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資料３－４ 研究報告の報告状況［877KB］ (11 ページ)
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| 出典情報 | 薬事審議会 医薬品等安全対策部会（令和6年度第1回 6／19）《厚生労働省》 |
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研究報告の報告状況
（2023年12月1日～2024年3月31日）
テルビナフィン塩酸塩
200 ボリコナゾール
タクロリムス水和物
Jedlowski, P.M. (University of Arizona College of Medicine, AZ., USA).
Association of nonmelanoma skin cancers, melanoma, and Merkel cell
carcinoma with dermatologic medications: A case-control pharmacovigilance
study of the FDA Adverse Events Reporting System. Dermatology. 2023;
239(5): 694-699.
生理食塩液
乳酸リンゲル液
乳酸リンゲル液（マルトース加）
201
維持液（１６）
酢酸リンゲル液（ブドウ糖加）
酢酸維持液（１）
Chen L, Zhao J, Lu L, Gong Z, Xu S, Yang X, et al. Association between
normal saline infusion volume in the emergency department and acute kidney
injury in heat stroke patients: a multicenter retrospective study. Ren-Fail.
2024;46:1:2294151
202 シクロホスファミド水和物
203 アセトアミノフェン
204 ボセンタン水和物
205 レボフロキサシン水和物
206 トラマドール塩酸塩・アセトアミノフェン配合剤
207 アセトアミノフェン
208 アスピリン
Ustun C, et al.. Post-transplantation cyclophosphamide is associated with
increased bacterial infections.. Bone Marrow Transplantation. 2024; 59(1):
76-84 DOI:10.1038/s41409-023-02131-z.
Tsukagoshi, E. et al..Clinical profiles of Japanese patients with StevensJohnson syndrome/toxic epidermal necrolysis collected by a nationwide
system from 2006 to 2023.Biol. Pharm. Bull. 2024;47(1):88-97.
Dong S, Guo X, Wang H, Sun C. Liver injury due to endothelin receptor
antagonists: a real-world study based on post-marketing drug monitoring
data. Ther-Adv-Respir-Dis. 2024;18:17534666231223606
Patel, N. et al. Fluoroquinolone-associated adverse events of interest among
hospitalized veterans affairs patients with community-acquired pneumonia
who were treated with a fluoroquinolone: A focus on tendonitis,
Clostridioides difficile infection, and aortic aneurysm. Pharmacotherapy.
2024;44(1):49-60.
Elli, C. et al. Serotonin syndrome: A pharmacovigilance comparative study of
drugs affecting serotonin levels. Europ. J. Clin. Pharmacol. 2024;80(2):231237.
Woodbury ML, et al. Examining the relationship of acetaminophen use during
pregnancy with early language development in children. Pediatr Res. 2023
Dec 11. doi: 10.1038/s41390-023-02924-4. Epub ahead of print. PMID:
38081897.
Erba, N..Association of sex with major bleeding risks in sub-Saharian
anticoagulated patients with mechanical heart valves: A cohort study from
the Khartoum Emergency Salam Centre.International Journal of Cardiology.
2024;394:131398.
ボノプラザンフマル酸塩
ボノプラザンフマル酸塩・アモキシシリン水和物・クラリスロマ
宇野 由佳里, 足立 政治, 馬淵 正敏, 中村 博式, 島崎 信, 西脇 伸二 他. 慢
イシン
209
性胃炎を有する患者へのPPI投与は発癌リスクとなりうるか. 第31回日本消化
ボノプラザンフマル酸塩・アモキシシリン水和物・メトロニダ
器関連学会週間合同抄録集. 2023;31:消P-55
ゾール
アスピリン・ボノプラザンフマル酸塩配合剤
【社内資料】Eli Lilly and Company. 2024（Early Termination of CYCLONE 3
210 アベマシクリブ
(JPEG) due to Futility）
211 バルプロ酸ナトリウム
212 ブデソニド
213 ゾルピデム酒石酸塩
214 ランソプラゾール
215 ワルファリンカリウム
216 人血清アルブミン
217 オメプラゾール
218 ケトプロフェン
Effects of valproic acid and levetiracetam monotherapy on balance functions
in patients with generalized epilepsy. Epilepsy & behavior, 2024, 151, 109622
Armanian, Amir Mohamad ; Iranpour, Ramin ; Lotfi, Asghar ; Amini,
Raziyeh ; Kahrizsangi, Negin Ghasemi ; Jamshad, Afrooz ; Shiranilapari,
Parastoo ; Feizi, Awat. Intratracheal Administration of Budesonide-instilled
Surfactant for Prevention of Bronchopulmonary Dysplasia: A Randomized
Controlled Clinical Trial. Iranian Journal of Neonatology. 2023; 14(4): 1-7.
Salvo, F. et al. (Universite de Bordeaux, Bordeaux, France). Dual orexin
receptor antagonists and suicide risk: findings from the WHO spontaneous
reporting database. J. Clin. Psychiat.. 2023; 84(6): 23br14923-.
Li, Z.-H. et al. (Southern Medical University, Guangzhou, China).
Association between regular proton pump inhibitors use and cardiovascular
outcomes: A large prospective cohort study. Int'l J. Cardiol.. 2024; 395:
131567-.
Haesuk Park et al. Trajectories of Oral Anticoagulation Adherence and
Associated Clinical Outcomes During Long-Term Anticoagulation Among
Medicare Beneficiaries With Venous Thromboembolism. The Annals of
Pharmacotherapy. 2023; 57 (12): 1349-1360.
Torp, Nikolaj; China, Louise; Israelsen, Mads; Krag, Aleksander; O'Brien,
Alastair. HIGH DOSES OF ALBUMIN INCREASES MORTALITY AND
COMPLICATIONS IN TERLIPRESSIN TREATED PATIENTS WITH
CIRRHOSIS: INSIGHTS FROM THE ATTIRE TRIAL. Hepatology.
2023;78(Supplement 1:S220-S221)
Fossmark, R. et al. .The impact of proton pump inhibitors on the course of
ulcerative colitis: a cohort study of over 10,000 newly diagnosed patients in
Norway.Scand. J. Gastroenterol. 2024;59(1):46-51.
Bruze, M, et al. Contact allergy to oxidised geraniol may be overrepresented in individuals with photocontact allergy to ketoprofen. Contact
Derm. 2024;90(1):79-83.
11
（2023年12月1日～2024年3月31日）
テルビナフィン塩酸塩
200 ボリコナゾール
タクロリムス水和物
Jedlowski, P.M. (University of Arizona College of Medicine, AZ., USA).
Association of nonmelanoma skin cancers, melanoma, and Merkel cell
carcinoma with dermatologic medications: A case-control pharmacovigilance
study of the FDA Adverse Events Reporting System. Dermatology. 2023;
239(5): 694-699.
生理食塩液
乳酸リンゲル液
乳酸リンゲル液（マルトース加）
201
維持液（１６）
酢酸リンゲル液（ブドウ糖加）
酢酸維持液（１）
Chen L, Zhao J, Lu L, Gong Z, Xu S, Yang X, et al. Association between
normal saline infusion volume in the emergency department and acute kidney
injury in heat stroke patients: a multicenter retrospective study. Ren-Fail.
2024;46:1:2294151
202 シクロホスファミド水和物
203 アセトアミノフェン
204 ボセンタン水和物
205 レボフロキサシン水和物
206 トラマドール塩酸塩・アセトアミノフェン配合剤
207 アセトアミノフェン
208 アスピリン
Ustun C, et al.. Post-transplantation cyclophosphamide is associated with
increased bacterial infections.. Bone Marrow Transplantation. 2024; 59(1):
76-84 DOI:10.1038/s41409-023-02131-z.
Tsukagoshi, E. et al..Clinical profiles of Japanese patients with StevensJohnson syndrome/toxic epidermal necrolysis collected by a nationwide
system from 2006 to 2023.Biol. Pharm. Bull. 2024;47(1):88-97.
Dong S, Guo X, Wang H, Sun C. Liver injury due to endothelin receptor
antagonists: a real-world study based on post-marketing drug monitoring
data. Ther-Adv-Respir-Dis. 2024;18:17534666231223606
Patel, N. et al. Fluoroquinolone-associated adverse events of interest among
hospitalized veterans affairs patients with community-acquired pneumonia
who were treated with a fluoroquinolone: A focus on tendonitis,
Clostridioides difficile infection, and aortic aneurysm. Pharmacotherapy.
2024;44(1):49-60.
Elli, C. et al. Serotonin syndrome: A pharmacovigilance comparative study of
drugs affecting serotonin levels. Europ. J. Clin. Pharmacol. 2024;80(2):231237.
Woodbury ML, et al. Examining the relationship of acetaminophen use during
pregnancy with early language development in children. Pediatr Res. 2023
Dec 11. doi: 10.1038/s41390-023-02924-4. Epub ahead of print. PMID:
38081897.
Erba, N..Association of sex with major bleeding risks in sub-Saharian
anticoagulated patients with mechanical heart valves: A cohort study from
the Khartoum Emergency Salam Centre.International Journal of Cardiology.
2024;394:131398.
ボノプラザンフマル酸塩
ボノプラザンフマル酸塩・アモキシシリン水和物・クラリスロマ
宇野 由佳里, 足立 政治, 馬淵 正敏, 中村 博式, 島崎 信, 西脇 伸二 他. 慢
イシン
209
性胃炎を有する患者へのPPI投与は発癌リスクとなりうるか. 第31回日本消化
ボノプラザンフマル酸塩・アモキシシリン水和物・メトロニダ
器関連学会週間合同抄録集. 2023;31:消P-55
ゾール
アスピリン・ボノプラザンフマル酸塩配合剤
【社内資料】Eli Lilly and Company. 2024（Early Termination of CYCLONE 3
210 アベマシクリブ
(JPEG) due to Futility）
211 バルプロ酸ナトリウム
212 ブデソニド
213 ゾルピデム酒石酸塩
214 ランソプラゾール
215 ワルファリンカリウム
216 人血清アルブミン
217 オメプラゾール
218 ケトプロフェン
Effects of valproic acid and levetiracetam monotherapy on balance functions
in patients with generalized epilepsy. Epilepsy & behavior, 2024, 151, 109622
Armanian, Amir Mohamad ; Iranpour, Ramin ; Lotfi, Asghar ; Amini,
Raziyeh ; Kahrizsangi, Negin Ghasemi ; Jamshad, Afrooz ; Shiranilapari,
Parastoo ; Feizi, Awat. Intratracheal Administration of Budesonide-instilled
Surfactant for Prevention of Bronchopulmonary Dysplasia: A Randomized
Controlled Clinical Trial. Iranian Journal of Neonatology. 2023; 14(4): 1-7.
Salvo, F. et al. (Universite de Bordeaux, Bordeaux, France). Dual orexin
receptor antagonists and suicide risk: findings from the WHO spontaneous
reporting database. J. Clin. Psychiat.. 2023; 84(6): 23br14923-.
Li, Z.-H. et al. (Southern Medical University, Guangzhou, China).
Association between regular proton pump inhibitors use and cardiovascular
outcomes: A large prospective cohort study. Int'l J. Cardiol.. 2024; 395:
131567-.
Haesuk Park et al. Trajectories of Oral Anticoagulation Adherence and
Associated Clinical Outcomes During Long-Term Anticoagulation Among
Medicare Beneficiaries With Venous Thromboembolism. The Annals of
Pharmacotherapy. 2023; 57 (12): 1349-1360.
Torp, Nikolaj; China, Louise; Israelsen, Mads; Krag, Aleksander; O'Brien,
Alastair. HIGH DOSES OF ALBUMIN INCREASES MORTALITY AND
COMPLICATIONS IN TERLIPRESSIN TREATED PATIENTS WITH
CIRRHOSIS: INSIGHTS FROM THE ATTIRE TRIAL. Hepatology.
2023;78(Supplement 1:S220-S221)
Fossmark, R. et al. .The impact of proton pump inhibitors on the course of
ulcerative colitis: a cohort study of over 10,000 newly diagnosed patients in
Norway.Scand. J. Gastroenterol. 2024;59(1):46-51.
Bruze, M, et al. Contact allergy to oxidised geraniol may be overrepresented in individuals with photocontact allergy to ketoprofen. Contact
Derm. 2024;90(1):79-83.
11