[Liver toxicity associated with flutamide].
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Biomedical subjects
Publications and source records attributed to A García Plaza.
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AIM: To evaluate which factors influence eradication success with standard triple therapy for Helicobacter pylori. PATIENTS AND METHODS: A prospective study was made of 891 patients infected by H. pylori and diagnosed with duodenal ulcer (n=422), gastric ulcer (n=221), or functional dyspepsia (n=248). Initially, an endoscopy with biopsies of antrum and body (haematoxylin-eosin stain), and a 13C-urea breath test were performed. All patients were treated for seven days with either omeprazole 20 mg twice daily in 442 patients (OCA) or pantoprazole 40 mg twice daily in 449 patients (PCA), associated to clarithromycin (500 mg twice a day) and amoxicillin (1 g twice a day). Two months after completing therapy urea breath test was repeated to confirm eradication. RESULTS: Mean age +/- SD was 51.6 +/- 15 years, 61% were male. Overall eradication rate was 73.7% (95% CI 69-77%) and 80.8% (77-84%) with OCA and PCA therapy, respectively, showing significant difference between treatment regimens (chi 2 =6.3; p= 0.01). As refers to underlying diseases, H. pylori eradication was achieved in 77.4% (74-80%) of peptic ulcers and 77% (71-82%) of functional dyspepsia (p=n.s.). With our two treatment regimens (OCA/PCA) eradication success was 74/81% in peptic ulcer (p=0.03), and 72/80% in functional dyspepsia (p=0.1). In the multivariate analysis, type of therapy was the only variable that correlated with eradication success (odds ratio 1.5; 95% CI: 1.1-2.1) (chi2 model: 6,4; p=0.01). CONCLUSIONS: Standard triple therapy containing a proton pump inhibitor, clarithromycin and amoxicillin for seven days achieves in our community a moderate eradication success; this result could improve by using pantoprazole instead of omeprazole. This therapy is equally effective in patients with peptic ulcer and functional dyspepsia.
INTRODUCTION: some authors suggest that Helicobacter pylori eradication favors gastric ulcer healing. OBJECTIVE: to study which factors influence ulcer healing in patients suffering from gastric ulcer with H. pylori infection. SUBJECTS AND METHODS: a prospective study of 230 patients with gastric ulcer associated to H. pylori infection. Chronic ingestion of non-steroidal anti-inflammatory drugs was considered as an exclusion. In an initial endoscopy, malignancy was histologically excluded and two biopsies each of antrum and body were obtained. Also, ELISA IgG serology and a 13C-urea breath test were performed. Eradication therapy with omeprazole (20 mg twice a day), clarithromycin (500 mg twice a day) and amoxicillin (1 g twice a day) was administered for seven days, followed by omeprazole 20 mg once a day for five more weeks. Endoscopy was repeated after 6 weeks of treatment and breath test was repeated 2 month after completing therapy. RESULTS: overall gastric ulcer healing was achieved in 80.8% (95% CI: 75-85%) of cases by intention-to-treat, and in 82.6% (77-87%) per protocol. Ulcer healing was achieved in 94.3% (90-97%) of patients with eradication success, but only in 40.8% (28-54%) of patients with eradication failure (p<0.0001). In the multivariate analysis, H. pylori eradication was the only variable that correlated with ulcer healing (odds ratio 24; 95% CI: 10-56; p<0.0001) (x2 model: 64.4; p<0.0001). Additional variables (age, sex, sporadic ingestion of NSAIDs, smoking, previous ulcer disease, ulcer size and location) were not related to healing. CONCLUSION: H. pylori eradication favors ulcer healing in patients with gastric ulcer, which is an argument in favor of the etiological role of the microorganism in this disease. Other factors did not influence ulcer healing.
OBJECTIVES: To assess de novo hepatitis B virus (HBV) transmission from liver donors with HBV serum markers (HBM) to their recipients and the need for HBV vaccination before liver transplantation. METHODS: A total of 108 orthotopic liver transplantations for nonviral disease and the risk of developing de novo hepatitis B based on HBMs before transplantation have been studied. Of the 108 patients, 94 met the study criteria and were divided into two groups: 27 who had HBMs before transplantation (from past infection or by previous vaccination) and 67 who had no HBM. Development of de novo hepatitis B was determined by analytical, serological, and histological parameters. RESULTS: No case (0%) of de novo hepatitis B was detected in the pretransplantation HBM group, whereas there were 10 cases (14.5%) in the other group (p < 0.005). CONCLUSIONS: The presence of pretransplantation HBM in liver transplant recipients protects these patients against the development of de novo hepatitis B. This is especially important considering that there is a high prevalence of donors with positive hepatitis B core antibody (especially in some countries), and that these donors transmit HBV infection to recipients without HBM in a significant number of cases. Thus, vaccination against HBV in patients who are candidates for liver transplantation is fundamental to avoid cases of de novo hepatitis B.
BACKGROUND: To study the hepatitis B virus (HBV) transmission from donors HBsAg-/AntiHBc+ to liver transplant recipients. PATIENTS AND METHOD: We studied retrospectively the HBV serological markers in 43 donors from our center and also the serological condition of the 41 recipients. The HBV serological markers were analyzed by ELISA and HBV DNA was detected by hybridation assays. RESULTS: 13 donors samples showed some HBV serological markers: 6 anti-HBc and anti- HBs (13.9%), 4 anti-HBc (9%) and 3 anti- HBs (6.9%). There were no cases of hepatitis B among liver recipients from donors with negative serological markers. Among the 13 recipients with HBV serological markers, 9 were followed during 39 (SD 17) months. The 5 recipients with no HBV markers, who received an anti- HBc+ with or without anti- HBs (100%) developed hepatitis B. The two liver recipients with anti-HBs solely, did not developed infection (0%). Of the 41 recipients, 15 had some HBV markers before transplant and two of them received an anti-HBc+ and did not develop the infection (0%). CONCLUSIONS: In our study, the prevalence of serological HBV infection in donors and recipients was of 30.2 and 31.7%, respectively. Anti-HBc with or without anti-HBs donors transmitted the HBV infection in all the cases (100%) to the susceptible recipients. The presence of anti-HBs in recipients protected these against the infection. Only the anti-HBs positive donors did not trasmit the HBV infection.
AIM: To study the clinical characteristics, treatment response and evolution in patients with microscopic colitis. MATERIAL AND METHODS: We performed a retrospective analysis of 24 patients (15 with collagenous colitis and 9 with lymphocytic colitis). Clinical and diagnostic features, treatment response and evolution according to the presence of maintenance therapy were evaluated. RESULTS: The mean age of the patients was 59.7 years and most were male. Nine patients took non-steroidal anti-inflammatory drugs (NSAID). No significant association was found with other drugs. Four patients presented associated rheumatological disease. Most patients presented insidious-onset diarrhea without pathological products, which was frequently associated with other symptoms (abdominal pain, bloating, weight loss, asthenia, tenesmus, and incontinence). Seven patients showed a slight increase in globular sedimentation rate. Fat in stools and radiological investigations (transit and opaque enema) were normal in patients who underwent these tests. Endoscopy revealed non-specific alterations in 42% of the patients while results were normal in the remaining patients. One patient showed clinical improvement on withdrawal of NSAIDs and 4 patients improved spontaneously. Clinical response was achieved in 7 of 13 patients treated with antimotility drugs, in 8 of 9 patients treated with salicylates, in 3 treated with oral corticoids, in 1 treated with cholestyramine and in 1 treated with topical budesonide. Nineteen patients required no maintenance therapy, 4 were administered salicylates and 1 was administered cholestyramine. After a mean follow-up of 42 months, evolution was chronic and intermittent in 14 patients and chronic and continuous in 1; 9 patients presented a single episode. No significant differences were found between patients administered maintenance therapy and those who were not or between collagenous colitis and lymphocytic colitis in the parameters analyzed. CONCLUSIONS: Microscopic colitis constitutes a group of diseases characterized by chronic diarrhea, few systemic effects and minimal radiological and/or endoscopic alterations. Evolution is characterized by recurrent episodes, with good response to treatment with cholestyramine, salicylates or corticoids when required.
BACKGROUND: To study the influence of Helicobacter pylori eradication on the incidence of ulcer recurrence during 12 months of follow-up in gastric ulcer patients. PATIENTS AND METHOD: Seventy-three patients with gastric ulcer were prospectively studied. At endoscopy two biopsies from both antrum and body for haematoxylin-eosin staining and one for rapid urease test were obtained. Likewise, serology and 13C-urea breath test were carried out. Fifty-six H. pylori infected patients were monitored after giving an eradication therapy with omeprazole, clarithromycin and amoxicillin. A first control endoscopy was performed immediately after completing treatment to confirm ulcer healing. A second control endoscopy (with histologic study) and a breath test were performed one month after completing therapy (eradication was defined as the absence of H. pylori by both methods). Finally, an endoscopy was repeated at 6 and 12 months to study ulcer recurrences. RESULTS: Mean age was 54 +/- 13 years (69% males). Cumulative ulcer recurrence rate for 12 months, respectively for patients with eradication success and failure, was 2.3% (95% CI, 0-12%) and 70% (34-93%) (chi 2: 23.9; p < 0.0001). Comparison between Kaplan-Meier curves for ulcer recurrence depending on H. pylori eradication showed significant differences (log-rank test; chi 2: 33.8; p < 0.0001). A patient successfully treated underwent ulcer recurrence while receiving treatment with acetylsalicylic acid, without recurrence of the infection. CONCLUSIONS: H. pylori eradication is associated with a dramatic reduction on the recurrence of gastric ulcer, with a cumulative recurrence rate during 12 months of only 2.3%, which suggests that definitive cure of gastric ulcer disease is possible by means of microorganism eradication.
BACKGROUND: To evaluate whether antral biopsies are enough for confirming Helicobacter pylori eradication with the "new" one week triple therapies with omeprazole. PATIENTS AND METHODS: 229 duodenal ulcer patients were treated with omeprazole for 7 days plus two antibiotics. Eradication was confirmed with histology (two biopsies from both gastric antrum and body) and 13C-urea breath test one month after the end of therapy. RESULTS: H. pylori eradication was achieved in 76.9% of the patients (95% CI: 71-82%). Histology at antrum was highly reliable to detect eradication failure: in all but in one case in which H. pylori was observed at gastric body, was the microogranism also observed at antrum. Infection prevalences at both locations were not homogeneous (McNemar: 6.4; p < 0.05). Concordance between antral biopsies and breath test for H. pylori diagnosis after therapy was excellent (kappa: 0.91; SE: 0.07), and both prevalences were homogeneous (McNemar: 1.3; p > 0.05). CONCLUSIONS: Taking antral biopsies is enough for confirming H. pylori eradication with the "new" one week triple therapies.
BACKGROUND: To report the prevalence of Helicobacter pylori in patients with bleeding duodenal ulcer and to verify the effect of eradication on hemorrhage recurrence. To evaluate the efficacy on H. pylori eradication and on ulcer healing of three one-week triple therapies and to compare their efficacy with that of a dual therapy. PATIENTS AND METHODS: One-hundred and eleven patients with bleeding duodenal ulcer not taking gastroerosive drugs were prospectively studied. At endoscopy, biopsies from gastric antrum and body were obtained (haematoxylin-eosin), and a 13C-urea breath test was also performed. Both diagnostic methods were repeated one month after completing one of the following treatments (randomized study): omeprazole (20 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (OAC, n = 27); omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and metronidazole (500 mg/12 h) (OCM, n = 27); lansoprazole (30 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (LAC, n = 27); and lansoprazole (30 mg/12 h) and clarithromycin (500 mg/8 h) (LC, n = 27). The first three therapies were administered for one week, and LC for two weeks. Once eradication was confirmed no antisecretory therapy was administered. A breath test was performed in the follow-up at 6 months and at one year. RESULTS: The prevalence of H. pylori infection was 97.3% (95% CI: 92-99%). Five patients were lost from the study during follow-up. The eradication efficacy (intention-to-treat) was: OAC, 89% (72-96%); OCM: 93% (77-98%); LAC, 93% (77-98%), and LC, 70% (51-84%). Overall triple therapy efficacy was higher than that of dual therapy (91% vs 70%; p < 0.05). Thirteen patients needed a 2nd or 3rd therapy, and eradication success was finally achieved in all cases. The type of therapy was the only variable which influenced on H. pylori eradication (OR: 4.5; 95% CI: 1.4-14%; p < 0.01) and H. pylori eradication was the only variable which influenced on ulcer healing (OR: 4.7; 95% CI: 1.2-19%; p < 0.05). The yearly reinfection rate was 2.8% (0.9-7.8%). No hemorrhage recurrences occurred during the one year follow-up period. CONCLUSIONS: H. pylori prevalence in bleeding doudenal ulcer is almost 100%. These patients will be spared of hemorrhage recurrence at least for one year if infection is eradicated. Therefore, eradication therapy is the therapy of choice, and maintenance therapy with antisecretory drugs is no longer needed. One-week triple therapies with a proton pump inhibitor and two antibiotics (clarithromycin plus amoxycillin or metronidazole) have a high efficacy in patients with bleeding duodenal ulcer.
AIM: Currently, highly effective Helicobacter pylori eradication therapies are used, and although eradication failures still appear in a considerable proportion of cases, the therapeutic efficacy in such refractory cases has been only exceptionally studied. Therefore, our aim was to evaluate the appropriate attitude when eradication therapy fails. METHODS: In 127 duodenal ulcer patients, several therapies with omeprazole (O) plus one or two antibiotics [amoxycillin (A), clarithromycin (C), metronidazole (M)] had failed to eradicate H. pylori. Re-treatment was administered depending on initial therapy; in no case was the same regimen repeated, and antibiotics with resistance risk (as C or M) were only re-administered using combination regimens with bismuth (B): O + A + C + B (when C was re-administered) and O + bismuth triple therapy (BTT) (when M was re-administered). RESULTS: First therapy and eradication rates, with the corresponding second therapy, were: CONCLUSION: BTT re-treatment in O + A failure achieves a relatively low eradication rate, probably lower than BTT for the first time, suggesting that other regimens should be tried. The following re-treatments are recommended in H. pylori eradication failure: in O + A failure, BTT (or O + BTT, as BTT re-treatment could be less effective than the initial BTT treatment); in O + C failure, O + A + M; in O + A + C failure, O + BTT; in O + A + M failure, O + A + C; and, finally, in O + C + M failure, O + BTT (or O + A + C + B).
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BACKGROUND: To compare the efficacy of two "new" one-week triple therapies (with omeprazole, metronidazole and clarithromycin or amoxycillin) for the eradication of Helicobacter pylori and healing duodenal ulcer. METHODS: Randomised therapeutic trial. Eighty-eight consecutive duodenal ulcer patients with H. pylori infection were studied. At endoscopy, biopsies from both gastric antrum and body were obtained for histologic study (H&E). Two different therapies were administered for one week: omeprazole (O) (20 mg b.i.d.) and metronidazole (M) (500 mg b.i.d.) associated with clarithromycin (C) (500 mg b.i.d.) (group OMC, n = 44) or amoxycillin (A) (1 g b.i.d.) (group OMA, n = 44). Endoscopy with biopsies was repeated one month after completing therapy, and a 13C-urea breath test was also performed. Compliance was evaluated by tablet count. Analysis of data: multiple logistic regression, intention-to-treat. Eradication was defined as the absence of H. pylori by all diagnostic methods. RESULTS: Mean age (standard deviation) was 45(14) years, 75% males. Distribution of variables was similar in both therapeutic groups. Forty-two patients in each group completed the protocol. Eradication was achieved in 90.5% (95% CI = 78-96%) in group OMC and in 57% (42-71%) in group OMA (p < 0.001). In the multivariate analysis the type of therapy was the only variable which influenced on H. pylori eradication (OR = 7.1; CI = 2.2-24; p = 0.001). Ulcer healing was demonstrated in 88% (75-95%) of patients in group OMC and in 71% (56-83%) in group OMA (p = 0.1). Ulcer healing was higher when eradication was achieved (90%; 80-95%) than in H. pylori-positive patients (50%; 31-69%) (p < 0.001). Eradication of H. pylori was the only variable which influenced on ulcer healing (OR = 9.3; CI = 2.8-31; p < 0.001). CONCLUSION: The "new" triple therapy with omeprazole, metronidazole and clarithromycin (administered in a twice-a-day basis and only for one week) had an excellent efficacy for the eradication of H. pylori, significantly higher than that obtained with amoxycillin instead of clarithromycin. Both therapies achieved a high ulcer healing rate when H. pylori was eradicated, even with omeprazole administered only for one week.
BACKGROUND/AIMS: Our aim was to investigate the effectiveness of metadoxine (pyridoxol L, 2 pyrrolidone-5-carboxylate) in the treatment of alcoholic fatty liver. METHODS: A double-blind randomized multicenter trial involving 136 chronic active alcoholic patients diagnosed with fatty liver by clinical, biochemical and ultrasonographic criteria was performed. Patients were treated with 1500 mg/day of metadoxine (n = 69) or placebo (n = 67) for 3 months. Patients were clinically and biochemically evaluated every month. Ultrasonography was performed before and after treatment. RESULTS: At the end of the study there was a significant improvement in the liver function tests in both groups. However, the changes were more rapid and greater in patients treated with metadoxine, in whom significant changes in serum levels of bilirubin, aminotransferases and gammaglutamyl transpeptidase were already observed after 1 month of treatment, and normalization of these parameters was observed at the end. After treatment, the percentage of patients with ultrasonographic signs of steatosis was significantly lower in the metadoxine group (28% vs 70%, p < 0.01) and the degree of steatosis was also lower in this group. Sixteen patients treated with metadoxine and 15 with placebo continued drinking. Alcohol intake was lower than initially, and similar in both groups. In the metadoxine group, the biochemical changes were similar in both the abstinent and the nonabstinent patients. In contrast, in the placebo group the improvement in the liver function tests was significantly higher in abstinents. Among patients who continued drinking, the prevalence (45% vs 92%, p < 0.05) and the degree of steatosis were also significantly lower in patients treated with metadoxine. CONCLUSIONS: In patients with alcoholic fatty liver, metadoxine accelerates the normalization of liver function tests and the ultrasonographic changes, even in those who do not completely abstain from alcohol intake. Thus, metadoxine could be useful in the treatment of the early stages of alcoholic liver disease.
BACKGROUND: The aim of this study was to demonstrate an association between Helicobacter pylori infection, ABO blood groups and Rhesus factor; providing the association between duodenal ulcer and O group blood as well as the former and H. pylori infection. METHODS: Three-hundred and one healthy subjects were prospectively studied. In all of them ABO blood groups and Rhesus factor were determined by standard techniques. Systemic IgG antibodies against H. pylori were assayed using a quantitative enzyme-linked immunosorbent assay technique (Helico-G, Porton, Cambridge, UK). RESULTS: The overall seroprevalence was 52.2%. H. pylori infection distribution was similar among ABO blood groups and Rhesus factor. No statistically significant differences were observed in mean values of IgG antibodies among different blood groups. CONCLUSIONS: Distribution of H. pylori seroprevalence does not differ between different ABO or Rhesus factor blood groups. This excludes a possible link between this microorganism and the high ulcer prevalence in O blood group.
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Helicobacter pylori infection and non-steroidal anti-inflammatory drugs (NSAIDs) are the two most important causal factors in gastroduodenal ulcer disease. The coincidence of both occurs frequently and, therefore, demonstration of a possible relationship, and the consequent attitude (giving or not eradication therapy) would have important implications. The lower H. pylori prevalence in gastric ulcer, in comparison with duodenal ulcer, seems to be due greatly to NSAIDs intake, although in a low number of patients this ulcer is not explained by either of these factors. Therefore, the finding of a gastroduodenal ulcer in an H. pylori-negative patient should suggest other possible causes, and among them NSAIDs outstands. Histologic gastritis found in a patient with NSAIDs intake is related to the subjacent presence of H. pylori and not with NSAIDs. It is not clear whether, in patients taking NSAIDs, the infection favors the appearance of dyspeptic symptoms. The possibility of H. pylori and NSAIDs having a synergistic effect on gastroduodenal ulcer disease is a debatable issue. H. pylori eradication in patients taking NSAIDs does not confer a clear advantage in ulcer healing, and the possible protecting effect of eradication on the development of an ulcer in subjects taking NSAIDs is doubtful. In an H. pylori-positive patient in whom an ulcer occurs while taking NSAIDs, it is not possible to know for sure whether the ulcer has been caused by the organism, by NSAIDs, or by both, and therefore it seems logical to administrate an eradication therapy. However, H. pylori eradication with the intention of preventing appearance of gastroduodenal lesions is not so evident. Finally, indications of traditional preventive treatment (with antisecretory drugs or mysoprostol) should not be influenced by the concomitant administration of H. pylori eradication therapy.
OBJECTIVE: Combinations of omeprazole plus two antibiotics for seven days have repeatedly been studied and high Helicobacter pylori eradication rates have been obtained, ranging from 80% and 90% in our country. Our objective was to verify whether length of such therapies (with omeprazole, metronidazole and clarithromycin or amoxicillin) can be shortened to five days with no loss of efficacy. METHODS DESIGN: randomized clinical trial. PATIENTS: forty-eight consecutive patients with duodenal ulcer were prospectively studied. The exclusion criteria were previous administration of antibiotics, bismuth or gastroerosive drugs, and associated diseases. During the initial endoscopy biopsy specimens from antrum and corpus were obtained (haematoxylin-eosin). Two therapies were administered for five days: omeprazole (20 mg/12 h) and clarithromycin (500 mg/12 h) plus metronidazole (500 mg/12 h) (n = 24) or amoxicillin (1 g/12 h) (n = 24). One month after therapy was completed a new endoscopy was performed, biopsy specimens were obtained, and the 13C-urea breath test was performed. Compliance of therapy was assessed by questioning the patient and counting the residual medication. DATA ANALYSIS: multiple logistic regression and "intention-to-treat" analysis. OUTCOME VARIABLE: eradication was defined as the absence of H. pylori by all diagnostic methods. RESULTS: Mean age +/- SD was 48 +/- 10 years, 73% were males. Twenty-three patients in each group completed the protocol and the distribution of investigated parameters was similar in both groups. Eradication was obtained in 91.7% (95% CI = 74%-98%) in the metronidazole group and 70.8% (51%-85%) in the amoxicillin group (chi 2 = 2.19; p = 0.13). In the multivariate analysis, OR for the effect of type of therapy on eradication was 4.5 (CI = 0.83-24.7; p = 0.077). No relevant secondary effects were reported. The most common secondary effect was a metallic taste of medication, which was perceived by half of patients in each group. CONCLUSION: The combination of omeprazole, clarithromycin, and metronidazole for only five days has a high eradicating efficacy (approximately 90%), similar to that obtained in previous studies with seven days of therapy. Nevertheless, the association of omeprazole, clarithromycin, and amoxicillin should probably be administered at least for one week to reach an optimal eradicating efficacy.
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