnancies, especially after failed emergency contraception, necessitating thorough laboratory and ultrasonographic diagnostic work-up.
View Article and Find Full Text PDFFront Pediatr
December 2024
Department of Pediatric Intensive Care Unit, Gansu Provincial Maternity and Child Care Hospital, Lanzhou, Gansu, China.
Intractable pneumothorax secondary to bronchopulmonary fistula is a rare complication in neonates. We present the first report of a newborn with spontaneous pneumothorax and bronchopleural fistula treated with extracorporeal membrane oxygenation (ECMO). Positive pressure mechanical ventilation resulted in persistent air leakage from the bronchopleural fistula.
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