論文・技術情報追加のお知らせ

1. Hematological toxicity of immune checkpoint inhibitors: a pharmacovigilance study.

ICIの血液毒性をFAERS解析し稀少重篤irAEのリスク因子を特定

対象DB：FAERS

2. Safety profile of olanzapine/samidorphan: focus on metabolic risks, opioid-related effects, and novel adverse events identified.

O/Sの有害事象を解析し代謝・精神症状の新規リスクを示唆

対象DB：FAERS

3. Pharmacovigilance study of the frequency of gastrointestinal ulceration reports associated with immune checkpoint inhibitors: insights from the FDA adverse event reporting system.

ICIで消化管潰瘍が多発し薬剤差・性差を確認

対象DB：FAERS

4. Comparative safety analysis of Riluzole, Edaravone and Tofersen in ALS management: insights from FAERS database.

ALS薬3剤の有害事象と血栓関連機序を比較解析

対象DB：FAERS

5. Safety evaluation of selective estrogen receptor degraders (SERDs) using real-world evidence from the FDA Adverse Event Reporting System (FAERS).

SERD2剤は概ね安全だが薬剤別に特徴的AEが存在

対象DB：FAERS

6. Risk Factors for Drug-Induced Severe Cutaneous Adverse Reactions: A Real-World Pharmacovigilance Analysis.

SCARsは高齢男性と多薬剤でリスク増、大きな民族差も

対象DB：FAERS

7. A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for etrasimod.

エトラシモドは既知AE中心で新規リスクなし、S1P薬より良好面も

対象DB：FAERS

8. HPV vaccine-related thyroid adverse events: temporal patterns and reporting trends.

HPVワクチンと甲状腺障害に信号、特に女性で注意

対象DB：FAERS,VAERS

9. Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System.

スタチンでTIN信号が近年増加、高齢者で要注意

対象DB：FAERS

10. A real-world analysis of Lomitapide-associated adverse events: Data from FAERS and CVAROD.

ロミタパイドでGI・肝障害が顕著、早期発現と新規リスクも判明

対象DB：CVAR,FAERS

11. Comprehensive pharmacovigilance of phytoalkaloid chemotherapeutics: Signal detection and time-to-onset analysis based on FAERS.

植物アルカロイド系抗癌剤で多彩なADEが早期発現し、新規リスクも確認

対象DB：FAERS

12. Pharmacovigilance Signal Detection of Drug-Induced Hospitalizations and Mortality: A 5-Year Nationwide Study.

薬剤死は高齢男性で多く、特に解毒剤・ステロイド・抗凝固薬が高リスク

対象DB：FAERS,KAERS

13. Possible Eye Disorders in Children Prenatally Exposed to Either Methadone or Buprenorphine in Comparison with Other Medications: An Examination of the Food and Drug Administration (FDA) Pharmacovigilance Database.

出生児の眼障害と妊娠期オピオイドの関連は認めず

対象DB：FAERS

14. Post marketing safety surveillance of atezolizumab based on a retrospective analysis of the FDA adverse events reporting system (FAERS).

アテゾリズマブで多様な重篤有害事象を確認

対象DB：FAERS

15. Adverse Effects of Posaconazole on Adrenal Steroid Biosynthesis: An Integrative Approach Using FAERS-Based Pharmacovigilance and Systematic Review with Meta-Analysis of Randomised Controlled Trials.

ポサコナゾールで偽アルド症の因果示唆

対象DB：FAERS

16. Disproportionality evaluation of adverse effects and suicide/self-injury risk factors associated with vortioxetine: a large-scale pharmacovigilance study.

ボルチオキセチンで自殺関連AEs強い信号

対象DB：FAERS,JADER

17. The real-world safety profile of ranolazine: pharmacovigilance analysis of the FAERS database.

ラノラジンで新たな心血管系AEs信号を確認

対象DB：FAERS

18. Muscle Adverse Events Associated with Inclisiran: Data Mining of FAERS database and Mendelian Randomization Analysis.

インクリセランで筋障害リスク示唆、MRでも支持

対象DB：FAERS

19. Reveal a Risk and Potential Mechanism for Keratoconus Progression with Isotretinoin:Toxicogenomic, Transcriptomics and Real-World Evidence Insights.

イソトレチノインと角膜拡張症に強い関連性を示した統合解析

対象DB：FAERS

20. Mining and analysis of reported ARDS population in FAERS database.

薬剤性ARDSは高致死率で早期発症が多く、継続的監視が必須

対象DB：FAERS

21. Bisphosphonate-related ocular adverse events: a pharmacovigilance study based on the FAERS database.

BPsで未記載含む多様な眼障害シグナルを確認

対象DB：FAERS

22. A Pharmacovigilance Study of Immune Checkpoint Inhibitor-Associated Cholangitis: Insights From the FDA Adverse Event Reporting System.

PD-1/PD-L1で胆管炎リスク高く発現中央値77日

対象DB：FAERS

23. Impact of sodium glucose cotransporter 2 inhibitors on bladder cancer and breast cancer: a pharmacovigilance analysis and Mendelian randomization study.

SGLT2阻害薬は膀胱がん報告が増加し因果も示唆

対象DB：FAERS

24. Safety profile of Japanese encephalitis vaccines: a comprehensive analysis of vaccine adverse event reports from 1993 to 2025.

日脳ワクチンでアレルギー系有害事象が多く報告

対象DB：FAERS,VAERS

25. Ocular toxicity events of cyclin-dependent kinase 4/6 inhibitors in breast cancer: a pharmacovigilance study based on the faers database.

CDK4/6阻害薬で眼障害リスク上昇が示唆された

対象DB：FAERS

26. Low-dose methotrexate adverse reaction risk in renal impairment: pharmacovigilance and physiological pharmacokinetic model assessment.

低用量MTXは腎機能低下で有害事象が増加する

対象DB：FAERS

27. Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the FAERS database (2018-2024).

多剤で頭痛リスク増大、早期発現に注意

対象DB：FAERS

28. Adverse events associated with ustekinumab in Crohn's disease treatment: an analysis based on the FAERS database.

ウステキヌマブは感染・心血管など重篤AEに注意が必要

対象DB：FAERS

29. Assessing the real-world safety of fenofibric acid for hyperlipidemia: results from WHO-VigiAccess and FAERS databases.

フェノフィブラート酸の多様な副作用リスクを実臨床で確認

対象DB：FAERS

30. Survey of Drugs Induced Skin Pigmentation (Hyper and Hypo Pigmentation).

FAERS解析で多様な薬剤の皮膚色素異常リスクを特定

対象DB：FAERS

31. Trends of adverse event reports associated with BRAF and MEK inhibitors and combinations: a retrospective disproportionality analysis using the FDA adverse event reporting system database from 2012 to 2021.

BRAF/MEK阻害薬で発熱・倦怠感など多彩な有害事象を確認

対象DB：FAERS

32. Evaluation of the real-world safety of Canakinumab in the treatment of systemic juvenile idiopathic arthritis in children aged 0-16: a comprehensive analysis based on FAERS data.

カナキヌマブ小児例で既知と新規の有害事象シグナルを確認

対象DB：FAERS

33. Class-Specific Adverse Events of Patients Treated with Small Interfering RNA Therapeutics: A Disproportionality Analysis of the United States Food and Drug Administration Adverse Event Reporting System Database Based on the MY FAERS Platform.

siRNA薬でクラス特有AE判明、特にインクリシランの肝毒性が顕著

対象DB：FAERS

34. AA amyloidosis as an adverse event of immune checkpoint inhibitor therapy: evidence from the FDA adverse event reporting system and a systematic review.

ICIでAAアミロイドーシスの稀だが重篤なリスク示唆

対象DB：FAERS

35. A systematic review and pharmacovigilance analysis of the risk of agranulocytosis associated with metamizole use.

メタミゾールに顆粒球減少症の高い報告リスク

対象DB：EudraVigilance

36. Association between exposure to proton pump inhibitors and hypertension: a descriptive and disproportionality analysis of VigiBase.

PPI使用と高血圧報告にクラス効果のシグナル

対象DB：VigiBase

37. Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase.

JAK阻害薬の妊娠ADRに有意なシグナルは確認されず

対象DB：VigiBase

38. Hereditary Angioedema Prophylaxis Therapy: Berotralstat and Lanadelumab Safety Profile.

HAE予防薬2剤で副作用傾向が異なり、経口は消化器系、多くは注射部位反応

対象DB：VigiBase

39. Age disparities in adverse reactions of drugs used in pain therapies in Switzerland.

疼痛治療薬のADRは高齢者で重篤・致死例が多い

対象DB：VigiBase

40. Association between oral management and complications after hematopoietic stem cell transplantation.

HSCT前の口腔管理は感染減少に有効だが、粘膜炎や死亡は改善せず

対象DB：DPC

41. Low BMI and postoperative outcomes in elderly hip fracture patients: a Japanese nationwide database study.

低BMIは高齢者の大腿骨骨折術後合併症と死亡を増加

対象DB：DPC

42. Validation of recorded diagnoses of acute kidney injury among surgical patients in the Japanese Diagnosis Procedure Combination database.

DPCのAKIコードは特異度高く感度低い

対象DB：DPC

43. Impact of enhanced hospital infection prevention measures during-COVID-19 pandemic on the incidence of surgical site infections following spinal instrumentation surgery for lumbar spinal stenosis: A nationwide database study.

コロナ禍で腰椎手術のSSI発生率が上昇した

対象DB：DPC

44. Changes in Smoking Patterns and Cervical Cancer Risk: Preventive Implications from a Nationwide Japanese Cohort.

喫煙は子宮頸がんリスクを段階的に上昇させた

対象DB：JMDC

45. Correlation between duration of first-line treatment with daratumumab, lenalidomide, and dexamethasone and overall survival in patients with transplant-ineligible multiple myeloma in Japan.

一次DRd治療期間は生存と強く相関した

対象DB：MDV

46. Frequency, patient characteristics, and clinical management for extravasation with docetaxel: a descriptive study using a large Japanese medical claims database.

DTX治療のEV発生率と管理の実態を報告した

対象DB：MDV

47. JAVEMACS-D: claims database analysis of avelumab maintenance therapy for advanced urothelial carcinoma in Japan.

日本のaUCでアベルマブ維持療法の実態と成績を報告

対象DB：MDV

48. Comparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation using antiarrhythmic drugs: An international cohort study.

DOACはVKAと同等の効果で出血リスクが低い

対象DB：CPRD

49. Adiposity and the first-onset of diagnosed mental illnesses: a population-based cohort study of 10 million UK adults.

高BMIと低BMIは多くの精神疾患リスクを高める

対象DB：CPRD

50. Experience with insulin detemir for type 2 diabetes in older people and people with comorbidities.

デテミルは高齢・合併症T2Dでも有効で低血糖少

対象DB：CPRD

51. Trajectories of Work Absence in England due to a Musculoskeletal or Mental Health Condition: An Electronic Health Record Cohort Study.

長期欠勤は高齢・北部在住・喫煙等と関連

対象DB：CPRD

52. Variations in social care need reporting amongst GP practices in England: a retrospective cohort study in people with multimorbidity.

社会的ケア需要の記録に大きなばらつき。標準化が必要

対象DB：CPRD

53. Applying High-Dimensional Propensity Scores in a Study of Inhaled Corticosteroids and COVID-19 Outcomes.

HDPS調整でICSのCOVID影響は概ね中立化

対象DB：CPRD

54. Consultations with locum doctors in UK general practice: longitudinal analysis of electronic health records.

英国で非常勤医の利用は多く地域差も大きい

対象DB：CPRD

55. Time to diagnosis and long-term outcomes for adults presenting with breathlessness.

慢性息切れで診断遅延は死亡率を上げる

対象DB：CPRD

56. Long-term survival after invasive pneumococcal disease: a matched cohort study using electronic health records in England.

IPD高齢者は感染後も長期死亡率が高い

対象DB：CPRD

57. Cannabis Use and Analgesic Prescribing in UK Primary Care: A Retrospective Cohort Study of Patients with Osteoarthritis.

大麻使用既往のOA患者は鎮痛薬処方が増加

対象DB：CPRD

58. Adverse outcomes in patients with a diagnosis of an eating disorder: primary care cohort study with linked secondary care and mortality records.

摂食障害は身体・精神疾患と死亡率増大

対象DB：CPRD

59. Burden of allergic rhinitis in the United Kingdom.

AR診断後は医療利用が増加し負担が拡大

対象DB：CPRD

60. Trajectories of type 2 diabetes and cancer in 330 000 individuals with prediabetes: 20-year observational study in England.

前糖尿病から糖尿病・癌への経過は年齢で大きく異なる

対象DB：CPRD

61. Time trends in the prescription of sodium-glucose co-transporter-2 inhibitors based on a claims database in Japan from 2014 to 2022: expanded use in older adults, those with comorbidities, and those potentially initiating diabetes treatment.

SGLT2阻害薬の使用が高齢・併存症患者へ拡大

対象DB：DeSC