Table 5.
Adverse events | Symptomatic treatment N (%) |
Examination N (%) |
Hospitalization N (%) |
Influence of MDR-TB regimen due to adverse events | |||||
---|---|---|---|---|---|---|---|---|---|
Dosing decrease N (%) |
Medication administration change N (%) |
Drug substitution N (%) |
Drug or treatment discontinuation N (%) |
Drugs implicated | Treatment permanent discontinuation N (%) |
||||
Arthralgia (N=507) | 52 (10.3) | 492 (97.0) | 0 | 4 (0.8) | 2 (0.4) | 8 (1.6) | 2 (0.4) | Z, Lfx | 0 |
Gastrointestinal disorders (N=491) | 271 (55.2) | 4 (0.8) | 21 (4.8) | 18 (3.7) | 158 (32.2) | 99 (20.2) | 57 (11.6) | All | 39 (7.9) |
Hypothyroidism (N=148) | 91 (61.5) | 139 (93.9) | 2 (4.8) | 0 | 0 | 5 (3.4) | 9 (6.1) | Pto, PAS | 0 |
Dermatological disorders (N=131) | 32 (24.4) | 44 (33.6) | 2 (1.4) | 0 | 21 (16.0) | 19 (14.5) | 21 (16.0) | All | 0 |
Hematologic disorders (N=115) | 17 (14.8) | 108 (93.9) | 2 (1.5) | 0 | 0 | 0 | 0 | NE | 0 |
CNS disorders (N=97) | 29 (29.9) | 1 (1.0) | 0 | 11 (11.3) | 5 (5.2) | 13 (13.4) | 7 (7.2) | All | 6 (6.2) |
Hepatotoxicity (N=86) | 83 (96.5) | 86 (100.0) | 10 (11.6) | 9 (10.5) | 2 (2.3) | 7 (8.1) | 44 (39.5) | All | 10 (11.6) |
Hypokalemia (N=52) | 33 (63.5) | 47 (90.4) | 1 (1.9) | 0 | 0 | 0 | 0 | NE | 0 |
Ototoxicity (N=44) | 1 (2.3) | 8 (18.2) | 0 | 4 (9.1) | 3 (6.8) | 15 (34.1) | 5 (11.4) | Km, Cm | 2 (4.5) |
Visual impairment (N=19) | 8 (42.1) | 5 (26.3) | 1 (7.1) | 1 (5.3) | 5 (26.3) | 3 (15.8) | 0 | E, Pto | 0 |
Nephrotoxicity (N=14) | 0 | 3 (21.4) | 0 | 0 | 0 | 0 | 1 | Pto, PAS | 0 |
Peripheral neuropathy (N=8) | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 2 | Pto, Cs | 0 |
Psychiatric disorders (N=3) | 1 (33.3) | 0 | 0 | 0 | 0 | 3 (100%) | 0 | Cs | 1 (33.3) |