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資料２－４ 研究報告の報告状況 (6 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3年度 第3回 3／11）《厚生労働省》 |
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研究報告の報告状況
(2021年8月1日～2021年11月30日)
NO 一般名
124 ワルファリンカリウム
文献名
Nita A.Limdi et al. Thromboembolic and Hemorrhagic Outcomes in the Direct Oral Anticoagulant Trials
Across the Spectrum of Kidney Function. Clinical Pharmacology and Therapeutics; 109(6): 1593-1605.
ロサルタンカリウム
125 ロサルタンカリウム・ヒドロクロロチ 【社内資料】アジ化不純物評価報告
アジド
Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, et al.. [Intervention Review]
126 レムデシビル
Remdesivir for the treatment of COVID-19. Cochrane Database of Systematic Reviews. 2021;8:1-93
Kim, J.C. et al..Use of hydrochlorothiazide and risk of nonmelanoma skin cancer in Koreans: a
ロサルタンカリウム・ヒドロクロロチ
127
retrospective cohort study using administrative healthcare data.Clin. Exp. Dermatol. 2021;46(4):680アジド
686.
Chae, Jungsoo; Cho, Geum Joon; Oh, Min-Jeong; Park, KeonVin; Han, Sung Won; Choi, Suk-Joo; Oh,
128 リトドリン塩酸塩
Soo-Young; Roh, Cheong-Rae. In utero exposure to ritodrine during pregnancy and risk of autism in
their offspring until 8 years of age. Scientific reports. 2021; 11(1): 1146-1146.
Pasina, L. et al.. Anticholinergic load and delirium in end-of-life patients. Europ. J. Clin. Pharmacol..
129 スコポラミン臭化水素酸塩水和物
2021; 77(9): 1419-1424.
P-13 皮膚悪性腫瘍の発生に関連する薬剤－JADERを用いた解析－.第7回日本医薬品安全性学会学術
130 プレドニゾロン酢酸エステル
大会.2021/7/24,25.WEB開催.
Wen X, et al.. Association of Gestational Opioid Exposure and Risk of Major and Minor Congenital
131 オキシコドン塩酸塩水和物
Malformations.. JAMA network open. 2021; 4(4): e215708-DOI:10.1001/jamanetworkopen.2021.5708.
Combination of vancomycin plus piperacillin and risk of acute kidney injury : a worldwide
132 バンコマイシン塩酸塩
pharmacovigilance database analysis
J. Antimicrob. Chemother. 2021,76(5),1311-1314
【Journal of Clinical Psychopharmacology. 41(2021)304-309】Risk of depression associated with finasteride
133 フィナステリド
treatment
クエチアピンフマル酸塩
Population-based signals of antidepressant drug interactions associated with unintentional traumatic
134 メマンチン塩酸塩
injury
シロドシン
Clin. Pharmacol. Ther. 2021,110(2),409-423
Chiwata, M. et al.. Efficacy and cardiovascular adverse events of long-term treatment with tyrosine
135 イマチニブメシル酸塩
kinase inhibitors for chronic myeloid leukemia: a report from the Nagasaki CML Study Group. Intern.
Med.. 2021; 60(14): 2207-2216.
Semrad TJ et al. Phase 1 study of alisertib (MLN8237) and weekly irinotecan in adults with advanced
136 イリノテカン塩酸塩水和物
solid tumors. Cancer Chemother. Pharmacol. 2021; 88(2): 335-341
エストリオール
エストラジオール吉草酸エステル Postmenopausal exogenous hormone therapy and Melanoma risk in women: A systematic review and
137 テストステロンエナント酸エステ time-response meta-analysis.Akshaya Srikanth Bhagavathula
ル・エストラジオール吉草酸エス Pharmacological Research 160(105182)2020
テル
Sadeghinezhad J, et al.. Study on the effect of maternal administration of oxaliplatin on offspring testes
138 オキサリプラチン
using unbiased design-based stereology.. Journal of Experimental and Clinical Medicine (Turkey).
2021;38:99-106
139 ベタメタゾン
140 デクスメデトミジン塩酸塩
141 酸化セルロース
142 ナルデメジントシル酸塩
Tamara I. Arnautovic et al. Antenatal Risk Factors Associated with Spontaneous Intestinal Perforation in
Preterm Infants Receiving Postnatal Indomethacin. THE JOURNAL OF PEDIATRICS 2021; 232: 59-64.
Chen, Peng.Dexmedetomidine promotes the progression of hepatocellular carcinoma through hepatic
stellate cell activation.Experimental and Molecular Medicine 2020;52(7):1062-1074.
Breast conserving surgery using oxidized regenerated cellulose as filling biomaterial: recommendations to
improve clinical outcomes. Franceschini G. BMC Women’s Health (2021) 21:281
【Biological and Pharmaceutical Bulletin. 44(2021)1081-1087】Analysis of predictive factors for diarrhea
after the administration of naldemedine
テストステロンエナント酸エステル
テストステロンエナント酸エステ Silvana Rocio Ferreira et al. Prenatal testosterone exposure induces insulin resistance, uterine oxidative
143
ル・エストラジオール吉草酸エス stress and pro-inflammatory status in rats.Molecular and cellular endocrinology 2021;519:111045.
テル
144
145
146
147
148
149
150
Kim, J.C. et al. Use of hydrochlorothiazide and risk of nonmelanoma skin cancer in Koreans: a
ロサルタンカリウム・ヒドロクロロチ
retrospective cohort study using administrative healthcare data. Clin. Exp. Dermatol. 2021, 46(4), 680アジド
686
Ajiji P, et al..Investigating the efficacy and safety of metronidazole during pregnancy; A systematic review
メトロニダゾール
and meta-analysis..European Journal of Obstetrics and Gynecology and Reproductive Biology: X
2021;11:100128(Article #).
Cheng-Yuan Li, Ying-Xiu Dai, Yun-Ting Chang, Ya-Mei Bai, Shih-Jen Tsai, Tzeng-Ji Chen, Mu-Hong
アセトアミノフェン
Chen. Prenatal exposure to acetaminophen increases the risk of atopic dermatitis in children: A
nationwide nested case-control study in Taiwan. Pediatr Allergy Immunol. 2021 Jul;32(5):1080-1088.
ボノプラザンフマル酸塩・アモキ Puig N, et al. Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple
シシリン水和物・クラリスロマイシ myeloma ineligible for autologous transplant: a randomized trial. Blood Cancer Journal. 2021;11:Article
ン
no. 101
アログリプチン安息香酸塩・メトホ Orloff J, et al. Safety and effectiveness of metformin in patients with reduced renal function: A systematic
ルミン塩酸塩配合剤
review. Diabetes, obesity & metabolism. 2021;23(9):2035-2047
Comparison of acute injury in patients prescribed vancomycin in combination with piperacillinバンコマイシン塩酸塩
tazobactam or cefepime for diabetic foot infections
J. Invest. Med. 2021,69(4),893-896
Intracerebral hemorrhage incidence, mortality, and association with oral anticoagulation use: A
クロピドグレル硫酸塩
population study
Stroke 2021,52(5),1673-1681
6
(2021年8月1日～2021年11月30日)
NO 一般名
124 ワルファリンカリウム
文献名
Nita A.Limdi et al. Thromboembolic and Hemorrhagic Outcomes in the Direct Oral Anticoagulant Trials
Across the Spectrum of Kidney Function. Clinical Pharmacology and Therapeutics; 109(6): 1593-1605.
ロサルタンカリウム
125 ロサルタンカリウム・ヒドロクロロチ 【社内資料】アジ化不純物評価報告
アジド
Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, et al.. [Intervention Review]
126 レムデシビル
Remdesivir for the treatment of COVID-19. Cochrane Database of Systematic Reviews. 2021;8:1-93
Kim, J.C. et al..Use of hydrochlorothiazide and risk of nonmelanoma skin cancer in Koreans: a
ロサルタンカリウム・ヒドロクロロチ
127
retrospective cohort study using administrative healthcare data.Clin. Exp. Dermatol. 2021;46(4):680アジド
686.
Chae, Jungsoo; Cho, Geum Joon; Oh, Min-Jeong; Park, KeonVin; Han, Sung Won; Choi, Suk-Joo; Oh,
128 リトドリン塩酸塩
Soo-Young; Roh, Cheong-Rae. In utero exposure to ritodrine during pregnancy and risk of autism in
their offspring until 8 years of age. Scientific reports. 2021; 11(1): 1146-1146.
Pasina, L. et al.. Anticholinergic load and delirium in end-of-life patients. Europ. J. Clin. Pharmacol..
129 スコポラミン臭化水素酸塩水和物
2021; 77(9): 1419-1424.
P-13 皮膚悪性腫瘍の発生に関連する薬剤－JADERを用いた解析－.第7回日本医薬品安全性学会学術
130 プレドニゾロン酢酸エステル
大会.2021/7/24,25.WEB開催.
Wen X, et al.. Association of Gestational Opioid Exposure and Risk of Major and Minor Congenital
131 オキシコドン塩酸塩水和物
Malformations.. JAMA network open. 2021; 4(4): e215708-DOI:10.1001/jamanetworkopen.2021.5708.
Combination of vancomycin plus piperacillin and risk of acute kidney injury : a worldwide
132 バンコマイシン塩酸塩
pharmacovigilance database analysis
J. Antimicrob. Chemother. 2021,76(5),1311-1314
【Journal of Clinical Psychopharmacology. 41(2021)304-309】Risk of depression associated with finasteride
133 フィナステリド
treatment
クエチアピンフマル酸塩
Population-based signals of antidepressant drug interactions associated with unintentional traumatic
134 メマンチン塩酸塩
injury
シロドシン
Clin. Pharmacol. Ther. 2021,110(2),409-423
Chiwata, M. et al.. Efficacy and cardiovascular adverse events of long-term treatment with tyrosine
135 イマチニブメシル酸塩
kinase inhibitors for chronic myeloid leukemia: a report from the Nagasaki CML Study Group. Intern.
Med.. 2021; 60(14): 2207-2216.
Semrad TJ et al. Phase 1 study of alisertib (MLN8237) and weekly irinotecan in adults with advanced
136 イリノテカン塩酸塩水和物
solid tumors. Cancer Chemother. Pharmacol. 2021; 88(2): 335-341
エストリオール
エストラジオール吉草酸エステル Postmenopausal exogenous hormone therapy and Melanoma risk in women: A systematic review and
137 テストステロンエナント酸エステ time-response meta-analysis.Akshaya Srikanth Bhagavathula
ル・エストラジオール吉草酸エス Pharmacological Research 160(105182)2020
テル
Sadeghinezhad J, et al.. Study on the effect of maternal administration of oxaliplatin on offspring testes
138 オキサリプラチン
using unbiased design-based stereology.. Journal of Experimental and Clinical Medicine (Turkey).
2021;38:99-106
139 ベタメタゾン
140 デクスメデトミジン塩酸塩
141 酸化セルロース
142 ナルデメジントシル酸塩
Tamara I. Arnautovic et al. Antenatal Risk Factors Associated with Spontaneous Intestinal Perforation in
Preterm Infants Receiving Postnatal Indomethacin. THE JOURNAL OF PEDIATRICS 2021; 232: 59-64.
Chen, Peng.Dexmedetomidine promotes the progression of hepatocellular carcinoma through hepatic
stellate cell activation.Experimental and Molecular Medicine 2020;52(7):1062-1074.
Breast conserving surgery using oxidized regenerated cellulose as filling biomaterial: recommendations to
improve clinical outcomes. Franceschini G. BMC Women’s Health (2021) 21:281
【Biological and Pharmaceutical Bulletin. 44(2021)1081-1087】Analysis of predictive factors for diarrhea
after the administration of naldemedine
テストステロンエナント酸エステル
テストステロンエナント酸エステ Silvana Rocio Ferreira et al. Prenatal testosterone exposure induces insulin resistance, uterine oxidative
143
ル・エストラジオール吉草酸エス stress and pro-inflammatory status in rats.Molecular and cellular endocrinology 2021;519:111045.
テル
144
145
146
147
148
149
150
Kim, J.C. et al. Use of hydrochlorothiazide and risk of nonmelanoma skin cancer in Koreans: a
ロサルタンカリウム・ヒドロクロロチ
retrospective cohort study using administrative healthcare data. Clin. Exp. Dermatol. 2021, 46(4), 680アジド
686
Ajiji P, et al..Investigating the efficacy and safety of metronidazole during pregnancy; A systematic review
メトロニダゾール
and meta-analysis..European Journal of Obstetrics and Gynecology and Reproductive Biology: X
2021;11:100128(Article #).
Cheng-Yuan Li, Ying-Xiu Dai, Yun-Ting Chang, Ya-Mei Bai, Shih-Jen Tsai, Tzeng-Ji Chen, Mu-Hong
アセトアミノフェン
Chen. Prenatal exposure to acetaminophen increases the risk of atopic dermatitis in children: A
nationwide nested case-control study in Taiwan. Pediatr Allergy Immunol. 2021 Jul;32(5):1080-1088.
ボノプラザンフマル酸塩・アモキ Puig N, et al. Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple
シシリン水和物・クラリスロマイシ myeloma ineligible for autologous transplant: a randomized trial. Blood Cancer Journal. 2021;11:Article
ン
no. 101
アログリプチン安息香酸塩・メトホ Orloff J, et al. Safety and effectiveness of metformin in patients with reduced renal function: A systematic
ルミン塩酸塩配合剤
review. Diabetes, obesity & metabolism. 2021;23(9):2035-2047
Comparison of acute injury in patients prescribed vancomycin in combination with piperacillinバンコマイシン塩酸塩
tazobactam or cefepime for diabetic foot infections
J. Invest. Med. 2021,69(4),893-896
Intracerebral hemorrhage incidence, mortality, and association with oral anticoagulation use: A
クロピドグレル硫酸塩
population study
Stroke 2021,52(5),1673-1681
6