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会議資料 (167 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00044.html |
| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第66回 12／12）《厚生労働省》 |
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要望番号；IV-203
levofloxacin or moxifloxacin) and monitor with a liver specialist for further reactions
See the MHRA January 2024 advice on restrictions and precautions for using
fluoroquinolone antibiotics because of the risk of disabling and potentially long-lasting
or irreversible side effects.
Not licensed for tuberculosis, so use would be off label. The prescriber should follow
relevant professional guidance, taking full responsibility for the decision. Informed
consent should be obtained and documented. See the General Medical Council's Good
practice in prescribing and managing medicines and devices for further information.
Article citation: Drug Safety Update volume 17, issue 6: January 2024: 2.
Published 22 January 2024
5）
Canadian Tuberculosis Standards, 8th edition (2022) 、Chapter 8: Drug-resistant
tuberculosis（要望書文献5）
4. Management of drug-resistant TB
4.1 Isolated resistance to isoniazid
Recommendations
We strongly recommend, in patients with mono-isoniazid resistance, a
treatment regimen including a later-generation fluoroquinolone (levofloxacin
is preferred), rifampin, ethambutol and pyrazinamide, given for 6 months
(Good evidence).
We conditionally recommend that, in patients with less extensive disease (eg,
noncavitary), and especially if there is increased risk of liver toxicity,
pyrazinamide be given for the first 2 months only; in the final 4 months,
rifampin, ethambutol and the fluoroquinolone should be given (Poor
evidence).
根拠エビデンス：Fregonese F et al., Lancet Respir Med 2018;6:265-275（INH-R TB の治療
レジメンの論文であるため、
「
（１）無作為化比較試験、薬物動態試験等の公表論文と
しての報告状況」では不記載）
4.2 Isolated resistance to rifampin
Recommendations
We conditionally recommend, in patients with isolated resistance (or
intolerance) to rifampin, either: 1) isoniazid, ethambutol and a fluoroquinolone
daily for 12 to 18 months, supplemented with pyrazinamide for at least
2 months during the intensive phase; 2) isoniazid and ethambutol for
18 months, supplemented with pyrazinamide for at least 2 months during the
intensive phase; or 3) treatment as MDR-TB (Poor evidence).
4.4 Resistance to two or more first-line drugs (polydrug-resistant TB) not including
MDR-TB
Polydrug-resistant TB is uncommon in Canada; the range of possible resistance patterns
and treatment options are outlined in Table 4.
113
167 / 451
levofloxacin or moxifloxacin) and monitor with a liver specialist for further reactions
See the MHRA January 2024 advice on restrictions and precautions for using
fluoroquinolone antibiotics because of the risk of disabling and potentially long-lasting
or irreversible side effects.
Not licensed for tuberculosis, so use would be off label. The prescriber should follow
relevant professional guidance, taking full responsibility for the decision. Informed
consent should be obtained and documented. See the General Medical Council's Good
practice in prescribing and managing medicines and devices for further information.
Article citation: Drug Safety Update volume 17, issue 6: January 2024: 2.
Published 22 January 2024
5）
Canadian Tuberculosis Standards, 8th edition (2022) 、Chapter 8: Drug-resistant
tuberculosis（要望書文献5）
4. Management of drug-resistant TB
4.1 Isolated resistance to isoniazid
Recommendations
We strongly recommend, in patients with mono-isoniazid resistance, a
treatment regimen including a later-generation fluoroquinolone (levofloxacin
is preferred), rifampin, ethambutol and pyrazinamide, given for 6 months
(Good evidence).
We conditionally recommend that, in patients with less extensive disease (eg,
noncavitary), and especially if there is increased risk of liver toxicity,
pyrazinamide be given for the first 2 months only; in the final 4 months,
rifampin, ethambutol and the fluoroquinolone should be given (Poor
evidence).
根拠エビデンス：Fregonese F et al., Lancet Respir Med 2018;6:265-275（INH-R TB の治療
レジメンの論文であるため、
「
（１）無作為化比較試験、薬物動態試験等の公表論文と
しての報告状況」では不記載）
4.2 Isolated resistance to rifampin
Recommendations
We conditionally recommend, in patients with isolated resistance (or
intolerance) to rifampin, either: 1) isoniazid, ethambutol and a fluoroquinolone
daily for 12 to 18 months, supplemented with pyrazinamide for at least
2 months during the intensive phase; 2) isoniazid and ethambutol for
18 months, supplemented with pyrazinamide for at least 2 months during the
intensive phase; or 3) treatment as MDR-TB (Poor evidence).
4.4 Resistance to two or more first-line drugs (polydrug-resistant TB) not including
MDR-TB
Polydrug-resistant TB is uncommon in Canada; the range of possible resistance patterns
and treatment options are outlined in Table 4.
113
167 / 451