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Table 1 Baseline characteristics of the patients

From: Factors affecting serum phenobarbital concentration changes in pediatric patients receiving elixir and powder formulations

  FAS (n = 60) PB elixir (n = 21) PB powder (n = 39)
  Oral route (n = 8) Enteral tube (n = 13) Oral route (n = 14) Enteral tube (n = 25)
Male (%) 33 (55) 4 (50) 8 (62) 6 (43) 15 (60)
Age (years) 1.0 [0.6–2.5] 1.0 [0.7–1.9] 0.8 [0.2–1.0] 0.9 [0.5–2.5] 2.0 [1.0–3.2]
Body weight (kg) 8.2 [4.7–11.7] 8.1 [5.9–11.6] 4.0 [2.8–8.1] 8.8 [6.2–11.5] 8.8 [4.8–14.3]
PB dose (mg/day) 40.0 [20.0–60.0] 40.0 [31.0–60.0] 16.0 [9.8–23.2] 50.0 [27.5–80.0] 50.0 [19.0–80.0]
Number of daily PB doses (times/day) 2.0 [2.0–2.0] 2.0 [2.0–2.0] 2.0 [1.1–2.5] 2.0 [1.5–2.0] 2.0 [2.0–2.0]
PB dose per body weight (mg/kg/time) 2.6 [1.9–3.7] 2.6 [2.1–4.3] 2.0 [1.1–2.5] 2.7 [1.9–3.6] 2.9 [2.2–4.7]
Serum PB concentration (μg/mL) 16.0 [11.2–25.0] 15.4 [11.1–20.1] 15.7 [12.7–18.8] 11.4 [10.1–23.7] 17.4 [9.9–34.9]
ALB (g/dL) 4.1 [3.7–4.4] 4.2 [3.3–4.6] 4.0 [3.5–4.4] 4.3 [3.8–4.5] 4.0 [3.7–4.4]
AST (U/L) 35.9 [28.4–53.9] 34.9 [21.6–46.5] 46.0 [31.5–63.5] 35.0 [28.7–50.5] 39.0 [30.0–75.9]
ALT (U/L) 20.8 [15.0–39.8] 19.2 [12.5–25.8] 29.8 [13.2–35.5] 22.6 [16.5–42.6] 29.6 [15.7–52.5]
LDH (U/L) 272.6 [222.4–334.2] 264.5 [212.5–312.6] 255.0 [243.0–271.5] 320.7 [253.4–388.0] 277.0 [225.5–367.7]
γGTP (U/L) 69.9 [28.8–170.9] 30.5 [23.5–93.0] 65.0 [31.5–289.5] 39.5 [27.7–57.5] 76.3 [34.0–172.5]
BUN (mg/dL) 8.9 [5.8–11.9] 8.2 [5.2–13.0] 9.0 [3.5–9.6] 6.1 [5.4–8.5] 9.4 [6.3–13.5]
Scr (mg/dL) 0.2 [0.2–0.3] 0.2 [0.2–0.3] 0.2 [0.1–0.3] 0.2 [0.2–0.3] 0.2 [0.1–0.3]
Interacting drug use
VPA (%) 13 (22) 0 (0) 3 (23) 5 (36) 5 (20)
Amiodarone (%) 1 (2) 0 (0) 1 (8) 0 (0) 0 (0)
Causative disorder *including duplication
Fever convulsion (%) 11 (18) 2 (25) 3 (23) 2 (14) 4 (16)
Epilepsy (%) 18 (30) 2 (25) 3 (23) 4 (29) 9 (36)
Acute encephalitis/acute encephalopathy (%) 4 (7) 1 (13) 2 (15) 0 (0) 1 (4)
Intracranial bleeding (%) 9 (15) 1 (13) 1 (8) 5 (36) 2 (8)
Hypoxic-ischemic encephalopathy (%) 16 (27) 1 (13) 7 (54) 3 (21) 5 (20)
Hyperammonemia (%) 2 (3) 1 (13) 0 (0) 0 (0) 1 (4)
Brain tumor (%) 4 (7) 1 (13) 0 (0) 2 (14) 1 (4)
Angiocholitis (%) 2 (3) 1 (13) 0 (0) 0 (0) 1 (4)
Not clear (%) 2 (3) 0 (0) 0 (0) 0 (0) 2 (8)
  1. Data are shown as frequency (percentage) or median [first quartile-third quartile]
  2. PB phenobarbital, FAS full analysis set, ALB serum albumin, AST aspartate aminotransferase, ALT alanine aminotransferase, LDH lactate dehydrogenase, γGTP γ-glutamyl transpeptidase, BUN blood urea nitrogen, Scr serum creatinine, VPA valproic acid
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Journal of Pharmaceutical Health Care and Sciences

ISSN: 2055-0294

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