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資料5-1 Ⅳ-203 モキシフロキサシン塩酸塩［15.1MB］ (104 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
<Recommendations>
1. Treatment of drug-resistant TB using 6-month regimens
Recommendation 1.1 The 6-month bedaquiline, pretomanid, linezolid and moxifloxacin
(BPaLM) regimen
No
1.1
Recommendations
WHO suggests the use of a 6-month treatment regimen composed of bedaquiline,
pretomanid, linezolid (600 mg) and moxifloxacin (BPaLM) rather than the
9-month or longer (18-month) regimens in MDR/RR-TB patients.
(Conditional recommendation, very low certainty of evidence)
Remarks
1. Drug susceptibility testing (DST) for fluoroquinolones is strongly encouraged in people
with MDR/RR-TB, and although it should not delay initiation of the BPaLM, results of the
test should guide the decision on whether moxifloxacin can be retained or should be dropped
from the regimen – in cases of documented resistance to fluoroquinolones, BPaL
without moxifloxacin would be initiated or continued.
2. This recommendation applies to the following:
a) People with MDR/RR-TB or with MDR/RR-TB and resistance to fluoroquinolones (preXDR-TB).
b) People with confirmed pulmonary TB and all forms of extrapulmonary TB except for
TB involving the CNS, osteoarticular or disseminated forms of TB with multiorgan
involvement.
c) Adults and adolescents aged 14 years and older.
d) All people regardless of HIV status.
e) Patients with less than 1-month previous exposure to bedaquiline, linezolid, pretomanid
or delamanid. When exposure is greater than 1 month, these patients may still receive
these regimens if resistance to the specific medicines with such exposure has been ruled
out.
3. This recommendation does not apply to pregnant and breastfeeding women owing to
limited evidence on the safety of pretomanid.
4. The recommended dose of linezolid is 600 mg once daily, both for the BPaLM and the
BPaL regimen.
100
<Recommendations>
1. Treatment of drug-resistant TB using 6-month regimens
Recommendation 1.1 The 6-month bedaquiline, pretomanid, linezolid and moxifloxacin
(BPaLM) regimen
No
1.1
Recommendations
WHO suggests the use of a 6-month treatment regimen composed of bedaquiline,
pretomanid, linezolid (600 mg) and moxifloxacin (BPaLM) rather than the
9-month or longer (18-month) regimens in MDR/RR-TB patients.
(Conditional recommendation, very low certainty of evidence)
Remarks
1. Drug susceptibility testing (DST) for fluoroquinolones is strongly encouraged in people
with MDR/RR-TB, and although it should not delay initiation of the BPaLM, results of the
test should guide the decision on whether moxifloxacin can be retained or should be dropped
from the regimen – in cases of documented resistance to fluoroquinolones, BPaL
without moxifloxacin would be initiated or continued.
2. This recommendation applies to the following:
a) People with MDR/RR-TB or with MDR/RR-TB and resistance to fluoroquinolones (preXDR-TB).
b) People with confirmed pulmonary TB and all forms of extrapulmonary TB except for
TB involving the CNS, osteoarticular or disseminated forms of TB with multiorgan
involvement.
c) Adults and adolescents aged 14 years and older.
d) All people regardless of HIV status.
e) Patients with less than 1-month previous exposure to bedaquiline, linezolid, pretomanid
or delamanid. When exposure is greater than 1 month, these patients may still receive
these regimens if resistance to the specific medicines with such exposure has been ruled
out.
3. This recommendation does not apply to pregnant and breastfeeding women owing to
limited evidence on the safety of pretomanid.
4. The recommended dose of linezolid is 600 mg once daily, both for the BPaLM and the
BPaL regimen.
100