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資料5-1 Ⅳ-203 モキシフロキサシン塩酸塩［15.1MB］ (115 ページ)
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| 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
Summary of Recommendations
Treatment of rifampin-resistant, fluoroquinolone-susceptible TB with a 6-month
bedaquiline, pretomanid, and linezolid, and moxifloxacin (BPaLM) regimen versus
15-month or longer regimens in adolescents aged 14 and older and adults with rifampinresistant pulmonary TB
Question: In adolescents aged 14 and older and adults with rifampin-resistant,
fluoroquinolone-susceptible pulmonary TB, is a 6-month BPaLM regimen as
effective and safe as the 15-month or longer drug-resistant TB regimens composed
according to current ATS/CDC/ERS/IDSA DR-TB treatment guidelines?
Recommendation: In adolescents aged 14 and older and adults with rifampinresistant, fluoroquinolone-susceptible pulmonary TB, we recommend the use of a
6-month BPaLM-treatment regimen, rather than the 15-month or longer regimens
in patients with MDR/RR-TB (strong recommendation, very low certainty of
evidence). See Table 1 for dosing details (Table 1 Q4)
根 拠 エ ビ デ ン ス ： TB-PRACTECAL 試 験 、 Nyang’wa BT et al., N Engl J Med.
2022;387:2331-2343（要望書文献 7）
Treatment of rifampin-resistant, fluoroquinolone-resistant TB with a 6-month
bedaquiline, pretomanid, linezolid (BPaL) regimen versus 15-month or longer regimens in
adolescents aged 14 and older and adults with rifampin-resistant pulmonary TB
Question: In adolescents aged 14 and older and adults with rifampin-resistant
pulmonary TB, is a 6-month BPaL regimen as efficacious and safe as the current
15-month or longer drug-resistant TB regimens composed according to current
ATS/CDC/ERS/IDSA drug-resistant (DR)-TB treatment guidelines?
Recommendation: In adolescents aged 14 and older and adults with rifampinresistant pulmonary TB with resistance or patient intolerance to fluoroquinolones,
who either have had no previous exposure to bedaquiline and linezolid or have been
exposed for less than 1 month, we recommend the use of the 6-month treatment
BPaL regimen, rather than more than 15-month regimens (strong recommendation,
very low certainty of evidence). See Table 1 for dosing details (Table 1 Q3)
根拠エビデンス：TB-PRACTECAL 試験、Nyang’wa BT et al., N Engl J Med.
2022;387:2331-2343（要望書文献 7）
、ZeNix 試験、Conradie F et al., N Engl J Med
2022;387:810-823（MFLX を含まない BPaL 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）
上記のほか、
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。
Treatment of isoniazid-susceptible, rifampin-susceptible TB in adults with a 4-month
rifapentine-moxifloxacin versus 6-month regimen
Question: In adolescents and adults with drug-susceptible pulmonary tuberculosis
(TB), is a 4-month regimen composed of 2 months of isoniazid, rifapentine,
pyrazinamide, and moxifloxacin followed by 2 months of isoniazid, rifapentine,
and moxifloxacin (2HPZM/2HPM) as efficacious and safe as the standard 6-month
drug-susceptible TB regimen of 2months of isoniazid, rifampin, pyrazinamide, and
ethambutol (2HRZE) followed by 4 months of isoniazid, and rifampin (4HR)
endorsed by the American Thoracic Society (ATS)/U.S. Centers for Disease Control
111
Summary of Recommendations
Treatment of rifampin-resistant, fluoroquinolone-susceptible TB with a 6-month
bedaquiline, pretomanid, and linezolid, and moxifloxacin (BPaLM) regimen versus
15-month or longer regimens in adolescents aged 14 and older and adults with rifampinresistant pulmonary TB
Question: In adolescents aged 14 and older and adults with rifampin-resistant,
fluoroquinolone-susceptible pulmonary TB, is a 6-month BPaLM regimen as
effective and safe as the 15-month or longer drug-resistant TB regimens composed
according to current ATS/CDC/ERS/IDSA DR-TB treatment guidelines?
Recommendation: In adolescents aged 14 and older and adults with rifampinresistant, fluoroquinolone-susceptible pulmonary TB, we recommend the use of a
6-month BPaLM-treatment regimen, rather than the 15-month or longer regimens
in patients with MDR/RR-TB (strong recommendation, very low certainty of
evidence). See Table 1 for dosing details (Table 1 Q4)
根 拠 エ ビ デ ン ス ： TB-PRACTECAL 試 験 、 Nyang’wa BT et al., N Engl J Med.
2022;387:2331-2343（要望書文献 7）
Treatment of rifampin-resistant, fluoroquinolone-resistant TB with a 6-month
bedaquiline, pretomanid, linezolid (BPaL) regimen versus 15-month or longer regimens in
adolescents aged 14 and older and adults with rifampin-resistant pulmonary TB
Question: In adolescents aged 14 and older and adults with rifampin-resistant
pulmonary TB, is a 6-month BPaL regimen as efficacious and safe as the current
15-month or longer drug-resistant TB regimens composed according to current
ATS/CDC/ERS/IDSA drug-resistant (DR)-TB treatment guidelines?
Recommendation: In adolescents aged 14 and older and adults with rifampinresistant pulmonary TB with resistance or patient intolerance to fluoroquinolones,
who either have had no previous exposure to bedaquiline and linezolid or have been
exposed for less than 1 month, we recommend the use of the 6-month treatment
BPaL regimen, rather than more than 15-month regimens (strong recommendation,
very low certainty of evidence). See Table 1 for dosing details (Table 1 Q3)
根拠エビデンス：TB-PRACTECAL 試験、Nyang’wa BT et al., N Engl J Med.
2022;387:2331-2343（要望書文献 7）
、ZeNix 試験、Conradie F et al., N Engl J Med
2022;387:810-823（MFLX を含まない BPaL 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）
上記のほか、
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。
Treatment of isoniazid-susceptible, rifampin-susceptible TB in adults with a 4-month
rifapentine-moxifloxacin versus 6-month regimen
Question: In adolescents and adults with drug-susceptible pulmonary tuberculosis
(TB), is a 4-month regimen composed of 2 months of isoniazid, rifapentine,
pyrazinamide, and moxifloxacin followed by 2 months of isoniazid, rifapentine,
and moxifloxacin (2HPZM/2HPM) as efficacious and safe as the standard 6-month
drug-susceptible TB regimen of 2months of isoniazid, rifampin, pyrazinamide, and
ethambutol (2HRZE) followed by 4 months of isoniazid, and rifampin (4HR)
endorsed by the American Thoracic Society (ATS)/U.S. Centers for Disease Control
111