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資料２－４ 研究報告の報告状況 (11 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3年度 第3回 3／11）《厚生労働省》 |
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研究報告の報告状況
(2021年8月1日～2021年11月30日)
NO 一般名
文献名
Causality assessment between reported fatal cerebral haemorrhage and suspected drugs : developing a
new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and
259 クロピドグレル硫酸塩
literature review
Europ. J. Clin. Pharmacol. 2021,77(10),1443-1452
Kang,X. et al.
テガフール・ギメラシル・オテラシ
260
A cross-sectional study of chemotherapy-related AKI
ルカリウム配合剤
Europ. J. Clin. Pharmacol. 2021,77(10),1503-1512
Torsade de pointes associated with chloroquine, hydroxychloroquine, and azithromycin : a retrospective
261 アジスロマイシン水和物
analysis of individual case safety reports from VigiBase
Europ. J. Clin. Pharmacol. 2021,77(10),1513-1521
Drugs and Dupuytren's disease : a pharmacovigilance study in VigiBase
262 バルプロ酸ナトリウム
Europ. J. Clin. Pharmacol. 2021,77(10),1587-1588
Secinti KD et al., Pregabalin does not Cause Midline Closure Defect but is not as Innocent as It is
263 プレガバリン
Thought., Turk Neurosurg. 2021;31(4):594-600.
Secinti IE et al., Retinal teratogenicity of pregabalin in chick embryo model., Cutan Ocul Toxicol. 2020
264 プレガバリン
Dec;39(4):304-310.
アヘン
アヘンチンキ
Rashidian H, et al. Association between opium use and bladder cancer: A case-control study in a high
265
アヘン・トコン
risk area of Iran. Clinical Epidemiology and Global Health. 2021;11:100772(Article #)
アヘンアルカロイド塩酸塩
Risk factors for the development of idiopathic pneumonia syndrome after HCT. 第83回 日本血液学会学
266 ブスルファン
術集会(Web). 2021;00(00):PS-44-1
トラマドール塩酸塩・アセトアミノ Akhtar, Muhammad Furqan.Maternotoxicity and fetotoxicity in Rattus norvegicus albinus exposed to
267
フェン配合剤
tramadol during the late phase of pregnancy.Birth Defects Research 2021;:1-15.
Shamiss, Y..Perioperative management of oral anticoagulants in cardiac surgery, when is the optimal stop
268 アスピリン
time.Journal of the American College of Cardiology. 2021;77(18,Suppl.1):1190.
ラベプラゾールナトリウム
Zhou, J. et al.. Proton pump inhibitor or famotidine use and severe COVID-19 disease: a propensity
269
ファモチジン
score-matched territory-wide study. Gut. 2021; 70(10): 2012-2013.
Deng Tuo, et al. Association Between 5-Alpha Reductase Inhibitor Use and The Risk of Depression: A
270 デュタステリド
Meta-Analysis. Urol J. 2020 Aug 23;18(2):144-150.
ブデソニド
Zexiong Li MM，Yesheng Ling MD，Qian Chen MM，Bingyuan Wu MD，Long Peng MD，Jinlai
グリコピロニウム臭化物
Liu MD，Suhua Li MD，Xixiang Tang MD. CLINICAL STUDY Inhaled Beta2－Agonists Increase
271
ホルモテロールフマル酸塩水和 In－Hospital Mortality in ICU Patients with Heart Failure A Real－World Propensity Score－
物
Matched Study. International Heart Journal 2021; 62(5): 1076-1082.
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
ブデソニド・ホルモテロールフマ
272
with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
ル酸塩水和物
2021; 62(5): 1076-1082.
グリコピロニウム臭化物
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
273 ホルモテロールフマル酸塩水和 with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
物
2021; 62(5): 1076-1082.
Risk of major adverse cardiovascular events for concomitant use of clopidogrel and proton pump
inhibitors in patients inheriting CYP2C19 loss-of-function alleles: meta-analys
274 クロピドグレル硫酸塩
Biswas M, Rahaman S, Biswas TK, lbrahim B.
Int J Clin Pharm. 2021 Oct;43(5):1360-1369.
The Prognostic Effect of Dexamethasone on Patients With Glioblastoma: A Systematic Review and Meta275 デキサメタゾン
Analysis.. Frontiers in Pharmacology.
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
ホルモテロールフマル酸塩水和
276
with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
物
2021; 62(5): 1076-1082.
Linda B. Ou et al. Domperidone and the risks of sudden cardiac death and ventricular arrhythmia: A
277 ドンペリドン
systematic review and meta-analysis of observational studies. Br. J. Clin. Pharmacol. 87（10）3649－3658
／（2021．10）
ゾルピデム酒石酸塩
Szmulewicz, A. et al.. The risk of overdose with concomitant use of Z-drugs and prescription opioids: A
278 トラマドール塩酸塩・アセトアミノ
population-based cohort study. Am. J. Psychiat.. 2021; 178(7): 643-650.
フェン配合剤
エストラジオール・酢酸ノルエチ
Liu Q. Menopausal hormone therapies and risk of colorectal cancer: a Swedish matched-cohort study.
279 ステロン
Alimentary Pharmacology & Therapeutics. 2021;53(11):1216-1225.
エストラジオール
Bercaire, L.. The impact of letrozole administration on oocyte morphology in breast cancer patients
280 レトロゾール
undergoing fertility preservation. JBRA assisted reproduction. 2020;24(3):257-264
Tsakiridis T, et al..Metformin in Combination with Chemoradiotherapy in Locally Advanced Non-Small
281 メトホルミン塩酸塩
Cell Lung Cancer: The OCOG-ALMERA Randomized Clinical Trial..JAMA Oncology 2021;7(9):13331341.
Guo D, et al. Association between vedolizumab and postoperative complications in IBD:a systematic
282 ベドリズマブ（遺伝子組換え）
review and meta-analysis. International Journal of Colorectal Disease. 2021;36:2081-2092
Huang KH, et al.. Pneumonia risk associated with the use of individual benzodiazepines and
エスゾピクロン
283
benzodiazepine related drugs among the elderly with parkinson's disease.. International Journal of
フルニトラゼパム
Environmental Research and Public Health. 2021; 18(17): 9410-9410.
ロサルタンカリウム・ヒドロクロロチ Schneider, R. et al..Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
284
アジド
study using an active comparator group.Brit. J. Dermatol. 2021;185(2):343-352.
Stokes, Sarah C et al. Preliminary Evaluation of a Novel Fetal Guinea Pig Myelomeningocele Model.
285 トレチノイン
BioMed research international. 2021; 2021: 2180883.
11
(2021年8月1日～2021年11月30日)
NO 一般名
文献名
Causality assessment between reported fatal cerebral haemorrhage and suspected drugs : developing a
new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and
259 クロピドグレル硫酸塩
literature review
Europ. J. Clin. Pharmacol. 2021,77(10),1443-1452
Kang,X. et al.
テガフール・ギメラシル・オテラシ
260
A cross-sectional study of chemotherapy-related AKI
ルカリウム配合剤
Europ. J. Clin. Pharmacol. 2021,77(10),1503-1512
Torsade de pointes associated with chloroquine, hydroxychloroquine, and azithromycin : a retrospective
261 アジスロマイシン水和物
analysis of individual case safety reports from VigiBase
Europ. J. Clin. Pharmacol. 2021,77(10),1513-1521
Drugs and Dupuytren's disease : a pharmacovigilance study in VigiBase
262 バルプロ酸ナトリウム
Europ. J. Clin. Pharmacol. 2021,77(10),1587-1588
Secinti KD et al., Pregabalin does not Cause Midline Closure Defect but is not as Innocent as It is
263 プレガバリン
Thought., Turk Neurosurg. 2021;31(4):594-600.
Secinti IE et al., Retinal teratogenicity of pregabalin in chick embryo model., Cutan Ocul Toxicol. 2020
264 プレガバリン
Dec;39(4):304-310.
アヘン
アヘンチンキ
Rashidian H, et al. Association between opium use and bladder cancer: A case-control study in a high
265
アヘン・トコン
risk area of Iran. Clinical Epidemiology and Global Health. 2021;11:100772(Article #)
アヘンアルカロイド塩酸塩
Risk factors for the development of idiopathic pneumonia syndrome after HCT. 第83回 日本血液学会学
266 ブスルファン
術集会(Web). 2021;00(00):PS-44-1
トラマドール塩酸塩・アセトアミノ Akhtar, Muhammad Furqan.Maternotoxicity and fetotoxicity in Rattus norvegicus albinus exposed to
267
フェン配合剤
tramadol during the late phase of pregnancy.Birth Defects Research 2021;:1-15.
Shamiss, Y..Perioperative management of oral anticoagulants in cardiac surgery, when is the optimal stop
268 アスピリン
time.Journal of the American College of Cardiology. 2021;77(18,Suppl.1):1190.
ラベプラゾールナトリウム
Zhou, J. et al.. Proton pump inhibitor or famotidine use and severe COVID-19 disease: a propensity
269
ファモチジン
score-matched territory-wide study. Gut. 2021; 70(10): 2012-2013.
Deng Tuo, et al. Association Between 5-Alpha Reductase Inhibitor Use and The Risk of Depression: A
270 デュタステリド
Meta-Analysis. Urol J. 2020 Aug 23;18(2):144-150.
ブデソニド
Zexiong Li MM，Yesheng Ling MD，Qian Chen MM，Bingyuan Wu MD，Long Peng MD，Jinlai
グリコピロニウム臭化物
Liu MD，Suhua Li MD，Xixiang Tang MD. CLINICAL STUDY Inhaled Beta2－Agonists Increase
271
ホルモテロールフマル酸塩水和 In－Hospital Mortality in ICU Patients with Heart Failure A Real－World Propensity Score－
物
Matched Study. International Heart Journal 2021; 62(5): 1076-1082.
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
ブデソニド・ホルモテロールフマ
272
with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
ル酸塩水和物
2021; 62(5): 1076-1082.
グリコピロニウム臭化物
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
273 ホルモテロールフマル酸塩水和 with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
物
2021; 62(5): 1076-1082.
Risk of major adverse cardiovascular events for concomitant use of clopidogrel and proton pump
inhibitors in patients inheriting CYP2C19 loss-of-function alleles: meta-analys
274 クロピドグレル硫酸塩
Biswas M, Rahaman S, Biswas TK, lbrahim B.
Int J Clin Pharm. 2021 Oct;43(5):1360-1369.
The Prognostic Effect of Dexamethasone on Patients With Glioblastoma: A Systematic Review and Meta275 デキサメタゾン
Analysis.. Frontiers in Pharmacology.
CLINICAL STUDY Inhaled Beta2－Agonists Increase In－Hospital Mortality in ICU Patients
ホルモテロールフマル酸塩水和
276
with Heart Failure A Real－World Propensity Score－Matched Study. International Heart Journal
物
2021; 62(5): 1076-1082.
Linda B. Ou et al. Domperidone and the risks of sudden cardiac death and ventricular arrhythmia: A
277 ドンペリドン
systematic review and meta-analysis of observational studies. Br. J. Clin. Pharmacol. 87（10）3649－3658
／（2021．10）
ゾルピデム酒石酸塩
Szmulewicz, A. et al.. The risk of overdose with concomitant use of Z-drugs and prescription opioids: A
278 トラマドール塩酸塩・アセトアミノ
population-based cohort study. Am. J. Psychiat.. 2021; 178(7): 643-650.
フェン配合剤
エストラジオール・酢酸ノルエチ
Liu Q. Menopausal hormone therapies and risk of colorectal cancer: a Swedish matched-cohort study.
279 ステロン
Alimentary Pharmacology & Therapeutics. 2021;53(11):1216-1225.
エストラジオール
Bercaire, L.. The impact of letrozole administration on oocyte morphology in breast cancer patients
280 レトロゾール
undergoing fertility preservation. JBRA assisted reproduction. 2020;24(3):257-264
Tsakiridis T, et al..Metformin in Combination with Chemoradiotherapy in Locally Advanced Non-Small
281 メトホルミン塩酸塩
Cell Lung Cancer: The OCOG-ALMERA Randomized Clinical Trial..JAMA Oncology 2021;7(9):13331341.
Guo D, et al. Association between vedolizumab and postoperative complications in IBD:a systematic
282 ベドリズマブ（遺伝子組換え）
review and meta-analysis. International Journal of Colorectal Disease. 2021;36:2081-2092
Huang KH, et al.. Pneumonia risk associated with the use of individual benzodiazepines and
エスゾピクロン
283
benzodiazepine related drugs among the elderly with parkinson's disease.. International Journal of
フルニトラゼパム
Environmental Research and Public Health. 2021; 18(17): 9410-9410.
ロサルタンカリウム・ヒドロクロロチ Schneider, R. et al..Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
284
アジド
study using an active comparator group.Brit. J. Dermatol. 2021;185(2):343-352.
Stokes, Sarah C et al. Preliminary Evaluation of a Novel Fetal Guinea Pig Myelomeningocele Model.
285 トレチノイン
BioMed research international. 2021; 2021: 2180883.
11