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資料5-1 Ⅳ-203 モキシフロキサシン塩酸塩［15.1MB］ (110 ページ)
出典
| 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
上記のほか、“Chapter 1 Drug-susceptible TB treatment”に DS-TB に対する 4 ヵ
月レジメンの一つとして、リファペンチン（RPT）、MFLX、INH 及び PZA が
推奨されている。
<Recommendations>
2. Treatment of drug-susceptible TB using 4-month regimens
Recommendation 2.1
No
Recommendations
2.1
People aged 12 years or older with drug-susceptible pulmonary TB, may receive a
4-month regimen of isoniazid, rifapentine, moxifloxacin and pyrazinamide (Note)
(Conditional recommendation, moderate certainty of evidence)
(Note) Two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by
two months of isoniazid, rifapentine, and moxifloxacin
根拠エビデンス：試験 31/A5349、Dorman SE et al., N Engl J Med 2021;384:1705-1708
（DS-TB における研究であるため、
「（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）
2）
ATS/CDC/ERS/IDSA Clinical Practice Guideline (Nahid P et al., Am J Respir Crit
Care Med 2019;200:e93-e142)（要望書文献 2）
Summary of Recommendations
For the selection of an effective MDR-TB treatment regimen and duration of MDR-TB
treatment:
1. We suggest using at least five drugs in the intensive phase of treatment and four drugs in
the continuation phase of treatment (conditional recommendation, very low certainty in
the evidence).
2. We suggest an intensive-phase duration of treatment of between 5 and 7 months after
culture conversion (conditional recommendation, very low certainty in the evidence).
3. We suggest a total treatment duration of between 15 and 21 months after culture
conversion (conditional recommendations, very low certainty in the evidence).
4. In patients with pre–XDR-TB and XDR-TB, which are both subsets of MDR-TB, we
suggest a total treatment duration of between 15 and 24 months after culture conversion
(conditional recommendations, very low certainty in the evidence).
＜関連する PICO question＞
PICO Question 1: Should patients with MDR-TB be prescribed five effective
drugs versus more or fewer agents during the intensive and continuation phases of
treatment?
Recommendation 1a: We suggest using at least five drugs in the intensive phase
of treatment of MDR-TB (conditional recommendation, very low certainty of
evidence).
Recommendation 1b: We suggest using at least four drugs in the continuation
phase of treatment of MDR-TB (conditional recommendation, very low certainty
of evidence)
PICO Question 2: Should patients with MDR-TB undergoing intensive-phase
treatment be treated for ≥6 months after culture conversion or <6 months after
106
上記のほか、“Chapter 1 Drug-susceptible TB treatment”に DS-TB に対する 4 ヵ
月レジメンの一つとして、リファペンチン（RPT）、MFLX、INH 及び PZA が
推奨されている。
<Recommendations>
2. Treatment of drug-susceptible TB using 4-month regimens
Recommendation 2.1
No
Recommendations
2.1
People aged 12 years or older with drug-susceptible pulmonary TB, may receive a
4-month regimen of isoniazid, rifapentine, moxifloxacin and pyrazinamide (Note)
(Conditional recommendation, moderate certainty of evidence)
(Note) Two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by
two months of isoniazid, rifapentine, and moxifloxacin
根拠エビデンス：試験 31/A5349、Dorman SE et al., N Engl J Med 2021;384:1705-1708
（DS-TB における研究であるため、
「（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）
2）
ATS/CDC/ERS/IDSA Clinical Practice Guideline (Nahid P et al., Am J Respir Crit
Care Med 2019;200:e93-e142)（要望書文献 2）
Summary of Recommendations
For the selection of an effective MDR-TB treatment regimen and duration of MDR-TB
treatment:
1. We suggest using at least five drugs in the intensive phase of treatment and four drugs in
the continuation phase of treatment (conditional recommendation, very low certainty in
the evidence).
2. We suggest an intensive-phase duration of treatment of between 5 and 7 months after
culture conversion (conditional recommendation, very low certainty in the evidence).
3. We suggest a total treatment duration of between 15 and 21 months after culture
conversion (conditional recommendations, very low certainty in the evidence).
4. In patients with pre–XDR-TB and XDR-TB, which are both subsets of MDR-TB, we
suggest a total treatment duration of between 15 and 24 months after culture conversion
(conditional recommendations, very low certainty in the evidence).
＜関連する PICO question＞
PICO Question 1: Should patients with MDR-TB be prescribed five effective
drugs versus more or fewer agents during the intensive and continuation phases of
treatment?
Recommendation 1a: We suggest using at least five drugs in the intensive phase
of treatment of MDR-TB (conditional recommendation, very low certainty of
evidence).
Recommendation 1b: We suggest using at least four drugs in the continuation
phase of treatment of MDR-TB (conditional recommendation, very low certainty
of evidence)
PICO Question 2: Should patients with MDR-TB undergoing intensive-phase
treatment be treated for ≥6 months after culture conversion or <6 months after
106