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資料3-4 研究報告の報告状況[877KB] (13 ページ)
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出典情報 | 薬事審議会 医薬品等安全対策部会(令和6年度第1回 6/19)《厚生労働省》 |
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研究報告の報告状況
(2023年12月1日~2024年3月31日)
239 ロサルタンカリウム・ヒドロクロロチアジド配合剤
240 バルプロ酸ナトリウム
241 アセトアミノフェン
242 ラベプラゾールナトリウム
243 メカセルミン(遺伝子組換え)
244 ゾルピデム酒石酸塩
245 エソメプラゾールマグネシウム水和物
トラマドール塩酸塩・アセトアミノフェン配合剤
エチゾラム
246 ブロチゾラム
ゾルピデム酒石酸塩
プレガバリン
Jianwen Sun, Chaoxiong Zhang, Xinhao Su, Haoyun Zhou, Siyun Zhou, Minjie
Jiang, Binbo Fang. Several first-line anti-hypertensives act on fibrosarcoma
progression and PD1ab blockade therapy. Journal of Orthopaedic Surgery
and Research. 2024;19(1):147.
Jackson BL, et al. Investigating the effects of valproic acid on placental
epigenetic modifications and development in the CD-1 mouse model.
Reproductive Toxicology. 2024;124:1-8
Maquet, Julien,Lafaurie, Margaux,Michel, Marc,Lapeyre-Mestre, Maryse,
Moulis, Guillaume.Drug-induced immune hemolytic anemia: detection of new
signals and risk assessment in a nationwide cohort study.Blood Advances
2024;8(3):817-826.
Hyun Jin Song. Proton pump inhibitors associated with an increased risk of
mortality in elderly: a systematic review and meta-analysis. Eur. J. Clin.
Pharmacol.. 2024; 80(3): 367-382.
Higher levels of insulin-like growth factor-1 in cord blood associate with risk
of asthma at age 3 - PubMed.pdf
Castaneda, J.M. et al. (University of Washington, WA., USA). Risks of
zolpidem among patients with chronic obstructive pulmonary disease. Ann.
Am. Thorac. Soc. 2024; 21(1): 68-75-.
Geng, T. , et al. Proton Pump Inhibitor Use and Risks of Cardiovascular
Disease and Mortality in Patients With Type 2 Diabetes. The Journal of
Clinical Endocrinology & Metabolism 2023 ; 108(6): e216‐e222
Hamina, A. et al. Fatal drug overdoses in individuals treated
pharmacologically for chronic pain: a nationwide register-based study. Brit.
J. Anaesth. 2024; 132(1): 86-95.
Haiyang Zhang et al. Assistance of next-generation sequencing for diagnosis
of disseminated Bacillus Calmette-Guerin disease with X-SCID in an infant: a
247 乾燥BCGワクチン
case report and literature review. Frontiers in cellular and infection
microbiology 2024;14:1341236. (Feb 12, 2024). DOI:
http://dx.doi.org/10.3389/fcimb.2024.1341236
Castaneda, J.M. et al.『Risks of zolpidem among patients with chronic
248 ゾルピデム酒石酸塩
obstructive pulmonary disease』Ann. Am. Thorac. Soc. 2024;21(1),68-75
Morciano C, et al. Post-marketing active surveillance of Guillain Barre
Syndrome following COVID-19 vaccination in persons aged .gtoreq.12 years
コロナウイルス(SARS-CoV-2)ワクチン(遺伝子組換え
249
in Italy: A multi-database self-controlled case series study. PloS one 2024;
サルアデノウイルスベクター)
19(1): 0290879-.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798452/
Faksova K, Walsh D, Jiang Y, Griffin J, Phillips A, Gentile A, et. al.. COVID19 vaccines and adverse events of special interest: A multinational Global
250 コロナウイルス(SARS-CoV-2)RNAワクチン*
Vaccine Data Network (GVDN) cohort study of 99 million vaccinated
individuals. Vaccines (Basel). 2024;UNK:UNK
Hyun Jin Song.Hyun Ju Seo.Xinyi Jiang.Nakyung Jeon.Yoon Jae Lee.In Hyuk
Ha. Proton pump inhibitors associated with an increased risk of mortality in
251 オメプラゾール
elderly: a systematic review and meta-analysis.Europ. J. Clin. Pharmacol.
2024;80(3):367-382.
Liang Tian,et al. Regular use of paracetamol and risk of liver cancer: a
252 アセトアミノフェン
prospective cohort study.BMC Cancer 2024;24(1).
Reconsidering repurposing: long-term metformin treatment impairs cognition
253 メトホルミン塩酸塩
in Alzheimer’s model mice Translational Psychiatry (2024) 14:34 ;
https://doi.org/10.1038/s41398-024-02755-9 So Yeon Cho, et.al
254 コロナウイルス(SARS-CoV-2)RNAワクチン*
255 レベチラセタム
256 アロプリノール
クエチアピンフマル酸塩
257 パロキセチン塩酸塩水和物
フルボキサミンマレイン酸塩
258
クロラムフェニコール
トブラマイシン
259 プラバスタチンナトリウム
260 プレガバリン
伊藤 澄信. 新型コロナワクチンの投与開始初期の重点的調査(コホート調査)
Hoeltzenbein, M. et al. (Charite Universitatsmedizin Berlin, Berlin,
Germany). Antiepileptic treatment with levetiracetam during the first
trimester and pregnancy outcome: An observational study. Epilepsia. 2024;
65(1): 26-36-.
Nicoletti, P. et al. (Icahn School of Medicine at Mount Sinai, NY., USA).
HLA-B*53:01 is a significant risk factor of liver injury due to phenytoin
and other antiepileptic drugs in African Americans. Am. J. Gastroenterol..
2024; 119(1): 200-202-.
Hiroki Morishita. P-Glycoprotein-Mediated Interaction Is a Risk Factor for
QT Prolongation in Concomitant Use of Antipsychotics and SSRIs as PGlycoprotein-Mediated Inhibitors: Analysis of the Japanese Adverse Drug
Event Report Database. The Journal of Clinical Pharmacology. 2024; 64(1):
118-224.
Su-hsun Liu et al. Antibiotics Versus Placebo for Acute Bacterial
Conjunctivitis: Findings From a Cochrane Systematic Review. Am. J.
Ophthalmol. 2024;257:143-153.
Wu Tingxi et al. Pregnancy-related adverse events associated with statins: a
real-world pharmacovigilance study of the FDA Adverse Event Reporting
System (FAERS). Expert Opinion on Drug Safety.2024;23;3: 313-321.
Mestre VF et al., Pregabalin alters reproductive performance in male mice
and causes congenital anomalies in offspring, Reprod Fertil Dev. 2023
Nov;35(18):750-759.
13
(2023年12月1日~2024年3月31日)
239 ロサルタンカリウム・ヒドロクロロチアジド配合剤
240 バルプロ酸ナトリウム
241 アセトアミノフェン
242 ラベプラゾールナトリウム
243 メカセルミン(遺伝子組換え)
244 ゾルピデム酒石酸塩
245 エソメプラゾールマグネシウム水和物
トラマドール塩酸塩・アセトアミノフェン配合剤
エチゾラム
246 ブロチゾラム
ゾルピデム酒石酸塩
プレガバリン
Jianwen Sun, Chaoxiong Zhang, Xinhao Su, Haoyun Zhou, Siyun Zhou, Minjie
Jiang, Binbo Fang. Several first-line anti-hypertensives act on fibrosarcoma
progression and PD1ab blockade therapy. Journal of Orthopaedic Surgery
and Research. 2024;19(1):147.
Jackson BL, et al. Investigating the effects of valproic acid on placental
epigenetic modifications and development in the CD-1 mouse model.
Reproductive Toxicology. 2024;124:1-8
Maquet, Julien,Lafaurie, Margaux,Michel, Marc,Lapeyre-Mestre, Maryse,
Moulis, Guillaume.Drug-induced immune hemolytic anemia: detection of new
signals and risk assessment in a nationwide cohort study.Blood Advances
2024;8(3):817-826.
Hyun Jin Song. Proton pump inhibitors associated with an increased risk of
mortality in elderly: a systematic review and meta-analysis. Eur. J. Clin.
Pharmacol.. 2024; 80(3): 367-382.
Higher levels of insulin-like growth factor-1 in cord blood associate with risk
of asthma at age 3 - PubMed.pdf
Castaneda, J.M. et al. (University of Washington, WA., USA). Risks of
zolpidem among patients with chronic obstructive pulmonary disease. Ann.
Am. Thorac. Soc. 2024; 21(1): 68-75-.
Geng, T. , et al. Proton Pump Inhibitor Use and Risks of Cardiovascular
Disease and Mortality in Patients With Type 2 Diabetes. The Journal of
Clinical Endocrinology & Metabolism 2023 ; 108(6): e216‐e222
Hamina, A. et al. Fatal drug overdoses in individuals treated
pharmacologically for chronic pain: a nationwide register-based study. Brit.
J. Anaesth. 2024; 132(1): 86-95.
Haiyang Zhang et al. Assistance of next-generation sequencing for diagnosis
of disseminated Bacillus Calmette-Guerin disease with X-SCID in an infant: a
247 乾燥BCGワクチン
case report and literature review. Frontiers in cellular and infection
microbiology 2024;14:1341236. (Feb 12, 2024). DOI:
http://dx.doi.org/10.3389/fcimb.2024.1341236
Castaneda, J.M. et al.『Risks of zolpidem among patients with chronic
248 ゾルピデム酒石酸塩
obstructive pulmonary disease』Ann. Am. Thorac. Soc. 2024;21(1),68-75
Morciano C, et al. Post-marketing active surveillance of Guillain Barre
Syndrome following COVID-19 vaccination in persons aged .gtoreq.12 years
コロナウイルス(SARS-CoV-2)ワクチン(遺伝子組換え
249
in Italy: A multi-database self-controlled case series study. PloS one 2024;
サルアデノウイルスベクター)
19(1): 0290879-.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798452/
Faksova K, Walsh D, Jiang Y, Griffin J, Phillips A, Gentile A, et. al.. COVID19 vaccines and adverse events of special interest: A multinational Global
250 コロナウイルス(SARS-CoV-2)RNAワクチン*
Vaccine Data Network (GVDN) cohort study of 99 million vaccinated
individuals. Vaccines (Basel). 2024;UNK:UNK
Hyun Jin Song.Hyun Ju Seo.Xinyi Jiang.Nakyung Jeon.Yoon Jae Lee.In Hyuk
Ha. Proton pump inhibitors associated with an increased risk of mortality in
251 オメプラゾール
elderly: a systematic review and meta-analysis.Europ. J. Clin. Pharmacol.
2024;80(3):367-382.
Liang Tian,et al. Regular use of paracetamol and risk of liver cancer: a
252 アセトアミノフェン
prospective cohort study.BMC Cancer 2024;24(1).
Reconsidering repurposing: long-term metformin treatment impairs cognition
253 メトホルミン塩酸塩
in Alzheimer’s model mice Translational Psychiatry (2024) 14:34 ;
https://doi.org/10.1038/s41398-024-02755-9 So Yeon Cho, et.al
254 コロナウイルス(SARS-CoV-2)RNAワクチン*
255 レベチラセタム
256 アロプリノール
クエチアピンフマル酸塩
257 パロキセチン塩酸塩水和物
フルボキサミンマレイン酸塩
258
クロラムフェニコール
トブラマイシン
259 プラバスタチンナトリウム
260 プレガバリン
伊藤 澄信. 新型コロナワクチンの投与開始初期の重点的調査(コホート調査)
Hoeltzenbein, M. et al. (Charite Universitatsmedizin Berlin, Berlin,
Germany). Antiepileptic treatment with levetiracetam during the first
trimester and pregnancy outcome: An observational study. Epilepsia. 2024;
65(1): 26-36-.
Nicoletti, P. et al. (Icahn School of Medicine at Mount Sinai, NY., USA).
HLA-B*53:01 is a significant risk factor of liver injury due to phenytoin
and other antiepileptic drugs in African Americans. Am. J. Gastroenterol..
2024; 119(1): 200-202-.
Hiroki Morishita. P-Glycoprotein-Mediated Interaction Is a Risk Factor for
QT Prolongation in Concomitant Use of Antipsychotics and SSRIs as PGlycoprotein-Mediated Inhibitors: Analysis of the Japanese Adverse Drug
Event Report Database. The Journal of Clinical Pharmacology. 2024; 64(1):
118-224.
Su-hsun Liu et al. Antibiotics Versus Placebo for Acute Bacterial
Conjunctivitis: Findings From a Cochrane Systematic Review. Am. J.
Ophthalmol. 2024;257:143-153.
Wu Tingxi et al. Pregnancy-related adverse events associated with statins: a
real-world pharmacovigilance study of the FDA Adverse Event Reporting
System (FAERS). Expert Opinion on Drug Safety.2024;23;3: 313-321.
Mestre VF et al., Pregabalin alters reproductive performance in male mice
and causes congenital anomalies in offspring, Reprod Fertil Dev. 2023
Nov;35(18):750-759.
13