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資料４－４ 研究報告の報告状況［714KB］ (12 ページ)
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| 出典情報 | 薬事審議会 医薬品等安全対策部会（令和8年度第1回 6／18）《厚生労働省》 |
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研究報告の報告状況
（2025年12月1日～2026年3月31日）
115 乾燥ＢＣＧワクチン
Shaomei Huang et al. Clinical Characteristics and Outcomes
of Severe Adverse Reactions to Bacille Calmette-Guerin
(BCG) Vaccination in China: A Single-Center Retrospective
Study. Sage Open Pediatrics 12 (Jan 1, 2025). DOI:
http://dx.doi.org/10.1177/30502225251346345
116 乾燥ＢＣＧワクチン
Stalin Ramprakash et al. BACILLE CALMETTE-GUERIN
(BCG) VACCINE-ASSOCIATED COMPLICATIONS
FOLLOWING STEM CELL TRANSPLANTATION IN
PATIENTS WITH INBORN ERRORS OF IMMUNITY (IEI) ?
SINGLE TERTIARY CENTRE EXPERIENCE FROM SOUTH
INDIA. Bone Marrow Transplantation, suppl. Supplement 1
59 (Oct 1, 2024): 406. DOI:
http://dx.doi.org/10.1038/s41409-024-02346-8
アジスロマイシン水和物
117 レボフロキサシン水和物
非ピリン系感冒剤（４）
Karkra, R. et al.Drug-induced vanishing bile duct syndrome:
A disproportionality analysis using the FDA Adverse Event
Reporting System (FAERS)database.Am. J. Gastroenterol.
120(10),Suppl.2,S521-S522,2025
118 ジクロフェナクナトリウム
Cho,J.et al.TOP10-SCAR: A global pharmacovigilance study
on medications most frequently related to severe cutaneous
adverse reactions.Allergy 2025;80(11):3181-3184.
119 ラタノプロスト
Chen, Xiao-Dong; Xiao, Kun-Hong; Wu, Shi-Nan; Wei,
Ming-Yan; Yu, Chao-Feng; Feng, Ke; Cai, Pei-Xin; Wang,
Yu-Ru; Miao, Yan-Liang; Li, Li; Wang, Bo-Zhao; Li, ShiYing; Chen, Qian. Drug-related retinal detachment
pharmacovigilance signals in the real world: evidence from
the FDA Adverse Event Reporting System. Eye
(Basingstoke). 2025; 39(18): 3284-3293.
120 プロゲステロン
タイトル：Vaginal progesterone and the risk of preterm birth
in patients with short cervix beyond 24 weeks
著者：Omri Dominsky,Matan Anteby,Roza BerkovitzShperling,Itamar Gilboa,Neta Simon,Daniel Weiner
Kalish,Yariv Yogev,Liran Hiersch,Eli Rimon
掲載：International Journal of Gynecology &
Obstetrics.2026;172:1039-1046
121 プレガバリン
Kimura, Y. et al. Gabapentinoids and risk for exacerbation of
chronic obstructive pulmonary disease. Ann. Am. Thorac.
Soc. 2025; 22(12): 1843-1852.
122
アスピリン・ボノプラザンフマル酸塩配
合剤
123 メトロニダゾール
Li BMH, Lai ECC. Aspirin Use During the First Trimester of
Pregnancy and the Risk of Congenital Malformations:
Emulating a Sequence of Target Trials.
Pharmacoepidemiology and Drug Safety. 2025;34(Suppl
1):Abstract Number 41
Cho, J..TOP10-SCAR: A global pharmacovigilance study on
medications most frequently related to severe cutaneous
adverse reactions.Allergy. 2025;80(11):3181-3184.
12/30
（2025年12月1日～2026年3月31日）
115 乾燥ＢＣＧワクチン
Shaomei Huang et al. Clinical Characteristics and Outcomes
of Severe Adverse Reactions to Bacille Calmette-Guerin
(BCG) Vaccination in China: A Single-Center Retrospective
Study. Sage Open Pediatrics 12 (Jan 1, 2025). DOI:
http://dx.doi.org/10.1177/30502225251346345
116 乾燥ＢＣＧワクチン
Stalin Ramprakash et al. BACILLE CALMETTE-GUERIN
(BCG) VACCINE-ASSOCIATED COMPLICATIONS
FOLLOWING STEM CELL TRANSPLANTATION IN
PATIENTS WITH INBORN ERRORS OF IMMUNITY (IEI) ?
SINGLE TERTIARY CENTRE EXPERIENCE FROM SOUTH
INDIA. Bone Marrow Transplantation, suppl. Supplement 1
59 (Oct 1, 2024): 406. DOI:
http://dx.doi.org/10.1038/s41409-024-02346-8
アジスロマイシン水和物
117 レボフロキサシン水和物
非ピリン系感冒剤（４）
Karkra, R. et al.Drug-induced vanishing bile duct syndrome:
A disproportionality analysis using the FDA Adverse Event
Reporting System (FAERS)database.Am. J. Gastroenterol.
120(10),Suppl.2,S521-S522,2025
118 ジクロフェナクナトリウム
Cho,J.et al.TOP10-SCAR: A global pharmacovigilance study
on medications most frequently related to severe cutaneous
adverse reactions.Allergy 2025;80(11):3181-3184.
119 ラタノプロスト
Chen, Xiao-Dong; Xiao, Kun-Hong; Wu, Shi-Nan; Wei,
Ming-Yan; Yu, Chao-Feng; Feng, Ke; Cai, Pei-Xin; Wang,
Yu-Ru; Miao, Yan-Liang; Li, Li; Wang, Bo-Zhao; Li, ShiYing; Chen, Qian. Drug-related retinal detachment
pharmacovigilance signals in the real world: evidence from
the FDA Adverse Event Reporting System. Eye
(Basingstoke). 2025; 39(18): 3284-3293.
120 プロゲステロン
タイトル：Vaginal progesterone and the risk of preterm birth
in patients with short cervix beyond 24 weeks
著者：Omri Dominsky,Matan Anteby,Roza BerkovitzShperling,Itamar Gilboa,Neta Simon,Daniel Weiner
Kalish,Yariv Yogev,Liran Hiersch,Eli Rimon
掲載：International Journal of Gynecology &
Obstetrics.2026;172:1039-1046
121 プレガバリン
Kimura, Y. et al. Gabapentinoids and risk for exacerbation of
chronic obstructive pulmonary disease. Ann. Am. Thorac.
Soc. 2025; 22(12): 1843-1852.
122
アスピリン・ボノプラザンフマル酸塩配
合剤
123 メトロニダゾール
Li BMH, Lai ECC. Aspirin Use During the First Trimester of
Pregnancy and the Risk of Congenital Malformations:
Emulating a Sequence of Target Trials.
Pharmacoepidemiology and Drug Safety. 2025;34(Suppl
1):Abstract Number 41
Cho, J..TOP10-SCAR: A global pharmacovigilance study on
medications most frequently related to severe cutaneous
adverse reactions.Allergy. 2025;80(11):3181-3184.
12/30