Objective: The mechanism underlying the development of neuropsychiatric symptoms such as unconsciousness, abnormal behavior, delirium, hallucinations, and convulsions in influenza has not been thoroughly investigated. The relationship between drug administration and neuropsychiatric symptoms during influenza is also poorly understood. This study is the first pharmacoepidemiologic study focused on investigating the relationship between drug administration and neuropsychiatric symptoms.
Design: Cohort study
Methods: Study subjects were patients under 18 years old who had influenza during the 2006/07 season. We prepared two kinds of questionnaires for doctor and for patient's family, and carried out the survey between January and March, 2007. Using data from 9,389 patients, we analyzed the relationship between neuropsychiatric symptoms, such as delirium, unconsciousness and convulsion, and drug administration of acetaminophen and oseltamivir.
Results: Analysis of the relationship between delirium and drug administration provided hazard ratios of 1.55(p=0.061)for acetaminophen and 1.51(p=0.084)for oseltamivir. These hazard ratios, which were adjusted for risk factors by multivariate analysis of the proportional hazard model, showed an increasing tendency of delirium after administration of each drug. In patients who received oseltamivir, a high incidence of delirium was observed between 6 and 12 hours after onset of fever. Furthermore, delirium was found to develop in a shorter time following oseltamivir use than it did after acetaminophen use. There was no relationship between unconsciousness and acetaminophen administration, as demonstrated by a hazard ratio of 1.06(p=0.839). The incidence of unconsciousness increased significantly with oseltamivir use with a hazard ratio of 1.79(p=0.0389), and unconsciousness was found to occur in a short time after oseltamivir use.
Conclusion: The results obtained from this study suggest that there are increased risks of delirium and unconsciousness with drug administration. Further pharmacoepidemiologic studies for hypothesis testing are required to study the relationship between abnormal behavior and drug administration.

Severe burn injuries often result in significant long-term physical complications with scarring and contractures, but cancers associated with chronic burn scars are relatively rare. We report a case of a 58-year-old man with skin cancer arising from a healed burn scar. He initially suffered from an extensive fire burn on both lower limbs as a child. The burn scars extended from his upper thighs to his toes bilaterally and caused severe contractures which immobilized the ankles in plantar flexion. Two years ago, he noticed a small ulcerated lesion on the right heel and self-treated it with topical ointments. However, the ulcer increased in size and became malodorous. He presented to a clinic with a large, ulcerated, tumorous lesion, and histology proved it to be squamous cell carcinoma. He subsequently underwent a right below-the-knee amputation, and the previous scars presented on the stump. Thus the patient received a total surface bearing prosthesis with an Icelandic roll-on silicone socket system, which is ideal for patients with extensive scarring at the stump because it may reduce prosthesis-induced stump injuries by evenly distributing the patient's weight in the socket. After he left the hospital, he walked so far with the prosthesis every day that small ulcers often developed at the right popliteal fossa. However, he did not take care to treat these lesions properly, so we had to educate him on how to treat them. Patients such as these will often require education for self-management, family involvement and regular follow-up to monitor scar ulceration and watch out for any malignant transformation.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10–20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0–32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.