Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis

doi:10.3748/wjg.v21.i16.4975

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastroenterol. Apr 28, 2015; 21(16): 4975-4985
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.4975

Table 1 Baseline characteristics of the patients

Characteristic	PDN (n = 35)	PDN+MTD (n = 35)	PTX (n = 33)	PTX+MTD (n = 32)	P value
Male, n (%)	33 (94.3)	32 (91.4)	31 (93.9)	28 (87.5)	0.40
Age, yr	43.1 ± 9.5	43.4 ± 9.0	43.4 ± 9.9	44.4 ± 9.1	0.94
Alcohol intake, g/d	313.7 ± 157.1	328.9 ± 142.5	365.9 ± 196.2	346.5 ± 173.6	0.61
Child-Pugh	12.4 ± 1.0	12.4 ± 0.9	12.6 ± 1.0	12.5 ± 1.0	0.82
Maddrey´s modified discriminant function	70.9 ± 25.6	67.3 ± 19.3	93.4 ± 84.7	78.3 ± 40.2	0.14
MELD	28 ± 4	29 ± 6	31 ± 9	31 ± 7	0.19
ABIC	8.199 ± 1.3	8.604 ± 2.9	8.675 ± 1.8	8,677 ± 1.6	0.73
Urea, mg/dL Log₁₀	1.60 ± 0.34	1.64 ± 0.31	1.66 ± 0.32	1.64 ± 0.42	0.94
Creatinine, mg/dL	1.5 ± 0.7	1.5 ± 0.8	1.7 ± 1.1	1.9 ± 1.5	0.21
Sodium, mEq/L	131.3 ± 5.8	132.7 ± 5.8	130.9 ± 5.1	131.7 ± 4.7	0.57
Albumin, mg/dL	1.9 ± 0.4	1.9 ± 0.5	1.8 ± 0.4	1.8 ± 0.5	0.89
Total bilirubin, mg/dL	24.4 ± 10.5	24.5 ± 10.1	23.0 ± 9.5	25.9 ± 11.6	0.73
Alkaline phosphatase, UI/L Log₁₀	2.3 ± 0.2	2.3 ± 0.2	2.2 ± 0.2	2.4 ± 0.2	0.29
Gamma-glutamyltransferase, UI/L Log₁₀	2.5 ± 0.3	2.4 ± 0.3	2.4 ± 0.4	2.4 ± 0.3	0.73
Aspartate aminotransferase, UI/L Log₁₀	2.3 ± 0.2	2.3 ± 0.2	2.2 ± 0.2	2.2 ± 0.3	0.39
Alanine aminotransferase, UI/L Log₁₀	1.7 ± 0.2	1.7 ± 0.2	1.7 ± 0.2	1.7 ± 0.4	0.28
Leucocytes, cell/mm³	20.9 ± 8.0	18.5 ± 8.0	19.5 ± 9.0	19.2 ± 10.3	0.71
Neutrophils, cell/mm³	16.2 ± 7.0	15.7 ± 7.5	16.6 ± 8.5	17.0 ± 9.9	0.92
Hemoglobin, g/dL	11.6 ± 2.7	11.8 ± 2.5	10.9 ± 3.0	11.4 ± 2.4	0.52
Platelets, cell/mm³	178.1 ± 119.5	186.0 ± 113.6	182.8 ± 117.7	153.0 ± 84.0	0.61
Prothrombin time in seconds	22.0 ± 5.8	21.1 ± 3.6	27.6 ± 18.5	23.2 ± 8.8	0.06
INR	1.9 ± 0.5	1.8 ± 0.3	2.4 ± 1.9	2.0 ± 0.7	0.06
Cirrhosis on liver ultrasound, n (%)	25 (71.4)	20 (57.1)	26 (78.8)	20 (62.5)	0.24

ABIC: Age-bilirubin-international normalized ratio-creatinine; INR: International normalized ratio; MELD: Model for end-stage liver disease; PDN: Prednisone; PDN+MTD: Prednisone + metadoxine; PTX: Pentoxifylline; PTX+MTD: Pentoxifylline + metadoxine.

Table 2 Development of complications at the 3-mo follow-up n (%)

Complication	PDN+MTD (n = 35)	PDN (n = 35)	PTX+MTD (n = 32)	PTX (n = 33)	P value²	HR (95%CI)³	P value⁴	HR (95%CI)⁵
HE	10 (28.6)	21 (60.0)	13 (40.6)	17 (51.5)	0.008¹	0.2 (0.1-0.7)	0.38	0.6 (0.2-1.7)
HRS	11 (31.4)	19 (54.3)	11 (34.4)	16 (48.5)	0.05¹	0.3 (0.1-1.0)	0.25	0.5 (0.2-1.5)
VB	10 (28.6)	13 (37.1)	11 (34.4)	14 (42.4)	0.44	0.6 (0.2-1.8)	0.51	0.7 (0.2-1.9)
Infections	11 (31.4)	14 (40.0)	11 (34.4)	12 (36.4)	0.45	0.6 (.02-1.8)	0.87	0.9 (0.3-2.5)
None	24 (68.6)	21 (60)	21 (65.6)	21 (63.6)
UTI	0 (0)	3 (8.6)	3 (9.4)	6 (18.25)
SBP	2 (5.7)	2 (5.7)	3 (9.4)	3 (9.15)
Pneumonia	9 (25.7)	7 (20)	1 (3.1)	1 (3.0)
EC	0 (0)	1 (2.85)	3 (9.4)	1 (3.0)
Diarrhea	0 (0)	1 (2.85)	1 (3.1)	1 (3.0)

¹Significant difference (P < 0.05);

²P value comparing the PDN vs the PDN+MTD groups;

³HR and 95%CI comparing the PDN vs the PDN+MTD groups;

⁴P value comparing the PTX vs the PTX+MTD groups;

⁵HR and 95%CI comparing the PTX vs the PTX+MTD groups. EC: Esophageal candidiasis; HE: Hepatic encephalopathy; HR: Hazard ratio; HRS: Hepatorenal syndrome; PDN: Prednisone; PDN+MTD: Prednisone + metadoxine; PTX: Pentoxifylline; PTX+MTD: Pentoxifylline + metadoxine; SBP: Spontaneous bacterial peritonitis; UTI: Urinary tract infection; VB: Variceal bleeding.

Table 3 Multivariate analysis: predictors of mortality at 6 mo in patients with severe alcoholic hepatitis

Variable	HR (95%CI)	P value
Relapse in alcohol intake¹	8.9 (3.9-20.2)	0.0001
Cirrhosis¹	2.3 (1.1-4.7)	0.02
Treatment with metadoxine²	0.3 (0.2-0.7)	0.005
Quantity of alcohol intake (> 150 g/d)	1.8 (0.4-7.7)	0.45

¹Risk factor;

²Protective factor. HR: Hazard ratio; 95%CI: 95% confidence interval.

Citation: Tijera FHDL, Servín-Caamaño AI, Serralde-Zúñiga AE, Cruz-Herrera J, Pérez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Pérez-Hernández JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol 2015; 21(16): 4975-4985
URL: https://www.wjgnet.com/1007-9327/full/v21/i16/4975.htm
DOI: https://dx.doi.org/10.3748/wjg.v21.i16.4975