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資料３－４ 研究報告の報告状況［790KB］ (2 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会（令和5年度第2回 11／30）《厚生労働省》 |
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研究報告の報告状況
（2023年4月1日～ 2023年7月31日）
25 オキシコドン塩酸塩水和物
26 ジクロフェナクナトリウム
27 乾燥ＢＣＧ膀胱内用（日本株）
28 ペマフィブラート
29 メトホルミン塩酸塩
30
インドメタシン
インドメタシン含有一般用医薬品
31 シルデナフィルクエン酸塩
32 トラマドール塩酸塩・アセトアミノフェン配合剤
33 トピラマート
34 バルプロ酸ナトリウム
35 リツキシマブ（遺伝子組換え）
36 ロサルタンカリウム
37 アドレナリン
38 メトトレキサート
39 レベチラセタム
40 リツキシマブ（遺伝子組換え）［後続２］
41 ジクロフェナクナトリウム
42 グルカゴン（遺伝子組換え）
43 メトトレキサート
44 トラマドール塩酸塩・アセトアミノフェン配合剤
45 硝酸イソソルビド
46 オメプラゾール
47 アスピリン・ボノプラザンフマル酸塩配合剤
48 アレンドロン酸ナトリウム水和物
49
ジクロフェナクナトリウム
ジクロフェナクナトリウム含有一般用医薬品
イブプロフェンピコノール
イブプロフェンピコノール含有一般用医薬品
Omoto T, et al.. Identifying risk factors for opioid-induced neurotoxicity in cancer patients
receiving oxycodone. Supportive care in cancer : official journal of the Multinational
Association of Supportive Care in Cancer. 2023; 31(4): 208-DOI:10.1007/s00520-02307676-9.
Bonkovsky, H. et al..Drug-induced liver injury (DILI) ascribed to non-steroidal antiinflammatory drugs (NSAIDs) in the USA: An update with genetic correlations from the U.S.
Drug-Induced Liver Injury Network (DILIN).Am. J. Gastroenterol. 2022;117(Suppl.):S874S875.
Ni, Beibei et al.Analysis on clinical features of granulomatous hepatitis induced by
intravesical instillation with Bacillus Calmette-Guerin vaccine.Adverse Drug Reactions
Journal 2022;24(5):252-257.
【社内資料】Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN
patiENts with diabeTes (PROMINENT)
Wang, Zikun.Diabetes, metformin use and risk of non-Hodgkin's lymphoma in
postmenopausal women: A prospective cohort analysis in the Women's Health
Initiative.International journal of cancer 2023;152(8):1556-1569.
飛田和 えりか. 極低出生体重児における急性腎不全の検討. 日本小児科学会雑誌.
2023;127(2):222.
Lui, Jason L; Shaw, Nathan M; Abbasi, Behzad; Hakam, Nizar; Breyer, Benjamin N. Adverse
reactions of pde5 inhibitors: An analysis of the world health organization pharmacovigilance
database. Andrology. 2023.
Maquet, J. et al. Drug-induced autoimmune hemolytic anemia: Detection of new signals in
the world pharmacovigilance database and risk assessment in a nationwide cohort study in
France.
Blood. 2022;140(Suppl.1):8176-8177.
Jacqueline M. Cohen, PhD , Silje Alvestad, MD, PhD, Carolyn E. Cesta, PhD,Marte-Helene
Bjork, MD, PhD,Maarit K. Leinonen, MD, PhD ,Mette Norgaard, MD, PhD, Kristjana
Einarsdottir, PhD, Anders Engeland. Comparative Safety of Antiseizure Medication
Monotherapy for Major Malformations. ANN NEUROL. 2023;93:551-562
Jacqueline M. Cohen, PhD , Silje Alvestad, MD, PhD, Carolyn E. Cesta, PhD,Marte-Helene
Bjork, MD, PhD,Maarit K. Leinonen, MD, PhD ,Mette Norgaard, MD, PhD, Kristjana
Einarsdottir, PhD, Anders Engeland. Comparative Safety of Antiseizure Medication
Monotherapy for Major Malformations. ANN NEUROL. 2023;93:551-562
Matsuda, Tsuyoshi、Mochizuki, Yasushi、Mukae, Yuta、Nakanishi, Hiromi、Mitsunar（以下
略）.A Retrospective Study on the Malignancies after Renal Transplantation.泌尿器科紀要
2023;69(2):33-39.
Zadeh, A.V. et al. RAS inhibition is associated with higher risk of 60-day COVID-19induced myocarditis. Circulation 2022;146(Suppl.1):A13037.
Li M, Cui Y, Ning S, Chen X, Li J. Analysis of perioperative risk factors for seizures in
children with congenital heart disease following cardiopulmonary bypass. [Chinese]. ChineseJ-Appl-Clin-Pediatr. 2021;36(1):14-18
Use of methotrexate and risk of skin cancer a nationwide case-control study
Belete, D. et al. (Queen Mary University of London, London, UK). Association between
antiepileptic drugs and incident Parkinson disease. JAMA Neurol.. 2023; 80(2): 183-187-.
Barzegar, M.. Effectiveness of BBIBP-CorV vaccine in preventing SARS-CoV2 infection and
severe outcomes in people living with multiple sclerosis: A population-based study. Multiple
sclerosis and related disorders. 2023;71:104548
Schmidt, M. et al..Dose-dependency of diclofenac's cardiovascular risks: a series of
nationwide emulated trials.ジクロフェナクの心血管リスクの用量依存性：一連の全国的な模擬
試験.Europ. Heart J. 2022;43(Suppl.2):2730.
Henrik TC, et al. Continuous intravenous glucagon in children with congenital
hyperinsulinism: A retrospective single center evaluation of effects and adverse effects. Horm
Res Paediatr 2023; 96 (suppl 2): 93.
豕瀬諒,その他. 生産年齢人口の関節リウマチ患者における悪性腫瘍の発現リスクの評価: 大
規模保険請求情報を用いた後方視的検討. 日本臨床腫瘍薬学会学術大会2023(2023.3.4,5)/
愛知県名古屋市:162
Association between opioid-related deaths and persistent opioid prescribing in primary care
in England: A nested case-control study
Chen, T.-C. et al. (University of Manchester, Manchester, UK)
Brit. J. Clin. Pharmacol. 88(2),798-809,2022
Ji Bak Kim，Seung－Woon Rha，Byoung Geol Choi. ORIGINAL ARTICLE Prognostic
impact of nitrate therapy in patients with myocardial bridge and coexisting coronary
artery spasm. Heart and Vessels. 2023; 38(3): 291-299.
M.S.Ritvos,M.Rasanen,S.Hayrynen,J.I.Kiiski,M.Niemi,J.Sinisalo.CYP2C19 loss-of-function
alleles and the use of omeprazole or esomeprazole increase the risk of cardiovascular
outcomes in patients using clopidogrel - a real-world study.2022.Pharmacology and
Pharmacotherapy - Pharmacogenetics.43(Suppl.2).2725-2725.
Wang M, et al. Benefits and Risks Associated with Low-Dose Aspirin Use for the Primary
Prevention of Cardiovascular Disease: A Systematic Review and Meta-Analysis of
Randomized Control Trials and Trial Sequential Analysis. American Journal of Cardiovascular
Drugs. 2022;22(6):657-675
Thakre A,et al.. A REAL-WORLD DISPROPORTIONALITY ANALYSIS OF ATRIAL
FIBRILLATION ADVERSE EVENTS ASSOCIATED WITH BISPHOSPHONATES.. Journal of
the American College of Cardiology. 2023; 81(8 Supplement): 86-86.
Holt, A. Risk of heart failure following short-term non-steroidal anti-inflammatory drug use
in patients with type 2 diabetes mellitus. Europ. Heart J. 2022;43(S2): 802Holt, A. et al. Heart failure following anti-inflammatory medications in patients with type 2
diabetes mellitus. J. Am. Coll. Cardiol.2023;81(15):1459-1470.
2 / 12
（2023年4月1日～ 2023年7月31日）
25 オキシコドン塩酸塩水和物
26 ジクロフェナクナトリウム
27 乾燥ＢＣＧ膀胱内用（日本株）
28 ペマフィブラート
29 メトホルミン塩酸塩
30
インドメタシン
インドメタシン含有一般用医薬品
31 シルデナフィルクエン酸塩
32 トラマドール塩酸塩・アセトアミノフェン配合剤
33 トピラマート
34 バルプロ酸ナトリウム
35 リツキシマブ（遺伝子組換え）
36 ロサルタンカリウム
37 アドレナリン
38 メトトレキサート
39 レベチラセタム
40 リツキシマブ（遺伝子組換え）［後続２］
41 ジクロフェナクナトリウム
42 グルカゴン（遺伝子組換え）
43 メトトレキサート
44 トラマドール塩酸塩・アセトアミノフェン配合剤
45 硝酸イソソルビド
46 オメプラゾール
47 アスピリン・ボノプラザンフマル酸塩配合剤
48 アレンドロン酸ナトリウム水和物
49
ジクロフェナクナトリウム
ジクロフェナクナトリウム含有一般用医薬品
イブプロフェンピコノール
イブプロフェンピコノール含有一般用医薬品
Omoto T, et al.. Identifying risk factors for opioid-induced neurotoxicity in cancer patients
receiving oxycodone. Supportive care in cancer : official journal of the Multinational
Association of Supportive Care in Cancer. 2023; 31(4): 208-DOI:10.1007/s00520-02307676-9.
Bonkovsky, H. et al..Drug-induced liver injury (DILI) ascribed to non-steroidal antiinflammatory drugs (NSAIDs) in the USA: An update with genetic correlations from the U.S.
Drug-Induced Liver Injury Network (DILIN).Am. J. Gastroenterol. 2022;117(Suppl.):S874S875.
Ni, Beibei et al.Analysis on clinical features of granulomatous hepatitis induced by
intravesical instillation with Bacillus Calmette-Guerin vaccine.Adverse Drug Reactions
Journal 2022;24(5):252-257.
【社内資料】Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN
patiENts with diabeTes (PROMINENT)
Wang, Zikun.Diabetes, metformin use and risk of non-Hodgkin's lymphoma in
postmenopausal women: A prospective cohort analysis in the Women's Health
Initiative.International journal of cancer 2023;152(8):1556-1569.
飛田和 えりか. 極低出生体重児における急性腎不全の検討. 日本小児科学会雑誌.
2023;127(2):222.
Lui, Jason L; Shaw, Nathan M; Abbasi, Behzad; Hakam, Nizar; Breyer, Benjamin N. Adverse
reactions of pde5 inhibitors: An analysis of the world health organization pharmacovigilance
database. Andrology. 2023.
Maquet, J. et al. Drug-induced autoimmune hemolytic anemia: Detection of new signals in
the world pharmacovigilance database and risk assessment in a nationwide cohort study in
France.
Blood. 2022;140(Suppl.1):8176-8177.
Jacqueline M. Cohen, PhD , Silje Alvestad, MD, PhD, Carolyn E. Cesta, PhD,Marte-Helene
Bjork, MD, PhD,Maarit K. Leinonen, MD, PhD ,Mette Norgaard, MD, PhD, Kristjana
Einarsdottir, PhD, Anders Engeland. Comparative Safety of Antiseizure Medication
Monotherapy for Major Malformations. ANN NEUROL. 2023;93:551-562
Jacqueline M. Cohen, PhD , Silje Alvestad, MD, PhD, Carolyn E. Cesta, PhD,Marte-Helene
Bjork, MD, PhD,Maarit K. Leinonen, MD, PhD ,Mette Norgaard, MD, PhD, Kristjana
Einarsdottir, PhD, Anders Engeland. Comparative Safety of Antiseizure Medication
Monotherapy for Major Malformations. ANN NEUROL. 2023;93:551-562
Matsuda, Tsuyoshi、Mochizuki, Yasushi、Mukae, Yuta、Nakanishi, Hiromi、Mitsunar（以下
略）.A Retrospective Study on the Malignancies after Renal Transplantation.泌尿器科紀要
2023;69(2):33-39.
Zadeh, A.V. et al. RAS inhibition is associated with higher risk of 60-day COVID-19induced myocarditis. Circulation 2022;146(Suppl.1):A13037.
Li M, Cui Y, Ning S, Chen X, Li J. Analysis of perioperative risk factors for seizures in
children with congenital heart disease following cardiopulmonary bypass. [Chinese]. ChineseJ-Appl-Clin-Pediatr. 2021;36(1):14-18
Use of methotrexate and risk of skin cancer a nationwide case-control study
Belete, D. et al. (Queen Mary University of London, London, UK). Association between
antiepileptic drugs and incident Parkinson disease. JAMA Neurol.. 2023; 80(2): 183-187-.
Barzegar, M.. Effectiveness of BBIBP-CorV vaccine in preventing SARS-CoV2 infection and
severe outcomes in people living with multiple sclerosis: A population-based study. Multiple
sclerosis and related disorders. 2023;71:104548
Schmidt, M. et al..Dose-dependency of diclofenac's cardiovascular risks: a series of
nationwide emulated trials.ジクロフェナクの心血管リスクの用量依存性：一連の全国的な模擬
試験.Europ. Heart J. 2022;43(Suppl.2):2730.
Henrik TC, et al. Continuous intravenous glucagon in children with congenital
hyperinsulinism: A retrospective single center evaluation of effects and adverse effects. Horm
Res Paediatr 2023; 96 (suppl 2): 93.
豕瀬諒,その他. 生産年齢人口の関節リウマチ患者における悪性腫瘍の発現リスクの評価: 大
規模保険請求情報を用いた後方視的検討. 日本臨床腫瘍薬学会学術大会2023(2023.3.4,5)/
愛知県名古屋市:162
Association between opioid-related deaths and persistent opioid prescribing in primary care
in England: A nested case-control study
Chen, T.-C. et al. (University of Manchester, Manchester, UK)
Brit. J. Clin. Pharmacol. 88(2),798-809,2022
Ji Bak Kim，Seung－Woon Rha，Byoung Geol Choi. ORIGINAL ARTICLE Prognostic
impact of nitrate therapy in patients with myocardial bridge and coexisting coronary
artery spasm. Heart and Vessels. 2023; 38(3): 291-299.
M.S.Ritvos,M.Rasanen,S.Hayrynen,J.I.Kiiski,M.Niemi,J.Sinisalo.CYP2C19 loss-of-function
alleles and the use of omeprazole or esomeprazole increase the risk of cardiovascular
outcomes in patients using clopidogrel - a real-world study.2022.Pharmacology and
Pharmacotherapy - Pharmacogenetics.43(Suppl.2).2725-2725.
Wang M, et al. Benefits and Risks Associated with Low-Dose Aspirin Use for the Primary
Prevention of Cardiovascular Disease: A Systematic Review and Meta-Analysis of
Randomized Control Trials and Trial Sequential Analysis. American Journal of Cardiovascular
Drugs. 2022;22(6):657-675
Thakre A,et al.. A REAL-WORLD DISPROPORTIONALITY ANALYSIS OF ATRIAL
FIBRILLATION ADVERSE EVENTS ASSOCIATED WITH BISPHOSPHONATES.. Journal of
the American College of Cardiology. 2023; 81(8 Supplement): 86-86.
Holt, A. Risk of heart failure following short-term non-steroidal anti-inflammatory drug use
in patients with type 2 diabetes mellitus. Europ. Heart J. 2022;43(S2): 802Holt, A. et al. Heart failure following anti-inflammatory medications in patients with type 2
diabetes mellitus. J. Am. Coll. Cardiol.2023;81(15):1459-1470.
2 / 12