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資料５－４ 研究報告の報告状況 (7 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_29460.html |
| 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
120 アスピリン・ボノプラザンフマル酸塩配合剤
121
モンテルカストナトリウム
ロスバスタチンカルシウム
122 イマチニブメシル酸塩
123 トラマドール塩酸塩・アセトアミノフェン配合剤
124 トラマドール塩酸塩・アセトアミノフェン配合剤
125 ラタノプロスト
文献名
Xie J, et al. The risk of aspirin and prednisone using in women with antithyroid antibodies
undergoing assisted reproductive technology. (37th Annual Meeting of the European Society of
Human Reproduction and Embryology, ESHRE 2021. Virtual. Abst no. P-757). Human
Reproduction. 2021;36(SUPPL 1):i481-i482
Deshayes, S. et al.. A worldwide pharmacoepidemiologic update on drug-induced antineutrophil
cytoplasmic antibody-associated vasculitis in the era of targeted therapies. Arthritis Rheumatol..
2022; 74(1): 134-139.
Maekawa, K. et al. Impacts of SNPs on adverse events and trough concentration of imatinib in
patients with gastrointestinal stromal tumors.
Drug Metabol. Pharmacokin. 2022;43:100441.
Eroglu, T.E. et al. 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.
Montastruc, J.-L. et al. Drug-induced hypohidrosis and anhidrosis: analysis of the WHO
pharmacovigilance database 2000-2020.
Europ. J. Clin. Pharmacol. 2022;78(5):887-889.
Wu, J.-H. et al., Ocular surface disease in glaucoma patients randomized to benzalkonium chloridecontaining latanoprost and preservative-free bimatoprost, J. Ocular Pharmacol. Ther. 37(10),556564,2021
126 メコバラミン
Pakpoom Ruangsomboon, et al. No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After
Total Knee Arthroplasty. A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial.
JBJS Open Access 2022:e22.
127 乾燥スルホ化人免疫グロブリン
畠 星羅 ほか.自己免疫性神経筋疾患での免疫グロブリン大量静注療法の副作用による汗疱の出
現頻度.臨床神経学 2022;62(4):267-271.
レボフロキサシン水和物
モキシフロキサシン塩酸塩
Creadore A, Desai S, Alloo A, Dewan AK, Bakhtiar M, Cruz-Diaz C et al. Clinical characteristics,
disease course, and outcomes of patients with acute generalized exanthematous pustulosis in the
US. JAMA Dermatol. 2022;158(2):176-83.
128
129 トラマドール塩酸塩・アセトアミノフェン配合剤
Talip E. Eroglu.Opioid use is associated with increased out-of-hospital cardiac arrest risk among
40 000-cases across two countrie.British Journal of Clinical Pharmacology. 2022;88(5):2256-2266.
130 レボフロキサシン水和物
Liao SH, et al.. Risk for hypoglycemic emergency with levofloxacin use, a population-based
propensity score matched nested case-control study.. PLoS One. 2022; 17(4): e0266471-.
131 ジヒドロコデインリン酸塩含有一般用医薬品
Talip E. Eroglu 他. Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries. Br J Clin Pharmacol. 2022;88:2256-2266
132 アロプリノール
Ha PTT, Tran QB, Chu CH, Nga DTQ, Nguyen HA, Nguyen DV, Phung TH. Allopurinol-induced
severe cutaneous adverse reactions in Vietnamese: the role of HLA alleles and other risk factors.
Pharmacogenomics. 2022;23:303-313
133 ミルタザピン
134 アリスキレンフマル酸塩
135 ミルタザピン
136
モンテルカストナトリウム
ロスバスタチンカルシウム
Joseph RM, et al.. The risk of all-cause and cause-specific mortality in people prescribed
mirtazapine: an active comparator cohort study using electronic health records. BMC Med. 2022;
20(1): 43-.
ジスバルカプセル_使用上の注意における相互作用の記載
ジスバルカプセル40mg添付文書
ラジレス錠１５０ｍｇ添付文書_新記載要領第1版
Joseph RM, et al.. The risk of all-cause and cause-specific mortality in people prescribed
mirtazapine: an active comparator cohort study using electronic health records. BMC Med. 2022;
20(1): 43-.
Deshayes,S. et al.
A worldwide pharmacoepidemiologic update on drug-induced antineutrophil cytoplasmic antibodyassociated vasculitis in the era of targeted therapies
Arthritis Rheumatol. 2022,74(1),134-139
137 セボフルラン
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
138 プロポフォール
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
139 ミダゾラム
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
140 モルヒネ塩酸塩水和物
Alaee, Elham.Prenatal exposure to morphine impairs attention and impulsivity in adult
rats.Psychopharmacology 2021;238(10):2729-2741.
141 セルトラリン塩酸塩
Dev Rie, C.. A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart
Defects of Antidepressant Classes and Individual Antidepressant. Drug Safety. 2021;44:291-312
142 酸化マグネシウム
吉野俊平.緊急血液透析を要した重度高マグネシウム血症に関する記述疫学的研究.日本集中治療
医学会(49);2022.
143 フェニトイン
Intravenous lacosamide and phenytoin for the treatment of acute exacerbations of trigeminal
neuralgia: A retrospective analysis of 144 cases. Cephalalgia, 2022, Apr 26, 3331024221092435
144 パロキセチン塩酸塩水和物
Dev Rie, C.. A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart
Defects of Antidepressant Classes and Individual Antidepressant. Drug Safety. 2021;44:291-312
7
（2022年4月1日～2022年7月31日）
NO
一般名
120 アスピリン・ボノプラザンフマル酸塩配合剤
121
モンテルカストナトリウム
ロスバスタチンカルシウム
122 イマチニブメシル酸塩
123 トラマドール塩酸塩・アセトアミノフェン配合剤
124 トラマドール塩酸塩・アセトアミノフェン配合剤
125 ラタノプロスト
文献名
Xie J, et al. The risk of aspirin and prednisone using in women with antithyroid antibodies
undergoing assisted reproductive technology. (37th Annual Meeting of the European Society of
Human Reproduction and Embryology, ESHRE 2021. Virtual. Abst no. P-757). Human
Reproduction. 2021;36(SUPPL 1):i481-i482
Deshayes, S. et al.. A worldwide pharmacoepidemiologic update on drug-induced antineutrophil
cytoplasmic antibody-associated vasculitis in the era of targeted therapies. Arthritis Rheumatol..
2022; 74(1): 134-139.
Maekawa, K. et al. Impacts of SNPs on adverse events and trough concentration of imatinib in
patients with gastrointestinal stromal tumors.
Drug Metabol. Pharmacokin. 2022;43:100441.
Eroglu, T.E. et al. 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.
Montastruc, J.-L. et al. Drug-induced hypohidrosis and anhidrosis: analysis of the WHO
pharmacovigilance database 2000-2020.
Europ. J. Clin. Pharmacol. 2022;78(5):887-889.
Wu, J.-H. et al., Ocular surface disease in glaucoma patients randomized to benzalkonium chloridecontaining latanoprost and preservative-free bimatoprost, J. Ocular Pharmacol. Ther. 37(10),556564,2021
126 メコバラミン
Pakpoom Ruangsomboon, et al. No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After
Total Knee Arthroplasty. A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial.
JBJS Open Access 2022:e22.
127 乾燥スルホ化人免疫グロブリン
畠 星羅 ほか.自己免疫性神経筋疾患での免疫グロブリン大量静注療法の副作用による汗疱の出
現頻度.臨床神経学 2022;62(4):267-271.
レボフロキサシン水和物
モキシフロキサシン塩酸塩
Creadore A, Desai S, Alloo A, Dewan AK, Bakhtiar M, Cruz-Diaz C et al. Clinical characteristics,
disease course, and outcomes of patients with acute generalized exanthematous pustulosis in the
US. JAMA Dermatol. 2022;158(2):176-83.
128
129 トラマドール塩酸塩・アセトアミノフェン配合剤
Talip E. Eroglu.Opioid use is associated with increased out-of-hospital cardiac arrest risk among
40 000-cases across two countrie.British Journal of Clinical Pharmacology. 2022;88(5):2256-2266.
130 レボフロキサシン水和物
Liao SH, et al.. Risk for hypoglycemic emergency with levofloxacin use, a population-based
propensity score matched nested case-control study.. PLoS One. 2022; 17(4): e0266471-.
131 ジヒドロコデインリン酸塩含有一般用医薬品
Talip E. Eroglu 他. Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries. Br J Clin Pharmacol. 2022;88:2256-2266
132 アロプリノール
Ha PTT, Tran QB, Chu CH, Nga DTQ, Nguyen HA, Nguyen DV, Phung TH. Allopurinol-induced
severe cutaneous adverse reactions in Vietnamese: the role of HLA alleles and other risk factors.
Pharmacogenomics. 2022;23:303-313
133 ミルタザピン
134 アリスキレンフマル酸塩
135 ミルタザピン
136
モンテルカストナトリウム
ロスバスタチンカルシウム
Joseph RM, et al.. The risk of all-cause and cause-specific mortality in people prescribed
mirtazapine: an active comparator cohort study using electronic health records. BMC Med. 2022;
20(1): 43-.
ジスバルカプセル_使用上の注意における相互作用の記載
ジスバルカプセル40mg添付文書
ラジレス錠１５０ｍｇ添付文書_新記載要領第1版
Joseph RM, et al.. The risk of all-cause and cause-specific mortality in people prescribed
mirtazapine: an active comparator cohort study using electronic health records. BMC Med. 2022;
20(1): 43-.
Deshayes,S. et al.
A worldwide pharmacoepidemiologic update on drug-induced antineutrophil cytoplasmic antibodyassociated vasculitis in the era of targeted therapies
Arthritis Rheumatol. 2022,74(1),134-139
137 セボフルラン
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
138 プロポフォール
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
139 ミダゾラム
M. Partanen.Longitudinal associations between exposure to anesthesia and neurocognitive
functioning in pediatric medulloblastoma.European Journal of Cancer. 2021;148:103-111.
140 モルヒネ塩酸塩水和物
Alaee, Elham.Prenatal exposure to morphine impairs attention and impulsivity in adult
rats.Psychopharmacology 2021;238(10):2729-2741.
141 セルトラリン塩酸塩
Dev Rie, C.. A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart
Defects of Antidepressant Classes and Individual Antidepressant. Drug Safety. 2021;44:291-312
142 酸化マグネシウム
吉野俊平.緊急血液透析を要した重度高マグネシウム血症に関する記述疫学的研究.日本集中治療
医学会(49);2022.
143 フェニトイン
Intravenous lacosamide and phenytoin for the treatment of acute exacerbations of trigeminal
neuralgia: A retrospective analysis of 144 cases. Cephalalgia, 2022, Apr 26, 3331024221092435
144 パロキセチン塩酸塩水和物
Dev Rie, C.. A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart
Defects of Antidepressant Classes and Individual Antidepressant. Drug Safety. 2021;44:291-312
7