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資料5-4 研究報告の報告状況 (4 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4年度第3回 12/1)《厚生労働省》 |
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研究報告の報告状況
(2022年4月1日~2022年7月31日)
NO
一般名
文献名
55 ミダゾラム
Hu AM, et al. Comparative Effectiveness of Midazolam, Propofol, and Dexmedetomidine in Patients
With or at Risk for Acute Respiratory Distress Syndrome: A Propensity Score-Matched Cohort
Study. Frontiers in Pharmacology. 2021;12:614465(Article #)
56 リスペリドン
Scarpone, M. et al. Previous psychiatric disorders and antipsychotic drugs in COVID-19 patients:
early findings on possible worse outcome. Europ. Heart J. 2021;42(Suppl.1):2753.
57 ジクロフェナクナトリウム
Jafarzadeh, S.R. et al. Long-term effect of prescription non-steroidal anti-inflammatory drug regular
use on the risk of a knee replacement. Arthritis Rheumatol. 2021;73(Suppl.9):3040-3042.
58 アスピリン・ボノプラザンフマル酸塩配合剤
Chang W, et al. Increased relative risk of delayed hemorrhage in patients taking
anticoagulant/antiplatelet medications with concurrent aspirin therapy: implications for clinical
practice based on 3-year retrospective analysis in a large health system. Emergency radiology.
2022;29(2):353-358
59 アスピリン・ボノプラザンフマル酸塩配合剤
Pallikadavath S, et al. Aspirin for the primary prevention of cardiovascular disease in individuals with
chronic kidney disease: a systematic review and meta-analysis. European Journal of Preventive
Cardiology. 2021;28(17):1953-1960
60 リスペリドン
Rahman, T. et al..Risk of breast cancer with prolactin elevating antipsychotic drugs: an
observational study of US women (ages 18-64 years).J. Clin. Psychopharmacol. 2022;42(1):7-16.
ドルテグラビルナトリウム
ドルテグラビルナトリウム・アバカビル硫酸塩・ラミブ
61 ジン
ドルテグラビルナトリウム・リルピビリン塩酸塩
ドルテグラビルナトリウム・ラミブジン
Asif S,Baxevanidi E,Hill A,Venter WDF,Fairlie L,Masenya M,Serenata C,Sokhela S,
Chandiwana N. The predicted risk of adverse pregnancy outcomes as a result of treatmentassociated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/
dolutegravir , tenofovir disoproxil fumarate/emtricitabine/ dolutegravir or teno. AIDS (London,
England). 2021;35:S117-S125
62 ヨウ化ナトリウム(131I)
Pasqual E, Schonfeld S, Morton LM, Villoing D, Lee C, Gonzalez AB, et al. Association Between
Radioactive Iodine Treatment for Pediatric and Young Adulthood Differentiated Thyroid Cancer and
Risk of Second Primary Malignancies. Journal of Clinical Oncology. 2022 Jan;
63 バンコマイシン塩酸塩
Mitsuboshi,S.et al.
Risk of kidney injury in patients on concomitant oral vancomycin and piperacillin-tazobactam:
Analysis of the pharmacovigilance database in Japan
Basic Clin. Pharmacol.Toxicol. 2022,130(1),208-212
64 バルプロ酸ナトリウム
65 エルデカルシトール
Larsson,D.et al.
Association between antiseizure drug monotherapy and mortality for patients with poststroke
epilepsy
JAMA Neurol. 2022,79(2),169-175
Toriumi S, Kobayashi A, Uesawa Y. Comprehensive Study of the Risk Factors for MedicationRelated Osteonecrosis of the Jaw Based on the Japanese Adverse Drug Event Report Database.
Pharmaceuticals. 2020
66 ミゾリビン
吉田 優汰 他.有害事象自発報告データベースを用いたミゾリビン関連急性腎障害リスクに対する
併用薬ならびに患者背景の影響解析.第38回 日本薬学会九州山口支部大会 プログラム集・要旨
集(Web) (第38回 日本薬学会九州山口支部大会(2021.11.13)) 2021;:A2-2-08./第38回 日本薬学
会九州山口支部大会;.
67 レムデシビル
Miyazaki K, Yoshimura Y, Miyata N, Sasaki H, Shiba A, Aga M, et al.. Acute pancreatitis or severe
increase in pancreatic enzyme levels following remdesivir administration in COVID-19 patients: an
observational study. scientific reports. 2022;12:1-10
68 イコサペント酸エチル
Berger Christine, et al. Omega-3 fortement doses pour la prevention cardiovasculaire : une fausse
bonne idee ? Rev. Med. Suisse. 2022 Mar 09;18(772):434-7.
69 バンコマイシン塩酸塩
Yu KC, et al.. Relationships between creatinine increase and mortality rates in patients given
vancomycin in 76 hospitals: The increasing role of infectious disease pharmacists. Am J Health Syst
Pharm. 2021; 78(23): 2116-2125.
精製ヒアルロン酸ナトリウム
Yang X. Do preoperative intra-articular injections of corticosteroids or hyaluronic acid increase the
70 精製ヒアルロン酸ナトリウム・コンドロイチン硫酸エス
risk of infection after total knee arthroplasty?. Bone & joint research. 2022;11:171-179.
テルナトリウム(1)
71 アスピリン・ボノプラザンフマル酸塩配合剤
Calderone D, et al. Efficacy and Safety of Aspirin for Primary Cardiovascular Risk Prevention in
Younger and Older Age: An Updated Systematic Review and Meta-analysis of 173,810 Subjects from
21 Randomized Studies. Thrombosis and haemostasis. 2022;122(3):445-455
72 ジゴキシン
P. Dominguez Erquicia、S. Raposeiras Roubin、E. Abu-Asi、M. Cespon Fernandez、D. Alonso
Rodriguez、S.J. Camacho Freire、N. Curbelos Fernandez、A. Lopez Masjuan Rios、M. Melendo Viu、
A. Iniguez Romo. Safety of Digoxin in Nonagenarian Patients with Atrial Fibrillation. Lessons from a
Spanishmulticenter registry. Europ. Heart J. 42(Suppl.1),2927,2021
73 オキシコドン塩酸塩水和物
Fugelstad A, et al.. Oxycodone-related deaths in Sweden 2006-2018.. Drug and Alcohol
Dependence. 2022; 234: 109402(Article #)-DOI:10.1016/j.drugalcdep.2022.109402.
74 オメプラゾール
Xuejiao Xun,Qifan yin,Yuhao Fu,Xueru He,Zhanju Dong. Proton pump inhibitors and the risk of
community-acquired pneumonia: an updated meta-analysis. Ann. Pharmacother. 56(5),524532,2022
75 ラベプラゾールナトリウム
Xuejiao Xun. Proton Pump Inhibitors and the Risk of Community-Acquired Pneumonia: An Updated
Metaanalysis. Ann. Pharmacother.. 2022; 56(5): 524-532.
4
(2022年4月1日~2022年7月31日)
NO
一般名
文献名
55 ミダゾラム
Hu AM, et al. Comparative Effectiveness of Midazolam, Propofol, and Dexmedetomidine in Patients
With or at Risk for Acute Respiratory Distress Syndrome: A Propensity Score-Matched Cohort
Study. Frontiers in Pharmacology. 2021;12:614465(Article #)
56 リスペリドン
Scarpone, M. et al. Previous psychiatric disorders and antipsychotic drugs in COVID-19 patients:
early findings on possible worse outcome. Europ. Heart J. 2021;42(Suppl.1):2753.
57 ジクロフェナクナトリウム
Jafarzadeh, S.R. et al. Long-term effect of prescription non-steroidal anti-inflammatory drug regular
use on the risk of a knee replacement. Arthritis Rheumatol. 2021;73(Suppl.9):3040-3042.
58 アスピリン・ボノプラザンフマル酸塩配合剤
Chang W, et al. Increased relative risk of delayed hemorrhage in patients taking
anticoagulant/antiplatelet medications with concurrent aspirin therapy: implications for clinical
practice based on 3-year retrospective analysis in a large health system. Emergency radiology.
2022;29(2):353-358
59 アスピリン・ボノプラザンフマル酸塩配合剤
Pallikadavath S, et al. Aspirin for the primary prevention of cardiovascular disease in individuals with
chronic kidney disease: a systematic review and meta-analysis. European Journal of Preventive
Cardiology. 2021;28(17):1953-1960
60 リスペリドン
Rahman, T. et al..Risk of breast cancer with prolactin elevating antipsychotic drugs: an
observational study of US women (ages 18-64 years).J. Clin. Psychopharmacol. 2022;42(1):7-16.
ドルテグラビルナトリウム
ドルテグラビルナトリウム・アバカビル硫酸塩・ラミブ
61 ジン
ドルテグラビルナトリウム・リルピビリン塩酸塩
ドルテグラビルナトリウム・ラミブジン
Asif S,Baxevanidi E,Hill A,Venter WDF,Fairlie L,Masenya M,Serenata C,Sokhela S,
Chandiwana N. The predicted risk of adverse pregnancy outcomes as a result of treatmentassociated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/
dolutegravir , tenofovir disoproxil fumarate/emtricitabine/ dolutegravir or teno. AIDS (London,
England). 2021;35:S117-S125
62 ヨウ化ナトリウム(131I)
Pasqual E, Schonfeld S, Morton LM, Villoing D, Lee C, Gonzalez AB, et al. Association Between
Radioactive Iodine Treatment for Pediatric and Young Adulthood Differentiated Thyroid Cancer and
Risk of Second Primary Malignancies. Journal of Clinical Oncology. 2022 Jan;
63 バンコマイシン塩酸塩
Mitsuboshi,S.et al.
Risk of kidney injury in patients on concomitant oral vancomycin and piperacillin-tazobactam:
Analysis of the pharmacovigilance database in Japan
Basic Clin. Pharmacol.Toxicol. 2022,130(1),208-212
64 バルプロ酸ナトリウム
65 エルデカルシトール
Larsson,D.et al.
Association between antiseizure drug monotherapy and mortality for patients with poststroke
epilepsy
JAMA Neurol. 2022,79(2),169-175
Toriumi S, Kobayashi A, Uesawa Y. Comprehensive Study of the Risk Factors for MedicationRelated Osteonecrosis of the Jaw Based on the Japanese Adverse Drug Event Report Database.
Pharmaceuticals. 2020
66 ミゾリビン
吉田 優汰 他.有害事象自発報告データベースを用いたミゾリビン関連急性腎障害リスクに対する
併用薬ならびに患者背景の影響解析.第38回 日本薬学会九州山口支部大会 プログラム集・要旨
集(Web) (第38回 日本薬学会九州山口支部大会(2021.11.13)) 2021;:A2-2-08./第38回 日本薬学
会九州山口支部大会;.
67 レムデシビル
Miyazaki K, Yoshimura Y, Miyata N, Sasaki H, Shiba A, Aga M, et al.. Acute pancreatitis or severe
increase in pancreatic enzyme levels following remdesivir administration in COVID-19 patients: an
observational study. scientific reports. 2022;12:1-10
68 イコサペント酸エチル
Berger Christine, et al. Omega-3 fortement doses pour la prevention cardiovasculaire : une fausse
bonne idee ? Rev. Med. Suisse. 2022 Mar 09;18(772):434-7.
69 バンコマイシン塩酸塩
Yu KC, et al.. Relationships between creatinine increase and mortality rates in patients given
vancomycin in 76 hospitals: The increasing role of infectious disease pharmacists. Am J Health Syst
Pharm. 2021; 78(23): 2116-2125.
精製ヒアルロン酸ナトリウム
Yang X. Do preoperative intra-articular injections of corticosteroids or hyaluronic acid increase the
70 精製ヒアルロン酸ナトリウム・コンドロイチン硫酸エス
risk of infection after total knee arthroplasty?. Bone & joint research. 2022;11:171-179.
テルナトリウム(1)
71 アスピリン・ボノプラザンフマル酸塩配合剤
Calderone D, et al. Efficacy and Safety of Aspirin for Primary Cardiovascular Risk Prevention in
Younger and Older Age: An Updated Systematic Review and Meta-analysis of 173,810 Subjects from
21 Randomized Studies. Thrombosis and haemostasis. 2022;122(3):445-455
72 ジゴキシン
P. Dominguez Erquicia、S. Raposeiras Roubin、E. Abu-Asi、M. Cespon Fernandez、D. Alonso
Rodriguez、S.J. Camacho Freire、N. Curbelos Fernandez、A. Lopez Masjuan Rios、M. Melendo Viu、
A. Iniguez Romo. Safety of Digoxin in Nonagenarian Patients with Atrial Fibrillation. Lessons from a
Spanishmulticenter registry. Europ. Heart J. 42(Suppl.1),2927,2021
73 オキシコドン塩酸塩水和物
Fugelstad A, et al.. Oxycodone-related deaths in Sweden 2006-2018.. Drug and Alcohol
Dependence. 2022; 234: 109402(Article #)-DOI:10.1016/j.drugalcdep.2022.109402.
74 オメプラゾール
Xuejiao Xun,Qifan yin,Yuhao Fu,Xueru He,Zhanju Dong. Proton pump inhibitors and the risk of
community-acquired pneumonia: an updated meta-analysis. Ann. Pharmacother. 56(5),524532,2022
75 ラベプラゾールナトリウム
Xuejiao Xun. Proton Pump Inhibitors and the Risk of Community-Acquired Pneumonia: An Updated
Metaanalysis. Ann. Pharmacother.. 2022; 56(5): 524-532.
4