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資料３－４ 研究報告の報告状況 (7 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4回 3／2）《厚生労働省》 |
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研究報告の報告状況
（2022年8月1日～2022年11月30日）
NO
一般名
153 イバブラジン塩酸塩
154 ベタメタゾン・ｄ－クロルフェニラミンマレイン酸塩
155 テオフィリン
156 ジゴキシン
157 プロゲステロン
158 ランソプラゾール
159 アスピリン・ダイアルミネート
160 テガフール・ウラシル
文献名
Lin YS, et al..Ivabradine in heart failure patients with reduced ejection fraction and history
of paroxysmal atrial fibrillation.ESC Heart Failure.2022;9:4:2548-2557
Rakers, F et al. (Jena University Hospital, Jena, Germany). Association between antenatal
glucocorticoid exposure and the activity of the stress system, cognition, and behavior in
8- to 9-year-old children: A prospective observational study. Acta Obstet. Gynecol.
Scand. 2022; 101(9): 996-1006-.
Okada A, Sera S, Taguchi M, Yamada H, Nagai N. Analysis of drug adverse events in
elderly patients based on the Japanese Adverse Drug Event Report Database. J Clin
Pharma Ther. 2022;47:1264-69
Bugiardini R, et al..Concerns about the use of digoxin in acute coronary
syndromes..European heart journal. Cardiovascular pharmacotherapy 2022;8(5):474-482.
Aspasia Louta et al. THE RELATIONSHIP BETWEEN CEFTRIAXONE AND BILIARY
LITHIASIS (CHOLELITIASIS) AND URINARY TRACT LITHIASIS (NEPHROLITHIASIS)
IN CHILDREN. 14th Panhellenic Scientific & Professional Nursing Congress of the
Hellenic Nurses Association (HNA).2021;153.
Ayako Watanabe et al, Biological ＆ pharmaceutical Bulletin,45(9)1373-1377(2022),
Identification of the Components of Proton Pump Inhibitors and Potassium-Competitive
Acid Blocker That Lead to Cardiovascular Events in Working-Age Individuals A 12Month Retros
Effect of aspirin on cancer incidence and mortality in older adults
McNeil, J.J. et al. (Monash University, Victoria, Australia)
J. Nat'l Cancer Instit. 113(3),258-265,2021
Huang W. Risk of cardiovascular disease among different fluoropyrimidine-based
chemotherapy regimens as adjuvant treatment for resected colorectal cancer. Frontiers in
Cardiovascular Medicine. 2022 Aug 03;
リラグルチド（遺伝子組換え）
João Sérgio Neves, et al. Risk of Adverse Events with Liraglutide in HFrEF: A post-hoc
161 インスリン デグルデク（遺伝子組換え）・リラグルチド（遺伝子
analysis of the FIGHT trial. Diabetes Obes Metab. 2022; online, in press
組換え）配合剤
Al-Herz, Waleed et al. BCG Vaccine-associated Complications in a Large Cohort of
162 乾燥ＢＣＧワクチン
Children With Combined Immunodeficiencies Affecting Cellular and Humoral Immunity.
The Pediatric infectious disease journal (Sep 7, 2022).
Kunihiro Nakada, Arinori Yoshida, Hiroki Sugie, Yasushi Furuta, Masayuki Sakurai.
Secondary primary malignancies in thyroid cancer survivors treated by radioiodine 1-131.
163 ヨウ化ナトリウム（１３１Ｉ）
Is it really linked with radioiodine therapy? an experience in a single center. 核医学. The
13th Congress of the World Federation of Nuclear Medicine and
Biology(2022.9.7,8,9,10,11,12,13). 2022;59(S)S170-S170
Hye-Rim Kang et al. Effectiveness and Safety of Extended Oral Anticoagulant Therapy in
164 ワルファリンカリウム
Patients with Venous Thromboembolism:A Retrospective Cohort Study. Clinical
Pharmacology and Therapeutics 2022;112(1):133-145.
Wang YW, et al. Meta-analysis of the association between new hypoglycemic agents and
digestive diseases. Medicine. 2022; 26: 101(34):e30072
Rehfeld JF, et.al Cholecystokinin secretion is suppressed by glucagon-like peptide-1: clue
to the mechanism of the adverse gallbladder events of GLP-1-derived drugs. Scandinavian
リラグルチド（遺伝子組換え）
journal of gastroenterology. 2018;53(12):1429-32.
インスリン デグルデク（遺伝子組換え）・リラグルチド（遺伝子
165
Smits MM, et al. Biliary effects of liraglutide and sitagliptin, a 12-week randomized
組換え）配合剤
placebo-controlled trial in type 2 diabetes patients. Diabetes Obes Metab.
セマグルチド（遺伝子組換え）
2016;18(12):1217-25.
Nexoe-Larsen CC, et al. Effects of liraglutide on gallbladder emptying: A randomized,
placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab.
2018;20(11):2557-64.
166 ハロペリドール
167 アスピリン
168
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子組換え
サルアデノウイルスベクター）
169 セルペルカチニブ
Chen WL, et al.. Haloperidol and Other Antipsychotics Exposure before Endometrial
Cancer Diagnosis: A Population-based Case-control Study. Clinical Psychopharmacology
and Neuroscience. 2022;20(3):526-535
Yi-Cheng Lin.Antiplatelet therapy for primary prevention of cardiovascular disease in
chronic kidney disease and type 2 diabetes.Journal of the American College of Cardiology.
2022;79(9,Suppl.A):1524.
Tamborska AA, et al.. Guillain-Barre syndrome following SARS-CoV-2 vaccination in the
UK: A prospective surveillance study. BMJ Neurology Open 2022; 4(2): 000309-.
Suspected Guillain-Barre syndrome or peripheral neuropathy following administration of
COVID-19 vaccine
Or Kalchiem-Dekel, et al.. Brief Report: Chylothorax and Chylous Ascites During RET
Tyrosine Kinase Inhibitor Therapy. Journal of Thoracic Oncology. 2022;17:1130-1136
アトルバスタチンカルシウム水和物
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（１）
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（２）
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物 Karadas, B. et al. Pregnancy outcomes following maternal exposure to statins: A
170
配合剤（３）
systematic review and meta-analysis. Brit. J. Clin. Pharmacol. 2022, 88(9), 3962-3976
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（４）
プラバスタチンナトリウム
シンバスタチン
ロスバスタチンカルシウム
171
バンコマイシン塩酸塩
アシクロビル
Kim, J.Y. et al. Risk factors for vancomycin-associated acute kidney injury: A systematic
review and meta-analysis. Brit. J. Clin. Pharmacol. 2022, 88(9), 3977-3989
172 オキサプロジン
Gideon Koren.et.al_. Nonsteroidal antiinflammatory drugs during third trimester and the
risk of premature closure of the ductus arteriosus: a meta-analysis. 2006; 40(5): 824-829.
173 ロルノキシカム
Gideon Koren.et.al_. Nonsteroidal antiinflammatory drugs during third trimester and the
risk of premature closure of the ductus arteriosus: a meta-analysis. 2006; 40(5): 824-829.
7
（2022年8月1日～2022年11月30日）
NO
一般名
153 イバブラジン塩酸塩
154 ベタメタゾン・ｄ－クロルフェニラミンマレイン酸塩
155 テオフィリン
156 ジゴキシン
157 プロゲステロン
158 ランソプラゾール
159 アスピリン・ダイアルミネート
160 テガフール・ウラシル
文献名
Lin YS, et al..Ivabradine in heart failure patients with reduced ejection fraction and history
of paroxysmal atrial fibrillation.ESC Heart Failure.2022;9:4:2548-2557
Rakers, F et al. (Jena University Hospital, Jena, Germany). Association between antenatal
glucocorticoid exposure and the activity of the stress system, cognition, and behavior in
8- to 9-year-old children: A prospective observational study. Acta Obstet. Gynecol.
Scand. 2022; 101(9): 996-1006-.
Okada A, Sera S, Taguchi M, Yamada H, Nagai N. Analysis of drug adverse events in
elderly patients based on the Japanese Adverse Drug Event Report Database. J Clin
Pharma Ther. 2022;47:1264-69
Bugiardini R, et al..Concerns about the use of digoxin in acute coronary
syndromes..European heart journal. Cardiovascular pharmacotherapy 2022;8(5):474-482.
Aspasia Louta et al. THE RELATIONSHIP BETWEEN CEFTRIAXONE AND BILIARY
LITHIASIS (CHOLELITIASIS) AND URINARY TRACT LITHIASIS (NEPHROLITHIASIS)
IN CHILDREN. 14th Panhellenic Scientific & Professional Nursing Congress of the
Hellenic Nurses Association (HNA).2021;153.
Ayako Watanabe et al, Biological ＆ pharmaceutical Bulletin,45(9)1373-1377(2022),
Identification of the Components of Proton Pump Inhibitors and Potassium-Competitive
Acid Blocker That Lead to Cardiovascular Events in Working-Age Individuals A 12Month Retros
Effect of aspirin on cancer incidence and mortality in older adults
McNeil, J.J. et al. (Monash University, Victoria, Australia)
J. Nat'l Cancer Instit. 113(3),258-265,2021
Huang W. Risk of cardiovascular disease among different fluoropyrimidine-based
chemotherapy regimens as adjuvant treatment for resected colorectal cancer. Frontiers in
Cardiovascular Medicine. 2022 Aug 03;
リラグルチド（遺伝子組換え）
João Sérgio Neves, et al. Risk of Adverse Events with Liraglutide in HFrEF: A post-hoc
161 インスリン デグルデク（遺伝子組換え）・リラグルチド（遺伝子
analysis of the FIGHT trial. Diabetes Obes Metab. 2022; online, in press
組換え）配合剤
Al-Herz, Waleed et al. BCG Vaccine-associated Complications in a Large Cohort of
162 乾燥ＢＣＧワクチン
Children With Combined Immunodeficiencies Affecting Cellular and Humoral Immunity.
The Pediatric infectious disease journal (Sep 7, 2022).
Kunihiro Nakada, Arinori Yoshida, Hiroki Sugie, Yasushi Furuta, Masayuki Sakurai.
Secondary primary malignancies in thyroid cancer survivors treated by radioiodine 1-131.
163 ヨウ化ナトリウム（１３１Ｉ）
Is it really linked with radioiodine therapy? an experience in a single center. 核医学. The
13th Congress of the World Federation of Nuclear Medicine and
Biology(2022.9.7,8,9,10,11,12,13). 2022;59(S)S170-S170
Hye-Rim Kang et al. Effectiveness and Safety of Extended Oral Anticoagulant Therapy in
164 ワルファリンカリウム
Patients with Venous Thromboembolism:A Retrospective Cohort Study. Clinical
Pharmacology and Therapeutics 2022;112(1):133-145.
Wang YW, et al. Meta-analysis of the association between new hypoglycemic agents and
digestive diseases. Medicine. 2022; 26: 101(34):e30072
Rehfeld JF, et.al Cholecystokinin secretion is suppressed by glucagon-like peptide-1: clue
to the mechanism of the adverse gallbladder events of GLP-1-derived drugs. Scandinavian
リラグルチド（遺伝子組換え）
journal of gastroenterology. 2018;53(12):1429-32.
インスリン デグルデク（遺伝子組換え）・リラグルチド（遺伝子
165
Smits MM, et al. Biliary effects of liraglutide and sitagliptin, a 12-week randomized
組換え）配合剤
placebo-controlled trial in type 2 diabetes patients. Diabetes Obes Metab.
セマグルチド（遺伝子組換え）
2016;18(12):1217-25.
Nexoe-Larsen CC, et al. Effects of liraglutide on gallbladder emptying: A randomized,
placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab.
2018;20(11):2557-64.
166 ハロペリドール
167 アスピリン
168
コロナウイルス（ＳＡＲＳ－ＣｏＶ－２）ワクチン（遺伝子組換え
サルアデノウイルスベクター）
169 セルペルカチニブ
Chen WL, et al.. Haloperidol and Other Antipsychotics Exposure before Endometrial
Cancer Diagnosis: A Population-based Case-control Study. Clinical Psychopharmacology
and Neuroscience. 2022;20(3):526-535
Yi-Cheng Lin.Antiplatelet therapy for primary prevention of cardiovascular disease in
chronic kidney disease and type 2 diabetes.Journal of the American College of Cardiology.
2022;79(9,Suppl.A):1524.
Tamborska AA, et al.. Guillain-Barre syndrome following SARS-CoV-2 vaccination in the
UK: A prospective surveillance study. BMJ Neurology Open 2022; 4(2): 000309-.
Suspected Guillain-Barre syndrome or peripheral neuropathy following administration of
COVID-19 vaccine
Or Kalchiem-Dekel, et al.. Brief Report: Chylothorax and Chylous Ascites During RET
Tyrosine Kinase Inhibitor Therapy. Journal of Thoracic Oncology. 2022;17:1130-1136
アトルバスタチンカルシウム水和物
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（１）
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（２）
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物 Karadas, B. et al. Pregnancy outcomes following maternal exposure to statins: A
170
配合剤（３）
systematic review and meta-analysis. Brit. J. Clin. Pharmacol. 2022, 88(9), 3962-3976
アムロジピンベシル酸塩・アトルバスタチンカルシウム水和物
配合剤（４）
プラバスタチンナトリウム
シンバスタチン
ロスバスタチンカルシウム
171
バンコマイシン塩酸塩
アシクロビル
Kim, J.Y. et al. Risk factors for vancomycin-associated acute kidney injury: A systematic
review and meta-analysis. Brit. J. Clin. Pharmacol. 2022, 88(9), 3977-3989
172 オキサプロジン
Gideon Koren.et.al_. Nonsteroidal antiinflammatory drugs during third trimester and the
risk of premature closure of the ductus arteriosus: a meta-analysis. 2006; 40(5): 824-829.
173 ロルノキシカム
Gideon Koren.et.al_. Nonsteroidal antiinflammatory drugs during third trimester and the
risk of premature closure of the ductus arteriosus: a meta-analysis. 2006; 40(5): 824-829.
7