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資料3-4 研究報告の報告状況[790KB] (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5年度第2回 11/30)《厚生労働省》 |
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研究報告の報告状況
(2023年4月1日~ 2023年7月31日)
144 トレチノイン
145 無水カフェイン
146 オキシコドン塩酸塩水和物
147 オキシコドン塩酸塩水和物
148 ペメトレキセドナトリウムヘミペンタ水和物
149 トルバプタン
150 プロゲステロン
151 ソマトロピン(遺伝子組換え)
152 パロキセチン塩酸塩水和物
153 乾燥人血液凝固第9因子複合体
154 A型インフルエンザHAワクチン(H1N1株)
155 アセトアミノフェン含有一般用医薬品
156 レボフロキサシン水和物
157 トロピカミド・フェニレフリン塩酸塩
158 アミノレブリン酸塩酸塩
159 プレガバリン
160 プレガバリン
161 デキサメタゾンリン酸エステルナトリウム
162 レボフロキサシン水和物
163 レボフロキサシン水和物
Ye, Q N et al. Expression and function of patatin-like phospholipase domain-containing 2 in
cleft palate induced by retinoic acid.The British journal of oral & maxillofacial surgery
2023;61(3):215-220.
Bruschettini M, Brattstrom P, Russo C, Onland W, Davis P, Soll R. Caffeine dosing regimens
in preterm infants with or at risk for apnea of prematurity. The Cochrane database of
systematic reviews. 2023 APR 11;4:CD013873.
Kimmel PL, et al. Opioid Use, Morbidity and Mortality in U.S. Dialysis Patients. (Abstract
Number: TH-PO1044). Journal of the American Society of Nephrology (Kidney Week 2016.
Chicago, IL, United States.). 2016; 27: 339A-DOI:.
Kimmel PL, et al. Opioid Use, Morbidity and Mortality in U.S. Kidney Transplant Patients.
(Abstract Number: SA-PO456). Journal of the American Society of Nephrology (Kidney Week
2016. Chicago, IL, United States.). 2016; 27: 734A-DOI:.
Bonnet M et al. Predictive factors associated with pemetrexed acute toxicity. Europ. J. Clin.
Pharmacol. 2023; 79(5): 635-641
Morris JH, et al.. Predictors of Rapid Correction of Hyponatremia Caused by the Syndrome
of Inappropriate Secretion of Antidiuretic Hormone during Treatment with Tolvaptan..
Journal of the American Society of Nephrology. 2016;27(00):206A
Caitlin C. Murphy et al. In utero exposure to 17a-hydroxyprogesterone caproate and risk of
cancer in offspring. Am J Obstet Gynecol. 2022; 26(1): e1-e14.
Ziv-Baran T, Modan-Moses D, Zacay G, Ackshota N, Levy-Shraga Y. Growth hormone
treatment and the risk of adolescent scoliosis: A large matched cohort study. Acta
paediatrica. 2023;112(6);1240-1248.
Desaunay P, et al.. Benefits and Risks of Antidepressant Drugs During Pregnancy: A
Systematic Review of Meta-analyses.. Paediatr Drugs. 2023; 25(3): 247-265.
Bouzat P, Charbit J, Abback PS, Huet-Garrigue D, Delhaye N, Leone M, et al. Efficacy and
Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients
With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial. J
Am Med Assoc. 2023;329(16):1367-1375
Hanna M. Ollila et al. Narcolepsy risk loci outline role of T cell autoimmunity and infectious
triggers in narcolepsy. Nature communications 2023.5.15;14(1):2709.
浦川 真哉. ERASプロトコールに基づく高容量アセトアミノフェン内服による大腸癌術後疼痛管
理の安全性. 第123回日本外科学会定期学術集会(抄録集)(Web). 2023;DP-082-2:16301630
Moghnieh R, et al. QTc prolongation during levofloxacin and triazole combination
chemoprophylaxis: Prevalence and predisposing risk factors in a cohort of hematopoietic cell
transplantation recipients. J Oncol Pharm Pract. 2023; 29(3): 534-542.
Khanna AK, et al.. Association of the exclusive use of intraoperative phenylephrine for
treatment of hypotension with the risk of acute kidney injury after noncardiac surgery.
Anaesthesia Critical Care and Pain Medicine. 2023; 42(5): 101224-.
Anaesthesia Critical Care and Pain Medicine:42(5), 101224, 2023
木村 修平. Ndufs4機能欠失マウスを用いたLeigh脳症に対する5-ALAの有効性の評価. 脳
と発達/(ISSN:0029-0831);第65回日本小児神経学会学術集会(2023.5.24,25,26,27)
Kostev K, Doege C, Jacob L, Smith L, Koyanagi A, Gollop C, et al.. Association between
Antiepileptic Drugs and Incident Parkinson's Disease among Patients Followed in
German Primary Care Practices.. Brain-Sci. 2023;13(3)
Kostev K, Doege C, Jacob L, Smith L, Koyanagi A, Gollop C, et al.. Association between
Antiepileptic Drugs and Incident Parkinson's Disease among Patients Followed in
German Primary Care Practices.. Brain-Sci. 2023;13(3)
Peter W Horby et al. Higher dose corticosteroids in patients admitted to hospital with
COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a
randomised, controlled, open-label, platform trial. Lancet 2023;401(10387):1499-1507.
Cortes, J. et al. (Memorial Hermann Texas Medical Center, TX., USA). Management of
Stenotrophomonas maltophilia pneumonia in mechanically ventilated patients. Crit. Care
Med. 2023; 51(1,Suppl.): 212-.
Kosuke Jo,Kenji Kono. 〈Original Article〉 Extended-spectrum beta-lactamase-
producing Escherichia coli isolates from patients with urinary tract infections in an
acute care hospital:Epidemiology and antibiogram. The Japanese Journal of
Antibiotics. 2023; 76(1): 1-11.
Nicoletti P,Dellinger A,Li YJ,Barnhart HX,Chalasani N,Fontana RJ,Odin JA,Serrano J,
Stolz A,Etheridge AS,Innocenti F,Govaere O,Grove JI,Stephens C,Aithal GP,Andrade
164 アモキシシリン水和物・クラブラン酸カリウム
RJ,Bjornsson ES,Daly AK,Lucena MI,Wa. Identification of Reduced ERAP2 Expression
and a Novel HLA Allele as Components of a Risk Score for Susceptibility to Liver Injury Due
to Amoxicillin Clavulanate. Gastroenterology. 2023;164:454-466
本村 茉子.術前アミノブレリン酸内服患者に対する経尿道的膀胱腫瘍切除術における周術期
165 アミノレブリン酸塩酸塩
低血圧の発症に関する後方視的検討.日本麻酔科学会第70回学術集会(2023.6.1,2,3)
テルミサルタン・ヒドロクロロチアジド配合剤
Haisma, M.S. et al. Chronic use of hydrochlorothiazide and risk of skin cancer in caucasian
166 テルミサルタン・アムロジピンベシル酸塩・ヒドロ adults: A PharmLines initiative inception cohort study. Acta Dermato
クロロチアジド配合剤
Vener.103,adv3933,2023
Togo, A. et al. (Royal Children's Hospital Melbourne, Victoria, Australia). Gastric outlet
167 アルプロスタジル アルファデクス
obstruction with prostaglandin E1 infusion in congenital diaphragmatic hernia. Arch. Dis.
Child. Fetal Neonatal Ed.. 2023; 108(2): F206-F207-.
Gyamfi-Bannerman, C. (University of California at San Diego, CA., USA).
168 ベタメタゾン・d-クロルフェニラミンマレイン酸塩 Neurodevelopmental outcomes after late preterm antenatal corticosteroids: the alps follow-up
study. Am. J. Obstet. Gynecol.. 2023; 228(1,Suppl.): S764-S765-.
Isono, T. et al.. Single-nucleotide polymorphisms, c.415C > T (Arg139Cys) and c.416G > A
169 メルカプトプリン水和物
(Arg139His), in the nudt15 gene are associated with thiopurine-induced leukopenia. Biol.
Pharm. Bull.. 2023; 46(3): 412-418.
7 / 12
(2023年4月1日~ 2023年7月31日)
144 トレチノイン
145 無水カフェイン
146 オキシコドン塩酸塩水和物
147 オキシコドン塩酸塩水和物
148 ペメトレキセドナトリウムヘミペンタ水和物
149 トルバプタン
150 プロゲステロン
151 ソマトロピン(遺伝子組換え)
152 パロキセチン塩酸塩水和物
153 乾燥人血液凝固第9因子複合体
154 A型インフルエンザHAワクチン(H1N1株)
155 アセトアミノフェン含有一般用医薬品
156 レボフロキサシン水和物
157 トロピカミド・フェニレフリン塩酸塩
158 アミノレブリン酸塩酸塩
159 プレガバリン
160 プレガバリン
161 デキサメタゾンリン酸エステルナトリウム
162 レボフロキサシン水和物
163 レボフロキサシン水和物
Ye, Q N et al. Expression and function of patatin-like phospholipase domain-containing 2 in
cleft palate induced by retinoic acid.The British journal of oral & maxillofacial surgery
2023;61(3):215-220.
Bruschettini M, Brattstrom P, Russo C, Onland W, Davis P, Soll R. Caffeine dosing regimens
in preterm infants with or at risk for apnea of prematurity. The Cochrane database of
systematic reviews. 2023 APR 11;4:CD013873.
Kimmel PL, et al. Opioid Use, Morbidity and Mortality in U.S. Dialysis Patients. (Abstract
Number: TH-PO1044). Journal of the American Society of Nephrology (Kidney Week 2016.
Chicago, IL, United States.). 2016; 27: 339A-DOI:.
Kimmel PL, et al. Opioid Use, Morbidity and Mortality in U.S. Kidney Transplant Patients.
(Abstract Number: SA-PO456). Journal of the American Society of Nephrology (Kidney Week
2016. Chicago, IL, United States.). 2016; 27: 734A-DOI:.
Bonnet M et al. Predictive factors associated with pemetrexed acute toxicity. Europ. J. Clin.
Pharmacol. 2023; 79(5): 635-641
Morris JH, et al.. Predictors of Rapid Correction of Hyponatremia Caused by the Syndrome
of Inappropriate Secretion of Antidiuretic Hormone during Treatment with Tolvaptan..
Journal of the American Society of Nephrology. 2016;27(00):206A
Caitlin C. Murphy et al. In utero exposure to 17a-hydroxyprogesterone caproate and risk of
cancer in offspring. Am J Obstet Gynecol. 2022; 26(1): e1-e14.
Ziv-Baran T, Modan-Moses D, Zacay G, Ackshota N, Levy-Shraga Y. Growth hormone
treatment and the risk of adolescent scoliosis: A large matched cohort study. Acta
paediatrica. 2023;112(6);1240-1248.
Desaunay P, et al.. Benefits and Risks of Antidepressant Drugs During Pregnancy: A
Systematic Review of Meta-analyses.. Paediatr Drugs. 2023; 25(3): 247-265.
Bouzat P, Charbit J, Abback PS, Huet-Garrigue D, Delhaye N, Leone M, et al. Efficacy and
Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients
With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial. J
Am Med Assoc. 2023;329(16):1367-1375
Hanna M. Ollila et al. Narcolepsy risk loci outline role of T cell autoimmunity and infectious
triggers in narcolepsy. Nature communications 2023.5.15;14(1):2709.
浦川 真哉. ERASプロトコールに基づく高容量アセトアミノフェン内服による大腸癌術後疼痛管
理の安全性. 第123回日本外科学会定期学術集会(抄録集)(Web). 2023;DP-082-2:16301630
Moghnieh R, et al. QTc prolongation during levofloxacin and triazole combination
chemoprophylaxis: Prevalence and predisposing risk factors in a cohort of hematopoietic cell
transplantation recipients. J Oncol Pharm Pract. 2023; 29(3): 534-542.
Khanna AK, et al.. Association of the exclusive use of intraoperative phenylephrine for
treatment of hypotension with the risk of acute kidney injury after noncardiac surgery.
Anaesthesia Critical Care and Pain Medicine. 2023; 42(5): 101224-.
Anaesthesia Critical Care and Pain Medicine:42(5), 101224, 2023
木村 修平. Ndufs4機能欠失マウスを用いたLeigh脳症に対する5-ALAの有効性の評価. 脳
と発達/(ISSN:0029-0831);第65回日本小児神経学会学術集会(2023.5.24,25,26,27)
Kostev K, Doege C, Jacob L, Smith L, Koyanagi A, Gollop C, et al.. Association between
Antiepileptic Drugs and Incident Parkinson's Disease among Patients Followed in
German Primary Care Practices.. Brain-Sci. 2023;13(3)
Kostev K, Doege C, Jacob L, Smith L, Koyanagi A, Gollop C, et al.. Association between
Antiepileptic Drugs and Incident Parkinson's Disease among Patients Followed in
German Primary Care Practices.. Brain-Sci. 2023;13(3)
Peter W Horby et al. Higher dose corticosteroids in patients admitted to hospital with
COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a
randomised, controlled, open-label, platform trial. Lancet 2023;401(10387):1499-1507.
Cortes, J. et al. (Memorial Hermann Texas Medical Center, TX., USA). Management of
Stenotrophomonas maltophilia pneumonia in mechanically ventilated patients. Crit. Care
Med. 2023; 51(1,Suppl.): 212-.
Kosuke Jo,Kenji Kono. 〈Original Article〉 Extended-spectrum beta-lactamase-
producing Escherichia coli isolates from patients with urinary tract infections in an
acute care hospital:Epidemiology and antibiogram. The Japanese Journal of
Antibiotics. 2023; 76(1): 1-11.
Nicoletti P,Dellinger A,Li YJ,Barnhart HX,Chalasani N,Fontana RJ,Odin JA,Serrano J,
Stolz A,Etheridge AS,Innocenti F,Govaere O,Grove JI,Stephens C,Aithal GP,Andrade
164 アモキシシリン水和物・クラブラン酸カリウム
RJ,Bjornsson ES,Daly AK,Lucena MI,Wa. Identification of Reduced ERAP2 Expression
and a Novel HLA Allele as Components of a Risk Score for Susceptibility to Liver Injury Due
to Amoxicillin Clavulanate. Gastroenterology. 2023;164:454-466
本村 茉子.術前アミノブレリン酸内服患者に対する経尿道的膀胱腫瘍切除術における周術期
165 アミノレブリン酸塩酸塩
低血圧の発症に関する後方視的検討.日本麻酔科学会第70回学術集会(2023.6.1,2,3)
テルミサルタン・ヒドロクロロチアジド配合剤
Haisma, M.S. et al. Chronic use of hydrochlorothiazide and risk of skin cancer in caucasian
166 テルミサルタン・アムロジピンベシル酸塩・ヒドロ adults: A PharmLines initiative inception cohort study. Acta Dermato
クロロチアジド配合剤
Vener.103,adv3933,2023
Togo, A. et al. (Royal Children's Hospital Melbourne, Victoria, Australia). Gastric outlet
167 アルプロスタジル アルファデクス
obstruction with prostaglandin E1 infusion in congenital diaphragmatic hernia. Arch. Dis.
Child. Fetal Neonatal Ed.. 2023; 108(2): F206-F207-.
Gyamfi-Bannerman, C. (University of California at San Diego, CA., USA).
168 ベタメタゾン・d-クロルフェニラミンマレイン酸塩 Neurodevelopmental outcomes after late preterm antenatal corticosteroids: the alps follow-up
study. Am. J. Obstet. Gynecol.. 2023; 228(1,Suppl.): S764-S765-.
Isono, T. et al.. Single-nucleotide polymorphisms, c.415C > T (Arg139Cys) and c.416G > A
169 メルカプトプリン水和物
(Arg139His), in the nudt15 gene are associated with thiopurine-induced leukopenia. Biol.
Pharm. Bull.. 2023; 46(3): 412-418.
7 / 12