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資料５－４ 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
99 オキシコドン塩酸塩水和物
文献名
Jakobsson G, et al.. Oxycodone-Related Deaths: The Significance of Pharmacokinetic and
Pharmacodynamic Drug Interactions.. European journal of drug metabolism and pharmacokinetics.
2022; 47(2): 259-270 DOI:10.1007/s13318-021-00750-9.
100 トラマドール塩酸塩・アセトアミノフェン配合剤
Talip E. Eroglu et.al.. Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries. Br. J. Clin. Pharmacol.. 2022; 88(5): 2256-2266.
101 グリメピリド
Hee Nam Y et al. Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin
Secretagogues and the Risk of Serious Hypoglycemia. Clin Pharmacol Ther. 2022; 111(1): 218-226.
102 無水カフェイン
Yang Y, Lu K, Cheng R, Zhou Q, Fang G, Li H, Shao J, Wang H, Li Z, Liu S, Li Z, Cai J, Xue M,
Chen X, Pan Z, Gao Y, Huang L, Li H, Song L, Wang S, Shu G, Wu W, Yu M, Xu Z, Li H, Xu Y,
Bao Z, Wu X, Ye L, Dong X, Yin Q, Yin X, Zhou J. Clinical effect of different maintenance doses of
caffeine citrate in the treatment of preterm infants requiring assisted ventilation: a pilot multicenter
study. Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics. 2022 MAR
15;24(3):240-248.
103 タクロリムス水和物
Arana A, et al..Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and
Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European
Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)..Clinical Epidemiology
2021;13(1141):1153.
104
フェンタニル
トラマドール塩酸塩・アセトアミノフェン配合剤
105 インダパミド
106
ビサコジル
乾燥水酸化アルミニウムゲル・水酸化マグネシウム
107 シルデナフィルクエン酸塩
108 ドパミン塩酸塩
109 ドンペリドン
Talip E. Eroglu et al.Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries.Br. J. Clin. Pharmacol. 2022;88(5):2256-2266.
Lin, Z. et al. Proportion of patients taking indapamide developing severe hypokalaemia. Europ.
Heart J. 2021;42(Suppl.1):2366.
Lin T.-L, Wu C.-Y, Fan Y.-H, Chang Y.-L, Ho H.J, Chen Y.-J. Association between early life
laxative exposure and risk of allergic diseases: A nationwide matched cohort study. Annals of
Allergy, Asthma & Immunology. 2022;128(3):291-298.e3.
Turner, Jessica M; Russo, Francesca; DePrest, Jan; Mol, Ben W; Kumar, Sailesh.
Phosphodiesterase-5 inhibitors in Pregnancy: Systematic review and meta-analysis of maternal and
perinatal safety and clinical outcomes. BJOG : an international journal of obstetrics and
gynaecology. 2022.
Suzuki R, Uchino S, Sasabuchi Y, Kawarai Lefor A, Sanui M. Dopamine use and its consequences in
the intensive care unit: a cohort study utilizing the Japanese Intensive care PAtient Database. CritCare. 2022;26(1):90
Benard-Laribiere A, Hucteau E, Debette S, Kirchgesner J, Bezin J, Pariente A. Risk of first
ischaemic stroke and use of antidopaminergic antiemetics: nationwide case-time-control study. The
BMJ. 2022;376(8331):e066192.
110 バルプロ酸ナトリウム
David Larsson, MD; Arton Baftiu, PhD; Cecilie Johannessen Landmark, PhD; Mia von Euler, MD,
PhD; Eva Kumlien, MD, PhD; Signild Asberg, MD, PhD; Johan Zelano, MD, PhD. Association
between antiseizure drug monotherapy and mortality for patients with poststroke epilepsy. JAMA
Neurol. 2022;79(2):169-175
111 アスピリン・ボノプラザンフマル酸塩配合剤
van der Steen W, et al. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during
endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised
controlled trial. The Lancet. 2022;399(10329):1059-1069
112
オランザピン
クエチアピンフマル酸塩
塩酸メトクロプラミド
113 メトクロプラミド
ドンペリドン
114
フルコナゾール
ボリコナゾール
Wallman, P. et al. (South London and The Maudsley NHS Foundation Trust, London, UK).
Antipsychotic use and pneumonia-related mortality. Brit. J. Clin. Pharmacol. 2021;87(12):48854886-.
Benard-Laribiere, A. et al. (Universite de Bordeaux, Bordeaux, France). Risk of first ischaemic
stroke and use of antidopaminergic antiemetics: nationwide case-time-control study. BMJ. 2022;
376(8331): e066192-.
Ji, H.-H. et al. (Children's Hospital of Chongqing Medical University, Chongqing, China). Antifungal
therapy with azoles induced the syndrome of acquired apparent mineralocorticoid excess: a
literature and database analysis. Antimicrob. Agents Chemother.. 2022; 66(1): e01668-21.
115 オランザピン
McNally, H. et al. (Colorado Blood Cancer Institute, CO., USA). Is there a higher incidence of graft
failure or delayed time to engraftment in patients undergoing autologous stem cell transplantation
who receive olanzapine for anti-emetic prophylaxis?. Blood. 2021; 138(Suppl.1): 4905-.
116 メトホルミン塩酸塩
Maarten J. Wensink. Preconception Antidiabetic Drugs in Men and Birth Defects in Offspring A
Nationwide Cohort Study. Annals of Internal Medicine. 2022;175(5):665-673
117 オランザピン
Wallman, P. et al.
『Antipsychotic use and pneumonia-related mortality』
Brit. J. Clin. Pharmacol. 2021; 87(12), 4885-4886
コデインリン酸塩水和物（１０％）
オキシコドン塩酸塩水和物
118
フェンタニルクエン酸塩
モルヒネ塩酸塩水和物
Eroglu TE, et al., Opioid use is associated with increased out-of-hospital cardiac arrest risk among
40000-cases across two countries, Brit. J Clinical Pharmacology. 2022; 88; 2256-2266
119 クロザピン
Tiihonen J. Long-term treatment with clozapine and other antipsychotic drugs and the risk of
haematological malignancies in people with schizophrenia: a nationwide case-control and cohort
study in Finland. The Lancet Psychiatry. 2022;9:353-362
6
（2022年4月1日～2022年7月31日）
NO
一般名
99 オキシコドン塩酸塩水和物
文献名
Jakobsson G, et al.. Oxycodone-Related Deaths: The Significance of Pharmacokinetic and
Pharmacodynamic Drug Interactions.. European journal of drug metabolism and pharmacokinetics.
2022; 47(2): 259-270 DOI:10.1007/s13318-021-00750-9.
100 トラマドール塩酸塩・アセトアミノフェン配合剤
Talip E. Eroglu et.al.. Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries. Br. J. Clin. Pharmacol.. 2022; 88(5): 2256-2266.
101 グリメピリド
Hee Nam Y et al. Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin
Secretagogues and the Risk of Serious Hypoglycemia. Clin Pharmacol Ther. 2022; 111(1): 218-226.
102 無水カフェイン
Yang Y, Lu K, Cheng R, Zhou Q, Fang G, Li H, Shao J, Wang H, Li Z, Liu S, Li Z, Cai J, Xue M,
Chen X, Pan Z, Gao Y, Huang L, Li H, Song L, Wang S, Shu G, Wu W, Yu M, Xu Z, Li H, Xu Y,
Bao Z, Wu X, Ye L, Dong X, Yin Q, Yin X, Zhou J. Clinical effect of different maintenance doses of
caffeine citrate in the treatment of preterm infants requiring assisted ventilation: a pilot multicenter
study. Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics. 2022 MAR
15;24(3):240-248.
103 タクロリムス水和物
Arana A, et al..Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and
Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European
Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)..Clinical Epidemiology
2021;13(1141):1153.
104
フェンタニル
トラマドール塩酸塩・アセトアミノフェン配合剤
105 インダパミド
106
ビサコジル
乾燥水酸化アルミニウムゲル・水酸化マグネシウム
107 シルデナフィルクエン酸塩
108 ドパミン塩酸塩
109 ドンペリドン
Talip E. Eroglu et al.Opioid use is associated with increased out-of-hospital cardiac arrest risk
among 40 000-cases across two countries.Br. J. Clin. Pharmacol. 2022;88(5):2256-2266.
Lin, Z. et al. Proportion of patients taking indapamide developing severe hypokalaemia. Europ.
Heart J. 2021;42(Suppl.1):2366.
Lin T.-L, Wu C.-Y, Fan Y.-H, Chang Y.-L, Ho H.J, Chen Y.-J. Association between early life
laxative exposure and risk of allergic diseases: A nationwide matched cohort study. Annals of
Allergy, Asthma & Immunology. 2022;128(3):291-298.e3.
Turner, Jessica M; Russo, Francesca; DePrest, Jan; Mol, Ben W; Kumar, Sailesh.
Phosphodiesterase-5 inhibitors in Pregnancy: Systematic review and meta-analysis of maternal and
perinatal safety and clinical outcomes. BJOG : an international journal of obstetrics and
gynaecology. 2022.
Suzuki R, Uchino S, Sasabuchi Y, Kawarai Lefor A, Sanui M. Dopamine use and its consequences in
the intensive care unit: a cohort study utilizing the Japanese Intensive care PAtient Database. CritCare. 2022;26(1):90
Benard-Laribiere A, Hucteau E, Debette S, Kirchgesner J, Bezin J, Pariente A. Risk of first
ischaemic stroke and use of antidopaminergic antiemetics: nationwide case-time-control study. The
BMJ. 2022;376(8331):e066192.
110 バルプロ酸ナトリウム
David Larsson, MD; Arton Baftiu, PhD; Cecilie Johannessen Landmark, PhD; Mia von Euler, MD,
PhD; Eva Kumlien, MD, PhD; Signild Asberg, MD, PhD; Johan Zelano, MD, PhD. Association
between antiseizure drug monotherapy and mortality for patients with poststroke epilepsy. JAMA
Neurol. 2022;79(2):169-175
111 アスピリン・ボノプラザンフマル酸塩配合剤
van der Steen W, et al. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during
endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised
controlled trial. The Lancet. 2022;399(10329):1059-1069
112
オランザピン
クエチアピンフマル酸塩
塩酸メトクロプラミド
113 メトクロプラミド
ドンペリドン
114
フルコナゾール
ボリコナゾール
Wallman, P. et al. (South London and The Maudsley NHS Foundation Trust, London, UK).
Antipsychotic use and pneumonia-related mortality. Brit. J. Clin. Pharmacol. 2021;87(12):48854886-.
Benard-Laribiere, A. et al. (Universite de Bordeaux, Bordeaux, France). Risk of first ischaemic
stroke and use of antidopaminergic antiemetics: nationwide case-time-control study. BMJ. 2022;
376(8331): e066192-.
Ji, H.-H. et al. (Children's Hospital of Chongqing Medical University, Chongqing, China). Antifungal
therapy with azoles induced the syndrome of acquired apparent mineralocorticoid excess: a
literature and database analysis. Antimicrob. Agents Chemother.. 2022; 66(1): e01668-21.
115 オランザピン
McNally, H. et al. (Colorado Blood Cancer Institute, CO., USA). Is there a higher incidence of graft
failure or delayed time to engraftment in patients undergoing autologous stem cell transplantation
who receive olanzapine for anti-emetic prophylaxis?. Blood. 2021; 138(Suppl.1): 4905-.
116 メトホルミン塩酸塩
Maarten J. Wensink. Preconception Antidiabetic Drugs in Men and Birth Defects in Offspring A
Nationwide Cohort Study. Annals of Internal Medicine. 2022;175(5):665-673
117 オランザピン
Wallman, P. et al.
『Antipsychotic use and pneumonia-related mortality』
Brit. J. Clin. Pharmacol. 2021; 87(12), 4885-4886
コデインリン酸塩水和物（１０％）
オキシコドン塩酸塩水和物
118
フェンタニルクエン酸塩
モルヒネ塩酸塩水和物
Eroglu TE, et al., Opioid use is associated with increased out-of-hospital cardiac arrest risk among
40000-cases across two countries, Brit. J Clinical Pharmacology. 2022; 88; 2256-2266
119 クロザピン
Tiihonen J. Long-term treatment with clozapine and other antipsychotic drugs and the risk of
haematological malignancies in people with schizophrenia: a nationwide case-control and cohort
study in Finland. The Lancet Psychiatry. 2022;9:353-362
6