PubMed Health⌕ Search

Biomedical subjects

J Salmerón

Publications and source records attributed to J Salmerón.

At least 19 recordsLinked to original sources

Cost-effectiveness analysis of lamivudine and adefovir dipivoxil in the treatment of patients with HBeAg-negative chronic hepatitis B.

AIM: To estimate the cost-effectiveness over a 4-year duration of lamivudine and adefovir dipivoxil for patients with hepatitis B 'e' antigen-negative chronic hepatitis B. METHODS: A decision analysis model has been used to perform a cost-effectiveness analysis of lamivudine and adefovir dipivoxil from the perspective of the Spanish Public Health System. Data were obtained from clinical trials. RESULTS: For the base-case, the total estimated cost per patient treated with lamivudine or adefovir dipivoxil for 4 years was 11,457 and 21,939 respectively. Virological response at year 4 for the lamivudine arm was 40.4% and 78.0% for the adefovir dipivoxil arm. The average cost-effectiveness ratio (cost per responding patient at year 4) was 28,375 for the lamivudine arm and 28,132 for the adefovir dipivoxil arm. The incremental cost-effectiveness ratio of adefovir dipivoxil vs. lamivudine (cost per additional responding patient with adefovir dipivoxil) was 27,872, demonstrating that this cost was slightly lower than the average cost-effectiveness ratios of adefovir dipivoxil or lamivudine. The sensitivity analysis demonstrated that the factors that most influence the cost-effectiveness were the response to adefovir dipivoxil and lamivudine at year 4. CONCLUSION: Long-term treatment with adefovir dipivoxil is a cost-effective strategy in patients with chronic hepatitis B 'e' antigen-negative hepatitis.

Adenine↗

Post-transfusional hepatitis in neonates hospitalized in a Neonatal Intensive Care Unit.

OBJECTIVE: To assess the significance of increased serum transaminase levels in neonates admitted to a Neonatal Intensive Care Unit and its relationship with blood transfusion. METHODS: Follow-up prospective study of 209 patients; 177 completed follow-up, of whom 129 were transfused and 48 were not; 57 were born after full gestation and 120 were born prematurely. The activity of serum levels of ALT, AST, and GGT was measured monthly up to six months of age, and until six months after the last transfusion. At the end of follow-up, and whenever an increase in serum transaminase levels was detected, the viral agents of hepatitis A, B, C, G, TT, cytomegalovirus, Epstein-Barr, and herpes 1 and 2, and toxoplasma were studied. Viral serology was also carried out in mothers and in donors when children tested positive. RESULTS: One hundred twenty nine neonates (73%) received 461 U red blood cell transfusions (3.6 +/- 3 U/patient). ALT levels increased in 54 (30.5%) patients, of whom 46 (36%) were transfused and eight (17%) were not (p < 0.05). The independent variables were 'infection by G virus' and 'parenteral nutrition for more than 12 days'; the variable 'transfusion' was close to the limit for statistical significance. Twenty patients (11.3%) had increased serum ALT levels 2.5 times above the normal value: 18 (14%) were transfused and two (4%) were not (p = 0.106). Only the G and TT viruses were related with transfusion; patients remained asymptomatic, although most neonates were chronically infected. CONCLUSION: Follow-up showed that increased serum ALT levels are common among severely ill neonates. Blood transfusions are safe concerning most hepatotropic viruses, but transmission of viruses G and TT is possible.

Female↗

Comparative study of the efficacy of an induction dose of interferon-alpha2b with ribavirin compared with standard combined treatment in naive patients with chronic hepatitis C.

The efficacy and secondary effects of an induction dose of interferon-alpha2b (IFN-alpha2b) with ribavirin compared with standard combined treatment in naive patients with chronic hepatitis C infection were compared. A prospective study was undertaken between March 1998 and November 2001 in which 84 Spanish hospitals took part. Six hundred and fourteen naive patients (age range 18-65 years) diagnosed with chronic hepatitis C virus (HCV) infection and without cirrhosis or co-infection by other viruses, were included. Patients were divided into two groups. Group A (n = 304) received induction treatment with a daily dose of 5 MU of IFN-alpha2b for 4 weeks, followed by 5 MU three times a week with ribavirin (1000-1200 mg/day, according to weight) until completing 1 year of treatment. Group B (n = 310) received the standard dose of IFN-alpha2b of 3 MU three times per week for 48 weeks together with ribavirin (1000-1200 mg/day, according to weight). Both groups were completely comparable according to age, gender, body weight, transaminase levels, genotype, viral load and hepatic inflammatory activity (Knodell Index). No control group was included for ethical reasons. Pegylated interferon was not available at the time of the study. Serum baseline samples were collected for the determination of genotype. Samples were also collected at baseline, weeks 4, 12, 24, 48 and 72, in order to detect and quantify HCV-RNA. The efficacy of treatment was evaluated by means of sustained viral response (SVR) characterized by persistent negativity of HCV-RNA at the end of the follow-up period. At week 4, the response to treatment was greater in group A (49.6%) compared with group B (34.5%) (P = 0.0002), and was maintained until week 12 (64.1% compared with 55.8% respectively) (P = 0.03). These differences disappeared at week 24, when group A (69%) was compared with group B (65%) (NS). At week 48, the response rate for group A was 50.6% compared with group B 47.4% (NS), and at week 72, the SVR in group A was 46% compared with 40.3% for group B (NS). The global SVR was 43.1%. On analysing the response to treatment according to genotype and viral load, we found that the induction treatment was slightly superior in patients with genotype 1 and an elevated viral load (>2 x 10(6) copies/ml). They achieved a SVR in group A of 39.1% compared with 25.5% in group B (P < 0.05). However, this slight improvement obtained in group A, was achieved at the expense of a greater percentage of dropouts compared with group B (6.4% vs 2.2%, P < 0.01); a greater rate of side effects (58.5 vs 36.7%, P < 0.05) and also a greater percentage of neutropenia (3.1% vs 0.9%, P < 0.05). The induction treatment presented a better initial response, but this was not maintained at the end of treatment, and did not improve the results obtained with the standard treatment. Although the patients with genotype 1 and elevated viral load had a better response with the induction treatment, this was accompanied by a greater percentage of dropouts and secondary effects. It would be interesting to repeat this type of study in the future, using pegylated interferon.

Adolescent↗

Preferences of Mexican anesthesiologists for vecuronium, rocuronium, or other neuromuscular blocking agents: a survey.

BACKGROUND: Several neuromuscular blocking (NMB) agents are available for clinical use in anesthesia. The present study was performed in order to identify preferences and behaviors of anesthesiologists for using vecuronium, rocuronium or other NMB agents in their clinical practice. MATERIAL AND METHODS: The cross-sectional survey was applied at the Updated Course of the Colegio Mexicano de Anestesiología performed last year. Of 989, 282 (28.5%) surveys were returned. RESULTS: Most anesthesiologists were working at both public and private hospitals, performed anesthetic procedures for hospitalized and ambulatory patients, and anesthetized children as well as adults. Respondents did not consider mechanomyography as the gold standard method for neuromuscular monitoring. The T25 was not recognized as a pharmacodynamic parameter that represents the clinical duration of the neuromuscular block. Most answered that vecuronium induces less histamine release than rocuronium, had never used any neuromuscular monitor, did not know the cost of vecuronium and rocuronium, and preferred rocuronium in multiple-sampling vials and vecuronium in either a vial for single or multiple sampling. Rocuronium was preferred for emergency surgery in patients with full stomach only. Almost all of anesthesiologists that conserve the unused drug did it without refrigeration and more than 30% conserve the unused drug in one syringe for further use. CONCLUSION: Vecuronium was preferred for most clinical situations, and the decision for this choice was not based on costs. Storage of unused drugs without refrigeration in a single syringe for purpose of future use in several patients represented a dangerous common practice.

Journal Article↗

Genomic and antigenomic chains of hepatitis C virus and hepatitis G virus in serum, liver and peripheral blood mononuclear cells.

OBJECTIVE: To determine HCV and HGV replication sites in patients with chronic hepatitis C and to study interaction between these two viruses. PATIENTS: HGV RNA was studied in 272 patients with chronic hepatitis C. Of these, 35 were positive (group I). Twenty-three patients with chronic hepatitis C not co-infected with HGV were selected (group II). RESULTS: Genomic and antigenomic chains of HCV were studied in both groups and those of HGV in group I in serum samples, peripheral blood mononuclear cells and liver tissue. In group I genomic chains of HCV and HGV were observed in 86 and 100%, respectively (ns), in serum samples (n = 35), and antigenomic chains in 17 and 23%, respectively (ns). In mononuclear cell samples (n = 15) 100% presented the genomic chain of HCV and 60% presented that of HGV (p < 0.05). Antigenomic chains were detected in 13 and 33%, respectively (ns). In liver tissue (n = 25) genomic chains were observed in 100 and 12%, respectively (p < 0.001); the antigenomic chain of HCV was detected in 76% while that of HGV was not present (p < 0.001). In group II genomic chains of HCV were found to be present in a very high percentage in all samples, while antigenomic chains appeared in 13% of serum and mononuclear cell samples and 89% of liver samples. CONCLUSIONS: HCV and HGV have different sites of replication: whereas HCV replicates mainly in the liver, HGV is not hepatotropic. Mononuclear cells could represent a replication site for HGV but they are less important for HCV. Lastly, HGV does not modify the viral replication of HCV.

Adult↗

Epidemiology of HPV infection among Mexican women with normal cervical cytology.

Cervical cancer is caused by human papillomavirus (HPV) and is the most common cancer among Mexican women, but no population-based studies have reported the prevalence and determinants of HPV infection in Mexico. A population-based study was carried out between 1996 and 1999, based on an age-stratified random sample of 1,340 women with normal cytologic diagnoses from 33 municipalities of Morelos State, Mexico. The prevalence of cervical HPV DNA was determined by reverse line blot strip assay to detect 17 cancer-associated and 10 non-cancer-associated HPV types. Two peaks of HPV DNA prevalence were observed. A first peak of 16.7% was observed in the age group under 25 years. HPV DNA prevalence declined to 3.7% in the age group 35-44 years, then increased progressively to 23% among women 65 years and older. Cancer-associated HPV types were the most common in all age groups; non-cancer-associated HPV types were rare in the young and became more common linearly with age. Twenty-four types of HPV were detected; HPV 16, HPV 53, HPV 31 and HPV 18 were the most common, but none was present in more than 1.7% of subjects. The main determinant of infection with both cancer-associated and non-cancer-associated HPV types was the number of sexual partners in all age groups. Less-educated women were at an increased risk of infection with cancer-associated but not with non-cancer-associated HPV types; low socioeconomic status was associated with detection of non-cancer-associated HPV types. Among young women an increasing number of pregnancies was associated with lower HPV detection and among older women low socioeconomic status was related to increased HPV detection, particularly for the age group 35-54 years. Among women with cancer-associated HPV types, there was a higher intensity of polymerase chain reaction signal in younger than in older age groups (p < 0.001). We present additional evidence for the sexually transmitted nature of HPV infection, regardless of age group and HPV type. We confirm previous findings of a second peak of high-risk HPV infections in postmenopausal women, in this case with a clear predominance of cancer-associated HPV types. In populations with this pattern, which can be related to reactivation of latent HPV infections or high previous exposure in older women, screening with HPV testing can have a reduced specificity among older women if proper cut-off points for HPV positivity are not used. Longitudinal studies of immune responses to HPV infection in different age groups are warranted.

Adult↗

[Infectious complications associated with liver transplantation: analysis of 104 patients].

OBJECTIVE: Infectious complications are the main cause of morbidity and mortality during the first year after liver transplantation. The aim of the present study was to determine the incidence, microorganisms and factors associated with the development of infectious complications. PATIENTS AND METHOD: Retrospective analysis of infectious episodes during the first year after transplantation in 104 patients undergoing transplantation between April 1995 and December 1996. The various clinical variables related to the pre-transplant disease, the surgical intervention and post-transplant evolution were evaluated with the aim of identifying predictive factors for the development of bacterial infectious complications. RESULTS: During the first year, 51 patients (49%) presented 111 infectious episodes. The most frequent infections were bacterial (66%); 21% were cytomegalovirus infections and 22% were fungal. The incidence of bacterial infections was highest during the first month (80% of all infectious episodes in this period). Two variables were independently associated with the development of bacterial infections in the first month following transplantation: prolonged ischemia of the graft (p = 0.002) and length of stay in the intensive care unit (p = 0.002). Infectious complications caused 8 of the 11 deaths that occurred during the 1-year follow-up. Mortality associated with invasive fungal infections was 100%. CONCLUSIONS: Although the overall incidence of infections and associated mortality has decreased, it remains the main cause of mortality and morbidity in the first year after transplantation.

Female↗

Neurodevelopment of neonates in neonatal intensive care units and growth of surviving infants at age 2 years.

SUMMARY: The presence of development disorders in neonates attended in a Neonatal Intensive Care Unit (NICU) is highly variable; the aim of this study, therefore, was to determine the evolution of somatic and neurosensory development in a group of neonates requiring treatment in the NICU and to analyse the perinatal and developmental aspects of children presenting abnormalities. PATIENTS AND METHODS: A total of 492 neonates (275 premature, 106 with birthweight < or =1500 g), who were treated in the NICU between January 1994 and December 1997, were followed-up until the age of 2 years. Data were obtained concerning birthweight, body length, head circumference, gestational age, normality of weight for gestational age, single/multiple birth, duration of stay in the NICU and the hospital, duration of mechanically assisted respiration and evolutive somatometry, neurological examination and the Brunet-Lezine development test, adjusted for the gestational age of the neonates, at 6, 12, 18 and 24 months. When abnormal results were detected, Early Attention (EA) programmes were applied. RESULTS: Somatometry at birth in relation to gestational age revealed a weekly weight gain of 8.6%, an increase in body length of 1% and in head circumference of 1% (p<0.001). The evolution of somatic development to the age of 2 years showed that neonates with a birthweight < or =1500 g did not reach the values of neonates with a greater birthweight. The prevalence of cerebral palsy among all neonates was 6.8%, 14.6% among those weighing < or =1500 g, 4% among those weighing 1501-2500 g and 5% among those weighing >2500 g. The overall rate of neurosensory injury was 10.5%. These neonates presented less somatic development than those did with no neurologic disorder. To sum up, most of the neonates attended in the NICU during the 1990s presented a normal pattern of development. Nevertheless, they should be the object of special attention during the first years of life, particularly those neonates with a birthweight < or =1500 g and those presenting neurosensory risk.

Birth Weight↗

Dietary fat intake and risk of type 2 diabetes in women.

BACKGROUND: The long-term relations between specific types of dietary fat and risk of type 2 diabetes remain unclear. OBJECTIVE: Our objective was to examine the relations between dietary fat intakes and the risk of type 2 diabetes. DESIGN: We prospectively followed 84204 women aged 34-59 y with no diabetes, cardiovascular disease, or cancer in 1980. Detailed dietary information was assessed at baseline and updated in 1984, 1986, and 1990 by using validated questionnaires. Relative risks of type 2 diabetes were obtained from pooled logistic models adjusted for nondietary and dietary covariates. RESULTS: During 14 y of follow-up, 2507 incident cases of type 2 diabetes were documented. Total fat intake, compared with equivalent energy intake from carbohydrates, was not associated with risk of type 2 diabetes; for a 5% increase in total energy from fat, the relative risk (RR) was 0.98 (95% CI: 0.94, 1.02). Intakes of saturated or monounsaturated fatty acids were also not significantly associated with the risk of diabetes. However, for a 5% increase in energy from polyunsaturated fat, the RR was 0.63 (0.53, 0.76; P < 0.0001) and for a 2% increase in energy from trans fatty acids the RR was 1.39 (1.15, 1.67; P = 0.0006). We estimated that replacing 2% of energy from trans fatty acids isoenergetically with polyunsaturated fat would lead to a 40% lower risk (RR: 0.60; 95% CI: 0.48, 0.75). CONCLUSIONS: These data suggest that total fat and saturated and monounsaturated fatty acid intakes are not associated with risk of type 2 diabetes in women, but that trans fatty acids increase and polyunsaturated fatty acids reduce risk. Substituting nonhydrogenated polyunsaturated fatty acids for trans fatty acids would likely reduce the risk of type 2 diabetes substantially.

Adult↗

High prevalence of human papillomavirus infection in Mexican males: comparative study of penile-urethral swabs and urine samples.

BACKGROUND: Although extensive information has been gathered about the prevalence and determinants of human papillomavirus infection among women, little is known about the prevalence and natural history of this infection among males. GOAL: To investigate the potential usefulness of urine specimens to assess the presence of genital human papillomavirus DNA infection. STUDY DESIGN: The authors conducted a study of 120 healthy men from Cuernavaca, Mexico. A urine specimen and urethral and coronal sulcus swab samples were collected and tested for human papillomavirus using the GP5+/6+ polymerase chain reaction enzyme immunoassay method. RESULTS: In 95% of the urethral-coronal sulcus samples, the beta-globin gene was detectable, indicating adequacy of the specimen for DNA amplification; however, only 14% of the urine specimens had detectable beta-globin. Removal of inhibitors by DNA purification in a sample of subjects produced beta-globin amplification, but no increase in human papillomavirus DNA positivity was detected. Human papillomavirus DNA was not detectable in penile-urethral swab samples in any of the subjects who reported not having engaged in sexual activity but was present in 43% of men who reported sexual activity, a strong indication of the sexual transmission of human papillomavirus. CONCLUSIONS: Human papillomavirus is a common sexually transmitted infection among Mexican males, and urine sample specimens cannot adequately detect the presence of this infection in males.

Adolescent↗

[Coinfection with hepatitis G virus in chronic hepatitis C. Response to treatment with interferon alpha].

BACKGROUND: It is thought that the cytopathic effect of HGV is not important. Nevertheless, the cytopathic effect on liver is less known in the cases of co-infection with HCV. The aim was to study the prevalence of co-infection in patients with chronic hepatitis C (CHC) and to analyse the clinical-epidemiological and histological data and the interferon (IFN) response. PATIENTS AND METHODS: We included 180 patients with CHC and the HGV-RNA was determined. RESULTS: The prevalence of co-infection was 12.2% (n = 22). No statistical differences were observed between the non co-infected and co-infected groups with regard to the age, sex, mechanism of transmission and alcohol abuse. Also, there were no differences in the hepatic biochemical, no organ-specific antibodies, histological lesions and Knodell index. The HCV biochemical response (BR) and virological response (VR) after 6 months post-IFN were the same in both groups (HGV negative: BR = 29%, VR = 12%; HGV positive: BR = 22%, VR = 18%). HGV was determined after 6 months posttreatment in the co-infected group (first cycle of IFN, n = 22; second cycle of IFN, n = 9): 12 (55%) were HGV-RNA negative and 5 (23%) HCV-RNA negative, (p = 0.021). When we compared the BR vs VR in this group, there were 12 HGV-RNA negative but only two had BR (NS). On the contrary, the BR was related to HCV-RNA negative (p = 0.023). CONCLUSION: The prevalence of HGV co-infection is important in our area (12.8%). The HGV does not increase the pathogenicity of HCV and does not change the IFN response, although the HGV is more IFN sensible than HCV. The determination of HGV is not necessary in patients with HCV.

Adolescent↗

Follow-up of transmission of hepatitis C to babies of human immunodeficiency virus-negative women: the role of breast-feeding in transmission.

BACKGROUND: The studies on hepatitis C virus (HCV) vertical transmission, the effect of potential risk factors and the role of breast-feeding have reported conflicting results. PATIENTS AND METHODS: Seventy-three infants of 63 anti-HCV-positive and anti-HIV-negative mothers were studied from 1993 to 1999 in the south of Spain. The mean period of follow-up in children was 29.2 +/- 19 months (range, 8 to 76 months); 6 (8%) children were lost to follow-up. Breast milk was studied for HCV-RNA in 68 samples of 35 mothers. RESULTS: Alanine aminotransferase was high in 19 (26%) and HCV-RNA was positive in 46 (63%) pregnant woman. Breast milk HCV-RNA was negative in nonviremic mothers and positive in 20% of the viremic mothers. The overall rate of vertical HCV transmission was 11.9% (n = 8) (95% confidence interval, 6 to 23%) if HCV-RNA was positive one or more times, but only 1.5% (n = 1) (95% confidence interval, 0.1 to 9%) if HCV-RNA was permanently positive. Seven HCV-infected children did not develop antibodies to HCV, and they had a spontaneous clearance of the virus. A 10-month-old baby was HCV-RNA-positive from birth to the end of the follow-up. The genotype in each of the infants was consistent with that of their mother. The rate of HCV transmission was higher for infants of mothers with higher HCV viremia (P < 0.01) and also for infants whose mothers were HCV-RNA-positive in breast milk (P < 0.05). There were no statistically significant differences between other risk factors. CONCLUSION: The presence of transitory viremia without seroconversion indicates that the vertical transmission of HCV is not important. This could be related to the viral charge and ingestion of milk of HCV-RNA-positive mothers. However, to advise avoidance of maternal breast feeding, it would be necessary to conduct larger studies.

Adult↗

Multicenter retrospective study of response to interferon in chronic hepatitis B.

AIM: The only agent known to have a lasting beneficial effect in chronic hepatitis B is interferon alpha, which achieves long-term remission in 25-40% of the patients. The goals of treatment are to induce clearance of HBV DNA from serum, to return serum aminotransferases to normal, and to improve histological findings in the liver. The most important factors predictive of response to treatment are high serum aminotranferases levels, low serum HBV DNA concentrations, and active histologic changes on liver biopsy. The aim of this study was to assess the response to interferon alpha in patients with chronic hepatitis B and to analyze the factors predictive of response. METHODS: We conducted a multicenter retrospective study to investigate the effect of interferon treatment in 132 patients with chronic hepatitis B in overall terms and based on HBeAg, and factors predictive of response. RESULTS: A overall sustained response was noted in 59 of 132 interferon-treated patients (45%) and 61 patients were nonresponders (46%). 12 patients relapsed (9%). None of the patients had negative HBsAg. No difference was observed in the response rate between the two treatment groups (HBeAg-positive and HBeAg-negative patients). Overall, high initial levels of serum AST and ALT predicted a good response. Age and liver biopsy findings were factors predictive of response in HBeAg-positive and HBeAg-negative patients respectively. Sex, epidemiological factors, treatment and type of virus did not correlate with the response to interferon. CONCLUSIONS: A sustained response to interferon alpha was observed in 45% of the patients with chronic hepatitis B. HBeAg seroconversion was found in up to 50% of HBeAg-positive patients. None of the patients had negative HBsAg. Overall, the response rate was higher in patients with high pretreatment serum aminotransferase levels. Age was the predictive factor in HBeAg-positive patients, and histological features were predictive in the HBeAg-negative group. However, further studies in a larger patient population are necessary to obtain well-substantiated conclusions.

Adolescent↗

[Retrospective study of the incidence of hepatitis G virus infection in transfused patients].

BACKGROUND: Recently the parenteral transmission of hepatitis G virus (HGV) has been shown. The aim of the study was to investigate the incidence of post-transfusion HGV. PATIENTS AND METHODS: HGV (RNA-HGV and anti-HGVE2) were retrospectively studied in 140 transfused patients. RESULTS: 12 (8.6%) were infected after transfusion: 9 of 12 (75%) the RNA-HGV remained detectable after 6 months and 3 (25%) seroconverted to anti-HGVE2. No patient had post-transfusional hepatitis criteria. In 5 (42%) the transaminases levels were slightly increased. The clinical evolution was favourable. No significant differences were found between patients with or without HGV infection. CONCLUSIONS: HGV is an agent associated with transfusion but it carries a low pathogenic capability.

Adolescent↗

Retreatment of chronic hepatitis B e antigen-positive patients with recombinant interferon alfa-2a. The European Concerted Action on Viral Hepatitis (EUROHEP).

Fifty-seven patients with chronic hepatitis B, hepatitis B virus (HBV) e antigen (HBeAg) and HBV DNA positivity, and aminotransferase elevation despite a previous course of any type of adequate interferon alfa (IFN-alpha) therapy were included in a multicenter prospective randomized controlled trial. The objective of the study was to compare a second course of IFN-alpha therapy (9 million units [MU] of IFN-alpha-2a, Roferon-A, thrice weekly for 6 months) versus no therapy in terms of loss of HBV DNA and HBeAg. At the end of the study, a sustained clearance of HBV DNA and HBeAg was observed in 9 of the 27 (33.3%) patients who had received retreatment with IFN-alpha compared with 3/30 (10%) patients who spontaneously cleared these markers in the untreated control group (chi2 = 4.66, P =.031; odds ratio: 4.5, 95%; confidence interval: 1.1-18.9). None of the responders lost HBsAg. Patients retreated with IFN-alpha were more likely to have biochemical remission in association with HBV clearance (5/27, 18.5%) compared with untreated patients (1/30, 3. 3%; Fisher's exact test P =.09 ). Histological improvement in the liver necroinflammatory activity was observed among sustained responders to IFN-alpha retreatment, consisting of regression of the portal and periportal inflammation and of the piecemeal necrosis; there was no change in the degree of liver fibrosis. Side effects were similar to those previously reported during IFN-alpha treatment; these were mild and reversible on IFN-alpha discontinuation. None of the baseline features were associated with response by Cox's regression analysis. In summary, viremic patients with chronic HBeAg-positive hepatitis may experience disease remission following retreatment with IFN-alpha. Thus, retreatment with IFN-alpha may be considered a therapeutic option.

Adolescent↗

Acute liver injury associated with the use of ebrotidine, a new H2-receptor antagonist.

BACKGROUND/AIM: Ebrotidine is a new H2-receptor antagonist marketed in Spain in early 1997 and withdrawn in July 1998. We report 11 cases of acute liver injury related to ebrotidine and submitted to a Regional Registry of Hepatotoxicity between June 1997 and August 1998. METHODS: In all cases a structured protocol was used to ascertain the role of ebrotidine and to exclude other causes (viral, immunologic, metabolic) of liver injury. RESULTS: All patients showed clinical symptoms of acute hepatitis, with a marked increase in aminotransferase activities (ALT values ranging from 15 to 91 times the upper limit of normal). Total bilirubin values were also greatly increased (mean 16 mg/dl), and the liver injury was defined as hepatocellular. Features of hypersensitivity were absent. Liver biopsy was done in three patients. Histopathological examination revealed mainly centrozonal necrosis (two cases) or massive necrosis (one patient). Withdrawal of the drug was followed by a gradual improvement in liver dysfunction, except in one patient who developed fulminant hepatic failure and died. There was a positive response to rechallenge in one patient after an inadvertent drug administration. CONCLUSION: Ebrotidine therapy seems to be associated with severe acute liver injury, and therefore its benefit/risk ratio is unfavorable. The relative rareness and unpredictability of the injury, the lack of dose-relationship and the absence of hallmarks of drug allergy are suggestive of an idiosyncratic metabolic mechanism.

Acute Disease↗