Table 5.
Diagnosis, treatment, and outcome aspects of visceral leishmaniasis primary episodes, diagnosed in public hospitals in Mainland Portugal, and incident in the period between 2010 and 2020, globally and by group
| Global | CU5 | NISA | PLWH | ISA | P-value | |
|---|---|---|---|---|---|---|
| Median time from presentation to diagnosis, days (IQI) | 10 | 5.5 | 11.0 | 10 | 17.5 | 0.011 |
| [4.5–19.5 | [2.25–12.5] | [5.5–30.0] | [4.0–17.5] | [9.5–30.0] | (H = 11.192, df = 3) | |
| Samples used (direct diagnosis), % ( n ) | ||||||
| Bone marrow | 94.1 | 96.4 | 100 | 93.4 | 82.6 | 0.058 |
| (160/170) | (27/28) | (34/34) | (71/76) | (19/23) | (FET) | |
| Aspirate | 91.4 | 81.5 | 97.1 | 93.0 | 89.5 | 0.158 |
| (139/152) | (22/27) | (33/34) | (66/71) | (17/19) | (FET) | |
| Biopsy | 50.7 | 59.3 | 50.0 | 46.5 | 57.9 | 0.639 |
| (77/152) | (16/27) | (17/34) | (33/71) | (11/19) | (χ 2 = 1.692, df = 3) | |
| Blood | 25.0 | 34.8 | 17.9 | 13.7 | 13.6 | 0.166 |
| (37/148) | (8/23) | (5/28) | (10/73) | (3/22) | (FET) | |
| Technique used in bone marrow sample, % ( n ) | ||||||
| Microscopy | 95.6 | 92.3 | 96.7 | 97.3 | 95.5 | 0.609 |
| (152/159) | (24/26) | (29/30) | (71/73) | (21/22) | (FET) | |
| Positive result | 80.9 | 66.7 | 75.9 | 83.1 | 90.5 | 0.193 |
| (123/152) | (16/24) | (22/29) | (59/71) | (19/21) | (FET) | |
| Polymerase chain reaction | 41.6 | 60.9 | 32.3 | 38.2 | 47.4 | 0.158 |
| (62/149) | (14/23) | (10/31) | (26/68) | (9/19) | (χ 2 = 5.194, df = 3) | |
| Positive result | 81.7 | 78.6 | 60.0 | 87.5 | 88.9 | 0.315 |
| (49/60) | (11/14) | (6/10) | (21/24) | (8/9) | (FET) | |
| Culture | 22.7 | 9.5 | 20.0 | 29.2 | 11.8 | 0.200 |
| (32/141) | (2/21) | (6/30) | (19/65) | (2/17) | (FET) | |
| Technique used in blood sample, % ( n ) | ||||||
| Polymerase chain reaction | 17.8 | 34.8 | 17.9 | 13.7 | 13.6 | 0.166 |
| (26/146) | (8/23) | (5/28) | (10/73) | (3/22) | (FET) | |
| Positive result | 73.1 | 87.5 | 60.0 | 80.0 | 33.3 | 0.321 |
| (19/26) | (7/8) | (3/5) | (8/10) | (1/3) | (FET) | |
| Serology, % ( n ) | ||||||
| Yesa | 52.5 | 54.2 | 69.7 | 41.4 | 50.0 | 0.063 |
| (83/158) | (13/24) | (23/33) | (29/70) | (11/22) | (χ 2 = 7.288, df = 3) | |
| Positive result | 82.9 | 92.3 | 86.4 | 72.4 | 81.8 | 0.482 |
| (68/82) | (12/13) | (19/22) | (21/29) | (9/11) | (FET) | |
| Samples sent to reference laboratory, % ( n ) | 40.0 | 55.0 | 44.0 | 31.1 | 47.4 | 0.216 |
| (50/125) | (11/20) | (11/25) | (19/61) | (9/19) | (χ 2 = 4.463, df = 3) | |
| Treatment of primary episode, % ( n ) | ||||||
| Yes | 99.4 | 100 | 100 | 98.7 | 100 | 1 |
| (161/162) | (27/27) | (32/32) | (78/79) | (24/24) | (FET) | |
| Median time from diagnosis to treatment, days (IQI) | 0 | 0 | 0 | 0 | 0 | 0.787 |
| [0–1] | [0–1] | [0–0.2] | [0–0.2] | [0–4.75] | (H = 1.060, df = 3) | |
| Median duration of treatment, days (IQI) | 21 | 21 | 21 | 21 | 24 | 0.031 |
| [10–38] | [7.75–21.0] | [10.0–21.0] | [10.0–38.0] | [11.0–38.0] | (H = 9.894, df = 3) | |
| Liposomal amphotericin B monotherapy | 98.8 | 92.6 | 100 | 100 | 100 | 1 |
| (158/160) | (25/27) | (32/32) | (77/77) | (24/24) | (FET) | |
| Side effects | 30.5 | 9.5 | 42.3 | 25.0 | 45.5 | 0.025 |
| (40/131) | (2/21) | (11/26) | (15/60) | (10/22) | (χ 2 = 9.365, df = 3) | |
| Outcome of treatment, % ( n ) | ||||||
| Median time to defervescence, days (IQI) | 3 | 2 | 3 | 3 | 6 | 0.008 |
| [1.75–5] | [1.0–3.0] | [1.0–3.0] | [2.0–5.5] | [2.5–10.5] | (H = 11.823, df = 3) | |
| Improvement at 7 days | 88.6 | 100 | 96.6 | 87.1 | 69.6 | 0.003 |
| (132/149) | (27/27) | (28/29) | (61/70) | (16/23) | (FET) | |
| Improvement at 30 days | 96.4 | 100 | 100 | 98.5 | 82.6 | 0.008 |
| (135/140) | (25/25) | (27/27) | (64/65) | (19/23) | (FET) | |
| Switch of treatment/retreatmentb | 3.9 | 3.6 | 3.2 | 2.7 | 8.3 | 0.583 |
| (6/153) | (1/28) | (1/31) | (2/73) | (2/24) | (FET) | |
| Death in current episode | 4.3 | 0 | 0 | 5.2 | 13.0 | 0.066 |
| (7/163) | (0/30) | (0/33) | (4/77) | (3/23) | (FET) | |
| Relapse | ||||||
| Rate (episodes/patient-year) | 0.112 | 0 | 0 | 0.175 | 0.147 | 0.578 |
| Median time to first relapse, months (IQI) | 12 | N/A | N/A | 15 | 6 | 0.009 |
| [7.25–33.5] | [9.5–36.0] | [5.0–11.0] | (U = 48.0) | |||
| Secondary profilaxis initiated c , % ( n ) | 29.7 | 4.3 | 0 | 54.9 | 16.7 | < 0.001 |
| (44/148) | (1/23) | (0/30) | (39/71) | (4/24) | (χ 2 = 43.327, df = 3) | |
| Follow-up in consultation, % ( n ) | ||||||
| Yes | 93.3 | 92.3 | 96.9 | 91.5 | 95.2 | 0.813 |
| (140/150) | (24/26) | (31/32) | (65/71) | (20/21) | (FET) | |
| Cure test performedd | 16.9 | 13.6 | 3.4 | 24.2 | 15.8 | 0.080 |
| (23/136) | (3/22) | (1/29) | (16/66) | (3/19) | (FET) | |
| Notification of case to SINAVE, % ( n ) | 49.7 | 75.8 | 50.0 | 40.0 | 50.0 | 0.006 |
| (92/185) | (25/33) | (18/36) | (36/90) | (13/26) | (χ 2 = 12.353, df = 3) | |
IQI Interquartile interval, FET Fisher’s exact test, CU5 Children 5 years of age or younger, NISA Non-immunosuppressed adults and children over 5 years old, ISA non-HIV infected immunosuppressed adults, PLWH People living with HIV, SINAVE Sistema Nacional de Vigilância Epidemiológica
aImmunofluorescent antibody test (33/45), Enzyme-linked immunosorbent assay (8/45), Western Blot (5/45), k39 rapid diagnostic test (2/45)
bDue to side effects n = 3, Due to non improval n = 3
cLiposomal amphotericin B n = 42, Miltefosine n = 1, unknown n = 1
dBone marrow microscopy n = 12, PCR in blood n = 10