Table 6.
Outcome of treatment of episodes of relapse of visceral leishmaniasis, diagnosed in public hospitals in Mainland Portugal in 2010–2020, according to drug or combination of drugs used
| Total | Monotherapy | LAmB | Miltefosine | Meglumine antimoniate | Combination | LAmB + Miltefosine | LAmB + Paromomycin | Others | P-value (monotherapy vs. combination) | P-value (LAmB vs. LAmB + miltefosine) | P-value (LAmB vs. miltefosine vs. meglumine) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number, % (n ) | 100 | 77.3 | 63.1 | 6.4 | 7.8 | 22.7 | 17.7 | 2.1 | 2.8 | |||
| (141/141) | (109/141) | (89/141) | (9/141) | (11/141) | (32/141) | (25/141) | (3/141) | (4/141)a | ||||
| Side effects, % (n ) | 44.0 | 43.7 | 39.4 | 55.6 | 71.4 | 44.8 | 37.5 | 100 | 50.0 | 0.914 | 0.866 | 0.169 |
| (51/116) | (38/87) | (28/71)b | (5/9)c | (5/7)d | (13/29) | (9/24)e | (3/3)f | (1/2) | (χ 2 = 0.012, df = 1) | (χ 2 = 0.028, df = 1) | (FET) | |
| Result, % (n ) | ||||||||||||
| Improvement at 7 days | 82.8 | 80.8 | 81.4 | 77.8 | 77.8 | 90.0 | 87.5 | 100 | 100 | 0.238 | 0.760 | 0.798 |
| (111/134) | (84/104) | (70/86) | (7/9) | (7/9) | (27/30) | (21/24) | (3/3) | (3/3) | (χ 2 = 1.395, df = 1) | (FET) | (FET) | |
| Improvement at 30 days | 86.2 | 83.5 | 84.0 | 75.0 | 87.5 | 93.3 | 91.7 | 100 | 100 | 0.235 | 0.507 | 0.852 |
| (106/123) | (76/91) | (63/75) | (6/8) | (7/8) | (28/30) | (22/24) | (3/3) | (3/3) | (FET) | (FET) | (FET) | |
| Subsequent relapse | ||||||||||||
| Median time to relapse, months (IQI) | 11.0 | 11.0 | 11.0 | 8.5 | 11.0 | 11.0 | 11.0 | 14.5 | 12.0 | 0.789 | 0.519 | 0.536 |
| [7.0–19.0] | [6.5–19.0] | [5.0–19.5] | [4.75–14.0] | [8.25–17.5] | [6.5–15.0] | [5.0–13.5] | [11.0–18.0] | [8.0–16.0] | (U = 696.5) | (U = 403,5) | (H = 1.248, df = 2) | |
IQI Interquartile interval, LAmB Liposomal amphotericin B
aLAmB + Meglumine + Voriconazol n = 1; LAmB + Paromomycin + Miltefosine n = 1; Meglumine + Miltefosine n = 1; Meglumine + Paromomycin n = 1
bRenal dysfunction n = 20, Fever/shivering n = 2
cDiarrhea n = 5
dPancreatitis n = 5, cardiac toxicity n = 1
eRenal dysfunction n = 6, diarrhea/vomiting n = 3
fRenal dysfunction n = 2, Ototoxicity n = 1