論文・技術情報追加のお知らせ

1. Descriptive Analysis of Adverse Events Reported for New Multiple Myeloma Medications Using FDA Adverse Event Reporting System (FAERS) Databases from 2015 to 2022.

新しい多発性骨髄腫薬では、イキザゾミブの有害事象が最も多く、死亡報告も最多

対象DB：FAERS

2. Real-World Data-Derived Pharmacovigilance on Drug-Induced Cognitive Impairment Utilizing a Nationwide Spontaneous Adverse Reporting System.

薬剤による認知障害はがん治療薬で顕著、入院リスクは男性とがん患者で高い

対象DB：FAERS,KAERS

3. Neuronal toxicity of monoclonal antibodies (mAbs): an analysis of post-marketing reports from FDA Adverse Event Reporting System (FAERS) safety database.

抗体治療における神経毒性のリスクが確認され、医療現場での注意が必要

対象DB：FAERS

4. Cytokine release syndrome associated with immune checkpoint inhibitors: a pharmacovigilance study based on spontaneous reports in FAERS.

免疫チェックポイント阻害剤でのサイトカイン放出症候群の発生が確認され、監視が重要

対象DB：FAERS

5. Eye disorders associated with selective serotonin reuptake inhibitors: a real-world disproportionality analysis of FDA adverse event reporting system.

SSRIは眼の副作用と関連があり、早期の監視が必要

対象DB：FAERS

6. Hypersensitivity Reactions Induced by Iodinated Contrast Media in Radiological Diagnosis: A Disproportionality Analysis Based on the FAERS Database.

非イオン性造影剤の過敏反応に関する安全性と重症度を評価

対象DB：FAERS

7. Immune-Related Adverse Events Associated with Atezolizumab: Insights from Real-World Pharmacovigilance Data.

アテゾリズマブ使用による免疫関連副作用の実態を報告

対象DB：FAERS

8. Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis.

薬物離脱症候群に関連する薬剤を特定

対象DB：FAERS

9. Safety of tildrakizumab: a disproportionality analysis based on the FDA adverse event reporting system (FAERS) database from 2018-2023.

ティルドラキズマブの副作用に関する新たなシグナルを確認

対象DB：FAERS

10. The real-world safety of oseltamivir and baloxavir marboxil in children: a disproportionality analysis of the FDA adverse event reporting system.

オセルタミビルとバロキサビルの小児における副作用を検出

対象DB：FAERS

11. Assessment of adverse events related to anti-interleukin-6 receptor monoclonal antibodies using the FDA adverse event reporting system:a real-world pharmacovigilance study.

IL-6受容体拮抗薬で新たな副作用シグナルを確認

対象DB：FAERS

12. Polypharmacy and Elevated Risk of Severe Adverse Events in Older Adults Based on the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database.

高齢者の多剤併用は重篤な副作用と関連

対象DB：FAERS,KAERS

13. The atypical antipsychotics and sexual dysfunction: a pharmacovigilance-pharmacodynamic study.

非定型抗精神病薬による性機能障害の関連が初めて実証

対象DB：FAERS

14. Neurological adverse events associated with oxaliplatin: A pharmacovigilance analysis based on FDA adverse event reporting system.

オキサリプラチンの神経毒性は、男性や併用薬がリスク低下、累積用量がリスク増加

対象DB：FAERS

15. Pharmacovigilance study of GLP-1 receptor agonists for metabolic and nutritional adverse events.

GLP-1受容体作動薬の代謝・栄養障害リスクは、セマグルチド、リラグルチド、エキセナチドで高い

対象DB：FAERS

16. Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS).

新生児へのシルデナフィル使用に関する副作用には、黄疸や肺出血などが新たに報告された

対象DB：FAERS

17. EVALUATION OF ANTICANCER THERAPY- RELATED DERMATOLOGIC ADVERSE EVENTS: INSIGHTS FROM FDA's FAERS DATASET.

113種の抗がん薬が皮膚の副作用と関連し、発疹や乾燥肌が多かった

対象DB：FAERS

18. Safety Profile of Lipid Emulsion in Clinical Practice: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System.

脂質乳剤は肝機能障害や感染のリスクがあり、使用時の注意が必要

対象DB：FAERS

19. Hemophagocytic lymphohistiocytosis induced by dabrafenib-trametinib in a patient with metastatic melanoma: a case report and pharmacovigilance analysis.

ダブラフェニブ/トラメチニブでHLHが稀に発生、注意が必要

対象DB：FAERS

20. The Association Between Deep Vein Thrombosis, Pulmonary Embolism, and Janus Kinase Inhibitors: Reporting Status and Signal Detection in the Japanese Adverse Drug Event Report Database.

JAK阻害剤は深部静脈血栓症と肺塞栓症のリスクあり

対象DB：JADER

21. Pregnancy Recommendations Solely Based on Preclinical Evidence Should Be Integrated with Real-World Evidence: A Disproportionality Analysis of Certolizumab and Other TNF-Alpha Inhibitors Used in Pregnant Patients with Psoriasis.

妊娠中の乾癬治療で、セルトリズマブは他の抗TNF薬と比較して安全性が高い

対象DB：EudraVigilance

22. Sexual Dysfunction Induced by Antidepressants-A Pharmacovigilance Study Using Data from VigiBase(TM).

抗うつ薬による性機能障害はSSRIsとSNRIsで顕著、リガンド親和性と関連

対象DB：VigiBase

23. Enzalutamide Prolonged the Duration of Drug Use in Comparison to Abiraterone Acetate and Cabazitaxel after Upfront Docetaxel: A Large Japanese Database Study.

ドセタキセル後、エンザルタミドがカバジタキセルより生存期間を延ばす

対象DB：DPC,MDV

24. Safety of transbronchial lung cryobiopsy compared to transbronchial forceps biopsy in patients with diffuse lung disease: An observational study using a national database in Japan.

TBLCとTBFBで肺病変の死亡率や合併症に有意差なし

対象DB：DPC

25. In-Hospital Mortality in Patients With Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation With Concomitant Use of Impella vs. Intra-Aortic Balloon Pump - A Retrospective Cohort Study Using a Japanese Claims-Based Database.

VA-ECMO患者において、ImpellaとIABPの死亡率は同等だが、Impellaは医療コストと入院期間が長い

対象DB：DPC

26. Updated Information on NDB.

NDB利用の研究増加中、さらなる活用が期待される

対象DB：NDB

27. The Clinical and Economic Burden of Antibiotic Use in Pediatric Patients With Varicella Infection: A Retrospective Cohort Analysis of Real-World Data in England.

水痘管理で抗生物質使用が多く、予防接種が負担軽減に有効

対象DB：CPRD

28. Trends in all-cause and cause-specific mortality by BMI levels in England, 2004-2019: a population-based primary care records study.

肥満者の死亡率減少、癌と神経疾患の死亡増加

対象DB：CPRD

29. Rising incidence, health resource utilization and costs of Polycystic Ovary Syndrome in the United Kingdom.

PCOSの発症率が増加し、医療費とリソース使用が増大

対象DB：CPRD

30. Use of heart failure medical therapy before and after a cancer diagnosis: A longitudinal study.

癌診断後に心不全治療薬の使用減少と投薬不良が増加

対象DB：CPRD

31. Clinical and economic burden of severe asthma with low blood eosinophil counts.

英国での低好酸球数重症喘息患者の負担と治療を調査

対象DB：CPRD