よむ、つかう、まなぶ。
資料３－４ 研究報告の報告状況 (8 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_31510.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4回 3／2）《厚生労働省》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
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
174 フルフェナム酸アルミニウム
175 パロキセチン塩酸塩水和物
176 ピタバスタチンカルシウム
177 クエチアピンフマル酸塩
178 クロピドグレル硫酸塩
179 チラブルチニブ塩酸塩
180 ガバペンチン
181 ピタバスタチンカルシウム
182 フマル酸ジメチル
183 バルサルタン
184 バルサルタン
185 プロパフェノン塩酸塩
186 ニコランジル
187 バンコマイシン塩酸塩
188 レボフロキサシン水和物
189 プレドニゾロン
190 ハロペリドール
191 ニコランジル
192 レボドパ・カルビドパ水和物
193 無水カフェイン
194 ロサルタンカリウム・ヒドロクロロチアジド
195 ベドリズマブ（遺伝子組換え）
196 バルサルタン・ヒドロクロロチアジド配合剤
197 ピタバスタチンカルシウム
198 ドキサプラム塩酸塩水和物
199 ゾルピデム酒石酸塩
200 アスピリン・ボノプラザンフマル酸塩配合剤
ロサルタンカリウム
201 ロサルタンカリウム・ヒドロクロロチアジド
クロピドグレル硫酸塩
文献名
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.
阿部 美有 他、妊娠中の薬剤使用と児の自閉スペクトラム症の関連に関する探索的研
究、第24回日本医薬品情報学会総会・学術大会講演要旨集/ 第24回 日本医薬品情報学
会総会・学術大会（2022.7.9-10）/ 106(2022)
Watanabe, M. et al. Prevention of contrast-induced nephropathy after cardiovascular
catheterization and intervention with high-dose strong statin therapy in Japan -The
PREVENT CINC-J study-. Circ. J. 2022;86(9):1455-1463.
Roy, S. et al. Abuse and misuse of second-generation antipsychotics: An analysis using
VigiBase, the World Health Organisation pharmacovigilance database.
Brit. J. Clin. Pharmacol. 2022;88(10):4646-4653.
Qureshi, A.I. et al. (University of Missouri, MO., USA). Clopidogrel bolus is inferior to
sustained clopidogrel pretreatment in patients undergoing carotid artery stent placement.
Neurosurgery. 2022; 90(6): 717-724-.
レター(医療機関の長及び治験責任医師に対してONO-4059-06試験、ONO-4059-10試
験及びONO-4059-08試験中断の要請）
Pan, Yiheng et al. Cardiovascular risk of gabapentin and pregabalin in patients with
diabetic neuropathy. Cardiovascular diabetology 2022;21(1):170.
Makoto Watanabe MD PhD. et al., ORIGINAL ARTICLE Population Science
Prevention of Contrast－Induced Nephropathy After Cardiovascular Catheterization
and Intervention With High-Dose Strong Statin Therapy in Japan
Ravn J. Risk factors for development of lymphopenia in dimethyl fumarate-treated patients
with multiple sclerosis. https://doi.org/10.1016/j.msard.2022.104081. Multiple Sclerosis
and Related Disorders. 2022 JUL 28;67:1-5.
Jeon H-L, Lee SH, Nam JH, Shin J-Y.. Cancer risk associated with the use of valsartan in
Korea: A nationwide cohort study.. Cancer-Epidemiol. 2022;80
Jeon H-L, Lee SH, Nam JH, Shin J-Y.. Cancer risk associated with the use of valsartan in
Korea: A nationwide cohort study.. Cancer-Epidemiol. 2022;80
Abd-Allah, Entsar R,et al.Effect of Rythmol (propafenone HCl) administration during
pregnancy in Wistar rats.Journal of biochemical and molecular toxicology
2022;36(8):e23085.
ATP敏感性钾离子通道开放剂用于冠状动脉粥样硬化性心脏病治疗真实世界研究
Final report assesment for CPCC-SIG-NIS-002. 臨床研究報告. 2020;1-39
Kiley, P.S. et al. Retrospective cohort study of the incidence of acute kidney injury with
vancomycin area under the curve-based dosing with concomitant piperacillin-tazobactam
compared to meropenem or cefepime. Antimicrob. Agents Chemother. 2022, 66(8),
e00040-22
Association of fluoroquinolone use with short-term risk of development of aortic aneurysm
Newton, E.R. et al. (University of North Carolina at Chapel Hill, NC., USA)
JAMA Surg. 156(3),264-272,2021
Yoshiya Tanaka et al. A pooled analysis of serious infections and herpes zoster-related
disease in Asian patients with rheumatoid arthritis treated with peficitinib (ASP015K) over
a median of 3 years. Modern Rheumatology. 2022; 32 4: 708-717.
He L, et al.. Characteristics and Spectrum of Cardiotoxicity Induced by Various
Antipsychotics: A Real-World Study From 2015 to 2020 Based on FAERS. Frontiers in
Pharmacology. 2022;12:1-12
Chien-Chang L, Sheng-Nan C, Babak T, Sot Shih-Hung L, Chia-Ying C, Wan-Ting H, et
al.. Use of nicorandil is associated with increased risk of incident atrial fibrillation. Aging.
2022;14:6975
Tomotaka Shiraishi, Noriko Nishikawa, Junko Takei,Yohei Aoshima, Yuka Hama, Yohei
Mukai, Yuji Tkahashi. High-levodopa plasma concentration predicts levodopa induced
dyskinesia in Parkinson's disease.. Clinical Neurology. 2020;60(Supplement1):S342
Chen X, Isambert N, Lopez-Lopez R, Giovannini M, Pognan N, Kapoor S, Quinlan M, You
B, Cui X, Rahmanzadeh G, Mau-Sorensen M. Effect of capmatinib on the
pharmacokinetics of substrates of CYP3A (midazolam) and CYP1A2 (caffeine) in patients
with MET-dysregulated solid tumours. British journal of clinical pharmacology. 2022 SEP
21;.
NAGY D, TOTH V, TOTH B, SOOS GY. Analysis of HCTZ use and the skin cancer risk
among the patients of Semmelweis University, Dermatological Department.. Acta
Pharmaceutica Hungarica. 2020;90(2-3):131
Singh S, et al. Comparative Risk of Serious Infections With Tumor Necrosis Factor α
Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases. Clinical
Gastroenterology and Hepatology. 2022;20(2):e74-e88
Nagy D, et al.. Analysis of HCTZ use and the skin cancer risk among the patients of
Semmelweis University, Dermatological Department.. Acta Pharmaceutica Hungarica/16th
Congressus Pharmaceuticus Hungaricus. Debrecen. 2020;90:131
Watanabe, M. et al.. Prevention of contrast-induced nephropathy after cardiovascular
catheterization and intervention with high-dose strong statin therapy in Japan -The
PREVENT CINC-J study-. Circ. J.. 2022; 86(9): 1455-1463.
Lotte, L.G. Sebek; Jarinda, A. Poppe; Van Den Bemt Patricia, M.L.A.; Sinno, H.R
Simons; Robert, B. Flint. Agitation as adverse drug reaction of doxapram in preterm
neonates: Prevalence and potential risk factors. Pharmaceutisch Weekblad. 2022; 157(11):
25-29.
Khan H, et al.. Zolpidem use and risk of suicide: A systematic review and meta-analysis.
Psychiatry Res. 2022; 316: 114777.
川崎 啓祐 他. 出血性消化性潰瘍に対する薬剤の影響度（第119回日本消化器病学会
九州支部例会/第113回日本消化器内視鏡学会九州支部例会 2022.6.24-25）. 第119回
日本消化器病学会九州支部例会/第113回日本消化器内視鏡学会九州支部例会プログラ
ム・抄録集. 2022;89(S3-09)
Fuentes, S. et al. An updated list of drugs suspected to be associated with immune
thrombocytopenia based on the WHO pharmacovigilance database.
Blood. 2022;140(8):922-927.
8
（2022年8月1日～2022年11月30日）
NO
一般名
174 フルフェナム酸アルミニウム
175 パロキセチン塩酸塩水和物
176 ピタバスタチンカルシウム
177 クエチアピンフマル酸塩
178 クロピドグレル硫酸塩
179 チラブルチニブ塩酸塩
180 ガバペンチン
181 ピタバスタチンカルシウム
182 フマル酸ジメチル
183 バルサルタン
184 バルサルタン
185 プロパフェノン塩酸塩
186 ニコランジル
187 バンコマイシン塩酸塩
188 レボフロキサシン水和物
189 プレドニゾロン
190 ハロペリドール
191 ニコランジル
192 レボドパ・カルビドパ水和物
193 無水カフェイン
194 ロサルタンカリウム・ヒドロクロロチアジド
195 ベドリズマブ（遺伝子組換え）
196 バルサルタン・ヒドロクロロチアジド配合剤
197 ピタバスタチンカルシウム
198 ドキサプラム塩酸塩水和物
199 ゾルピデム酒石酸塩
200 アスピリン・ボノプラザンフマル酸塩配合剤
ロサルタンカリウム
201 ロサルタンカリウム・ヒドロクロロチアジド
クロピドグレル硫酸塩
文献名
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.
阿部 美有 他、妊娠中の薬剤使用と児の自閉スペクトラム症の関連に関する探索的研
究、第24回日本医薬品情報学会総会・学術大会講演要旨集/ 第24回 日本医薬品情報学
会総会・学術大会（2022.7.9-10）/ 106(2022)
Watanabe, M. et al. Prevention of contrast-induced nephropathy after cardiovascular
catheterization and intervention with high-dose strong statin therapy in Japan -The
PREVENT CINC-J study-. Circ. J. 2022;86(9):1455-1463.
Roy, S. et al. Abuse and misuse of second-generation antipsychotics: An analysis using
VigiBase, the World Health Organisation pharmacovigilance database.
Brit. J. Clin. Pharmacol. 2022;88(10):4646-4653.
Qureshi, A.I. et al. (University of Missouri, MO., USA). Clopidogrel bolus is inferior to
sustained clopidogrel pretreatment in patients undergoing carotid artery stent placement.
Neurosurgery. 2022; 90(6): 717-724-.
レター(医療機関の長及び治験責任医師に対してONO-4059-06試験、ONO-4059-10試
験及びONO-4059-08試験中断の要請）
Pan, Yiheng et al. Cardiovascular risk of gabapentin and pregabalin in patients with
diabetic neuropathy. Cardiovascular diabetology 2022;21(1):170.
Makoto Watanabe MD PhD. et al., ORIGINAL ARTICLE Population Science
Prevention of Contrast－Induced Nephropathy After Cardiovascular Catheterization
and Intervention With High-Dose Strong Statin Therapy in Japan
Ravn J. Risk factors for development of lymphopenia in dimethyl fumarate-treated patients
with multiple sclerosis. https://doi.org/10.1016/j.msard.2022.104081. Multiple Sclerosis
and Related Disorders. 2022 JUL 28;67:1-5.
Jeon H-L, Lee SH, Nam JH, Shin J-Y.. Cancer risk associated with the use of valsartan in
Korea: A nationwide cohort study.. Cancer-Epidemiol. 2022;80
Jeon H-L, Lee SH, Nam JH, Shin J-Y.. Cancer risk associated with the use of valsartan in
Korea: A nationwide cohort study.. Cancer-Epidemiol. 2022;80
Abd-Allah, Entsar R,et al.Effect of Rythmol (propafenone HCl) administration during
pregnancy in Wistar rats.Journal of biochemical and molecular toxicology
2022;36(8):e23085.
ATP敏感性钾离子通道开放剂用于冠状动脉粥样硬化性心脏病治疗真实世界研究
Final report assesment for CPCC-SIG-NIS-002. 臨床研究報告. 2020;1-39
Kiley, P.S. et al. Retrospective cohort study of the incidence of acute kidney injury with
vancomycin area under the curve-based dosing with concomitant piperacillin-tazobactam
compared to meropenem or cefepime. Antimicrob. Agents Chemother. 2022, 66(8),
e00040-22
Association of fluoroquinolone use with short-term risk of development of aortic aneurysm
Newton, E.R. et al. (University of North Carolina at Chapel Hill, NC., USA)
JAMA Surg. 156(3),264-272,2021
Yoshiya Tanaka et al. A pooled analysis of serious infections and herpes zoster-related
disease in Asian patients with rheumatoid arthritis treated with peficitinib (ASP015K) over
a median of 3 years. Modern Rheumatology. 2022; 32 4: 708-717.
He L, et al.. Characteristics and Spectrum of Cardiotoxicity Induced by Various
Antipsychotics: A Real-World Study From 2015 to 2020 Based on FAERS. Frontiers in
Pharmacology. 2022;12:1-12
Chien-Chang L, Sheng-Nan C, Babak T, Sot Shih-Hung L, Chia-Ying C, Wan-Ting H, et
al.. Use of nicorandil is associated with increased risk of incident atrial fibrillation. Aging.
2022;14:6975
Tomotaka Shiraishi, Noriko Nishikawa, Junko Takei,Yohei Aoshima, Yuka Hama, Yohei
Mukai, Yuji Tkahashi. High-levodopa plasma concentration predicts levodopa induced
dyskinesia in Parkinson's disease.. Clinical Neurology. 2020;60(Supplement1):S342
Chen X, Isambert N, Lopez-Lopez R, Giovannini M, Pognan N, Kapoor S, Quinlan M, You
B, Cui X, Rahmanzadeh G, Mau-Sorensen M. Effect of capmatinib on the
pharmacokinetics of substrates of CYP3A (midazolam) and CYP1A2 (caffeine) in patients
with MET-dysregulated solid tumours. British journal of clinical pharmacology. 2022 SEP
21;.
NAGY D, TOTH V, TOTH B, SOOS GY. Analysis of HCTZ use and the skin cancer risk
among the patients of Semmelweis University, Dermatological Department.. Acta
Pharmaceutica Hungarica. 2020;90(2-3):131
Singh S, et al. Comparative Risk of Serious Infections With Tumor Necrosis Factor α
Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases. Clinical
Gastroenterology and Hepatology. 2022;20(2):e74-e88
Nagy D, et al.. Analysis of HCTZ use and the skin cancer risk among the patients of
Semmelweis University, Dermatological Department.. Acta Pharmaceutica Hungarica/16th
Congressus Pharmaceuticus Hungaricus. Debrecen. 2020;90:131
Watanabe, M. et al.. Prevention of contrast-induced nephropathy after cardiovascular
catheterization and intervention with high-dose strong statin therapy in Japan -The
PREVENT CINC-J study-. Circ. J.. 2022; 86(9): 1455-1463.
Lotte, L.G. Sebek; Jarinda, A. Poppe; Van Den Bemt Patricia, M.L.A.; Sinno, H.R
Simons; Robert, B. Flint. Agitation as adverse drug reaction of doxapram in preterm
neonates: Prevalence and potential risk factors. Pharmaceutisch Weekblad. 2022; 157(11):
25-29.
Khan H, et al.. Zolpidem use and risk of suicide: A systematic review and meta-analysis.
Psychiatry Res. 2022; 316: 114777.
川崎 啓祐 他. 出血性消化性潰瘍に対する薬剤の影響度（第119回日本消化器病学会
九州支部例会/第113回日本消化器内視鏡学会九州支部例会 2022.6.24-25）. 第119回
日本消化器病学会九州支部例会/第113回日本消化器内視鏡学会九州支部例会プログラ
ム・抄録集. 2022;89(S3-09)
Fuentes, S. et al. An updated list of drugs suspected to be associated with immune
thrombocytopenia based on the WHO pharmacovigilance database.
Blood. 2022;140(8):922-927.
8