Research Article
Oral Realgar-Indigo Naturalis Formula Treatment for Acute Promyelocytic Leukemia in Children: A Randomized, Control Clinical Trial
Table 5
Incidence of adverse reactions following two courses of treatment (n (%)).
| | | Induction phase | Consolidation phase | | ATO (n = 11) | RIF (n = 8) | -value | ATO (n = 11) | RIF (n = 8) | -value |
| | Respiratory infection | 8 (72.70%) | 4 (50.00%) | 0.297 | 7 (63.63%) | 2 (25%) | 0.115 | | Gastrointestinal reaction | 7 (63.63%) | 7 (87.50%) | 0.267 | 7 (63.63%) | 5 (62.5%) | 0.663 | | Rash | 1 (9.09%) | 1 (12.50%) | 0.678 | 1 (9.09%) | 0 (0) | 0.111 | | Headache | 4 (36.36%) | 4 (50.00%) | 0.449 | 7 (63.63%) | 1 (12.5%) | 0.037 | | Sepsis | 1 (9.09%) | 0 (0) | 0.579 | 1 (9.09%) | 0 (0) | 0.579 | | Hepatic toxicity | 0 (0) | 3 (37.50%) | 0.058 | 1 (9.09%) | 1 (12.5%) | 0.678 | | Fundal hemorrhage | 0 (0) | 1 (12.50%) | 0.421 | 1 (9.09%) | 0 (0) | 0.579 | | Arthralgia | 1 (9.09%) | 1 (12.50%) | 0.678 | 0 (0) | 0 (0) | — | | DIC | 1 (9.09%) | 1 (12.50%) | 0.678 | 0 (0) | 0 (0) | — | | Cardiac toxicity | 0 (0) | 0 (0) | — | 1 (9.09%) | 0 (0) | 0.579 | | | 23 | 22 | 0.556 | 26 | 9 | 0.019 |
|
|
Fisher’s exact test; RIF: realgar-indigo naturalis formula; ATO: arsenic trioxide. |
