Incidence, clinical features, and risk factors of fluoroquinolone-induced acute liver injury: a case-control study

Figures & data

Figure 1 The technical flow chart of this study.

Notes: The information on patients using fluoroquinolones was extracted and preliminarily analyzed by the ADE active surveillance and assessment system from the hospital information system. After the secondary evaluation by two clinical pharmacists, the incidence, clinical features and risk factors of fluoroquinolone-induced acute liver injury were researched.
Abbreviation: ADE, adverse drug events.

Table 1 Characteristics of cases and controls

Variable	No. (%) of patients or mean ± SD		P-value*
	Cases (n=91)	Controls (n=369)
Age (year)	56.32±18.47	58.97±16.10	0.17
Sex (male)	69 (75.8)	195 (52.8)	<0.01
BMI (kg/m^2	22.54±3.83	23.95±4.02	<0.01
Albumin (g/L)	34.31±5.10	35.47±4.73	0.04
Hemoglobin (g/L)	107.82±25.95	113.51±20.70	0.05
Alcohol abuse	31 (34.1)	40 (10.8)	<0.01
Smoking			<0.01
Never	45 (49.4)	253 (68.6)
Current	33 (36.3)	53 (14.4)
Past	13 (14.3)	63 (17.0)
Allergy history	25 (27.5)	81 (22.0)	0.27
Comorbidities
Hypertension	31 (34.1)	128 (34.7)	1.00
Diabetes mellitus	16 (17.6)	64 (17.3)	1.00
Cardiovascular disease	14 (15.4)	64 (17.3)	0.76
Hepatitis B carrier	14 (15.4)	23 (6.2)	<0.01
Combination drug			<0.01
Proton pump inhibitors	75 (82.4)	238 (64.5)
Cephalosporins	42 (46.2)	107 (29.0)
Carbapenems	33 (36.3)	51 (13.8)
Antifungal agents	23 (25.3)	38 (10.3)
Aminoglycosides	7 (7.7)	23 (6.2)

Note:

* χ² or t-test, as appropriate.

Table 2 Univariate and multivariate analyses of risk factors fluoroquinolone-induced acute liver injury

Variable	Unadjusted OR (95% CI)	Adjusted OR (95% CI)*
Age (year)	0.99 (0.98–1.00)	0.98 (0.96–0.99)
Sex (male)	2.80 (1.66–4.72)	2.19 (1.07–4.48)
BMI (kg/m^2)
<18.5	2.30 (1.15–4.60)	2.32 (1.00–5.39)
≥18.5	1	1
Albumin (g/L)
≤25	2.94 (0.68–12.7)	4.02 (0.72–22.31)
26–34	1.57 (0.97–2.52)	1.22 (0.68–2.17)
≥35	1	1
Hemoglobin (g/L)
<110	1.59 (1.01–2.53)	1.38 (0.77–2.48)
≥110	1	1
Alcohol abuse	4.25 (2.47–7.32)	2.91 (1.39–6.11)
Smoking
Never	1	1
Current	3.50 (2.04–6.00)	1.91 (0.79–4.61)
Past	1.16 (0.59–2.28)	2.33 (0.98–5.55)
Allergy history	1.35 (0.80–2.27)	1.36 (0.74–2.49)
Comorbidities
Hypertension	0.97 (0.60–1.58)	1.18 (0.63–2.23)
Diabetes mellitus	1.02 (0.56–1.86)	0.91 (0.42–1.97)
Cardiovascular disease	0.87 (0.46–1.63)	1.46 (0.64–3.32)
Hepatitis B carrier	2.74 (1.35–5.56)	2.38 (1.04–5.48)
Combination drug
Proton pump inhibitors	6.41 (1.95–21.02)	3.33 (0.92–12.06)
Cephalosporins	7.98 (2.37–26.84)	1.84 (1.06–3.21)
Carbapenems	13.16 (3.81–45.42)	2.53 (1.35–4.73)
Antifungal agents	12.31 (3.46–43.80)	2.02 (1.00–4.06)
Aminoglycosides	6.19 (1.47–25.99)	0.90 (0.32–2.52)

Note:

* Adjusted for all variables in the table.