Table 1.
Distribution of patient comorbidities (n = 156)
| Comorbidity | Frequency (percentage) |
|---|---|
| Type 2 diabetes mellitus (yes/no) | 50/106 (32.1%/67.9%) |
| Myocardial infarction (yes/no) | 10/146 (6.4%/93.6%) |
| Heart failure (yes/no) | 64/92 (41%/59%) |
| Peripheral vascular disease (yes/no) | 22/134 (14.1%/85.9%) |
| Cerebrovascular disease (yes/no) | 12/144 (7.7%/92.3%) |
| Dementia (yes/no) | 10/146 (6.4%/93.6%) |
| Connective tissue disease (yes/no) | 5/151 (3.2%/96.8%) |
| Chronic obstructive pulmonary disease (yes/no) | 25/131 (16%/84%) |
| Peptic ulcer disease (yes/no) | 29/127 (18.6%/81.4%) |
| Liver disease (yes/no) | 5/151 (3.2%/96.8%) |
| Hemiplegia (yes/no) | 14/142 (9%/91%) |
| Solid tumor (yes/no) | 18/138 (11.5%/88.5%) |
| Chronic renal insufficiency (yes/no) | 38/118 (24.4%/75.6%) |
| Leukemia (yes/no) | 6/150 (3.8%/96.2%) |
| Lymphoma (yes/no) | 2/154 (1.3%/98.7%) |
Table 2.
Administered antibiotics (n = 156)
| Antibiotic | Frequency (percentage) |
|---|---|
| Meropenem (aayes/no) | 71/85 (45.5%/54.5%) |
| Imipenem/cilastatin (yes/no) | 22/134 (14.1%/85.9%) |
| Piperacillin/tazobactam (yes/no) | 12/144 (7.7%/92.3%) |
| Vancomycin (yes/no) | 82/74 (52.6%/47.4%) |
| Teicoplanin (yes/no) | 17/139 (10.9%/89.1%) |
| Linezolid (yes/no) | 9/147 (5.8%/94.2%) |
| Colistimethate sodium (yes/no) | 26/130 (16.7%/83.3%) |
| Tigecycline (yes/no) | 20/136 (12.8%/87.2%) |
Table 3.
Mean laboratory values (n = 156)
| Laboratory parameter | Mean ± SD, median, IQR | Units |
|---|---|---|
| Platelets | 277.69 ±161, 263.5, 212 | ×109/L |
| Urea | 10.6 ± 10.8, 7.55, 7 | mmol/L |
| Serum creatinine | 145.71 ± 173.68, 79, 80 | μmol/L |
| Leukocytes | 13.78 ± 17.99, 11.2, 8.3 | ×109/L |
| Neutrophils | 9.09 ± 7.72, 7.94, 6.2 | ×109/L |
| ALT | 65.68 ± 143.5, 22, 29 | U/L |
| AST | 76.68 ± 207.4, 27, 30 | U/L |
| GGT | 95.24 ± 121.2, 47.5, 98 | U/L |
| Total bilirubin | 25.9 ± 51.9, 13.45, 10 | μmol/L |
| Direct bilirubin | 12.84 ± 35.2, 4.1, 4.8 | μmol/L |
| Amylase | 73.15 ± 84.95, 56, 64 | U/L |
| Lipase | 103.13 ± 290, 8, 42 | U/L |
| CRP | 133.65 ± 92.83, 125, 140 | mg/L |
Table 4.
Other relevant characteristics of the study population (n = 156)
| Parameter | Frequency (percentage) for categorical variables, Mean ± SD, median, IQR for continuous variables |
|---|---|
| Adverse drug reaction (yes/no) | 52/104 (33.3%/66.7%) |
| Recovery (yes/no) | 33/123 (21.2%/78.8%) |
| Death (yes/no) | 47/109 (30.1%/69.9%) |
| Prolonged hospitalization (yes/no) | 11/145 (7.1%/92.9%) |
| Allergy history (yes/no) | 21/135 (13.5%/86.5%) |
| ICU stay (yes/no) | 74/82 (47.4%/52.6%) |
| Age | 64.12 ± 13.75, 65.5, 17 |
| Duration of ADR | 2.81 ± 5.52, 0, 4 |
| Charlson comorbidity index | 4.5 ± 2.36, 4, 3 |
| Duration of antibiotic therapy | 9.68 ± 5.83, 9, 6 |
| Length of hospitalization | 36.58 ± 36.59, 29, 27 |
| Total consultations | 17.27 ± 17.24, 11, 15 |
| Pharmacologist consultations | 4.93 ± 3.99, 4, 5 |
Table 5.
Characteristics of study participants according to the outcome – occurrence of ADRs.
| Parameter | Cases (n=52) Frequency (%), median, [IQR] | Controls (n=104) Frequency (%), median, [IQR] | p-value |
|---|---|---|---|
| Sex (M/F) | 33/19 (63.5%/36.5%) | 65/39 (62.5%/37.5%) | 0.907 |
| Acute myocardial infarction | 4/48(7.7%/92.3%) | 6/98(5.8%/94.2%) | 0.644 |
| Heart failure | 15/37(28.8/71.2%) | 49/55(47.1%/52.9%) | 0.029 |
| Peripheral vascular disease | 8/44(15.4%/84.6%) | 14/90(13.5%/86.5%) | 0.745 |
| Cerebrovascular stroke | 2/50(3.8%/96.2%) | 10/94(9.6%/90.4%) | 0.202 |
| Dementia | 3/49(5.8%/94.2%) | 7/97(6.7%/93.3%) | 0.817 |
| Connective tissue disease | 1/51(1.9%/98.1%) | 4/100(3.8%/96.2%) | 0.520 |
| Peptic ulcer disease | 5/47(9.6%/90.4%) | 24/80(23.1%/76.9%) | 0.042 |
| Chronic obstructive pulmonary disease | 7/45(13.5%/86.5%) | 18/86(17.3%/82.7%) | 0.537 |
| Liver disease | 3/49(5.8%/94.2%) | 2/102(1.9%/98.1%) | 0.199 |
| Diabetes mellitus | 16/36(30.8%/69.2) | 34/70(32.7%/67.3%) | 0.808 |
| Hemiplegia | 5/47(9.6%/90.4%) | 9/95(8.7%/91.3%) | 0.843 |
| Chronic renal insufficiency | 18/34(34.6%/65.4) | 20/84(19.2%/80.8%) | 0.035 |
| Solid tumor | 5/47(9.6%/90.4%) | 13/91(12.5%/87.5%) | 0.595 |
| Leukemia | 0/52(0%/100%) | 6/98(5.8%/94.2%) | 0.077 |
| Lymphoma | 0/52(0%/100%) | 2/102(1.9%/98.1%) | 0.314 |
| Allergy | 4/48(7.7%/92.3%) | 17/87(16.3%/83.7%) | 0.135 |
| Meropenem | 23/29(44.2%/55.8) | 48/56(46.2%/53.8%) | 0.820 |
| Imipenem | 8/44(15.4%/84.6%) | 14/90(13.5%/86.5%) | 0.745 |
| Piperacillin/tazobactam | 5/47(9.6%/90.4%) | 7/97(6.7%/93.3%) | 0.524 |
| Vancomycin | 24/28(46.2%/53.8) | 58/46(55.8%/44.2%) | 0.257 |
| Teicoplanin | 3/49(5.8%/94.2%) | 14/90(13.5%/86.5%) | 0.146 |
| Linezolid | 2/50(3.8%/96.2%) | 7/97(6.7%/93.3%) | 0.466 |
| Colistin | 10/42(19.2%/80.8) | 16/88(15.4%/84.6%) | 0.543 |
| Tigecycline | 7/45(13.5%/86.5%) | 13/91(12.5%/87.5%) | 0.866 |
| ICU stay | 27/25(51.9%/48.1) | 47/57(45.2%/54.8%) | 0.427 |
| Recovery | 33/19(63.5%/36.5) | 0/104(0%/100%) | 0.000 |
| Death | 15/37(28.8%/71.2) | 32/72(30.8%/69.2%) | 0.805 |
| Prolonged hospitalization | 11/41(21.2%/78.8) | 0/104(0%/100%) | 0.000 |
| Age | 64.5[16] | 67.1[19] | 0.507 |
| Duration of ADR | 7[8] | 0[0] | 0.000 |
| Charlson comorbidity index | 4[3] | 4.5[3] | 0.436 |
| Duration of antibiotic therapy | 6.5[8] | 10[5] | 0.005 |
| Length of hospitalization | 30[26] | 28.5[26] | 0.801 |
| Total consultations | 12[14] | 11[16] | 0.509 |
| Pharmacologist consultations | 4[6] | 4[4] | 0.722 |
| AST | 30[29] | 26[31] | 0.719 |
| ALT | 22[30] | 21.5[30] | 0.328 |
| GGT | 50.5[116] | 40.5[97] | 0.594 |
| Total bilirubin | 12[9.7] | 13.9[11.1] | 0.293 |
| Direct bilirubin | 3.55[4.1] | 4.1[4.9] | 0.344 |
| Amylase | 61.5[47] | 49[62] | 0.250 |
| Urea | 7.75[7.7] | 7.4[7] | 0.870 |
| Creatinine | 86.5[135.8] | 77[65] | 0.307 |
| Leukocytes | 9.5[6.5] | 11.7[9.3] | 0.037 |
| Neutrophils | 6.8[4.8] | 8.52[6.64] | 0.068 |
| Platelets | 256[166] | 267[241] | 0.936 |
| CRP | 133.3[149.5] | 120.4[116.1] | 0.897 |
Table 6.
Statistically significant predictors of ADR occurrence identified by multivariate logistic regression
| Risk factor | Crude OR (95% CI) | Adjusted OR (95% CI) | P value |
|---|---|---|---|
| Heart failure | 0.455 (0.223–0.928) | 0.262 (0.115–0.599) | 0.002 |
| Peptic ulcer disease | 0.355 (0.127–0.992) | 0.268 (0.091–0.790) | 0.017 |
| Chronic renal insufficiency | 2.224 (1.049–4.713) | 3.356 (1.415–7.955) | 0.006 |