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資料５－４ 研究報告の報告状況 (1 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4年度第3回 12／1）《厚生労働省》 |
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研究報告の報告状況
（2022年4月1日～2022年7月31日）
NO
一般名
令和４年12月１日
令和４年度第３回
医薬品等安全対策部会
資料５－４
文献名
リスペリドン
オランザピン
1
ブロナンセリン
クエチアピンフマル酸塩
Maeshima,T.et al.
Risk of unfavorable outcomes of thromboembolism with antipsychotic drug use:analysis Using the
Japanese Adverse Drug Event Report database
臨床薬理 2022,53(1),3-10
2 クロピドグレル硫酸塩
Desai,A.et al.
Risk of GI bleeding after urgent ERCP in patients on dual anti-platelet therapy:A nationwide
poputation-based cohort study
Am.J.Gastroenterol.2021,116(Suppl.),S296
3 オクスカルバゼピン
Effect of levetiracetam and oxcarbazepine on 4-year fragility fracture risk among prepubertal and
pubertal children with epilepsy.
Whitney D, Caird M, Hurvitz E, Rajapakse C, Fedak Romanowski E.
Epilepsia. 2021 SEP;62(9):2180-2189.
4 アルプラゾラム
Noh, Y.. First-trimester exposure to benzodiazepines and risk of congenital malformations in
offspring: A population-based cohort study in South Korea. PLoS medicine. 2022;19(3):e1003945
5 アセトアミノフェン
6 トラスツズマブ（遺伝子組換え）［後続３］
Chao Zeng, Lynn Rosenberg, Xiaoxiao Li, et al. Sodium-containing acetaminophen and
cardiovascular outcomes in individuals with and without hypertension. European Heart Journal.
2022; 0(0): 1-14.
Yang, H.. Risk of heart disease following treatment for breast cancer: results from a populationbased cohort study. eLife. 2022;11
7 ボリコナゾール
Hendrix, M.. Voriconacole Versus Itraconazole for the Initial and Step-down Treatment of
Histoplasmosis: A Retrospective Cohort. Clinical infectious disease: an official publication of the
Infectious Diseases. 2021;73(11):e3727-e3732
8 ノルアドレナリン
Klitgaard TL, et al..Lower versus higher oxygenation targets in critically ill patients with severe
hypoxaemia: secondary Bayesian analysis to explore heterogeneous treatment effects in the
Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial.British journal of
anaesthesia.2022;128(1):55-64.
9 クロピドグレル硫酸塩
Effects of the CYP2C19 LoF allele on major adverse cardiovascular events assosiated with
clopidogrel in acute coronary syndrome patients undergoing percutaneous coronary intervention: a
meta-analysis
M Biswas, C Sukasem, MS Khatun Kali, B Ibrahim
Pharmacogenomics. 2022 Feb;23(3):207-220
10 ハロペリドール
Fife D, et al.. Stroke Risk Among Non-Elderly Users of Haloperidol or First-Generation
Antipsychotics vs Second-Generation Antipsychotics: A Cohort Study from a US Health Insurance
Claims Database.. Drugs - Real World Outcomes. 2021;8(4):481-496
11 トラマドール塩酸塩・アセトアミノフェン配合剤
Tarar, Z.I. et al.. Non-alcoholic fatty liver disease is associated with worse outcomes in hospitalized
patients with acetaminophen toxicity: A retrospective cohort study. Am. J. Gastroenterol.. 2021;
116(Suppl.): S509-.
12 トラマドール塩酸塩・アセトアミノフェン配合剤
Bowie, A.C. et al. Prescribed opioid analgesics in early pregnancy and the risk of congenital
anomalies: a population-based cohort study.
CMAJ 2022;194(5):E152-E162.
13 乾燥ＢＣＧワクチン
Chua N, et al. A systematic review of live vaccine outcomes in infants exposed to biologic disease
modifying anti-rheumatic medications (DMARDs) in-utero. Rheumatology (Oxford). 2022 Mar
8;keac141. doi: 10.1093/rheumatology/keac141.
14
リスペリドン
オランザピン
Rahman, T. et al.. Risk of breast cancer with prolactin elevating antipsychotic drugs: an
observational study of US women (ages 18-64 years). J. Clin. Psychopharmacol.. 2022; 42(1): 7-16.
フェノバルビタール
15 フェニトイン
カルバマゼピン
Neuropsychological effects in children exposed to anticonvulsant monotherapy during gestation:
Phenobarbital, carbamazepine, and phenytoin
Epilepsy & behavior, 2022, 127, 108533
16 クロピドグレル硫酸塩
Desai, A. et al. (MetroHealth Medical Center, OH., USA). Comparison of post-ERCP GI bleeding
between patients on dual anti-platelet therapy and aspirin alone: A nationwide population-based
cohort study. Am. J. Gastroenterol.. 2021; 116(Suppl.): S296-S297-.
クロピドグレル硫酸塩
17
ランソプラゾール
Kim, B.J. et al. (Chung-Ang University College of Medicine, Seoul, Korea). Systematic review with
meta-analysis: influence of individual proton pump inhibitors on clinical outcomes in patients
receiving clopidogrel following percutaneous coronary intervention. Am. J. Gastroenterol.. 2021;
116(Suppl.): S292-.
18 アセトアミノフェン
Tarar, Z.I. et al. (University of Missouri School of Medicine, MO., USA). Non-alcoholic fatty liver
disease is associated with worse outcomes in hospitalized patients with acetaminophen toxicity: A
retrospective cohort study. Am. J. Gastroenterol.. 2021; 116(Suppl.): S509-.
19 エタネルセプト（遺伝子組換え）［後続１］
Tumor Necrosis Factor Inhibitors and the Risk of Cancer among Older Americans with Rheumatoid
Arthritis
Monica E. D’Arcy, Daniel C. Beachler, Ruth M. Pfeiffer, Jeffrey R. Curtis, Xavier Mariette,
Raphaele Seror, Parag Mahale, Donna R. Rivera, Elizabeth L. Yanik, and Eric A. Engels
Cancer Epidemiology, Biomarkers & Prevention 30,11 2059-2067 2021
20 アルテプラーゼ（遺伝子組換え）
Lindsey R. Kuohn B.A., Alison L. Herman B.A., Alexandria L. Soto B.S., Emily J. Gilmore M.D.,
Kevin N. Sheth M.D., Jennifer A. Kim M.D.Ph.D., Stacy C. Brown M. D., Lawrence J. Hirsch M.
D., et.al.. Hospital Revisits for Post-Ischemic Stroke Epilepsy after Acute Stroke Interventions.
Journal of Stroke and Cerebrovascular Diseases. 2022;31(1):1-11
1
（2022年4月1日～2022年7月31日）
NO
一般名
令和４年12月１日
令和４年度第３回
医薬品等安全対策部会
資料５－４
文献名
リスペリドン
オランザピン
1
ブロナンセリン
クエチアピンフマル酸塩
Maeshima,T.et al.
Risk of unfavorable outcomes of thromboembolism with antipsychotic drug use:analysis Using the
Japanese Adverse Drug Event Report database
臨床薬理 2022,53(1),3-10
2 クロピドグレル硫酸塩
Desai,A.et al.
Risk of GI bleeding after urgent ERCP in patients on dual anti-platelet therapy:A nationwide
poputation-based cohort study
Am.J.Gastroenterol.2021,116(Suppl.),S296
3 オクスカルバゼピン
Effect of levetiracetam and oxcarbazepine on 4-year fragility fracture risk among prepubertal and
pubertal children with epilepsy.
Whitney D, Caird M, Hurvitz E, Rajapakse C, Fedak Romanowski E.
Epilepsia. 2021 SEP;62(9):2180-2189.
4 アルプラゾラム
Noh, Y.. First-trimester exposure to benzodiazepines and risk of congenital malformations in
offspring: A population-based cohort study in South Korea. PLoS medicine. 2022;19(3):e1003945
5 アセトアミノフェン
6 トラスツズマブ（遺伝子組換え）［後続３］
Chao Zeng, Lynn Rosenberg, Xiaoxiao Li, et al. Sodium-containing acetaminophen and
cardiovascular outcomes in individuals with and without hypertension. European Heart Journal.
2022; 0(0): 1-14.
Yang, H.. Risk of heart disease following treatment for breast cancer: results from a populationbased cohort study. eLife. 2022;11
7 ボリコナゾール
Hendrix, M.. Voriconacole Versus Itraconazole for the Initial and Step-down Treatment of
Histoplasmosis: A Retrospective Cohort. Clinical infectious disease: an official publication of the
Infectious Diseases. 2021;73(11):e3727-e3732
8 ノルアドレナリン
Klitgaard TL, et al..Lower versus higher oxygenation targets in critically ill patients with severe
hypoxaemia: secondary Bayesian analysis to explore heterogeneous treatment effects in the
Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial.British journal of
anaesthesia.2022;128(1):55-64.
9 クロピドグレル硫酸塩
Effects of the CYP2C19 LoF allele on major adverse cardiovascular events assosiated with
clopidogrel in acute coronary syndrome patients undergoing percutaneous coronary intervention: a
meta-analysis
M Biswas, C Sukasem, MS Khatun Kali, B Ibrahim
Pharmacogenomics. 2022 Feb;23(3):207-220
10 ハロペリドール
Fife D, et al.. Stroke Risk Among Non-Elderly Users of Haloperidol or First-Generation
Antipsychotics vs Second-Generation Antipsychotics: A Cohort Study from a US Health Insurance
Claims Database.. Drugs - Real World Outcomes. 2021;8(4):481-496
11 トラマドール塩酸塩・アセトアミノフェン配合剤
Tarar, Z.I. et al.. Non-alcoholic fatty liver disease is associated with worse outcomes in hospitalized
patients with acetaminophen toxicity: A retrospective cohort study. Am. J. Gastroenterol.. 2021;
116(Suppl.): S509-.
12 トラマドール塩酸塩・アセトアミノフェン配合剤
Bowie, A.C. et al. Prescribed opioid analgesics in early pregnancy and the risk of congenital
anomalies: a population-based cohort study.
CMAJ 2022;194(5):E152-E162.
13 乾燥ＢＣＧワクチン
Chua N, et al. A systematic review of live vaccine outcomes in infants exposed to biologic disease
modifying anti-rheumatic medications (DMARDs) in-utero. Rheumatology (Oxford). 2022 Mar
8;keac141. doi: 10.1093/rheumatology/keac141.
14
リスペリドン
オランザピン
Rahman, T. et al.. Risk of breast cancer with prolactin elevating antipsychotic drugs: an
observational study of US women (ages 18-64 years). J. Clin. Psychopharmacol.. 2022; 42(1): 7-16.
フェノバルビタール
15 フェニトイン
カルバマゼピン
Neuropsychological effects in children exposed to anticonvulsant monotherapy during gestation:
Phenobarbital, carbamazepine, and phenytoin
Epilepsy & behavior, 2022, 127, 108533
16 クロピドグレル硫酸塩
Desai, A. et al. (MetroHealth Medical Center, OH., USA). Comparison of post-ERCP GI bleeding
between patients on dual anti-platelet therapy and aspirin alone: A nationwide population-based
cohort study. Am. J. Gastroenterol.. 2021; 116(Suppl.): S296-S297-.
クロピドグレル硫酸塩
17
ランソプラゾール
Kim, B.J. et al. (Chung-Ang University College of Medicine, Seoul, Korea). Systematic review with
meta-analysis: influence of individual proton pump inhibitors on clinical outcomes in patients
receiving clopidogrel following percutaneous coronary intervention. Am. J. Gastroenterol.. 2021;
116(Suppl.): S292-.
18 アセトアミノフェン
Tarar, Z.I. et al. (University of Missouri School of Medicine, MO., USA). Non-alcoholic fatty liver
disease is associated with worse outcomes in hospitalized patients with acetaminophen toxicity: A
retrospective cohort study. Am. J. Gastroenterol.. 2021; 116(Suppl.): S509-.
19 エタネルセプト（遺伝子組換え）［後続１］
Tumor Necrosis Factor Inhibitors and the Risk of Cancer among Older Americans with Rheumatoid
Arthritis
Monica E. D’Arcy, Daniel C. Beachler, Ruth M. Pfeiffer, Jeffrey R. Curtis, Xavier Mariette,
Raphaele Seror, Parag Mahale, Donna R. Rivera, Elizabeth L. Yanik, and Eric A. Engels
Cancer Epidemiology, Biomarkers & Prevention 30,11 2059-2067 2021
20 アルテプラーゼ（遺伝子組換え）
Lindsey R. Kuohn B.A., Alison L. Herman B.A., Alexandria L. Soto B.S., Emily J. Gilmore M.D.,
Kevin N. Sheth M.D., Jennifer A. Kim M.D.Ph.D., Stacy C. Brown M. D., Lawrence J. Hirsch M.
D., et.al.. Hospital Revisits for Post-Ischemic Stroke Epilepsy after Acute Stroke Interventions.
Journal of Stroke and Cerebrovascular Diseases. 2022;31(1):1-11
1