Análisis coste efectividad a 2 años del tratamiento quirúrgico de la hiperplasia benigna de próstata mediante vaporización fotoselectiva de la próstata con GreenLight-PhotoVaporization 120 W versus resección transuretral de la próstata / Cost-effectiveness analysis at 2 years of surgical treatment of benign prostatic hyperplasia by photoselective vaporization of the prostate with GreenLight-Photo vaporization 120 W versus transurethral resection of the prostate

Introducción: El gold standard del tratamiento quirúrgico de la sintomatología del tracto urinario inferior asociado a la hiperplasia benigna de próstata ha sido la resección transuretral de la próstata; GreenLight-PhotoVaporization ha demostrado ser una alternativa quirúrgica tan efectiva como aquella. Objetivo: Analizar la eficiencia comparada, en un horizonte temporal de 2 años, de GreenLight-PhotoVaporization 120 W respecto de la resección transuretral de la próstata en el tratamiento quirúrgico de la hiperplasia benigna de próstata desde la perspectiva del sistema de salud de España. Métodos: Se realizó un análisis de coste utilidad a partir de los resultados obtenidos retrospectivamente en 98 pacientes intervenidos secuencialmente mediante resección transuretral de la próstata (n: 50) y GreenLight-PhotoVaporization 120 W (n: 48). Se utilizó un modelo de Markov para estimar el coste (Euros, 2012) y los resultados (años de vida ajustados a calidad) tras un seguimiento de 2 años. Resultados: El coste total asociado al tratamiento con GreenLight-PhotoVaporization 120 W fue inferior (3.377 Euros; IC 95%: 3.228; 3.537) al de la resección transuretral de la próstata (3.770 Euros; IC 95%: 3.579; 3.945). El determinante del coste se presenta en la fase quirúrgica (diferencia: -450 Euros; IC 95%: -625; -158) debido a que GreenLight-PhotoVaporization 120 W no precisaba ingresar al paciente tras la cirugía. Conclusiones: El tratamiento quirúrgico de los pacientes con HBP mediante GreenLight-PhotoVaporization 120 W muestra mayor eficiencia respecto de la resección transuretral de la próstata al observarse una efectividad similar y un coste inferior (-393 Euros; IC 95%: -625; -158)

Introduction: Transurethral resection of the prostate is the gold standard of surgical treatment of lower urinary tract symptoms associated to benign prostate hyperplasia. The new Green Light Photovaporization has been shown to be an alternative that is as effective for this condition as the transurethral resection of the prostate. Objectives: To compare the efficiency of Green Light Photovaporization 120 W versus transurethral resection of the prostate in the treatment of benign prostate hyperplasia (BPH) in a 2-year time horizon from the perspective of the Spanish health service perspective. Methods: A cost utility analysis was performed retrospectively with the data from 98 patients treated sequentially with transurethral resection of the prostate (n: 50) and Green Light Photovaporization 120 W (n: 48). A Markov model was designed to estimate the cost (2012 Euro) and results (quality adjusted life years) in a 2-year time horizon. Results: The total cost associated to Green Light Photovaporization 120 W treatment was less (3,377 Euros; 95% CI: 3,228; 3,537) than that of the transurethral resection of the prostate (3,770 Euros; 95% CI: 3,579; 3,945). The determining factor of the cost was the surgical phase (difference: −450 Euros; 95% CI: −625; −158) because admission to hospital after surgery was not necessary with the GreenLight-PhotoVaporization. Conclusions: Surgical treatment of BPH patients with GreenLight-PhotoVaporization 120 W is more efficient than transurethral resection of the prostate in the surgical treatment of benign prostate hyperplasia as it has similar effectiveness and lower cost (-393 Euro; 95% CI: -625; -158)

Cost-effectiveness analysis at 2 years of surgical treatment of benign prostatic hyperplasia by photoselective vaporization of the prostate with GreenLight-Photo vaporization 120 W versus transurethral resection of the prostate.

INTRODUCTION: Transurethral resection of the prostate is the gold standard of surgical treatment of lower urinary tract symptoms associated to benign prostate hyperplasia. The new Green Light Photovaporization has been shown to be an alternative that is as effective for this condition as the transurethral resection of the prostate. OBJECTIVES: To compare the efficiency of Green Light Photovaporization 120 W versus transurethral resection of the prostate in the treatment of benign prostate hyperplasia (BPH) in a 2-year time horizon from the perspective of the Spanish health service perspective. METHODS: A cost utility analysis was performed retrospectively with the data from 98 patients treated sequentially with transurethral resection of the prostate (n: 50) and Green Light Photovaporization 120 W (n: 48). A Markov model was designed to estimate the cost (2012€) and results (quality adjusted life years) in a 2-year time horizon. RESULTS: The total cost associated to Green Light Photovaporization 120 W treatment was less (3,377€; 95% CI: 3,228; 3,537) than that of the transurethral resection of the prostate (3,770€; 95% CI: 3,579; 3,945). The determining factor of the cost was the surgical phase (difference: -450€; 95% CI: -625; -158) because admission to hospital after surgery was not necessary with the GreenLight-PhotoVaporization. CONCLUSIONS: Surgical treatment of BPH patients with GreenLight-PhotoVaporization 120 W is more efficient than transurethral resection of the prostate in the surgical treatment of benign prostate hyperplasia as it has similar effectiveness and lower cost (-393€; 95% CI: -625; -158).

The prevalence of coeliac disease is significantly higher in children compared with adults.

BACKGROUND: Some limited studies of coeliac disease have shown higher frequency of coeliac disease in infancy and adolescence than in adulthood. This finding has remained unnoticed and not adequately demonstrated. AIM: To assess whether there are age and gender differences in coeliac disease prevalence. METHODS: A total of 4230 subjects were included consecutively (1 to ≥80 years old) reproducing the reference population by age and gender. Sample size was calculated assuming a population-based coeliac disease prevalence of 1:250. After an interim analysis, the paediatric sample was expanded (2010 children) due to high prevalence in this group. Anti-transglutaminase and antiendomysial antibodies were determined and duodenal biopsy was performed if positive. Log-linear models were fitted to coeliac disease prevalence by age allowing calculation of percentage change of prevalence. Differences between groups were compared using Chi-squared test. RESULTS: Twenty-one subjects had coeliac disease (male/female 1:2.5). Coeliac disease prevalence in the total population was 1:204. Coeliac disease prevalence was higher in children (1:71) than in adults (1:357) (P = 0.00005). A significant decrease of prevalence in older generations was observed [change of prevalence by age of -5% (95% CI: -7.58 to -2.42%)]. In the paediatric expanded group (1-14 years), a decrease of coeliac disease prevalence was also observed [prevalence change: -17% (95% CI: -25.02 to -6.10)]. CONCLUSIONS: The prevalence of coeliac disease in childhood was five times higher than in adults. Whether this difference is due to environmental factors influencing infancy, or latency of coeliac disease in adulthood, remains to be demonstrated in prospective longitudinal studies.

Liver dysfunction related to hepatitis B and C in patients with inflammatory bowel disease treated with immunosuppressive therapy.

BACKGROUND: There is no information about the frequency of liver dysfunction in patients with inflammatory bowel disease (IBD) treated with immunosuppressants and infected with hepatitis B (HBV) and/or C virus (HCV). AIM: To assess the influence of immunosuppressants on the course of HBV and HCV infection in IBD. METHODS: Patients with IBD with HBV and/or HCV infection from 19 Spanish hospitals were included. Clinical records were reviewed for the type of immunosuppressant used, treatment duration, liver function tests and viral markers before, during and after each immunosuppressant. Logistic and Cox regression analysis were used to identify predictors of outcome. RESULTS: 162 patients were included; 104 had HBV markers (25 HBsAg positive) and 74 had HCV markers (51 HCV-RNA positive), and 16 patients had markers of both infections. Liver dysfunction was observed in 9 of 25 HBsAg positive patients (36%), 6 of whom developed hepatic failure. Liver dysfunction in HCV was observed in 8 of 51 HCV-RNA positive patients (15.7%), and only one developed hepatic failure. The frequency and severity of liver dysfunction was significantly higher in HBV-infected patients than in HCV-infected patients (p=0.045 and p=0.049, respectively). Treatment with ≥2 immunosuppressants was an independent predictor of HBV reactivation (OR 8.75; 95% CI 1.16 to 65.66). The majority of patients without reactivation received only one immunosuppressant for a short period and/or prophylactic antiviral treatment. No definite HBV reactivations were found in anti-HBc positive patients lacking HBsAg. CONCLUSION: Liver dysfunction in patients with IBD treated with immunosuppressants is more frequent and severe in those with HBV than in HCV carriers and is associated with combined immunosuppression.

Diagnostic value of duodenal antitissue transglutaminase antibodies in gluten-sensitive enteropathy.

BACKGROUND: In gluten-sensitive enteropathy, antitissue transglutaminase antibodies are synthesized in the duodenum. AIM: To compare the diagnostic yield of these autoantibodies in cultured duodenal biopsies, duodenal aspirate and serum. METHODS: Patients (n = 315, 135 female, 180 male; age: 37.3 +/- 1.1 years) referred for duodenal biopsies, were recruited and HLA-DQ2/DQ8 haplotyped. Histological measurements were made from duodenal biopsies and cultured duodenal biopsies were used for antitissue transglutaminase antibodies analysis by enzyme-linked immunosorbent assay. Duodenal aspirate was collected in a subgroup of 81 patients. Patients were classified, according to their histology, response to a gluten-free diet and DQ2/DQ8 status, as definite, likely or nongluten-sensitive enteropathy. RESULTS: Histology was normal in 59% of patients; 28% had lymphocytic enteritis, 1% had crypt hyperplasia and 13% showed atrophy. In Marsh III patients, there was complete agreement between duodenal and serological antitissue transglutaminase antibodies measurements. Marsh I patients showed a slight antitissue transglutaminase antibodies sensitivity improvement in cultured duodenal biopsy compared to serum in definite (22% vs. 19%) and likely gluten-sensitive enteropathy (20% vs. 14%) patients. Combined serum and cultured duodenal biopsy antitissue transglutaminase antibodies assessment increased serological sensitivity from 19% to 30% in Marsh I patients. CONCLUSION: Duodenal antitissue transglutaminase antibodies detection improves serological determination sensitivity in Marsh I patients, providing diagnostic value and therapeutic impact.

Comparison of a monoclonal with a polyclonal antibody-based enzyme immunoassay stool test in diagnosing Helicobacter pylori infection before and after eradication therapy.

BACKGROUND: Detection of Helicobacter pylori antigen in stool samples has been a subject of controversy. However, it has been included in several clinical guidelines as a recommended non-invasive testing procedure in dyspeptic patients. AIM: To compare a monoclonal enzyme immunoassay for detection of H. pylori stool antigen (Amplified IDEIA HpStAR, DakoCytomation) with a polyclonal enzyme immunoassay (HpSA test, Premier Platinum HpSA, Meridian Diagnostics) in diagnosing infection and in determining H. pylori status after eradication treatment. METHODS: We evaluated stool samples of 198 patients diagnosed with H. pylori infection and of 41 patients without infection. The results of the monoclonal enzyme immunoassay HpStAR were compared with those of the polyclonal enzyme immunoassay HpSA. RESULTS: The sensitivity and specificity of HpStAR were 91.9% and 70.7%, while those of HpSA were 89.4% and 80.5%, respectively. In the 126 patients evaluated 6 weeks after eradication therapy, the overall agreement between urea breath test and HpStAR was 90.5% (P = 0.710) and between urea breath test and HpSA was 76.9% (P = 0.410). CONCLUSIONS: HpStAR is a rapid and easy-to-perform test with similar sensitivity to HpSA in the diagnosis of H. pylori infection, although it had lower specificity. In contrast, HpStAR is more accurate after eradication therapy than HpSA.

Spectrum of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease: clinical relevance of lymphocytic enteritis.

BACKGROUND: Limited data on a short series of patients suggest that lymphocytic enteritis (classically considered as latent coeliac disease) may produce symptoms of malabsorption, although the true prevalence of this situation is unknown. Serological markers of coeliac disease are of little diagnostic value in identifying these patients. AIMS: To evaluate the usefulness of human leucocyte antigen-DQ2 genotyping followed by duodenal biopsy for the detection of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease and to assess the clinical relevance of lymphocytic enteritis diagnosed with this screening strategy. PATIENTS AND METHODS: 221 first-degree relatives of 82 DQ2+ patients with coeliac disease were consecutively included. Duodenal biopsy (for histological examination and tissue transglutaminase antibody assay in culture supernatant) was carried out on all DQ2+ relatives. Clinical features, biochemical parameters and bone mineral density were recorded. RESULTS: 130 relatives (58.8%) were DQ2+, showing the following histological stages: 64 (49.2%) Marsh 0; 32 (24.6%) Marsh I; 1 (0.8%) Marsh II; 13 (10.0%) Marsh III; 15.4% refused the biopsy. 49 relatives showed gluten sensitive enteropathy, 46 with histological abnormalities and 3 with Marsh 0 but positive tissue transglutaminase antibody in culture supernatant. Only 17 of 221 relatives had positive serological markers. Differences in the diagnostic yield between the proposed strategy and serology were significant (22.2% v 7.2%, p<0.001). Relatives with Marsh I and Marsh II-III were more often symptomatic (56.3% and 53.8%, respectively) than relatives with normal mucosa (21.1%; p = 0.002). Marsh I relatives had more severe abdominal pain (p = 0.006), severe distension (p = 0.047) and anaemia (p = 0.038) than those with Marsh 0. The prevalence of abnormal bone mineral density was similar in relatives with Marsh I (37%) and Marsh III (44.4%). CONCLUSIONS: The high number of symptomatic patients with lymphocytic enteritis (Marsh I) supports the need for a strategy based on human leucocyte antigen-DQ2 genotyping followed by duodenal biopsy in relatives of patients with coeliac disease and modifies the current concept that villous atrophy is required to prescribe a gluten-free diet.

Chronic hepatitis B reactivation following infliximab therapy in Crohn's disease patients: need for primary prophylaxis.

BACKGROUND: There is little information about the effect of infliximab on the clinical course of liver disease in Crohn's disease patients with concomitant hepatitis B virus (HBV) infection. Theoretically, immunosuppression induced by infliximab will facilitate viral replication which could be followed by a flare or exacerbation of disease when therapy is discontinued. There are no specific recommendations on surveillance and treatment of HBV before infliximab infusion. Two cases of severe hepatic failure related to infliximab infusions have been described in patients with rheumatic diseases. PATIENTS AND METHODS: Hepatitis markers (C and B) and liver function tests were prospectively determined to 80 Crohn's disease patients requiring infliximab infusion in three hospitals in Spain. RESULTS: Three Crohn's disease patients with chronic HBV infection were identified. Two of the three patients with chronic HBV infection suffered severe reactivation of chronic hepatitis B after withdrawal of infliximab therapy and one died. A third patient, who was treated with lamivudine at the time of infliximab therapy, had no clinical or biochemical worsening of liver disease during or after therapy. From the remaining 80 patients, six received the hepatitis B vaccine. Three patients had antibodies to both hepatitis B surface antigen (anti-HBs) and hepatitis B core protein (anti-HBc) with normal aminotransferase levels, and one patient had positive anti-hepatitis C virus (HCV) antibodies, negative HCV RNA, and normal aminotransferase levels. Except for the patients with chronic HBV infection, no significant changes in hepatic function were detected. CONCLUSIONS: Patients with Crohn's disease who are candidates for infliximab therapy should be tested for hepatitis B serological markers before treatment and considered for prophylaxis of reactivation using antiviral therapy if positive.

Bile acid malabsorption in microscopic colitis and in previously unexplained functional chronic diarrhea.

Bile acid malabsorption (BAM) has been described in patients with collagenous colitis. There are no similar studies in lymphocytic colitis. The possibility that BAM might not necessarily be part of the microscopic colitis process and that both entities could simply be concomitant has not been evaluated. Our aim was to assess the frequency and severity of BAM in patients with microscopic colitis as well as in patients with previously unexplained functional chronic diarrhea. Likewise, we wanted to investigate the effect of cholestyramine on the induction and maintenance of remission of these conditions. A [75Se]HCAT abdominal retention test was performed in 26 patients with collagenous colitis, 25 with lymphocytic colitis, and 32 with previously unexplained functional chronic diarrhea. Patients with microscopic colitis who had BAM as well as a subgroup of eight collagenous colitis patients without BAM received treatment with cholestyramine. All patients with previously unexplained chronic diarrhea who had BAM were treated with cholestyramine. Twenty-two (43.1%) patients with microscopic colitis and 24 (75%) patients with previously unexplained functional chronic diarrhea presented with BAM. The frequency of BAM was higher in lymphocytic colitis than in collagenous colitis (60% vs 27%; P = 0.025). Cholestyramine induced clinical remission in 19 of 22 patients with microscopic colitis and BAM, none of eight patients with collagenous colitis without BAM, and all patients with previously unexplained chronic diarrhea and BAM. In conclusion, BAM seems to be common in patients with microscopic colitis-mainly in lymphocytic colitis-and in those with previously unexplained functional chronic diarrhea, suggesting that idiopathic BAM and microscopic colitis are often concomitant conditions. In this setting, cholestyramine seems to be highly effective in stopping diarrhea.

Accuracy of an enzyme immunoassay for the detection of Helicobacter pylori in stool specimens in the diagnosis of infection and posttreatment check-up.

OBJECTIVE: The aim of this study was to assess the reliability of a newly developed enzyme immunoassay for Helicobacter pylori-specific antigen detection in stools (HpSA) compared to other standardized diagnostic techniques such as histology (H), rapid urease test (RUT) and 13C-urea breath test (UBT) to diagnose H. pylori infection and to evaluate its usefulness in determining H. pylori status after treatment. METHODS: One hundred eighty-eight patients referred to our department for upper gastrointestinal endoscopy were included. H. pylori infection was confirmed in all patients by HpSA test in stools, RUT, UBT, and H. Patients were defined as positive for H. pylori if RUT and UBT or H were positive. A total of 142 symptomatic patients received eradication treatment and were reassessed 6 wk after therapy; for 70 of these patients, stool samples were also collected at 24 h and 6 months after finishing eradication treatment. In the posttreatment follow-up, UBT was used as gold standard. RESULTS: The sensitivity of HpSA test for the diagnosis of H. pylori infection using a cut-off value of 0.130 was 89.5% and its specificity 77.8%. This specificity was lower than that obtained with UBT, H, and RUT. In the early follow-up the sensitivity of HpSA test was null. At 6 weeks and at 6 months post-treatment its sensitivity was 70.4% and 50% and its specificity was 81.6% and 79.3%, respectively. CONCLUSIONS: The HpSA stool test, using a cut-off value of 0.130, may be useful for the primary diagnosis of H. pylori infection, with sensitivity similar to that obtained with other standard tests, but with less specificity. HpSA test is not useful for early monitoring of treatment efficacy. At 6 wk and at 6 months posttreatment, HpSA test lacks accuracy as compared to UBT for evaluating the outcome of the eradication treatment.

[The evaluation of a new immunoenzyme analysis for the detection of Helicobacter pylori infection in stool samples]. / Evaluación de un nuevo enzimoinmunoanálisis para la detección de la infección por Helicobacter pylori en muestras fecales.

BACKGROUND: Detection of bacterial antigen in stool specimens (HpSAT) is a new promising tool for diagnosing Helicobacter pylori infection. OBJECTIVE: To evaluate diagnostic accuracy of HpSAT in the diagnosis of Helicobacter pylori infection. PATIENTS AND METHODS: We evaluate the presence of Helicobacter pylori infection by the rapid urease test and the 13C-urea breath test in endoscopic biopsies. Patients who were positive for both tests were considered to have Helicobacter pylori infection. Patients negative for both tests were considered free of infection. The presence of Helicobacter pylori infection was also determined in stool specimens by means of HpSAT. RESULTS: The sensitivity of HpSAT was 92.8%, the specificity 92.3%, the positive predictive value 98.1% and the negative predictive value 75%. CONCLUSIONS: HpSAT is a reliable tool for diagnosing Helicobacter pylori infection.

Incidence of collagenous and lymphocytic colitis: a 5-year population-based study.

OBJECTIVE: The incidence of collagenous and lymphocytic colitis is not well known. We sought to assess the incidence of collagenous and lymphocytic colitis in a well-defined population during a 5-yr study period. METHODS: From January 1, 1993, to December 31, 1997, all new patients diagnosed with collagenous or lymphocytic colitis living in the catchment area of the Hospital Mutua de Terrassa (Barcelona, Spain) were identified. Since 1993 all patients with chronic diarrhea were referred for a diagnostic colonoscopy. Multiple biopsy sampling of the entire colon was performed when appearance of the colonic mucosa was grossly normal. RESULTS: Twenty-three cases of collagenous colitis and 37 of lymphocytic colitis were diagnosed. The female:male ratios were 4.75:1 and 2.7:1 for collagenous and lymphocytic colitis, respectively. The mean age at onset of symptoms was 53.4+/-3.2 (range, 29-82) yr for collagenous colitis, and 64.3+/-2.7 (range, 28-87) yr for lymphocytic colitis (p = 0.012). The mean annual incidence per 100,000 inhabitants based on the year of onset of symptoms was 1.1 (95% confidence interval [CI], 0.4-1.7) for collagenous colitis, and 3.1 (95% CI, 2.0-4.2) for lymphocytic colitis. A peak incidence was observed in older women in both diseases. A rate of microscopic colitis of 9.5 per 100 normal-looking colonoscopies performed in patients with chronic watery diarrhea was observed. Normal rectal biopsies were found in 43 % and 8% of patients with collagenous and lymphocytic colitis, respectively. CONCLUSIONS: The incidence of lymphocytic colitis is three times higher than that of collagenous colitis. Microscopic colitis should be considered as a major possibility in the work-up of chronic diarrhea in older women.

[Eosinophilic esophagitis as a cause of dysphagia with a 10-year history]. / Esofagitis eosinofílica como causa de disfagia de 10 años de evolución.

A new case of eosinophilic esophagitis is reported in a young male with a 10-year history of dysphagia who did not present manifestations of allergy, reflux or other involvement of the digestive tract by eosinophilic infiltration. A review of the literature up to the present is provided with emphasis on the fact that this is an entity to take into account in the differential diagnosis of dysphagia, especially in young people and that this disease is probably underdiagnosed.

Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized and multicenter trial.

BACKGROUND/AIMS: Silymarin has protective effects in different experimental conditions, but its efficacy in human liver cirrhosis has not been completely established. Therefore, this study was carried out to determine the effect of silymarin in alcoholics with liver cirrhosis with respect to survival and clinical and laboratory changes. METHODS: From February 1986 to June 1989, we enrolled 200 alcoholics with histologically or laparoscopically proven liver cirrhosis in a randomized, double-blind multicenter trial comparing 450 mg of silymarin (150 mg/ three times per day) with placebo. The primary outcome was time to death, and the secondary outcome was the progression of liver failure. Additional analyses were also performed in 75 patients in whom anti-hepatitis C virus antibodies were measured after completion of the trial. RESULTS: One hundred and three patients were assigned to receive silymarin and 97 to receive placebo. The two groups were well matched for demographic and baseline clinical and laboratory features. A 2-year study period was completed in 125 patients (57 receiving silymarin and 68 receiving placebo). Twenty-nine patients (15 receiving silymarin, and 14 receiving placebo) died during the trial. Survival was similar in patients receiving silymarin or placebo. The effect of silymarin on survival was not influenced by sex, the persistence of alcohol intake, the severity of liver dysfunction or by the presence of alcoholic hepatitis in the liver biopsy. Silymarin did not have any significant effect on the course of the disease. No relevant side-effects were observed in any group. CONCLUSIONS: The results of this study indicate that silymarin has no effect on survival and the clinical course in alcoholics with liver cirrhosis.

Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.

OBJECTIVE: One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. METHODS: On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment. RESULTS: H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98). CONCLUSIONS: High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

[Endoscopic ligation with elastic bands in the prevention of hemorrhage recurrence caused by esophageal varices. Study of 45 patients]. / Ligadura endoscópica con bandas elásticas en la prevención de la recidiva hemorrágica por varices esofágicas. Estudio en 45 pacientes.

The aim of the present study was to determine the usefulness of elastic band ligation in the prevention of hemorrhage recurrence by esophageal varices. Forty-five patients without known hepatocarcinoma who had survived a hemorrhagic variceal episode were included in the study. Seventeen patients (38%) were Child-Pugh A, 22 (49%) B, and 6 (13%) C, with the hepatitis C virus and alcohol being the etiology of cirrosis in 55 and 20% of the cases, respectively. The first ligation session was performed between the third and fifth days after the hemorrhagic episode and the posterior sessions were carried out at intervals of 2-4 weeks. The ligation sessions were performed without antibiotic prophylaxis and with placement of an overtube. A mean of 4 +/- 2 bands were placed per session (range, 1-8) and the mean number of sessions required per patient to achieve erradication of the varices was 3.5 +/- 1.5 (range, 2-8). The rate of bleeding recurrence was 17.7% (9 episodes, five by variceal rupture and four by ulcer secondary to ligation). All the episodes of bleeding recurrence occurred between the sessions, with the mortality being 11% (5/45 patients). In the 40 remaining patients the varices were erradicated although 19 (47.5%) required one or two additional sessions of sclerotherapy. The accumulated percentage of patients free of bleeding recurrence was 82% during a mean follow-up of 10.2 +/- 6.7 months. Ten lesions of dislaceration of the esophageal mucosa caused by placement of the were observed overtube. In conclusion, endoscopic elastic band ligation is a useful technique for the erradication of esophageal varices an in the prevention of bleeding recurrence.

Low dose alpha interferon therapy can be effective in chronic active hepatitis C. Results of a multicentre, randomised trial.

BACKGROUND: There is some controversy concerning the efficacy of low dose alpha interferon therapy in chronic hepatitis C. AIMS: To evaluate the effectiveness of treatment with low doses of alpha interferon in chronic hepatitis C. PATIENTS: One hundred and forty one patients with anti-HCV positive chronic active hepatitis C from six hospitals were enrolled in the study. METHODS: Patients were randomised to treatment with 5 MU (group A) or 1.5 MU (group B) injections. The dose was reduced in responders from group A or increased in non-responders from group B to maintain treatment with the minimal effective dose. Patients were treated for 48 weeks and followed up for 24 additional weeks with no treatment. Normalisation of alanine aminotransferase (ALT) was used to evaluate response. RESULTS: A sustained response was seen in eight patients from group A (12%) and in 15 (21%) from group B. This difference was not statistically significant. Increasing the dose of interferon led to sustained response in only five of 58 patients (9%) from group B who did not respond to 1.5 MU injections. In contrast, 15 of 21 patients (71%) in whom ALT remained normal with 1.5 MU injections developed a sustained response. By multivariate analysis sustained response seemed associated with young age and was more frequent in patients with genotype 3 HCV infection. Sustained response was preceded by a rapid normalisation of ALT and was inversely related to the amount of alpha interferon necessary to maintain ALT at low values during treatment. CONCLUSIONS: Some patients with chronic hepatitis C are very sensitive to alpha interferon and can be successfully treated with low doses. Treatment with higher doses may be effective in a minority of patients who do not respond to low doses.

Impact of colloidal bismuth subnitrate in the eradication rates of Helicobacter pylori infection-associated duodenal ulcer using a short treatment regimen with omeprazole and clarithromycin: a randomized study.

UNLABELLED: Recent trials have shown that duodenal ulcers treated by H2-blockers heal faster if Helicobacter pylori is eradicated concurrently. OBJECTIVES: To evaluate the efficacy of a short treatment regimen in H. pylori eradication and ulcer healing and to assess the impact of colloidal bismuth subnitrate (CBS) in H. pylori eradication rate. METHODS: Sixty-one patients with H. pylori-associated duodenal ulcer were randomized in two short treatment groups. Group A patients (31) were given omeprazole 20 mg b.i.d. x 8 days. Clarithromycin (500 mg, b.i.d.) and CBS (120 mg, q.i.d.) were added 24 h after starting omeprazole and were given for 7 days. Group B patients (30) were treated as group A patients but without CBS. Endoscopies were performed at entry and 4 wk after the end of treatment. Presence of H. pylori was assessed at each endoscopy by urease test, and biopsy specimens were examined for histological evidence of gastritis and by Gram stain and culture for H. pylori infection. No patient received follow-up treatment. RESULTS: H. pylori eradication rates were achieved in 25/31 (80.6%) group A patients and in 15/30 (50%) in group B patients (p = 0.012). Duodenal ulcer healing was documented in 30/31 (96.8%) patients in group A and in 25/30 (83%) patients in group B. CONCLUSIONS: The addition of CBS to the double therapy with omeprazole and clarithromycin substantially improves the eradication rate of H. pylori. Short therapy with omeprazole 20 mg/b.i.d., clarithromycin 500 mg/b.i.d., and CBS 120 mg/q.i.d. is a safe, well tolerated combination that achieves a 80.6% eradication rate of H. pylori and duodenal ulcer healing rates as good as those achieved by omeprazole 20 mg/d when given for 4 wk.

[The endoscopic treatment of postcholecystectomy biliary leakage]. / Tratamiento endoscópico de la fuga biliar poscolecistectomía.

Although there is a decrease in the total number of complications observed on performance of laparoscopy cholecystectomy (LC) there does appear to be an increase in biliary tract lesions. Seven cases of postcholecystectomy biliary leakage treated with endoscopic methods are presented. These cases include 4 patients with leakage from the cystic canal stump and 3 with leakage from the common bile duct. In 5 cases the biliary tract lesion occurred following LC, 1 after conventional cholecystectomy and in 1 reconverted LP. CPRE identified the site of the leakage in the 7 patients and in 2 residual choledocholithiasis. In 5 cases treatment consisted in endoscopic papillotomy and placement of biliary endoprosthesis while only papillotomy was performed in 2 patients. In one of these cases CPRE was repeated and the sphincterotomy widened due to persistence of the leakage at 5 days, with the same finally closing at 15 days of the second CPRE. Closure of the biliary leakage was obtained in the other 6 cases in less than 72 hours post-CPRE. No complications secondary to the technique were observed. It was concluded that CPRE together with endoscopic papillotomy and placement of biliary prostheses is an effective and safe treatment for postcholecystectomy biliary leakages of the common bile duct or cystic duct.