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Cite this article: da Silva Folhadela MR, Fernandes Pereira MT, Gomes HC, da Silva E, Rocha MF, et al. (2016) Prospective Study on Predictors of Death in Patients with Alcoholic Hepatitis. Ann Public Health Res 3(4): 1050.

*Corresponding authorPatricia da Silva Fucuta, Gastroenterology and Hepatology Unit, Hospital de Base, Sao Jose do Rio Preto, Sao Paulo, Brazil, Tel: 55-17-3301-5000; Email:

Submitted: 15 October 2016

Accepted: 09 November 2016

Published: 11 November 2016

Copyright© 2016 da Silva Fucutaet al.

OPEN ACCESS

Keywords•Alcoholic hepatitis•Alcoholism•Prognosis•In-hospital mortality

Research Article

Prospective Study on Predictors of Death in Patients with Alcoholic HepatitisMárcia Raquel da Silva Folhadela, Márcia Tatianna Fernandes Pereira, Hélcio Cardoso Gomes, Edson Cartapatti da Silva, Marcia Fumie da Rocha and Patricia da Silva Fucuta*Gastroenterology and Hepatology Unit, Hospital de Base, Brazil

Abstract

Objective: To analyze alcoholic hepatitis (AH) death predictors.

Methods: Prospective study on hospitalized patients with AH. Student’s t test, Mann-Whitney, the Chi-squared and Fisher’s exact test were used for comparative analysis. The accuracies in predicting death of Maddrey discriminant function (MDF) and MELD score were determined by the measurement of areas under the ROC curve (AUROC). The best cutoffs to predict death were identified by the ROC curve and sensitivity (SE), specificity (S), positive predictive value (PPV) and negative predictive value (NPV) were calculated. P-value<0.05 was considered significant.

Results: Of the 554 hospitalizations, 76 were due to AH (67 patients). Most patients were male (94%), cirrhotic (85%), Child-Pugh C (66%) and mean age was 50 years. High creatinine levels at hospital admission were observed in 25% of the patients; 15% evolved to hepatorenal syndrome. Infection was present in 47%. In-hospital death rate was 24%. Comparison of the variables between death and hospital discharge, respectively: Na 131x136mEq (p=0.006); ALT 84x36IU/l (p=0.001); C-reactive protein 6.0x3.1mg/dl (p=0.03); creatinine 1,5x0.8mg/dl (p=0.006); MDF 62x24 (p=0.001); MELD 28x18 (p<0.0001). AUROC MDF: 0.795 (95% CI 0.65; 0.93); AUROC MELD: 0.867 (95% CI 0.75; 0.97); SE and NPV in predicting death for MDF cutoffs of 32 and 27 were 0.8 and 0.91 versus 0.87 and 0.93; for MELD 19 was 0.87 and 0.92, respectively.

Conclusions: In-hospital mortality was high. The main complications were infection and renal failure. The overall accuracy of prognostic models MELD and MDF was moderate and they performed better in correctly exclude probability of in-hospital mortality; as a goal of early detection of patients at highest risk of death the MDF cutoff of 27 could maximize the sensitivity to a limited extent, but further studies are necessary with a larger sample size to analyze the potential benefits and risks of pharmacotherapy indication in this context.

ABBREVIATIONSAH: Alcoholic Hepatitis; ALT: Alanine Aminotransferase; AST:

Aspartate Aminotransferase; AUROC: Area Under the ROC Curve; MDF: Modified Maddrey Discriminant Function; MELD: Model for End-Stage Liver Disease; NPV: Negative Predictive Value; PPV: Positive Predictive Value; S: Specificity; SE: Sensitivity

INTRODUCTIONAlcoholic hepatitis (AH) is a clinical syndrome characterized

by rapid onset of jaundice, malaise, fever and tender hepatomegaly in a patient with excessive alcohol consumption; malnutrition, ascites, and encephalopathy may be present [1]. Histologically

the main features are steatosis, hepatocyte ballooning, mega mitochondria, Mallory bodies and inflammatory infiltrate with neutrophils; some degree of fibrosis and cirrhosis as well may co-exist in many cases [2,3].

Although liver biopsy may confirm the diagnosis, determine the presence of concomitant diseases and provide information for prognosis, its role in AH is controversial, since it is an invasive procedure [4]. In fact liver biopsy cannot be performed in the presence of severe AH due to coagulopathy unless through a trans-jugular route (a not widely available complex procedure) [3-5].

Thus clinical features and laboratory tests are often adequate

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for establishing the diagnosis of AH in a patient with heavy alcohol drinking. The mainly laboratorial features are elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels, although rarely above 300 IU/l, leukocytosis with neutrophilia, anemia, and hyperbilirubinemia (usually above 5 mg/dl) [1,5-7].

AH is a significant cause of liver-related morbidity and mortality and in the setting of severe AH short-term mortality rates are high, approximately 25% to 45% [8,9]. Clinical models have been developed to predict mortality in AH and optimize strategies to improve prognosis of these patients.

Maddrey discriminant function [4.6 x prothrombin time (PT) in seconds + serum bilirubin (mg/dl)] was described for the first time in 1978 in a study comparing 55 patients receiving steroids (n=24) or placebo (n=31); all of the patients who died had discriminant function > 93 [10]. The Maddrey discriminant function was later modified and a control PT was introduced in the formula [11], which is now called the modified Maddrey discriminant function (MDF) that is used today. Other prognostic scores commonly used are MELD (Model for End-Stage Liver Disease), GASH (Glasgow alcoholic hepatitis score), ABIC (age-bilirubin-INR-creatinine), and Lille score. Actually all of these prognostic tools have limitations and perform better at predicting short-term survival rather than short-term mortality in AH [12,13].

The aim of the present study was to analyze the predictors of death in hospitalized patients with AH in a tertiary hospital.

MATERIALS AND METHODSThis was a cohort study. All consecutive patients with AH

hospitalized at the Gastroenterology and Hepatology Unit, Hospital de Base, São José do Rio Preto - SP, from February 1, 2011 to March 31, 2012 were evaluated. The study was approved by the Research Ethics Committee of the São José do Rio Preto Medical School (FAMERP) and follows the guidelines of the Helsinki Declaration.

Variables analyzed

Demographic, epidemiologic, clinical and laboratory data, pharmacotherapy, mortality rate and the prognostic MDF and MELD scores were analyzed.

Statistical analysis

The descriptive analysis included absolute and relative frequencies for categorical variables and mean, median, standard deviation and variation for continuous variables. Student’s t test or Mann-Whitney test were used for the comparison of continuous variables. The Chi-squared test or Fisher’s exact test were used for the comparison of groups of categorical variables when appropriate.

The accuracy in predicting death of the severity scores for AH, MDF and MELD was determined by the measurement of the area under the ROC curve (AUROC). The best cutoffs to predict death or hospital discharge were identified based on the ROC curve. Diagnostic accuracy was also evaluated by the calculation of sensitivity (SE), specificity (S), positive predictive value (PPV) and negative predictive value (NPV).

Descriptive level < 0.05 was considered significant. The statistical analysis was performed using the IBM-SPSS Statistics software for Windows version 18 (IBM Corporation, NY, USA).

RESULTSDuring the study period, there were 554 hospitalizations

for 362 patients, of which 76 were due to AH (67 patients). The prevalence of AH was 14%.

Overall characteristics of the patients

Mean age was 50 years and only 6 patients were female. Most of them had liver cirrhosis (85%) and Child-Pugh C (66%). Mean alcohol ingestion was 130g/day, ranging from 25 to 400 g/day and the mean time of alcoholism was 29 years. The clinical characteristics of the sample are described in Table (1).

Alcohol alone was the cause of cirrhosis in 85% of the patients and there was an association with hepatitis C virus in 15% of the cases. None of the patients had association with the hepatitis B virus and 5% of the patients had positive serology for human immunodeficiency virus (HIV). Twelve percent were diabetic and 24% were hypertensive. Eleven percent of the patients had withdrawal syndrome.

Laboratory data at admission

Patients had high AST levels which were higher than ALT levels (130 U/L x 43U/L) and the median AST/ALT ratio was 3.0. It is noteworthy that 25% of the patients had abnormal creatinine levels at admission, of which 15% evolved to HRS. Laboratory data at admission are described in Table (2).

Complications

During hospitalization, 10 patients (15.4%) evolved to pneumonia, 6 (9.2%) to urinary tract infection (UTI), 4 (6%) to blood stream infections, 4 (6%) to spontaneous bacterial peritonitis, 3 (4.5) to bacterioascites, 2 (3%) to cellulite, 1 (1.5%) to secondary bacterial peritonitis and 2 (3%) had unidentified source of infection. The main bacteria observed in the ascitic fluid culture were: Escherichia coli in 33.3%, Streptococci in 16.7%, Staphylococci in 16.7% and other bacteria in 33.3%. In the urine culture, Streptococci, Escherichia coli and Klebisiela were each observed in 33.3%. The main bacteria found in the blood culture were Staphylococci in 45.5%.

Pharmacotherapy

Treatment with steroids or pentoxyfilline was indicated for patients with MDF cut off greater than or equal to 32. Of the 67 patients with AH, 20 (30%) patients met this criterion and were treated with pentoxyfilline (16 patients), steroids (1 patient) or both pentoxyfilline and steroids (3 patients).

Endpoint

The in-hospital mortality rate was 24%. When the death-related variables were evaluated, it was observed that MDF and MELD were significantly associated to mortality, in addition to 7 laboratory variables: serum sodium, albumin, INR, bilirubin, C-reactive protein, creatinine and ALT. The comparative analysis between groups (hospital discharge and in-hospital death) may be observed in Table (3).

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Table 1: Overall characteristics of the 67 patients studied.

Characteristics

Males 63 (94%)

Age, years 50 ± 10.7 (32 – 75)

Alcohol ingestion, g/day 130 (25 – 400)

Time of alcoholism, years 29 (3 – 60)

Smoking 36 (61%)

Tobacco load, packages/year 30 (3 – 300)

Hospitalization period, days 6 (1 – 42)

Cirrhosis 56 (85%)

MELD 19 (7 – 37)

Maddrey Discriminant Function 28 (1,3 – 123,82)Decompensation of cirrhosis Ascitis Hepatic encephalopathy Variceal bleeding

28,4 (42.2%)17 (33.3%)12 (26.6%)

Categorical variables are described in number and proportion;continuous variables are described as mean ± standard deviation or median (range).Abbreviations: MELD: Model of End-Stage Liver Disease.

Table 2: Laboratory data of the 67 patients studied.

Variables RV

Hematocrit, % 32.2% ± 6.31 40 to 55

Hemoglobin, g/dl 10.8 ± 2.3 12 to 17

Mean corpuscular volume, fl 96.5 ± 7.6 80 to 100

Leukocytes, cell/mm3 8030 (2070 - 2706) 4000 to 11000

Platelets, thousand/mm3 142.5 ± 73.6 150 to 450

Albumin, g/dl 2.9 (1.4 – 4.9) 3.5 to 5.2

Total bilirubin, mg/dl 5,4 (0,6 – 38,6) < 1

Direct bilirubin, mg/dl 4.8 (0.3 – 33.0) < 0.2

Prothrombin activity, % 58.48 ± 20.93 70 to 100Aspartate Aminotransferase, IU/l 130 (36 – 651) 32 (F) 40 (M)

Alanine aminotransferase, IU/l 43 (1 – 269) 33(F) 41(M)Gamma-glutamyl transferase, IU/l 522 (43 – 3267) 40 (F) 60 (M)

Alkaline phosphatase, IU/l 162 (60 – 620) 105(F) 130(M)

Creatinine, mg/dl 0.8 (0.4 – 4.2) 0.7 to 1.2

C-Reactive Protein 3.44 (0,03 – 30.81) 0 to 0.5

Continuous variables are described as mean ± SD or median (range). Abbreviations: RV: Reference Value; F: Female; M: Male.

The ROC curve was developed to determine the accuracy of the MDF and MELD scores in predicting death. The areas under the curve for the two models were significant: MDF 0.795 (95% CI 0.65; 0.93) and MELD 0.867 (95% CI 0.75; 0.97). The ROC curves may be observed in Figure (1) and Figure (2). Table (4) presents SE, S, PPV, NPV, and accuracy for both scores. At the MDF cutoff of 32, SE was 80% and NPV for ruling out in-hospital mortality was 91% but the PPV was low (40%); at a lower MDF cutoff of 27, the SE and NPV were 87% and 93%, respectively, and PPV was 37%.

DISCUSSIONThe prevalence of AH for in-hospital patients as well as

the clinical and demographic characteristics of patients in the present study was similar to that reported in the literature [2,14,15]. Alcohol alone was the main cause of cirrhosis and was associated to hepatitis C virus in some patients, similarly to a large population-based study in the United States [14] where 19% of the patients had the same association and likewise, there were no patients infected by the hepatitis B virus.

A heterogeneous clinical scenario was observed, leading to variable hospitalization periods. This was also indicated by laboratory tests with a marked variability in bilirubin and prothrombin activity levels as well as MDF values. Infection and acute renal failure were frequent findings.

The in-hospital mortality rate in the present study was high. The variables that were significantly associated to death were similar to those of another study [16] including sodium, albumin, INR, bilirubin, C-reactive protein, creatinine and ALT; in addition, MDF and MELD were also predictors of death.

The MDF cutoff of 32 had a sensitivity of 0.8 and a high negative predictive value, of 0.91, which were similar to the rates observed in other studies [16,17]. The MDF cutoff of 32 as a severity criterion in AH was determined in a study by Carithers et al in 198911 by the equivalence to a value of 93 in the previous

Table 3: Predictors of in-hospital mortality in patients hospitalized for alcoholic hepatitis.

Hospital discharge

In-hospital death p

Age, years 50.04 ± 10.94 50.56 ± 10.85 0.86Lengh of hospital stay, days 6 (1 - 42) 10.5 (1 - 30) 0.98

Child-Pugh 10 (5 – 14) 12 (10 – 14) 0.001

MELD 17.84 ± 5.93 27.67 ± 6.13 < 0.0001

MDF 23.9 (1.3 – 98.8) 60.2 (2.02 – 123.82) 0.001

Sodium, mEq/dl 135.9 ± 6.1 131.0 ± 5.6 0,006

Albumin, g/l 2.95 (1.77 – 4.65) 2.64 (1.40 – 4.90) 0.036

INR 1.42 (0.95 – 3.0) 1.86 (1.02 – 4.12) 0.009

Bilirubin, mg/dl 5.0 (0.6 – 21.4) 11.6 (0.7 – 38.6) 0.008C-reative protein, mg/dl

3.11(0.03– 19.32)

6.02 (0.09 – 30.81) 0.034

Creatinine, mg/dl 0.8 (0.4 – 2.2) 1.45 (0.4 – 4.2) 0.006

ALT, IU/l 36.5 (1 – 269) 83.5 (26 – 151) 0.012

Pharmacotherapy*

Yes 8/19 (42.1%) 11/19 (57.9%)0.054

No 39/47 (83%) 8/47 (17%)Categorical variables are described as number (percentage); continous variables are described as mean ± standard deviation or median (range).Abbreviations: MELD: Model of End-Stage Liver Disease; MDF: Modified Maddrey Discriminant Function; INR: International Normalized Ratio; ALT: Alanine Aminotransferase.*Pentoxyfilline, steroids or both.

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MDF = [4.6 X (PT in seconds - control PT) + serum bilirubin mg/dL)]. Patients with MDF > 32 or hepatic encephalopathy were included in the study and treated with placebo or steroids. The 28-day mortality was 35% in the placebo group and 6% in the group treated with methylprednisolone [3]. In 2002, the analysis of three studies with the aim of to determine the efficacy of steroids in AH reaffirmed the cutoff value of 32 as a prognostic factor in AH [18].

The maximization of the test sensitivity becomes a priority in situations when the aim is to identify patients at highest risk of death. Thus in the present study the cutoff of 27 for MDF were also analyzed and had greater sensitivity (0.87) than the cutoff of 32 and an excellent high NPV (0.93); but the ability to correctly predict in-hospital mortality remained low (0.37). Although the MDF cutoff of 27 could maximize sensitivity to a limited extent and correctly exclude in-hospital mortality probability, further studies are necessary with a larger sample size to compare the potential benefits and risks of pharmacotherapy indication in this context. In fact, a study carried out by Kulkarni et al. [16], evaluated the role of MDF in 89 patients and concluded that the cutoff of 32 maximized sensitivity and specificity in predicting mortality in AH, but found a non-negligible mortality rate of 16.7% for patients with MDF < 32. Furthermore, a recent population-based study [19] found an optimal MDF cutoff of 37 for the prediction of 90-day mortality and the authors concluded that MELD and MDF as prognostic factors have better performance particularly to identify patients with a low risk for death [19].

The MELD score has also been evaluated and compared with MDF and it has been useful in guiding the beginning of drug therapy in several studies [20,21]. The cutoff of 11 points had the same sensitivity, but had greater specificity than the MDF in predicting the 30-day mortality in a study [20]. Furthermore, it has been demonstrated that a cutoff of 20 or more points at admission had greater sensitivity and specificity to prevent in-hospital mortality and was better than both MDF and Child-Pugh-Turcotte in another study [21]. In the present study, the cutoff of 19 for MELD score had a similar sensitivity (0.87) when compared to MDF cutoff of 27, with a specificity of 0.5 in predicting death.

Pharmacotherapy for patients with AH remains controversial. In the present study treatment with pentoxyfilline or steroids did not influence mortality and our result is consistent with other studies [17,19]. The current guidelines [22,23] for management of AH suggest drug therapy is indicated for patients with high risk for in-hospital mortality; the two options are pentoxyfilline and prednisolone and the choice between then may take into account variables such as sepsis or digestive bleeding. The drug should be started after serology for HBV, HCV and HIV and abdominal US are obtained to exclude other causes of jaundice, in addition to bacterial cultures, screening for renal failure and early treatment for hepatorenal syndrome.

But a more recent multicenter study [24] has questioned these drugs and determined that neither prednisolone nor pentoxifylline influenced mortality; the authors also concluded administration of 40mg of prednisolone daily for 1 month had a benefic effect in short term mortality but not in medium or long-term outcome of AH. Thus a recent publication [25] has included only the steroid as therapeutic option.

Figure 1 MDF as predictor of in-hospital mortality in patients with alcoholic hepatitis. The area under the ROC curve was significant: 0.867 (95% CI 0.75; 0.97); P = 0.001. Abbreviations: MDF: Modified Maddrey Discriminant Function; ROC: Receiver Operating Characteristic.

Figure 2 MELD as predictor of in-hospital mortality in patients with alcoholic hepatitis. The area under the ROC curve was significant: 0.867 (95% CI 0.75; 0.97), P< 0.001. Abbreviations: MELD: Model for End-Stage Liver Disease; ROC: Receiver Operating Characteristic.

study of Maddrey et al. [10]; in this study [10] all of the patients who died had a discriminant function > 93 in the original formula (that did not considered the control PT in seconds). The study of Carithers et al. [11], included 66 patients and led to the formula

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The management of AH has not significantly changed in the last decades. In a recent review [25] potential new treatment options for AH are discussed and include modification of gut microbiota composition and their products such as lipopolysaccharide, nutritional interventions, immune modulation, genetic polymorphism and epigenetic modification of alcohol induced liver damage and liver regeneration by cytokine granulocyte colony-stimulating factor; these are potential new therapies for steroid non-responsive/ineligible patients [25].

CONCLUSIONIn conclusion AH was a severe event with a high mortality

rate. The main complications were infection and renal failure. The overall accuracy of prognostic models MELD and MDF was moderate in the present study and they performed better in correctly exclude the probability of in-hospital mortality; as a goal of early detection of patients at highest risk of death the MDF cutoff of 27 could maximize the sensitivity of the score to a limited extent, but further studies are necessary with a larger sample size to analyze the potential benefits and risks of pharmacotherapy indication in this context and patients outcome.

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Table 4: Accuracy of modified Maddrey discriminant function (A) and Model for End-Stage Liver Disease (B) score as predictors of death.

A

MDF SE S PPV NPV Accuracy

32 0.80 0.65 0.40 0.91 0.68

27 0.87 0.55 0.37 0.93 0.62

B

MELD SE S PPV NPV Accuracy

19 0.87 0.50 0.35 0.92 0.59Abbreviations: MDF: Modified Maddrey Discriminant Function; MELD: Model for End-Stage Liver Disease; SE: Sensitivity; S: Specificity; PPV: Positive Predictive Value; NPV: Negative Predictive Value.

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da Silva Folhadela MR, Fernandes Pereira MT, Gomes HC, da Silva E, Rocha MF, et al. (2016) Prospective Study on Predictors of Death in Patients with Alcoholic Hepatitis. Ann Public Health Res 3(4): 1050.

Cite this article

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