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資料２－４ 研究報告の報告状況 (10 ページ)
出典
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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
文献名
アバカビル硫酸塩
Dorjee K，Desai M，Choden T，Baxi SM，Hubbard AE，Reingold AL. Acute myocardial infarction
ドルテグラビルナトリウム・アバカ
233
associated with abacavir and tenofovir based antiretroviral drug combinations in the United States. AIDS
ビル硫酸塩・ラミブジン
Research and Therapy. 2021;18:57(Article #)
ラミブジン・アバカビル硫酸塩
Khan, N.. Coprescription of Opioids With Other Medications and Risk of Opioid Overdose. Clinical
234 ロラゼパム
Pharmacology and Therapeutics. 2021;110(4):1011-1017
Chen X, Sun H, Cassady K, Yang S, Chen T, Wang L, Yan H, Zhang X, Feng Y. The Addition of
235 シロリムス
Sirolimus to GVHD Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation: A MetaAnalysis of Efficacy and Safety. Frontiers in oncology. 2021 SEP 09;11:683263.
Zhou J，Wang X，Lee S，Wu WKK，Cheung BMY，Zhang Q，Tse G. Proton pump inhibitor or famotidine
236 オメプラゾール
use and severe COVID-19 disease: a propensity score-matched territory-wide study. Gut 2021; 70(10):
2012-2013.
Zhou J，Wang X，Lee S，Wu WKK，Cheung BMY，Zhang Q，Tse G. Proton pump inhibitor or famotidine
エソメプラゾールマグネシウム水
237
use and severe COVID-19 disease: a propensity score-matched territory-wide study. Gut 2021; 70(10):
和物
2012-2013.
Jiang, H H; Wang, K X; Bi, K H; Lu, Z M; Zhang, J Q; Cheng, H R; Zhang, M Y; Su, J J; Cao, Y X.
238 シルデナフィルクエン酸塩
Sildenafil might impair maternal-fetal immunotolerance by suppressing myeloid-derived suppressor cells
in mice. Journal of reproductive immunology. 2020; 142: 103175-103175.
Khan, N.. Coprescription of Opioids With Other Medications and Risk of Opioid Overdose. Clinical
239 アルプラゾラム
Pharmacology and Therapeutics. 2021;110(4):1011-1017
OMAR SAEED MD et al.Oral Anticoagulation and Adverse Outcomes after Ischemic Stroke in
240 ワルファリンカリウム
Heart Failure Patients without Atrial Fibrillation. 2021;27(8):857-868
Daniel R. Morales. Antithyroid drug use during pregnancy and the risk of birth defects in offspring:
241 プロピルチオウラシル
systematic reviewand meta-analysis of observational studies with methodological considerations. Br. J.
Clin. Pharmacol.. 2021; 87(10): 3890-3900.
Ferraris A, Blasco B, Tentoni N, et al. Antipsychotic use and bloodstream infections among adult
ハロペリドール
242
patients with chronic obstructive pulmonary disease: A cohort study. The Journal of Clinical Psychiatry.
リスペリドン
2021;82(3):20m13516.
Levetiracetam Versus Phenytoin or Fosphenytoin for Second-line Treatment of Pediatric Status
243 フェニトイン
Epilepticus: A Meta-AnalysisPediatric critical care medicine, 2021, 22(9), e480-e491
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
ロサルタンカリウム・ヒドロクロロチ
244
study using an active comparator group.
アジド
Brit. J. Dermatol. 2021;185(2):343-352.
コロナウイルス（ＳＡＲＳ－ＣｏＶ－ WHO Collaborating Centre for International Drug Monitoring. 20210830-AZD1222-UMCfeedback on
245 ２）ワクチン（遺伝子組換えサルア Giant cell arteritis. 2021.Analyses of reports the WHO global databas of individual case safety repots,
デノウイルスベクター）
VigiBase
Montastruc, J.-L. et al. (Centre Hospitalier Universitaire, Toulouse, France). Drugs and Dupuytren's
246 フェノバルビタールナトリウム
disease: a pharmacovigilance study in VigiBase. Europ. J. Clin. Pharmacol.. 2021; 77(10): 1587-1588-.
OMAR SAEED et al.Oral Anticoagulation and Adverse Outcomes after Ischemic Stroke in Heart Failure
247 ワルファリンカリウム
Patients without Atrial Fibrillation.Journal of Cardiac Failure 2021;（27）:857-868.
Liu, X.. Effect of renal injury or trough level on hematologic toxicity caused by linezolid. The 70th Japan
248 リネゾリド
Association for Infectious Diseases East Japan Regional Society A. 2021;70th:160
アログリプチン安息香酸塩
Kuwata H, et al. Association between dipeptidyl peptidase-4 inhibitors and increased risk for bullous
アログリプチン安息香酸塩・メトホ
249
pemphigoid within 3 months from first use: A 5-year population-based cohort study using the Japanese
ルミン塩酸塩配合剤
National Database. Journal of Diabetes Investigation. 2021;doi: 10.1111/jdi.13676
トレラグリプチンコハク酸塩
テルミサルタン・ヒドロクロロチア
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
250 ジド配合剤
study using an active comparator group.Br. J. Dermatol. 2021;185(2):343-352.
ヒドロクロロチアジド
テルミサルタン・アムロジピンベシ
ル酸塩・ヒドロクロロチアジド配合 Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
251
剤
study using an active comparator group.Br. J. Dermatol. 2021;185(2):343-352.
ヒドロクロロチアジド
Yana Vinogradova et al.Use of menopausal hormone therapy and risk of dementia: nested case-control
252 ノルエチステロン
studies using QResearch and CPRD databases.BMJ.2021;(8308):n2182.
Peacock A, et al.. All-cause and cause-specific mortality among people with regular or problematic
253 コカイン塩酸塩
cocaine use: a systematic review and meta-analysis.. Addiction (Abingdon, England). 2021; 116(4): 725742 DOI:10.1111/add.15239.
De Nunzio C, Nacchia A, Lombardo R, Franco A, Tema G, Baldassarri V, et al.. P0033 - Sexual adverse
254 フィナステリド
events-related to dutasteride e finasteride: Analysis of real-life data from EudraVigilance database.
European Urology. 2021;79(S1):S47-S48
Ersboll AK, Sengupta K, Pukkala E, Bolin K, Aas E, Emneus M, et al.. Desloratadine Exposure and
255 デスロラタジン
Incidence of Seizure: A Nordic Post authorization Safety Study Using a New User Cohort Study Design,
2001?2015. Drug Safety. 2021
ベタメタゾン・ｄ－クロルフェニラミ Glucocorticoid use and risk of first and recurrent venous thromboembolism : self-controlled case-series
256
ンマレイン酸塩
and cohort studyBrit. J. Haematol. 2021,193(6),1194-1202
クエチアピンフマル酸塩
Antipsychotic use and bloodstream infections among adult patients with chronic obstructive pulmonary
257 オランザピン
disease : A cohort study
リスペリドン
J. Clin. Psychiat. 2021,82(3),20m13516
Drug-induced liver injury in Switzerland : an analysis of drug-related hepatic disorders in the WHO
アトルバスタチンカルシウム水和
258
pharmacovigilance database Vigibase from 2010 to 2020
物
Swiss Med. Wkly 2021,151,w20503
10
(2021年8月1日～2021年11月30日)
NO 一般名
文献名
アバカビル硫酸塩
Dorjee K，Desai M，Choden T，Baxi SM，Hubbard AE，Reingold AL. Acute myocardial infarction
ドルテグラビルナトリウム・アバカ
233
associated with abacavir and tenofovir based antiretroviral drug combinations in the United States. AIDS
ビル硫酸塩・ラミブジン
Research and Therapy. 2021;18:57(Article #)
ラミブジン・アバカビル硫酸塩
Khan, N.. Coprescription of Opioids With Other Medications and Risk of Opioid Overdose. Clinical
234 ロラゼパム
Pharmacology and Therapeutics. 2021;110(4):1011-1017
Chen X, Sun H, Cassady K, Yang S, Chen T, Wang L, Yan H, Zhang X, Feng Y. The Addition of
235 シロリムス
Sirolimus to GVHD Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation: A MetaAnalysis of Efficacy and Safety. Frontiers in oncology. 2021 SEP 09;11:683263.
Zhou J，Wang X，Lee S，Wu WKK，Cheung BMY，Zhang Q，Tse G. Proton pump inhibitor or famotidine
236 オメプラゾール
use and severe COVID-19 disease: a propensity score-matched territory-wide study. Gut 2021; 70(10):
2012-2013.
Zhou J，Wang X，Lee S，Wu WKK，Cheung BMY，Zhang Q，Tse G. Proton pump inhibitor or famotidine
エソメプラゾールマグネシウム水
237
use and severe COVID-19 disease: a propensity score-matched territory-wide study. Gut 2021; 70(10):
和物
2012-2013.
Jiang, H H; Wang, K X; Bi, K H; Lu, Z M; Zhang, J Q; Cheng, H R; Zhang, M Y; Su, J J; Cao, Y X.
238 シルデナフィルクエン酸塩
Sildenafil might impair maternal-fetal immunotolerance by suppressing myeloid-derived suppressor cells
in mice. Journal of reproductive immunology. 2020; 142: 103175-103175.
Khan, N.. Coprescription of Opioids With Other Medications and Risk of Opioid Overdose. Clinical
239 アルプラゾラム
Pharmacology and Therapeutics. 2021;110(4):1011-1017
OMAR SAEED MD et al.Oral Anticoagulation and Adverse Outcomes after Ischemic Stroke in
240 ワルファリンカリウム
Heart Failure Patients without Atrial Fibrillation. 2021;27(8):857-868
Daniel R. Morales. Antithyroid drug use during pregnancy and the risk of birth defects in offspring:
241 プロピルチオウラシル
systematic reviewand meta-analysis of observational studies with methodological considerations. Br. J.
Clin. Pharmacol.. 2021; 87(10): 3890-3900.
Ferraris A, Blasco B, Tentoni N, et al. Antipsychotic use and bloodstream infections among adult
ハロペリドール
242
patients with chronic obstructive pulmonary disease: A cohort study. The Journal of Clinical Psychiatry.
リスペリドン
2021;82(3):20m13516.
Levetiracetam Versus Phenytoin or Fosphenytoin for Second-line Treatment of Pediatric Status
243 フェニトイン
Epilepticus: A Meta-AnalysisPediatric critical care medicine, 2021, 22(9), e480-e491
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
ロサルタンカリウム・ヒドロクロロチ
244
study using an active comparator group.
アジド
Brit. J. Dermatol. 2021;185(2):343-352.
コロナウイルス（ＳＡＲＳ－ＣｏＶ－ WHO Collaborating Centre for International Drug Monitoring. 20210830-AZD1222-UMCfeedback on
245 ２）ワクチン（遺伝子組換えサルア Giant cell arteritis. 2021.Analyses of reports the WHO global databas of individual case safety repots,
デノウイルスベクター）
VigiBase
Montastruc, J.-L. et al. (Centre Hospitalier Universitaire, Toulouse, France). Drugs and Dupuytren's
246 フェノバルビタールナトリウム
disease: a pharmacovigilance study in VigiBase. Europ. J. Clin. Pharmacol.. 2021; 77(10): 1587-1588-.
OMAR SAEED et al.Oral Anticoagulation and Adverse Outcomes after Ischemic Stroke in Heart Failure
247 ワルファリンカリウム
Patients without Atrial Fibrillation.Journal of Cardiac Failure 2021;（27）:857-868.
Liu, X.. Effect of renal injury or trough level on hematologic toxicity caused by linezolid. The 70th Japan
248 リネゾリド
Association for Infectious Diseases East Japan Regional Society A. 2021;70th:160
アログリプチン安息香酸塩
Kuwata H, et al. Association between dipeptidyl peptidase-4 inhibitors and increased risk for bullous
アログリプチン安息香酸塩・メトホ
249
pemphigoid within 3 months from first use: A 5-year population-based cohort study using the Japanese
ルミン塩酸塩配合剤
National Database. Journal of Diabetes Investigation. 2021;doi: 10.1111/jdi.13676
トレラグリプチンコハク酸塩
テルミサルタン・ヒドロクロロチア
Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
250 ジド配合剤
study using an active comparator group.Br. J. Dermatol. 2021;185(2):343-352.
ヒドロクロロチアジド
テルミサルタン・アムロジピンベシ
ル酸塩・ヒドロクロロチアジド配合 Schneider, R. et al. Risk of skin cancer in new users of thiazides and thiazide-like diuretics: a cohort
251
剤
study using an active comparator group.Br. J. Dermatol. 2021;185(2):343-352.
ヒドロクロロチアジド
Yana Vinogradova et al.Use of menopausal hormone therapy and risk of dementia: nested case-control
252 ノルエチステロン
studies using QResearch and CPRD databases.BMJ.2021;(8308):n2182.
Peacock A, et al.. All-cause and cause-specific mortality among people with regular or problematic
253 コカイン塩酸塩
cocaine use: a systematic review and meta-analysis.. Addiction (Abingdon, England). 2021; 116(4): 725742 DOI:10.1111/add.15239.
De Nunzio C, Nacchia A, Lombardo R, Franco A, Tema G, Baldassarri V, et al.. P0033 - Sexual adverse
254 フィナステリド
events-related to dutasteride e finasteride: Analysis of real-life data from EudraVigilance database.
European Urology. 2021;79(S1):S47-S48
Ersboll AK, Sengupta K, Pukkala E, Bolin K, Aas E, Emneus M, et al.. Desloratadine Exposure and
255 デスロラタジン
Incidence of Seizure: A Nordic Post authorization Safety Study Using a New User Cohort Study Design,
2001?2015. Drug Safety. 2021
ベタメタゾン・ｄ－クロルフェニラミ Glucocorticoid use and risk of first and recurrent venous thromboembolism : self-controlled case-series
256
ンマレイン酸塩
and cohort studyBrit. J. Haematol. 2021,193(6),1194-1202
クエチアピンフマル酸塩
Antipsychotic use and bloodstream infections among adult patients with chronic obstructive pulmonary
257 オランザピン
disease : A cohort study
リスペリドン
J. Clin. Psychiat. 2021,82(3),20m13516
Drug-induced liver injury in Switzerland : an analysis of drug-related hepatic disorders in the WHO
アトルバスタチンカルシウム水和
258
pharmacovigilance database Vigibase from 2010 to 2020
物
Swiss Med. Wkly 2021,151,w20503
10