Table 2. Distribution and characteristics of adverse drug reactions (ADRs) of tuberculosis patients.
| ADR distribution and characteristics | Tuberculosis treatment | p-value | |
|---|---|---|---|
| RHZ n = 55 |
RHEZ-FDC n = 86 |
||
| Patients with > 1 episode–n (%) | 18 (32.7) | 46 (53.5) | <0.01 |
| Treatment intrerruption1 - n (%) | 6 (10.9) | 8 (9.3) | 0.14 |
| Treatment modifications2 - n (%) | 2 (3.6) | 4 (4.6) | 0.79 |
| ADR characteristics3 | |||
| Expected ADRs—n (%) | 99 (92.5) | 165 (97.1) | 0.08 |
| Causality ADRs–n (%) | |||
| Possible | 94 (87.9) | 165 (97.1) | <0.01 |
| Probable | 13 (12.1) | 4 (2.4) | <0.01 |
1The interruptions were due to toxicity, being two to four days, the minimum and maximum interruption time respectively.
2In the RHZ group, two modifications were for decreased dose isoniazid: 75mg/kg/day. In the group RHEZ, two modifications were for dose of isoniazid: 75mg/kg /day and two decreases dose isoniazid in 75 mg/kg/day and rifampicin at 150 mg/kg/day. All modifications were made after the reintroduction of the scheme with drugs as follows: rifampicin + ethambutol, followed by isoniazid and finally pyrazinamide.
3ADRs total in each group: n = 107 in RHZ group and n = 170 in RHEZ group