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Biomedical subjects

F Gomollón

Publications and source records attributed to F Gomollón.

At least 19 recordsLinked to original sources

[Is the breath test reliable in primary care diagnosis of Helicobacter pylori infection?].

OBJECTIVE: To evaluate the reliability of the breath test urea 13C in the primary care for the diagnosis of Helicobacter pylori (Hp) infection. DESIGN: Descriptive, prospective and multicentric.Location. Urban area belonging to the Health Center Actur Sur of Zaragoza with participation of Miguel Servet Hospital. PARTICIPANTS: 87 patients with clinical diagnosis of functional dispepsia. In all of them was made a breath test with 13C urea as well as a gastroscopy with taking of samples for histology and ureasa fast test. MAIN MEASUREMENTS: Age, sex and the presence of positivity or negativity of infection by Hp were valued in the histology, ureasa test and in the breath test, considering the histology and the ureasa test like gold tests for this measurement, reason why it was demanded that the positive or outside negative result in both considering it nonambiguous. RESULTS: Two cases were excluded by ambiguous results. The 77.6% (66/85) were positive by histology and ureasa test, and these, 92.4% (61/66) were positives to the breath test. The sensitivity of this test was 92% and the specificity 100%. CONCLUSIONS: The breath test in primary care has a high value diagnosis of Hp infection, being able to avoid, in some cases, another invasives techniques like gastroscopy.

Adult↗

[Comparison between two 13C-urea breath tests for the diagnosis of Helicobacter pylori infection: isotope ratio mass spectrometer versus infrared spectrometer].

OBJECTIVES: To compare the accuracy of the breath test using the isotope ratio mass spectrometer (IRMS) versus the nondispersive isotope-selective infrared spectrometer (NDIRS) in the diagnosis of Helicobacter pylori infection. METHOD: Multicenter study in 4 Spanish hospitals. One group of dyspeptic patients who had not undergone prior eradication therapy and another group of patients with gastric ulcer or gastrointestinal bleeding due to gastroduodenal ulcer receiving H. pylori eradication therapy were included in the study. A reference standard based on histology and the rapid urease test was used. The breast test (TAU-KIT, Isomed S.L., Madrid, Spain) was performed with citric acid and 100 mg of 13C-urea. Samples of expired air were collected in tubes and bags for reading with the IRMS (ABCA, PDZ, Crewe, Manchester, England) and the NDIRS (UBiT-IR200, Otsuka Electronics, Co, Osaka, Japan), respectively. The endoscopist, pathologist and person responsible for reading the urease test and both breath tests were blinded to the results of the other diagnostic methods. RESULTS: Forty-one patients were included. The prevalence of H. pylori was 26%. No differences were found on comparing the mean values obtained with the IRMS and the NDIRS: 13 (standard deviation) (24) and 14 (25) delta units, respectively. The area under the ROC curve for the IRMS and the NDIRS was 0.96. The diagnostic accuracy for the best cut-off point with the IRMS and the NDIRS was, respectively: sensitivity (90 and 100%), specificity (96 and 89%), positive predictive value (90 and 77%), negative predictive value (96 and 100%), + likelihaod ratio (25 and 9.3) and (0.1 and 0). A close correlation was found between the values of the IRMS and those of the NDIRS (lineal regression equation, Y = 1.1 + 1.004. X; r = 0.97). CONCLUSION: Both the spectrometers used to evaluate the breath test, the IRMS and the NDIRS, offer a high degree of accuracy in the diagnosis of H. pylori infection.

Breath Tests↗

Low frequency of upper gastrointestinal complications in a cohort of high-risk patients taking low-dose aspirin or NSAIDS and omeprazole.

BACKGROUND: There is very little information available on the incidence of complications and on the best prevention therapy in high-risk patients taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or aspirin. Randomized-controlled trials in such patients are rare for ethical reasons. We studied the incidence of gastrointestinal complications in high-risk patients taking long-term low-dose aspirin or non-aspirin-NSAIDs combined with omeprazole in a real-life clinical setting. METHODS: This was a multicentre, prospective and observational study including 247 consecutive high-risk patients who had a clinical indication for long-term treatment with either low-dose aspirin or non-aspirin NSAIDs and omeprazole therapy. The occurrence of gastrointestinal complications was measured. RESULTS: In addition to a recent history of peptic ulcer bleeding, all patients had at least 1 other risk factor and 112 (45.3%) had 3 or more risk factors; 78.9% were taking low-dose aspirin and the remainder non-aspirin NSAIDs. Mean follow-up was 14.6 +/- 10.38 months. Three patients taking low-dose aspirin developed upper gastrointestinal bleeding (1.2%; 95% CI 0.3-3.5; 1.0 event/100 patients/year). This was similar to the rate observed in studies involving non-high-risk patients taking low-dose aspirin and higher than that observed in patients not taking low-dose aspirin. Two additional patients developed a lower gastrointestinal bleeding event (0.81% (0.04%-3.12%); 0.67 events/100 patients/year), which was within the range expected in NSAID users. CONCLUSIONS: The use of omeprazole in the high-risk patient taking low-dose aspirin or NSAIDs seems to be a safe therapeutic approach in this population and is associated with a low frequency of upper gastrointestinal complications.

Adult↗

Validation of the 13c-urea breath test for the initial diagnosis of helicobacter pylori infection and to confirm eradication after treatment.

OBJECTIVES: the breath test with 13C-urea (UBT) is a method widely used in Spain, but its diagnostic accuracy has not been evaluated in a clinical trial until now. Our objective was to validate the UBT (TAU-KIT) both as an initial diagnostic method for the detection of H. pylori infection and as a method to confirm eradication. METHODS: a multi-centre study in 7 Spanish hospitals was performed. A group of dyspeptic patients who had not previously received eradication treatment was included, and a second group of patients with gastric ulcer or upper gastrointestinal bleeding due to peptic ulcer was also included (eradication of H. pylori was confirmed 6 to 8 weeks after treatment completion with omeprazole, clarithromycin and amoxycillin). In both groups an endoscopy was performed with biopsies for histology and rapid urease test. Patients were considered infected if both tests yielded positive results, and not infected when both tests were negative. The UBT 13C-urea (TAU-KIT, Isomed S.L., Madrid, Spain) was performed with citric acid and 100 mg of 13C-urea. The pathologist and persons responsible for endoscopy, urease test and UBT were all unaware of the results from the other diagnostic methods. RESULTS: in the pre-treatment group (36 patients) the prevalence of H. pylori was 72%, the area under the ROC curve for the diagnosis of infection with the UBT was 0.99, and the best cut-off point was 5 units, with the following results: sensitivity= 96% (95% CI = 81-99%), specificity= 100% (69-100%), positive predictive value (PPV) = 100% (87-100%), negative predictive value (NPV) = 92% (59-100%), likelihood ratio (LR) + = infinity, and LR- = 0.04. In the post-treatment group (85 patients) the prevalence of H. pylori was 16%, the area under the ROC curve was 0.99, and the best cut point was 4.6, with the following results: sensitivity= 100% (77-100%), specificity = 97% (90-99%), PPV = 88% (62-98%), NPV = 100% (95-100%), LR+ = 35, and LR- = 0. CONCLUSION: UBT provides excellent accuracy both for the initial diagnosis of H. pylori infection and to confirm eradication after treatment.

Adult↗

[Failure of rapid serology for Helicobacter pylori as diagnostic method in primary care consultation].

OBJECTIVE: To evaluate the validity of a rapid serology test for diagnosing Helicobacter pylori infection in our area. DESIGN: Longitudinal, prospective study. SETTING: Urban primary care centre. MEASUREMENTS: As reference tests for defining the presence/absence of Helicobacter pylori, histology and the urease gastric mucous membrane test (Jatrox(R) test) were used. Both tests can be either positive or negative, without intermediate values. RESULTS: 47 consecutive patients were included. Histology (confirmed with the urease test) showed infection in 38 cases (80.85% prevalence). The results of rapid serology (95% CI) were: sensitivity 0.66 (0.51-0.81), specificity 1 (1-1), positive predictive value 1 (1-1), and negative predictive value 0.41 (0.2-0-61). CONCLUSIONS: In a population with high prevalence of infection, a positive in the rapid serology test confirms infection. However, a negative does not discount infection, which significantly reduces the test's overall diagnostic value. This confirms in the primary care context the findings of hospital-based studies.

Adult↗

[Budesonide in inflammatory bowel disease: a meta-analysis].

BACKGROUND: Budesonide is a synthetic glucocorticoid used in the Crohns's disease (CD) and ulcerative colitis (UC). The aim of the study was to evaluate its efficacy in inducing and maintaining remission of CD in oral administration and in inducing endoscopic and histologic remission in distal UC when was given as enema. MATERIAL AND METHOD: Systematic review of controlled clinical trials was made and meta-analysis were performed using the Peto method. Eight studies provided data regarding CD (4 in induction of remission and 4 in maintenance therapy) and 4 regarding UC. RESULTS: CD-inducing remission: in total 560 patients were involved; 280 received 9 mg/d of budesonide and 280 received 40-46 mg/d of prednisolone. Clinical remission was similar in both groups [0.76 (0.54-1.06)] [0R (CI 95%)] and adverse events were more frequent in patients treated with prednisolone [0.42 (0.30-0.58)]. Plasma cortisol was evaluated in 292 patients (146 each group); values were significantly lower in prednisolone group [0.32 (0.20-0.50)]. CD-maintaining remission: in total 449 patients were enrolled; 174 and 90 received 3 mg/d or 6 mg/d of budesonide respectively and 185 received placebo. There were not significant differences between placebo and budesonide 3 mg/d [1.04 (0.56-1.92)]. Budesonide 6 mg/d was also similar to placebo group [0.91 (0.59-1.39)]. UC: 325 patients were included, 156 received budesonide and 169 were given conventional glucocorticoids. No significant differences were found between both groups in endoscopic remission rates [1.15 (0.71-1.88)]. CONCLUSIONS: Budesonide is as useful as prednisolone in treatment of active CD and it has a lower impact in serum cortisol levels. Nevertheless, at evaluated dose, it is not useful for maintenance therapy. In UC is as effective as conventional glucocorticoids.

Anti-Inflammatory Agents↗

Environmental risk factors and Crohn's disease: a population-based, case-control study in Spain.

BACKGROUND: The pathogenesis of inflammatory bowel disease probably involves an interaction between genetic and environmental factors: cigarette smoking, appendectomy and oral contraceptives have been the factors most frequently linked to its aetiology AIM: To analyse the association between known environmental risk factors and development of Crohn's disease in the community of Aragón, Spain. PATIENTS AND METHODS: A case-control, population-based study has been carried out. All patients diagnosed with Crohn's disease in the community of Aragón from 1st February 1992 to 31st January 1995 were prospectively included. The Lennard Jones criteria were used to define the cases and selected controls among the healthy population matched with patients for age, sex and rural/urban habitat. Statistical analysis included multivariate analysis using conditional logistic regression, testing 38 different models. RESULTS: A total of 103 patients were diagnosed with Crohn's disease in Aragón from 1st February, 1992 to 31st January, 1995. Of these 62 patients (60.2%) with Crohn's disease were smokers, compared with 42 (40.8%) controls (p<0.001). Cigarette smoking is considered a risk factor for Crohn's disease with an odds ratio of 3.09 (95% confidence interval, 1.58-6.05). After multivariate analysis, the positive association is maintained. A dose-dependent relation could not be demonstrated. No statistical differences (p=0.50) were detected in the analysis of previous appendectomy. Use of oral contraceptive acts as a risk factor with a p=0.048; odds ratio 2, 8, 95% confidence interval: 1.009-7.774; but this association disappears in the multivariate analysis. Eight patients had a family history (3 first degree and 5 second degree relatives) versus none of the controls (p=0.002). Of the variables studied for childhood hygiene none appeared significant. CONCLUSION: Smoking, family history, and oral contraceptive use, appear as risk factors for developing Crohn's disease in univariate analysis, but only smoking remains significant in all models of multivariate analysis.

Adolescent↗

Helicobacter pylori: strategies for treatment.

Helicobacter pylori (Hp) is a Gram-negative bacteria able to live in the human stomach, a very surprising fact considering the acid environment of gastric mucosa. Identified by Marshall and Warren in 1982 [1,2], this bacterium seems aetiologically related to many gastric diseases, previously known as 'acid related diseases'. Compelling evidence demonstrates that Hp is the most important aetiological agent of gastritis [3], the principal causal factor in peptic ulcer [4], contributes to the genesis of gastric cancer [5] and has a critical role in the development of many mucosa-associated lymphoid tissue (MALT) lymphomas [6]. Although experimental data have recently provided hard evidence to support the role of Hp in the genesis of gastritis, ulcer and carcinoma [7], a critical argument for Hp generating peptic ulcer disease has been, in fact, the change in the natural history of peptic ulcer that follows the cure of the infection.

Drug Resistance, Multiple↗

[The scintigraphy of somatostatin receptors in the carcinoid tumor].

UNLABELLED: This study aimed to evaluate the diagnostic utility of 111In-DTPA-D-Phe1-octreotide scintigraphy in the different situations that can be present when an examination is requested during the clinical course of the carcinoid tumor (CT). MATERIALS AND METHODS: We have performed 41 scintigraphies with 111In-octreotide (145-185 MBq) in 35 patients (19 females and 16 males) with clinically suspected or confirmed CT. The patients were classified into five groups: Group A: Indolent symptoms of CT (n=9); B: CT staging located in lung (n=4), stomach (n=2), cecum (n=1), thymus (n=1) and pancreas (n=1); C: Carcinoid syndrome (n=1); D: CT staging after surgery located in pancreas (n=1), ovary (n=1), cecum (n=1), stomach (n=1), appendix (n=1) and ileum (n=1); and E: Post-treatment follow-up (n=13), with CT located in bronchial tree (n=5), small intestine (n=3), appendix (n=2), thymus (n=1), ovary (n=1) and unknown primary tumor (n=1). Three patients of this group had one scintigraphic study before the treatment. Head and neck, thorax and abdomen images were obtained at 4 and 24 h in all of the patients and SPECT images of the abdomen (n=14), thorax (n=10), and brain (n=1) were obtained at 24 h in 25 patients. RESULTS: Group A: In the 3 patients with a positive scintigraphy, the definitive diagnosis was meningioma, Hurtle cell's carcinoma and lung adenocarcinoma. The clinical follow-up in the six other patients, at least during one year, did not show any evidence of CT. Group B: Six of the 9 CT were detected with the scintigraphy. In 2 cases of bronchial CT, the scan showed sarcoidotic regional lymph node involvement and CT hepatic and bone metastases, respectively. Group C: The scintigraphy detected hepatic metastases from an unknown primary tumor. Group D: The scintigraphy was positive in 3 cases (hepatic or/and abdominal metastases) and was normal in the other 3. The scintigraphy was negative in one patient with peritoneal metastases. Group E: The scintigraphy was normal in 7 patients in concordance with the clinical follow-up. In 3 patients with a scintigraphy performed prior to treatment, the scintigraphy detected recurrence (thymic CT), progression of the metastatic disease (ovarian CT) and partial regression of the hepatic metastases (carcinoid syndrome). In the three other patients, the scintigraphy showed metastases located in liver in one patient and hepatic and extra-hepatic metastases in the two other patients. The sensitivity and specificity of 111In-Octreotide in the detection of the primary tumor and metastases were 72% and 84% respectively. CONCLUSIONS: The 111In-Octreotide scintigraphy has a low diagnostic utility in patients with indolent symptoms of CT. However, it is the first line of diagnosis for the staging of the CT and to evaluate the follow up after therapy.

Adult↗

[High eradication rates in Helicobacter pylori infection in patients with duodenal ulcer who failed previous eradication therapy].

BACKGROUND: To analyze the effectiveness of a second-line treatment of Helicobacter pylori infection in patients with duodenal ulcer based on previous antibiotic regimen. PATIENTS AND METHODS: Open, prospective, uncontrolled study, but guided by protocol including 30 consecutive patients with endoscopic diagnosis of active duodenal ulcer and failure of a first-line H. pylori eradication treatment diagnosed by urea breath test or a new endoscopy with histology and positive urease test. Treatment consisted in 10 days with omeprazole (20 mg/12 h), bismuth subcitrate (120 mg/6 h), tetracycline (500 mg/6 h) and metronidazole (500 mg/8 h) (OBTM) if previous regimen was with clarithromycin; or 10 days with omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and amoxycillin (1g/12 h) (OCA) if previous regimen did not include clarithromycin; using metronidazole (500 mg/8 h) instead of amoxycillin (OCM) in case of allergy. Eradication was defined as a negative 13C-urea breath test 2 months after the end of therapy. RESULTS: One patient had to stop treatment due to the side effects and in 2 patients urea breath test was not performed (3 patients due to the OBTM group). Per protocol eradication was achieved in 25 out of 27 patients (92.6%) and by intention-to-treat eradication was attained in 25 out of 30 cases (83.3%). When both groups analyzed separately, the OCA combination was successful in 5 from 6 patients (83.3%; 95% CI 35.9-99.6); while the OBTM combination was successful in 20 from 21 valuable patients (95. 2%; 95% CI 76.2-99.9). In this second case we make an intention to treat analysis and eradication was achieved in 20 from 24 (83.3%; 95% CI 62.6-95.3). CONCLUSION: The eradicative treatment for H. pylori based in different antibiotics used in subsequent attempts get high eradication rates in patients with duodenal ulcer.

Adult↗

[Cost-effectiveness analysis of 2 strategies of Helicobacter pylori eradication: results of a prospective and randomized study in primary care].

BACKGROUND: To analyze cost-effectiveness of two different strategies to treat H. pylori infection in peptic ulcer in the primary care setting. PATIENTS AND METHODS: Consecutive patients with endoscopic diagnosis of peptic ulcer were randomized to one of two strategies: a) treatment during 7 days with omeprazole, tetracycline, metronidazole and bismuth subcitrate ("quadruple" therapy) and if failure second-line treatment with omeprazole, amoxycillin and clarithromycin during 7 days (OCA7), and b) initial treatment with OCA7 and if failure treatment with "quadruple therapy". End point was eradication 8 weeks after last treatment dose. Direct and indirect costs were estimated (euros, 1997) and a cost-effectiveness analysis using a decision-tree model was undertaken after real clinical data. 95% confidence intervals are given. RESULTS: After screening 255 patients, 97 were finally included. 48 patients were given strategy a and 49 strategy b. Eradication was obtained (intention-to-treat) in 72.9% (CI 95%: 58.2-84.7) in group a versus 91.8% (CI 95%: 80.4-97.7) (p < 0.05) in group b. Mean cost per case treated was lower in group a (237 versus 268 euros) but cost per case eradicated was lower in group b (320 versus 296 euros). The cost was primarily determined by efficacy. CONCLUSIONS: Treatment with OCA7 followed by rescue with "quadruple" therapy if failure is more efficient in our area that the inverse strategy. Efficiency is mostly determined by efficacy.

Adolescent↗