Agra 1981.
| Methods | Randomized trial of 2 4.5‐month and one 3‐month regimens, each with SHRZ. A regimen adding ethionamide as a 5th drug was discontinued because of high side effect rates and is not included in this review. | |
| Participants | 266 adults with smear‐ and culture‐positive TB, and <15 days of previous TB treatment entered Excluded from relapse analysis: Pretreatment ineligibility: 34/266 (13%) Continued drug after trial: 4/266 (2%) Defaulted: 3RSZH: 7/62 (11.3%) 3SHRZ/1.5RH: 4/34 (11.7%) 3SHRZ/1.5SHZI: 5/54 (9.3%) |
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| Interventions | 1. 3SHRZ followed by 1.5 month placebo tablets
2. 3SHRZ/1.5RH
3. 3SHRZ/1.5SHZI Daily dosages for first 3 months (all regimens): S: 0.75 g H: 58 mg/kg R: 10 mg/kg Z: 35 mg/kg Regimen 2 daily dosage final 1.5 months: H: 5‐8 mg/kg R: 10 mg/kg Regimen 3 twice weekly dosage final 1.5 months: S: 0.75 g H: 14 mg/kgoZ: 60 mg/kg All participants made monthly visits to the clinic and were given supplies of daily placebo tablets through 2 years after the start of the study. |
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| Outcomes | Sputum conversion during and immediately following treatment Radiologic assessment at various points int ime Relapse at 1 year (defined as a positive sputum culture in 2 consecutive months) |
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| Notes | More than 10% of the patients entered "defaulted" in treatment, and were not included in the analysis. The two 4.5‐month regimens are combined in the box and line diagram. |
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