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資 料４－１ 令和３年度第６回安全技術調査会の審議結果について (320 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26025.html |
| 出典情報 | 薬事・食品衛生審議会 薬事分科会血液事業部会（令和4年度第1回 6／8）《厚生労働省》 |
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文献
1.
Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia
after ChAdOx1 nCov-19 Vaccination. N Engl J Med. 2021;384:2092-2101. doi: 10.1056/NEJMoa2104840.
2.
Schultz NH, Sørvoll IH, Michelsen AE, Munthe LA, Lund-Johansen F, Ahlen MT, Wiedmann M, Aamodt AH,
Skattør TH, Tjønnfjord GE, Holme PA. Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19
Vaccination. N Engl J Med. 2021;384:2124-2130. doi: 10.1056/NEJMoa2104882.
3.
Scully M, Singh D, Lown R, Poles A, Solomon T, Levi M, Goldblatt D, Kotoucek P, Thomas W, Lester W.
Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination. N Engl J Med.
2021;384:2202-2211. doi: 10.1056/NEJMoa2105385.
4.
Muir KL, Kallam A, Koepsell SA, Gundabolu K: Thrombotic Thrombocytopenia after Ad26.COV2.S
Vaccination. N Engl J Med. 2021;384:1964-1965. doi: 10.1056/NEJMc2105869.
5.
See I, Su JR, Laie A, Woo EJ, Guh AY, Shimabukuro TT, Streiff MB, Rao AK, Wheeler AP, Beavers S, Durbin
AP, Edwards K, Miller E, Harrington TA, Mba-Jonas A, Nair N, Nguyen DT, Talaat KR, Urrutia VC, Walker
SC, Creech CB, Clark TA, DeStefano F, Broder KR. US Case Reports of Cerebral Venous Sinus Thrombosis
With
Thrombocytopenia
After
Ad26.COV2.S
Vaccination.
March
2
to
April
21,
2021
JAMA. 2021;325:2448-2456. doi:10.1001/jama.2021.7517
6.
Hippisley-Cox J, Patone M, Mei XW, Saatci D, Dixon S, Khunti K, Zaccardi F, Watkinson P, Shankar-Hari
M, Doidge J, Harrison DA, Griffin SJ, Sheikh A, Coupland CAC. Risk of thrombocytopenia and
thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case
series study. BMJ 2021; 374: n1931.
7.
ISTH Interim Guidance for the diagnosis and treatment on vaccine-induced immune thrombotic
thrombocytopenia (Updated 20 April, 2021) https://www.isth.org/news/561406/（2021/10/30 アク
セス）
8.
Thrombosis
with
Thrombocytopenia
syndrome
(also
termed
vaccine-induced
thrombotic
thrombocytopenia) (Version 1.6; last updated August 12, 2021) https://www.hematology.org/covid19/vaccine-induced-immune-thrombotic-thrombocytopenia（2021/10/30 アクセス）
9.
Oldenburg J, Klamroth R, Langer F, Albisetti M, von Auer C, Ay C, Korte W, Scharf RE, Pötzsch B,
Greinacher A. Diagnosis and Management of Vaccine-Related Thrombosis following AstraZeneca COVID19 Vaccination: Guidance Statement from the GTH. Hamostaseologie. 2021;41:184-189. doi: 10.1055/a1469-7481.
10. Gresele P, Marietta M, Ageno W, Marcucci R, Contino L, Donadini MP, Russo L, Tiscia GL, Palareti G,
Tripodi A, Mannucci PM, De Stefano V. Management of cerebral and splanchnic vein thrombosis
associated with thrombocytopenia in subjects previously vaccinated with Vaxzevria (AstraZeneca): a
position statement from the Italian Society for the Study of Haemostasis and Thrombosis (SISET). Blood
Transfus. 2021;15:284-283. doi: 10.2450/2021.0117-21.
19
318
1.
Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia
after ChAdOx1 nCov-19 Vaccination. N Engl J Med. 2021;384:2092-2101. doi: 10.1056/NEJMoa2104840.
2.
Schultz NH, Sørvoll IH, Michelsen AE, Munthe LA, Lund-Johansen F, Ahlen MT, Wiedmann M, Aamodt AH,
Skattør TH, Tjønnfjord GE, Holme PA. Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19
Vaccination. N Engl J Med. 2021;384:2124-2130. doi: 10.1056/NEJMoa2104882.
3.
Scully M, Singh D, Lown R, Poles A, Solomon T, Levi M, Goldblatt D, Kotoucek P, Thomas W, Lester W.
Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination. N Engl J Med.
2021;384:2202-2211. doi: 10.1056/NEJMoa2105385.
4.
Muir KL, Kallam A, Koepsell SA, Gundabolu K: Thrombotic Thrombocytopenia after Ad26.COV2.S
Vaccination. N Engl J Med. 2021;384:1964-1965. doi: 10.1056/NEJMc2105869.
5.
See I, Su JR, Laie A, Woo EJ, Guh AY, Shimabukuro TT, Streiff MB, Rao AK, Wheeler AP, Beavers S, Durbin
AP, Edwards K, Miller E, Harrington TA, Mba-Jonas A, Nair N, Nguyen DT, Talaat KR, Urrutia VC, Walker
SC, Creech CB, Clark TA, DeStefano F, Broder KR. US Case Reports of Cerebral Venous Sinus Thrombosis
With
Thrombocytopenia
After
Ad26.COV2.S
Vaccination.
March
2
to
April
21,
2021
JAMA. 2021;325:2448-2456. doi:10.1001/jama.2021.7517
6.
Hippisley-Cox J, Patone M, Mei XW, Saatci D, Dixon S, Khunti K, Zaccardi F, Watkinson P, Shankar-Hari
M, Doidge J, Harrison DA, Griffin SJ, Sheikh A, Coupland CAC. Risk of thrombocytopenia and
thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case
series study. BMJ 2021; 374: n1931.
7.
ISTH Interim Guidance for the diagnosis and treatment on vaccine-induced immune thrombotic
thrombocytopenia (Updated 20 April, 2021) https://www.isth.org/news/561406/（2021/10/30 アク
セス）
8.
Thrombosis
with
Thrombocytopenia
syndrome
(also
termed
vaccine-induced
thrombotic
thrombocytopenia) (Version 1.6; last updated August 12, 2021) https://www.hematology.org/covid19/vaccine-induced-immune-thrombotic-thrombocytopenia（2021/10/30 アクセス）
9.
Oldenburg J, Klamroth R, Langer F, Albisetti M, von Auer C, Ay C, Korte W, Scharf RE, Pötzsch B,
Greinacher A. Diagnosis and Management of Vaccine-Related Thrombosis following AstraZeneca COVID19 Vaccination: Guidance Statement from the GTH. Hamostaseologie. 2021;41:184-189. doi: 10.1055/a1469-7481.
10. Gresele P, Marietta M, Ageno W, Marcucci R, Contino L, Donadini MP, Russo L, Tiscia GL, Palareti G,
Tripodi A, Mannucci PM, De Stefano V. Management of cerebral and splanchnic vein thrombosis
associated with thrombocytopenia in subjects previously vaccinated with Vaxzevria (AstraZeneca): a
position statement from the Italian Society for the Study of Haemostasis and Thrombosis (SISET). Blood
Transfus. 2021;15:284-283. doi: 10.2450/2021.0117-21.
19
318