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資料５－４ 研究報告の報告状況 (12 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
227 オメプラゾール
228 モルヒネ塩酸塩水和物
229 プレガバリン
230
文献名
Petra Czarniak, Fariba Ahmadizar , Jeff Hughes, Richard Parsons, Maryam Kavousi, Mohammad
Ikram, Bruno H. Stricker. Proton pump inhibitors are associated with incident type 2 diabetes
mellitus in a prospective population-based cohort Study. 2022. Brit. J. Clin. Pharmacol. 88(6).27182726.
Mountasser M. Al-Mouqdad.Association between morphine exposure and impaired brain
development on term-equivalent age brain magnetic resonance imaging in very preterm
infants.Scientific reports 2022;12(1):.
Tomoyuki Yamada.Risk of Pregabalin-lnduced Hypoglycemia: Analysis of the Japanese Adverse Drug
Event Report Database.J Clin Pharmacol ;:.
ボノプラザンフマル酸塩・アモキシシリン水和物・クラ Rodriguez CL, et al. Drug interactions in hospital prescriptions in Denmark: Prevalence and
リスロマイシン
associations with adverse outcomes. Pharmacoepidemiology and drug safety. 2022;31(6):632-642
A.C. de Macedo Andrade, et al. Hydrochlorothiazide use is associated with the risk of cutaneous
テルミサルタン・アムロジピンベシル酸塩・ヒドロクロロ
and lip squamous cell carcinoma: A systematic review and meta-analysis. Europ. J. Clin. Pharmacol.
チアジド配合剤
2022;78(6):919-930.
A.C. de Macedo Andrade, et al. Hydrochlorothiazide use is associated with the risk of cutaneous
232 テルミサルタン・ヒドロクロロチアジド配合剤
and lip squamous cell carcinoma: A systematic review and meta-analysis. Europ. J. Clin. Pharmacol.
2022;78(6):919-930.
231
233 バルプロ酸ナトリウム
Valproic Acid Serum Concentration and incidence of Toxicity in Pediatric Patients
Journal of child neurology, 2022, 37(6), 461-470
オメプラゾール
234 ラベプラゾールナトリウム
ランソプラゾール
Jeong Yee, et al. Proton pump inhibitor use and hearing loss in patients with type 2 diabetes:
Evidencefrom a hospital-based case-control study and a population-based cohort study. Br. J. Clin.
Pharmacol. 2022; 88（6）:2738-46.
235 乾燥人フィブリノゲン
Association of perioperative prothrombin complex concentrate and fibrinogen concentrate
administration with thrombotic complications after liver transplantation.European Journal of
Anaesthesiology 2021;38(Suppl.59):217.
236
Wong CKH, et al. Metformin Use in Relation to Clinical Outcomes and Hyperinflammatory
アログリプチン安息香酸塩・メトホルミン塩酸塩配合
Syndrome Among COVID-19 Patients With Type 2 Diabetes: A Propensity Score Analysis of a
剤
Territory-Wide Cohort. Frontiers in Endocrinology. 2022;13:Article 810914
237 アスピリン・ボノプラザンフマル酸塩配合剤
Jiang J, et al. Effect of taking aspirin before diagnosis on the prognosis of esophageal squamous cell
carcinoma and analysis of prognostic factors. Journal of International Medical Research.
2022;50(4):DOI: 10.1177/03000605221089799
238 グリメピリド
Nehal Islam. Sulfonylureas and the Risk of Ventricular Arrhythmias Among People with Type 2
Diabetes: A Systematic Review of Observational Studies. Clin. Pharmacol. Ther. 2022; 111(6):
1248-1257.
239 乾燥ＢＣＧ膀胱内用（日本株）
Nurminen, Pertti et al. Incidence of and mortality from Bacille Calmette-Guerin (BCG) infections
after BCG instillation therapy. BJU International. 2022;129(6):737-743.
アスピリン
240 チクロピジン塩酸塩
クロピドグレル硫酸塩
ロラゼパム
241
トリアゾラム
242
フェンタニルクエン酸塩
フェンタニル
抗破傷風人免疫グロブリン
243 ｐＨ４処理酸性人免疫グロブリン
ｐＨ４処理酸性人免疫グロブリン（皮下注射）
244
Medsafe. Prescriber Update: Lorazepam, triazolam. Medsafe Website. 2022
Eroglu, T.E. Opioid use is associated with increased out-of-hospital cardiac arrest risk among 40
000-cases across two countries. Brit. J. Clin. Pharmacol. 2022;88(5):2256-2266.
Kapoor M. et al. IVIg exposure and thromboembolic event risk: cohort study using the UK Biobank.
ANZAN 2022 ASM. 10th May - 13th May 2022.
アログリプチン安息香酸塩・ピオグリタゾン塩酸塩配 Spence JD, et al. Efficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in
合剤
patients with insulin resistance. Diabetes, Obesity and Metabolism. 2022;24(6):1150-1158
245 シロリムス
246
Yuya Taguchi, et al.Gastrointestinal and Intracranial Bleeding Events After Second-Generation
Drug-Eluting Stent Implantation.Circulation Journal 2022;86(5):775-786.
Asran S, Wiesner R, Trotter J. De Novo Sirolimus and Reduced-Dose Tacrolimus Versus StandardDose Tacrolimus After Liver Transplantation: The 2000?2003 Phase II Prospective Randomized
Trial. American Journal of Transplantation. 2014;14:356-366.
Kaulen LD, et al.. Neurological autoimmune diseases following vaccinations against SARS-CoV-2: a
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子
case series.. European Journal of Neurology 2022; 29(2): 555-563.
組換えサルアデノウイルスベクター）
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8652629/pdf/ENE-9999-0.pdf
247 リドカイン塩酸塩
Paskins, Z. et al
Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic
injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel
group, three arm, randomised controlled trial
BMJ 2022, 377（8336）,e068446
248 アスピリン
Safety and efficacy of aspirin,unfractionated heparin,both,or neither during endovascular stroke
treatment(MR CLEAN-MED):an open-label,multicentre,randomised controlled trial(X68/The
Lancet/(ISSN:1474-547X);()/ 399(10329)1059-1069/(2022.3.12) )
12
（2022年4月1日～2022年7月31日）
NO
一般名
227 オメプラゾール
228 モルヒネ塩酸塩水和物
229 プレガバリン
230
文献名
Petra Czarniak, Fariba Ahmadizar , Jeff Hughes, Richard Parsons, Maryam Kavousi, Mohammad
Ikram, Bruno H. Stricker. Proton pump inhibitors are associated with incident type 2 diabetes
mellitus in a prospective population-based cohort Study. 2022. Brit. J. Clin. Pharmacol. 88(6).27182726.
Mountasser M. Al-Mouqdad.Association between morphine exposure and impaired brain
development on term-equivalent age brain magnetic resonance imaging in very preterm
infants.Scientific reports 2022;12(1):.
Tomoyuki Yamada.Risk of Pregabalin-lnduced Hypoglycemia: Analysis of the Japanese Adverse Drug
Event Report Database.J Clin Pharmacol ;:.
ボノプラザンフマル酸塩・アモキシシリン水和物・クラ Rodriguez CL, et al. Drug interactions in hospital prescriptions in Denmark: Prevalence and
リスロマイシン
associations with adverse outcomes. Pharmacoepidemiology and drug safety. 2022;31(6):632-642
A.C. de Macedo Andrade, et al. Hydrochlorothiazide use is associated with the risk of cutaneous
テルミサルタン・アムロジピンベシル酸塩・ヒドロクロロ
and lip squamous cell carcinoma: A systematic review and meta-analysis. Europ. J. Clin. Pharmacol.
チアジド配合剤
2022;78(6):919-930.
A.C. de Macedo Andrade, et al. Hydrochlorothiazide use is associated with the risk of cutaneous
232 テルミサルタン・ヒドロクロロチアジド配合剤
and lip squamous cell carcinoma: A systematic review and meta-analysis. Europ. J. Clin. Pharmacol.
2022;78(6):919-930.
231
233 バルプロ酸ナトリウム
Valproic Acid Serum Concentration and incidence of Toxicity in Pediatric Patients
Journal of child neurology, 2022, 37(6), 461-470
オメプラゾール
234 ラベプラゾールナトリウム
ランソプラゾール
Jeong Yee, et al. Proton pump inhibitor use and hearing loss in patients with type 2 diabetes:
Evidencefrom a hospital-based case-control study and a population-based cohort study. Br. J. Clin.
Pharmacol. 2022; 88（6）:2738-46.
235 乾燥人フィブリノゲン
Association of perioperative prothrombin complex concentrate and fibrinogen concentrate
administration with thrombotic complications after liver transplantation.European Journal of
Anaesthesiology 2021;38(Suppl.59):217.
236
Wong CKH, et al. Metformin Use in Relation to Clinical Outcomes and Hyperinflammatory
アログリプチン安息香酸塩・メトホルミン塩酸塩配合
Syndrome Among COVID-19 Patients With Type 2 Diabetes: A Propensity Score Analysis of a
剤
Territory-Wide Cohort. Frontiers in Endocrinology. 2022;13:Article 810914
237 アスピリン・ボノプラザンフマル酸塩配合剤
Jiang J, et al. Effect of taking aspirin before diagnosis on the prognosis of esophageal squamous cell
carcinoma and analysis of prognostic factors. Journal of International Medical Research.
2022;50(4):DOI: 10.1177/03000605221089799
238 グリメピリド
Nehal Islam. Sulfonylureas and the Risk of Ventricular Arrhythmias Among People with Type 2
Diabetes: A Systematic Review of Observational Studies. Clin. Pharmacol. Ther. 2022; 111(6):
1248-1257.
239 乾燥ＢＣＧ膀胱内用（日本株）
Nurminen, Pertti et al. Incidence of and mortality from Bacille Calmette-Guerin (BCG) infections
after BCG instillation therapy. BJU International. 2022;129(6):737-743.
アスピリン
240 チクロピジン塩酸塩
クロピドグレル硫酸塩
ロラゼパム
241
トリアゾラム
242
フェンタニルクエン酸塩
フェンタニル
抗破傷風人免疫グロブリン
243 ｐＨ４処理酸性人免疫グロブリン
ｐＨ４処理酸性人免疫グロブリン（皮下注射）
244
Medsafe. Prescriber Update: Lorazepam, triazolam. Medsafe Website. 2022
Eroglu, T.E. Opioid use is associated with increased out-of-hospital cardiac arrest risk among 40
000-cases across two countries. Brit. J. Clin. Pharmacol. 2022;88(5):2256-2266.
Kapoor M. et al. IVIg exposure and thromboembolic event risk: cohort study using the UK Biobank.
ANZAN 2022 ASM. 10th May - 13th May 2022.
アログリプチン安息香酸塩・ピオグリタゾン塩酸塩配 Spence JD, et al. Efficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in
合剤
patients with insulin resistance. Diabetes, Obesity and Metabolism. 2022;24(6):1150-1158
245 シロリムス
246
Yuya Taguchi, et al.Gastrointestinal and Intracranial Bleeding Events After Second-Generation
Drug-Eluting Stent Implantation.Circulation Journal 2022;86(5):775-786.
Asran S, Wiesner R, Trotter J. De Novo Sirolimus and Reduced-Dose Tacrolimus Versus StandardDose Tacrolimus After Liver Transplantation: The 2000?2003 Phase II Prospective Randomized
Trial. American Journal of Transplantation. 2014;14:356-366.
Kaulen LD, et al.. Neurological autoimmune diseases following vaccinations against SARS-CoV-2: a
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子
case series.. European Journal of Neurology 2022; 29(2): 555-563.
組換えサルアデノウイルスベクター）
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8652629/pdf/ENE-9999-0.pdf
247 リドカイン塩酸塩
Paskins, Z. et al
Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic
injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel
group, three arm, randomised controlled trial
BMJ 2022, 377（8336）,e068446
248 アスピリン
Safety and efficacy of aspirin,unfractionated heparin,both,or neither during endovascular stroke
treatment(MR CLEAN-MED):an open-label,multicentre,randomised controlled trial(X68/The
Lancet/(ISSN:1474-547X);()/ 399(10329)1059-1069/(2022.3.12) )
12