Figura 1. Diagrama de flujo del estudio.
Tabla I. Caracterización de prescripciones y reacciones adversas según medicamento. |
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Prescripciones (n = 3.160) |
Reacciones adversas (n = 4.133) |
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Frecuencia (%) |
Edad |
Hombres |
Dosis |
Equivalentes |
Gravedad |
Definitiva |
Recuperación |
Incidencia |
|
Tramadol |
1.469 (46,49) |
43 (28-60) |
550 (39,80) |
50 (50-50) |
5 (5-5) |
545 (29,58) |
47 (2,48) |
1.827 (95,05) |
26 (24-29) |
Morfina |
621 (19,65) |
47 (31-63) |
245 (41,67) |
3 (2-5) |
3 (2,6-5) |
226 (30,34) |
30 (3,90) |
742 (94,16) |
140 (117-166) |
Hidromorfona |
253 (8,01) |
56,5 (36,5-74) |
88 (36,36) |
0,5 (0,3-2) |
3,3 (2-13,3) |
149 (43,70) |
11 (3,11) |
315 (87,26) |
87 (67-111) |
Fentanilo |
321 (10,16) |
39 (23-60) |
148 (47,13) |
0,1 (0,05-0,5) |
8 (3,6-20) |
118 (40,41) |
5 (1,66) |
293 (95,13) |
250 (197-314) |
Meperidina |
181 (5,73) |
36 (27-53) |
59 (33,91) |
40 (30-60) |
3,3 (2,4-5,7) |
48 (23,76) |
0 (0,00) |
219 (97,77) |
219 (162-289) |
Oxicodona |
124 (3,92) |
58 (38-70) |
44 (36,36) |
10 (5-20) |
7,5 (5-15) |
80 (44,69) |
0 (0,00) |
113 (59,47) |
52 (32-80) |
Codeína |
41 (1,30) |
44,5 (38-59) |
7 (20,00) |
30 (30-30) |
1,5 (1,5-1,5) |
13 (22,03) |
0 (0,00) |
48 (78,68) |
– |
Buprenorfina |
43 (1,36) |
49 (35-74) |
13 (35,14) |
0,04 (0,02-0,04) |
24 (12-24) |
14 (23,73) |
3 (5,17) |
34 (82,93) |
– |
Tapentadol |
44 (1,39) |
60 (46-81) |
17 (42,50) |
50 (50-75) |
6,7 (6,7-10) |
4 (7,41) |
3 (5,36) |
38 (79,17) |
– |
Metadona |
33 (1,04) |
33,5 (27-49) |
10 (30,30) |
10 (10-40) |
14,3 (14,3-57) |
29 (61,70) |
0 (0,00) |
31 (64,58) |
92 (30-214) |
Dihidrocodeína |
30 (0,95) |
45 (31-61) |
6 (22,22) |
12,1 (4,84-24,2) |
0,4 (0,2-0,8) |
19 (55,88) |
0 (0,00) |
30 (81,08) |
0,4 (0-1) |
Figura 2. Descripción de medicamentos prescritos según la dosis equianalgésica (a), la vía de administración (b) y la incidencia de reacciones adversas (c).
Tabla II. Reacciones adversas a opioides según el sistema afectado. |
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|
n |
Hombres (n = 1.487) |
Gravedad (n = 1.245) |
Definitiva (n = 99) |
Recuperación (n = 3.690) |
Dermatológicas |
1.300 |
480 (38,52) |
222 (18,64) |
24 (1,94) |
1.234 (97,01) |
Urticaria |
457 |
168 (38,71) |
68 (16,46) |
8 (1,85) |
442 (98,66) |
Prurito |
381 |
119 (32,69) |
66 (18,97) |
6 (1,64) |
364 (97,07) |
Erupción |
207 |
85 (43,37) |
27 (14,36) |
6 (3,14) |
191 (95,02) |
Gastrointestinalesa |
657 |
202 (31,46) |
217 (34,61) |
21 (3,28) |
591 (92,49) |
Náuseas |
231 |
76 (33,93) |
65 (29,82) |
6 (2,69) |
217 (98,19) |
Emesisa |
229 |
60 (27,3) |
79 (36,07) |
7 (3,15) |
217 (96,44) |
Estreñimiento |
87 |
38 (44,19) |
29 (33,72) |
6 (6,98) |
83 (98,81) |
Neurológicasa |
565 |
165 (30,05) |
214 (40,38) |
20 (3,63) |
514 (92,28) |
Mareoa |
165 |
33 (20,75) |
62 (39,49) |
3 (1,89) |
159 (98,15) |
Alteración de concienciaa |
163 |
46 (28,93) |
69 (44,23) |
5 (3,18) |
152 (93,83) |
Cefalea |
48 |
15 (31,25) |
14 (30,43) |
2 (4,26) |
41 (87,23) |
Generales |
399 |
145 (37,66) |
130 (35,14) |
13 (3,41) |
334 (86,30) |
Alergia |
142 |
55 (41,04) |
31 (23,31) |
6 (4,44) |
133 (97,79) |
Edema no especificado |
31 |
9 (32,14) |
13 (50) |
0 (0,00) |
29 (93,55) |
Anafilaxia |
30 |
6 (20) |
23 (76,67) |
4 (13,33) |
28 (93,33) |
Respiratorias |
344 |
124 (37,24) |
170 (52,80) |
11 (3,32) |
302 (89,61) |
Depresión respiratoriab |
134 |
58 (56,03) |
76 (62,81) |
0 (0,00) |
124 (94,66) |
Disnea |
93 |
28 (30,11) |
46 (51,11) |
0 (0,00) |
81 (88,04) |
Angioedema |
34 |
11 (32,35) |
9 (28,13) |
1 (2,94) |
25 (78,13) |
Cardiovasculares |
243 |
98 (42,06) |
127 (55,46) |
4 (1,72) |
222 (94,47) |
Arritmia |
101 |
43 (43,88) |
44 (46,32) |
2 (2,08) |
95 (98,96) |
Hipotensión arterial |
74 |
26 (36,11) |
43 (60,56) |
0 (0,00) |
68 (94,44) |
Falla cardiorrespiratoria |
14 |
8 (57,14) |
13 (100) |
0 (0,00) |
9 (69,23) |
Vasculares periféricasb |
174 |
87 (53,05) |
16 (10,06) |
1 (0,61) |
167 (97,66) |
Flebitisb |
165 |
84 (54,19) |
12 (8) |
1 (0,65) |
158 (97,53) |
Psiquiátricasb |
155 |
68 (46,26) |
52 (35,14) |
4 (2,68) |
131 (89,12) |
Ansiedad |
25 |
7 (28) |
8 (33,33) |
2 (8,33) |
21 (87,50) |
Agitación |
16 |
7 (43,75) |
5 (33,33) |
0 (0,00) |
16 (100) |
Alucinaciones |
14 |
3 (23,08) |
3 (21,43) |
1 (7,14) |
12 (85,71) |
Musculoesqueléticas |
75 |
27 (33) |
20 (28,17) |
1(1,33) |
42 (58,33) |
Debilidad |
14 |
7 (50) |
2 (15,38) |
1 (7,14) |
11 (84,62) |
Órganos de los sentidos |
45 |
11 (25) |
14 (31,82) |
0 (0,00) |
40 (88,89) |
Edema palpebrala |
25 |
4 (16,66) |
7 (28) |
0 (0,00) |
25 (100) |
Conjuntivitis |
6 |
3 (60) |
1 (20) |
0 (0,00) |
5 (83,33) |
Alteración visual |
4 |
2 (50) |
3 (75) |
0 (0,00) |
4 (100) |
Urinariasb |
37 |
20 (54,05) |
7 (20) |
0 (0,00) |
26 (74,29) |
Alteración de la función renalb |
19 |
16 (84,21) |
5 (26,32) |
0 (0,00) |
14 (82,35) |
Retención urinaria |
8 |
3 (37,50) |
1 (12,50) |
0 (0,00) |
8 (100) |
Metabólicas |
27 |
13 (50) |
12 (48) |
0 (0,00) |
18 (66,67) |
Alteración de la glucemia |
9 |
6 (66,67) |
7 (77,78) |
0 (0,00) |
6 (66,67) |
Hematológicasb |
26 |
17 (70,83) |
10 (43,48) |
0 (0,00) |
17 (68) |
Alteración plaquetaria |
6 |
4 (66,67) |
1 (16,67) |
0 (0,00) |
4(66,67) |
Anemiab |
5 |
5 (100) |
3 (60) |
0 (0,00) |
2 (40) |
Neutropenia |
4 |
3 (75) |
1 (35) |
0 (0,00) |
4 (100) |
Hepatobiliares |
18 |
5 (27,78) |
11 (61,11) |
0 (0,00) |
6 (33,33) |
Alteración de la química hepática |
12 |
4 (33,33) |
7 (58,33) |
0 (0,00) |
5 (41,67) |
Ictericia |
2 |
1 (50) |
1 (50) |
0 (0,00) |
0 (0,00) |
Esteatorrea |
2 |
0 (0,00) |
2 (100) |
0 (0,00) |
0 (0,00) |
Reproductivas |
6 |
2 (33,33) |
2 (40) |
0 (0,00) |
1 (16,67) |
Disfunción eréctil |
2 |
- |
0 (0,00) |
0 (0,00) |
0,00 |
Fetales y neonatales |
4 |
0 (0,00) |
2 (50) |
0 (0,00) |
4 (100) |
Llanto anormal |
2 |
0 (0,00) |
0 (0,00) |
0 (0,00) |
0 (0,00) |
Asfixia neonatal |
1 |
0 (0,00) |
1 (100) |
0 (0,00) |
0 (0,00) |
Diferencias de proporciones (p < 0,50). a Mayor en mujeres; b Mayor en hombres. |
Figura 3. Distribución de reacciones adversas según medicamento y sistema afectado.
Figura 4. Odds ratios (OR) ajustadas, previas a la depuración del modelo (a) y área bajo la curva de éste (b).
Problems and adverse reactions related to opioid analgesics in Colombia Introduction. The prevalence of pathologies that generate chronic pain is high (10-40%), as is the use of opioids. In Colombia, these drugs rank among the first in terms of prescriptions and the number of deaths related to their consumption is rising (0.71/1,000,000 inhabitants). This study seeks to characterise opioid-related problems (ORP) and the variables associated with their resolution. Materials and methods. It is a study based on secondary information. Incidences were calculated using Ministry of Health data and characteristics related to non-recoverable adverse reactions (ADRs) were determined. Results. Altogether 4,437 problems were identified in 3,063 patients (39.51%, male), adults (45 years old; IQR: 29-62). The most common opioids were tramadol (46.49%, 5 mg; IQR: 5-5) and morphine (19.65%, 3 mg; IQR: 2.6-5). The majority of ORP were ADRs (93.15%) and of these, 32.28% were severe. Women had proportionally more gastrointestinal and neurological disorders, while men had a higher frequency of vascular, psychiatric, urinary and haematological problems (p < 0.05). These reactions did not resolve in 8.39%, and prognosis was associated with oral administration – odds ratio (OR): 9.24; 95% confidence interval (CI 95%): 6.36-13.42; severity (OR: 3.96; CI 95%: 2.71-5.76); age (OR: 1.01; CI 95%: 1.001-1.01); weak opioids (OR: 0.57; CI 95%: 0.4-0.84); and neurological-cardiovascular reactions (OR: 0.36; CI 95%: 0.21-0.61). Conclusions. Interventions to optimise the prescription of opioids should be encouraged to prevent ADRs with poor prognosis. Studies should be conducted to further investigate the impact of gender and route of administration on the occurrence of ADRs, as well as the severity of skin and gastrointestinal problems, which may be underestimated. Key words. [DeCS] System. Analgesics. Opioids. Pain. Pharmacovigilance. Side effects. |