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資料3-4 研究報告の報告状況[790KB] (5 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)
97 ジクロフェナクナトリウム
98 シルデナフィルクエン酸塩
99 タダラフィル
100 リツキシマブ(遺伝子組換え)[後続2]
101 フェノバルビタールナトリウム
102 ノルアドレナリン
103 ノルフロキサシン
104 ノルフロキサシン
エスシタロプラムシュウ酸塩
105 パロキセチン塩酸塩水和物
ベンラファキシン塩酸塩
ベンラファキシン塩酸塩
106 エスシタロプラムシュウ酸塩
パロキセチン塩酸塩水和物
107 ロスバスタチンカルシウム
108 ホスフェニトインナトリウム水和物
109 リドカイン
110 プロポフォール
111 オメプラゾール
112 ジクロフェナクナトリウム
ベタメタゾン吉草酸エステル
ベタメタゾン吉草酸エステル・フラジオマイシン
113 硫酸塩
ベタメタゾン吉草酸エステル・フラジオマイシン
硫酸塩含有一般用医薬品
114 アシクロビル
115 精製ヒアルロン酸ナトリウム
116 ジゴキシン
117 フェノバルビタールナトリウム
118 フェノバルビタールナトリウム
119 葉酸
120 ロサルタンカリウム・ヒドロクロロチアジド配合剤
Schmidt M, Arendt-Nielsen L, Hauge E.M, Soerensen H.T, Pedersen L. Dose-dependency of
diclofenac's cardiovascular risks: a series of nationwide emulated trials. European Heart
Journal. 2022;43(Suppl.2):2730.
Labban, M.; Beatrici, E.; Filipas, D.K.; Stone, B.V.; Nguyen, D.-D.; Adib, E.; Melnick,
K.R.; Cole, A.P.; Lipsitz, S.; Choueiri, T.K.; Trinh, Q.-D.. Pharmacovigilance analysis of
melanoma adverse events in men treated with sildenafil for erectile dysfunction. European
Urology. 2023; 83: S1815-S1815.
Lui, Jason L.; Shaw, Nathan M.; Abbasi, Behzad; Hakam, Nizar; et al..Adverse reactions of
PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance
database.Andrology 2023.
Chevalier, K.. CovAID: Identification of factors associated with severe COVID-19 in patients
with inflammatory rheumatism or autoimmune diseases. Frontiers in Medicine. 2023
Yoshiaki Yamamoto, et al.. Risk factors for hyperammonemia in pediatric patients with
epilepsy. Epilepsia. 2013; 54(6): 983-989.
Cattaneo A, et al..Investigating the relationship between high-dose norepinephrine
administration and the incidence of delayed cerebral infarction in patients with aneurysmal
subarachnoid hemorrhage: A single-center retrospective evaluation..PloS one
2023;18(3.0):e0283180.
Perez-Cameo, Cristina 1 ; Oriol, Isabel; Lung, Mayli; Llado, Laura; Dopazo, Cristina;
Nuvials, Xavier; Los-Arcos, Ibai; Sabe, Nuria; Castells, Lluis; Len, Oscar. Impact of
Prophylactic Norfloxacin in Multidrug Resistant Bacterial Infections in the Early Liver
Posttransplant Period. Experimental and clinical transplantation : official journal of the
Middle East Society for Organ Transplantation. 2023; 21(3): 236-244.
Maquet, J. et al. Drug-induced autoimmune hemolytic anemia: Detection of new signals in
the world pharmacovigilance database and risk assessment in a nationwide cohort study in
France. Blood. 2022; 140(Suppl.1): 8176-8177.
Chu CS, Lee FL, Bai YM, Su TP, Tsai SJ, Chen TJ, et al.. Antidepressant drugs use and
epilepsy risk:A nationwide nested case-control study.. Epilepsy-Behav. 2023;140:109102
Chu CS, Lee FL, Bai YM, Su TP, Tsai SJ, Chen TJ, et al.. Antidepressant drugs use and
epilepsy risk:A nationwide nested case-control study.. Epilepsy-Behav. 2023;140:109102
Pienkos SM, Moore AR, Guan J, Levitt JE, Matthay MA, Baron RM, et al.. Effect of total
cholesterol and statin therapy on mortality in ARDS patients: a secondary analysis of the
SAILS and HARP-2 trials.. Crit-Care. 2023;27(1):126
NPC-06-7試験について.
日本人健康成人男性を対象としたNPC-06の反復静脈内投与がアメナメビルの薬物動態に及
ぼす影響の検討 治験総括報告書. 2023 JUL 11;.
Jonathan Eisenberg et al. Adverse Outcomes in Topical Lidocaine Exposure: A Pediatric
Case Series From the United States National Poison Data System. Clinical pediatrics.
2023: 99228231159646
Kotani Y, Pruna A, Turi S, Borghi G, Lee TC, Zangrillo A, et al. Propofol and survival: an
updated meta-analysis of randomized clinical trials. Crit-Care. 2023;27(1):139
Yunha Noh,Han Eol Jeong,Ahhyung Choi,Eun-Young Choi,Bjorn Pasternak,Hedvig
Nordeng,Mette Bliddal,Kenneth K. C. Man,Ian C. K. Wong,Dong Keon Yon,JuYoungShin.Prenatal and infant exposure to acid-suppressive medications and risk of allergic
diseases in children.JAMA Pediatr. 2023;177(3):267-277.
Schmidt M, et al.. Dose-dependency of diclofenac's cardiovascular risks: A series of
nationwide emulated trials.. Eur. Respir. J.. 2022; 60(Sl 66): 2730-.
Figueiredo TM,de Barros JWF,Dos Santos BC,Pacheco TL,de Lima RJ,Anselmo-Franci
JA,Kempinas WDG. Reproductive outcomes of neonatal exposure to betamethasone in male
and female rats. Journal of applied toxicology : JAT. 2023;43:752-763
Alexander Balcerac, Kevin Bihan, Dimitri Psimaras, Benedicte Lebrun-Vignes, Joe-Elie
Salem, Nicolas Weiss.
Drugs associated with posterior reversible encephalopathy syndrome, a worldwide signal
detection study. Journal of Neurology 2023, 270 : 975-985.
A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis..
Investigative radiology. 58:255-362.
Gazzaniga G, et al..Effect of digoxin on all-cause and cardiovascular mortality in patients
with atrial fibrillation with and without heart failure : an umbrella review of systematic
reviews and 12 meta-analyses..European journal of clinical pharmacology 2023;79(4):473483.
G.Zaccara, et al.. Effect of associated antiepileptic treatment on valproate-induced
hyperammonemia. Therapeutic Drug Monitoring. 1985; 7(2): 185-190.
Peter Y.M.Woo, et al. Incidence, Presentation, and Risk Factors for Sodium ValproateAssociated Hyperammonemia in Neurosurgical Patients: A Prospective, observational Study.
World Neurosurgery. 2020; (144): 597-604.
Jiang, Yuhong et al. Dose-response association between dietary folate and niacin intakes with
diabetes among Chinese adults: a cross-sectional study.Journal of health, population, and
nutrition 2023;42(1):31.
Haisma, M.S. et al. Chronic use of hydrochlorothiazide and risk of skin cancer in caucasian
adults: A PharmLines initiative inception cohort study. Acta Dermato-Vener.
2023;103,adv3933.
5 / 12
(2023年4月1日~ 2023年7月31日)
97 ジクロフェナクナトリウム
98 シルデナフィルクエン酸塩
99 タダラフィル
100 リツキシマブ(遺伝子組換え)[後続2]
101 フェノバルビタールナトリウム
102 ノルアドレナリン
103 ノルフロキサシン
104 ノルフロキサシン
エスシタロプラムシュウ酸塩
105 パロキセチン塩酸塩水和物
ベンラファキシン塩酸塩
ベンラファキシン塩酸塩
106 エスシタロプラムシュウ酸塩
パロキセチン塩酸塩水和物
107 ロスバスタチンカルシウム
108 ホスフェニトインナトリウム水和物
109 リドカイン
110 プロポフォール
111 オメプラゾール
112 ジクロフェナクナトリウム
ベタメタゾン吉草酸エステル
ベタメタゾン吉草酸エステル・フラジオマイシン
113 硫酸塩
ベタメタゾン吉草酸エステル・フラジオマイシン
硫酸塩含有一般用医薬品
114 アシクロビル
115 精製ヒアルロン酸ナトリウム
116 ジゴキシン
117 フェノバルビタールナトリウム
118 フェノバルビタールナトリウム
119 葉酸
120 ロサルタンカリウム・ヒドロクロロチアジド配合剤
Schmidt M, Arendt-Nielsen L, Hauge E.M, Soerensen H.T, Pedersen L. Dose-dependency of
diclofenac's cardiovascular risks: a series of nationwide emulated trials. European Heart
Journal. 2022;43(Suppl.2):2730.
Labban, M.; Beatrici, E.; Filipas, D.K.; Stone, B.V.; Nguyen, D.-D.; Adib, E.; Melnick,
K.R.; Cole, A.P.; Lipsitz, S.; Choueiri, T.K.; Trinh, Q.-D.. Pharmacovigilance analysis of
melanoma adverse events in men treated with sildenafil for erectile dysfunction. European
Urology. 2023; 83: S1815-S1815.
Lui, Jason L.; Shaw, Nathan M.; Abbasi, Behzad; Hakam, Nizar; et al..Adverse reactions of
PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance
database.Andrology 2023.
Chevalier, K.. CovAID: Identification of factors associated with severe COVID-19 in patients
with inflammatory rheumatism or autoimmune diseases. Frontiers in Medicine. 2023
Yoshiaki Yamamoto, et al.. Risk factors for hyperammonemia in pediatric patients with
epilepsy. Epilepsia. 2013; 54(6): 983-989.
Cattaneo A, et al..Investigating the relationship between high-dose norepinephrine
administration and the incidence of delayed cerebral infarction in patients with aneurysmal
subarachnoid hemorrhage: A single-center retrospective evaluation..PloS one
2023;18(3.0):e0283180.
Perez-Cameo, Cristina 1 ; Oriol, Isabel; Lung, Mayli; Llado, Laura; Dopazo, Cristina;
Nuvials, Xavier; Los-Arcos, Ibai; Sabe, Nuria; Castells, Lluis; Len, Oscar. Impact of
Prophylactic Norfloxacin in Multidrug Resistant Bacterial Infections in the Early Liver
Posttransplant Period. Experimental and clinical transplantation : official journal of the
Middle East Society for Organ Transplantation. 2023; 21(3): 236-244.
Maquet, J. et al. Drug-induced autoimmune hemolytic anemia: Detection of new signals in
the world pharmacovigilance database and risk assessment in a nationwide cohort study in
France. Blood. 2022; 140(Suppl.1): 8176-8177.
Chu CS, Lee FL, Bai YM, Su TP, Tsai SJ, Chen TJ, et al.. Antidepressant drugs use and
epilepsy risk:A nationwide nested case-control study.. Epilepsy-Behav. 2023;140:109102
Chu CS, Lee FL, Bai YM, Su TP, Tsai SJ, Chen TJ, et al.. Antidepressant drugs use and
epilepsy risk:A nationwide nested case-control study.. Epilepsy-Behav. 2023;140:109102
Pienkos SM, Moore AR, Guan J, Levitt JE, Matthay MA, Baron RM, et al.. Effect of total
cholesterol and statin therapy on mortality in ARDS patients: a secondary analysis of the
SAILS and HARP-2 trials.. Crit-Care. 2023;27(1):126
NPC-06-7試験について.
日本人健康成人男性を対象としたNPC-06の反復静脈内投与がアメナメビルの薬物動態に及
ぼす影響の検討 治験総括報告書. 2023 JUL 11;.
Jonathan Eisenberg et al. Adverse Outcomes in Topical Lidocaine Exposure: A Pediatric
Case Series From the United States National Poison Data System. Clinical pediatrics.
2023: 99228231159646
Kotani Y, Pruna A, Turi S, Borghi G, Lee TC, Zangrillo A, et al. Propofol and survival: an
updated meta-analysis of randomized clinical trials. Crit-Care. 2023;27(1):139
Yunha Noh,Han Eol Jeong,Ahhyung Choi,Eun-Young Choi,Bjorn Pasternak,Hedvig
Nordeng,Mette Bliddal,Kenneth K. C. Man,Ian C. K. Wong,Dong Keon Yon,JuYoungShin.Prenatal and infant exposure to acid-suppressive medications and risk of allergic
diseases in children.JAMA Pediatr. 2023;177(3):267-277.
Schmidt M, et al.. Dose-dependency of diclofenac's cardiovascular risks: A series of
nationwide emulated trials.. Eur. Respir. J.. 2022; 60(Sl 66): 2730-.
Figueiredo TM,de Barros JWF,Dos Santos BC,Pacheco TL,de Lima RJ,Anselmo-Franci
JA,Kempinas WDG. Reproductive outcomes of neonatal exposure to betamethasone in male
and female rats. Journal of applied toxicology : JAT. 2023;43:752-763
Alexander Balcerac, Kevin Bihan, Dimitri Psimaras, Benedicte Lebrun-Vignes, Joe-Elie
Salem, Nicolas Weiss.
Drugs associated with posterior reversible encephalopathy syndrome, a worldwide signal
detection study. Journal of Neurology 2023, 270 : 975-985.
A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis..
Investigative radiology. 58:255-362.
Gazzaniga G, et al..Effect of digoxin on all-cause and cardiovascular mortality in patients
with atrial fibrillation with and without heart failure : an umbrella review of systematic
reviews and 12 meta-analyses..European journal of clinical pharmacology 2023;79(4):473483.
G.Zaccara, et al.. Effect of associated antiepileptic treatment on valproate-induced
hyperammonemia. Therapeutic Drug Monitoring. 1985; 7(2): 185-190.
Peter Y.M.Woo, et al. Incidence, Presentation, and Risk Factors for Sodium ValproateAssociated Hyperammonemia in Neurosurgical Patients: A Prospective, observational Study.
World Neurosurgery. 2020; (144): 597-604.
Jiang, Yuhong et al. Dose-response association between dietary folate and niacin intakes with
diabetes among Chinese adults: a cross-sectional study.Journal of health, population, and
nutrition 2023;42(1):31.
Haisma, M.S. et al. Chronic use of hydrochlorothiazide and risk of skin cancer in caucasian
adults: A PharmLines initiative inception cohort study. Acta Dermato-Vener.
2023;103,adv3933.
5 / 12