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資料5-1 Ⅳ-203 モキシフロキサシン塩酸塩［15.1MB］ (114 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
PICO Question 20b: Should patients with isoniazid-resistant TB be treated with a
regimen composed of fluoroquinolone, rifampin, and ethambutol for 6 months and
pyrazinamide for the first 2 months compared with a regimen composed of a
fluoroquinolone, rifampin, ethambutol, and pyrazinamide for 6 months?
Recommendation 20a: We suggest adding a later-generation fluoroquinolone to a
6-month regimen of daily rifampin, ethambutol, and pyrazinamide for patients with
isoniazid-resistant TB (conditional recommendation, very low certainty in the
evidence).
Recommendation 20b: In patients with isoniazid-resistant TB treated with a daily
regimen of a later-generation fluoroquinolone, rifampin, ethambutol, and
pyrazinamide, we suggest that the duration of pyrazinamide can be shortened to
2 months in selected situations (i.e., noncavitary and lower-burden disease or
toxicity from pyrazinamide) (conditional recommendation, very low certainty in the
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）
For the management of contacts to patients with MDR-TB:
25. We suggest offering treatment for latent TB infection (LTBI) for contacts to patients
with MDR-TB versus following with observation alone (conditional recommendation,
very low certainty in the evidence).
We suggest 6 to 12 months of treatment with a later-generation fluoroquinolone alone
or with a second drug, on the basis of drug susceptibility of the source-case M.
tuberculosis isolate. On the basis of evidence of increased toxicity, adverse events, and
discontinuations, pyrazinamide should not be routinely used as the second drug.
＜関連する PICO question＞
PICO Question 21: Treatment of Contacts Exposed to MDR-TB: Should contacts
exposed to an infectious patient with MDR-TB be offered LTBI treatment versus
followed with observation alone?
Recommendation 21: For contacts with presumed MDR LTBI due to exposure to
an infectious patient with MDR-TB, we suggest offering treatment for LTBI
(conditional recommendation, very low certainty in the evidence). We suggest 6 to
12 months of treatment with a later-generation fluoroquinolone alone or with a
second drug, on the basis of drug susceptibility of the source-case M. tuberculosis
isolate. On the basis of evidence of increased toxicity, adverse events, and
discontinuations, pyrazinamide should not be routinely used as the second drug.
根拠エビデンス：Marks SM et al., Clin Infect Dis 2017;64:1670-1677
（予防的使用の研究であり、MFLX と LVFX の使用割合も明らかでないため、
「（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）
3）
Updates on the treatment of drug-susceptible and drug-resistant tuberculosis, An
official ATS/CDC/ERS/IDSA Clinical Practice Guideline (Saukkonen JJ et al., Am J
Respir Crit Care Med 2025;211:15-33)（企業文献 3）
110
PICO Question 20b: Should patients with isoniazid-resistant TB be treated with a
regimen composed of fluoroquinolone, rifampin, and ethambutol for 6 months and
pyrazinamide for the first 2 months compared with a regimen composed of a
fluoroquinolone, rifampin, ethambutol, and pyrazinamide for 6 months?
Recommendation 20a: We suggest adding a later-generation fluoroquinolone to a
6-month regimen of daily rifampin, ethambutol, and pyrazinamide for patients with
isoniazid-resistant TB (conditional recommendation, very low certainty in the
evidence).
Recommendation 20b: In patients with isoniazid-resistant TB treated with a daily
regimen of a later-generation fluoroquinolone, rifampin, ethambutol, and
pyrazinamide, we suggest that the duration of pyrazinamide can be shortened to
2 months in selected situations (i.e., noncavitary and lower-burden disease or
toxicity from pyrazinamide) (conditional recommendation, very low certainty in the
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）
For the management of contacts to patients with MDR-TB:
25. We suggest offering treatment for latent TB infection (LTBI) for contacts to patients
with MDR-TB versus following with observation alone (conditional recommendation,
very low certainty in the evidence).
We suggest 6 to 12 months of treatment with a later-generation fluoroquinolone alone
or with a second drug, on the basis of drug susceptibility of the source-case M.
tuberculosis isolate. On the basis of evidence of increased toxicity, adverse events, and
discontinuations, pyrazinamide should not be routinely used as the second drug.
＜関連する PICO question＞
PICO Question 21: Treatment of Contacts Exposed to MDR-TB: Should contacts
exposed to an infectious patient with MDR-TB be offered LTBI treatment versus
followed with observation alone?
Recommendation 21: For contacts with presumed MDR LTBI due to exposure to
an infectious patient with MDR-TB, we suggest offering treatment for LTBI
(conditional recommendation, very low certainty in the evidence). We suggest 6 to
12 months of treatment with a later-generation fluoroquinolone alone or with a
second drug, on the basis of drug susceptibility of the source-case M. tuberculosis
isolate. On the basis of evidence of increased toxicity, adverse events, and
discontinuations, pyrazinamide should not be routinely used as the second drug.
根拠エビデンス：Marks SM et al., Clin Infect Dis 2017;64:1670-1677
（予防的使用の研究であり、MFLX と LVFX の使用割合も明らかでないため、
「（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）
3）
Updates on the treatment of drug-susceptible and drug-resistant tuberculosis, An
official ATS/CDC/ERS/IDSA Clinical Practice Guideline (Saukkonen JJ et al., Am J
Respir Crit Care Med 2025;211:15-33)（企業文献 3）
110