Estudo multicêntrico de grupos paralelos, randomizado, cego para o investigador, para avaliar a eficácia, segurança e tolerabilidade do racecadotril versus Saccharomyces boulardii no tratamento da diarréia aguda em adultos / A multicentric, randomised, investigator-blind, parallel group study to assess the eficacy, safety and tolerability of Racecadotril versus Saccharomyces boulardii no tratamento da diarréia aguda em adultos

No presente estudo randomizado, paralelo, cego para o investigador, comparamos a eficácia do inibidor da encefalinase racecadotril ao Saccharomyces boulardii em 336 pacientes adultos ambulatoriais avaliáveis com diarréia aguda. Foram incluídos 175 pacientes avaliáveis no grupo com racecadotril e 161 pacientes avaliáveis foram incluidos no grupo com Saccharomyces boulardii. A duraçäo mädia da diarréia foi significativamente mais curta após o tratamento com racecadotril em comparaçäo com Saccharomyces boulardii. O tempo de recuperaçäo também foi mais curto com racecadotril em comparaçäo com S. boulardii, independente da gravidade da diarréia. Em casos brandos foi observada uma diferença de 24 horas entrte o tempo de recuperaçäo para racecadotril e S. boulardii e em casos graves a diferença entre os grupos foi de 17 horas. Além disso, a probabilidade de cura com racecadotril após dois dias de tratamento foi duas vezes maior e significante em comparaçäo ao Saccharomyces boulardii. Após três dias de tratamento, mais de dois terços dos pacientes em uso de racecadotril apresentaram recuperaçäo completa ao passo que quase metade dos pacientes com Saccharomyces boulardii näo haviam se recuperado. Em casos mais graves, a probabilidade de cura no dia 2 do tratamento com racecadotril foi três a quatro vezes maior em comparaçäo ao S. boulardii. Tanto racecadotril quanto Saccharomyces boulardii apresentaram um bom perfil de segurança.(au)

One-week triple therapy with omeprazole plus azithromycin and secnidazole is ineffective in eradicating "helicobacter pylori"

Background: There is not yet consensus on the most effective treatment for the helicobacter pylori infection, particularly in most developing countries. Azithromycin is a new macrolide and relatively novel agent for H. pylori eradication with an in vitro MIC90 lower than 1 mg/ml.Secnidazole, a nitromidazole that causes fewer side effects than metronidazole, was recenty reported to be used, for the firt time, in the treatment of H. pylori infection. Aim: To evaluate, in a prospective, randomized, single-center study, the association of twodifferent doses of omeprazole, azithromycin and secnidazole in H. pylori eradication. Patients and methods: After informed consent, 55 patients (36m,19F) with duodenal ulcer associated with H. pylori infection were randomized to receive omeprazole 20mg uid (Group A) or 20mg bid (Group B) for sevem days plus azithromycin 500mg uid for six days and secnidazole 2,000mg uid in the first, fourth and seventh day. The H. pylori status was assessed before and 60-90 days posttreatment using urease test, histology and 13C-urea breath test. Statistical analysis was performed by X² test. Results: The two groups had similar demographic characteristics. Fifty-five patients (36M, 19F) were enrolled. Six patients did not show-up for the second visit posttreatment. So, of the 49 evaluable patients, 25por cento (6/24) in Group A and 44por cento(11/25) in Group B wereeradicated, in a per protocol (PP) analysis. Intetion-to-treat (ITT) eradication rates were 21,4por cento (6/28) in Group A and 40.7por cento (11/27) im Group B. The differences betweem ITT and PP analysis from the two groups were not statistically significant. Conclusions: This study shows a very low eradication rate with the two regimens comprising of omeprazole, azithromycin and secnidazole and therefore, should not be recommended for thetreatment of H. pylori infection

Application of isotope-selective non-dispersive infrared spectrometry for the evaluation of the 13C-urea breath test: comparison with three concordant methods

The aim of this work was to compare the performance of isotope-selective non-dispersive infrared spectrometry (IRIS) for the 13C-urea breath test with the combination of the 14C-urea breath test (14C-UBT), urease test and histologic examination for the diagnosis of H. pylori (HP) infection. Fifty-three duodenal ulcer patients were studied. All patients were submitted to gastroscopy to detect HP by the urease test, histologic examination and 14C-UBT. To be included in the study the results of the 3 tests had to be concordant. Within one month after admission to the study the patients were submitted to IRIS with breath samples collected before and 30 min after the ingestion of 75 mg 13C-urea dissolved in 200 ml of orange juice. The samples were mailed and analyzed 11.5 (4-21) days after collection. Data were analyzed statistically by the chi-square and Mann-Whitney test and by the Spearman correlation coefficient. Twenty-six patients were HP positive and 27 negative. There was 100 per cent agreement between the IRIS results and the HP status determined by the other three methods. Using a cutoff value of delta-over-baseline (DOB) above 4.0 the IRIS showed a mean value of 19.38 (minimum = 4.2, maximum = 41.3, SD = 10.9) for HP-positive patients and a mean value of 0.88 (minimum = 0.10, maximum = 2.5, SD = 0.71) for negative patients. Using a cutoff value corresponding to 0.800 per cent CO2/weight (kg), the 14C-UBT showed a mean value of 2.78 (minimum = 0.89, maximum = 5.22, SD = 1.18) in HP-positive patients. HP-negative patients showed a mean value of 0.37 (minimum = 0.13, maximum = 0.77, SD = 0.17). IRIS is a low-cost, easy to manage, highly sensitive and specific test for H. pylori detection. Storing and mailing the samples did not interfere with the performance of the test.

Histology of the mucosa of gastric antrum and body before and after eradication of Helicobacter pylori

1. Helicobacter pylori status and the histology of the antral and oxyntic mucosa were evaluated in 25 patients with duodenal ulcer treated with a triple schedule of furazolidone, metronidazole and amoxicillin, and in 16 patients treated only with cimetidine. 2. Before treatment, H. pylori was detected in all patients. One month after treatment with the antimicrobial agents, H. pylori was not found in 18 (72.0 per cent ) of 25 patients treated with the triple schedule. In the patients treated with cimetidine (N = 16) the H. pylori tests continued to be positive after treatment. 3. Inflammatory activity and intensity of gastritis were significantly reduced in patients treated with the antimicrobial agents but not in cimetidine-treated patients. Three patients who had negative cultures and improvement of gastritis 1 month after treatment became H. pylori positive again within 2 months, with concomitant reappearance of gastritis. 4. This study provides additional evidence that histological gastritis observed in H. pylori-positive patients with duodenal ulcer is due to the presence of the microorganism

Antiácido de alta potência versus cimetidina no tratamento da úlcera duodenal: comodidade posológica / High potency antacid versus cometidine in the treatment of duodenal ulcer: commodus psosology

Foram estudados 98 pacientes com úlcera péptica duodenal distribuídos de forma randômica em dois grupos. Um grupo recebeu antiácido liquido de alta potência (282,4mEq/dia) dividido em 4 tomadas durante 4 semanas e outro recebeu cimetidina (800 mg/dia) dividida em 2 tomadas por igual período. A potência antiácida da associaçäo líquida utilizada é de 7,06 mEq/ml. Todos os pacientes foram avaliados clinicamente no pré-tratamento e duas e quatro semanas após, com exames endoscópicos realizados na admissäo e após quatro semanas. A eficácia, considerada como cicatrizaçäo da úlcera duodenal associada a melhora da sintomatologia foi equivalente para ambos os tratamentos, näo havendo diferença estatisticamente significante. A tolerabilidade de ambas as drogas foi considerada boa

Comparison of the urease test and of direct smear examination in the control of treatment of Helicobacter pylori-induced infection

The sensitivity and specificity of the preformed urease test and of carbolfuchsin-stained smears for the diagnosis of the presence of Helicobacter pylori in gastric mucosa were evaluated before and after antimicrobial treatment. The results obtained by culture were used as the reference point. We studied 41 patients with endoscopically diagnosed duodenal ulcer. Twenty-five of these were treated with furazolidone (100 mg t.i.d.), amoxicillin (500 mg t.i.d.) and metronidazole (250 mg t.i.d.) for 5 days and then with only furazolidone (100 mg t.i.d.) for an additional 25 days. The 16 control patients were treated with cimetidine (800 mg, 4 times a day). The sensitivity of the urease test and of direct smear examination was 100 per cent before treatment and 84.6 per cent and 92.3 per cent , respectively, after treatment. We conclude that the urease test and carbolfuchsin-stained smears, which are highly sensitive for H. pylori diagnosis, present reduced sensitivity when they are employed for the follow-up of patients treated with antimicrobials

Relationship between Sakita endoscopic stage and duration of treatment for duodenal ulcer healing

Endoscopic staging of peptic ulcer lesions according to Sakita will be a methodological improvement in therapeutic trials provided that the correlation between stages and the time spent in treatments is proved valid. We describe a double-blind controlled randomized trial carried out to determine the efficacy of cimentidine in patients with duodenal ulcer in the H stage of Sakita endoscopic staging. Fifty-two patients with duodenal ulcer (H stage) were randomly allocated to receive either 400 mg cimetidine twice daily (N = 26), or placebo (N = 26) for two weeks; patients with unhealed ulcers continued the same treatment for an additional week. Of the cimetidine-treated patients, 19 (73%) were healed after two weeks and 23 (88.5%) after three weeks of treatment, and of the placebo-treated patients, 8 (31%) were healed after two and 13 (50%) after three weeks. These differences indicate a natural tendency of the H stage lesions to heal faster than reported for the active (stage A) lesions and still faster if treated with cimetidine. These findings, by establishing a relationship between the ulcer stage and the time spent in treatment, may help the physician to treat duodenal ulcer patients and will enable the adoption of an important, uniform criterion for selection of duodenal ulcer patients for therapeutic trials, especially in multicenter trials

Efeitos da pirenzepina sobre o pH do conteudo gastrico e sobre a secrecao acida basal e a estimulada pelo betazol, em pacientes com ulcera duodenal. / Effects of pirenzepin on pH of the gastric content and on the basal acid secretion and the stimulated by betazole, in patients with duodenal ulcer

O efeito da pirenzepina sobre o pH do conteudo gastrico e sobre a secrecao basal de acido e a estimulada pelo betazol foi estudado em pacientes com ulcera duodenal.Os resultados demonstraram que a pirenzepina, duas horas apos uma dose de 50 mg, por via oral, reduziu significativamente a acidez gastrica basal, mas nao modificou a secrecao estimulada pelo betazol. Verificou-se, tambem, que a pirenzepina, na dose de 150 mg, em tres tomadas diarias de 50mg nao alterou significativamente o pH do conteudo gastrico, durante as 24 horas do dia

Efeito de diferentes esquemas terapeuticos de antiacido sobre a acidez do conteudo gastrico, variando a dose e o horario de administracao, em pacientes com ulcera duodenal. / Effect of different therapeutic schedules of antacids on the pH of gastric content, varying dosage and time of administration, in patients with duodenal ulcer

Foram comparados os efeitos de tres diferentes esquemas terapeuticas de antiacido sobre o pH do conteudo gastrico, em 10 pacientes portadores de ulcera peptica duodenal: esquema I (periodo/controle), sem antiacido; esquema II, com 6 doses de antiacido com uma potencia antiacida de 49mEq por dose, ministradas 1 e 3 horas apos as tres principais refeicoes; esquema III, com 3 doses de antiacido de 98mEq, 2 horas apos as refeicoes e, finalmente, esquema IV, com 3 doses com potencia antiacida de 147mEq de antiacido, tambem, ministradas 2 horas apos as refeicoes. A cada hora, de 8 as 22 horas, colhia-se uma aliquota do conteudo gastrico para determinacao potenciometrica do pH. Considerouse sucesso terapeutico a ocorrencia de pH igual ou superior a 3,0. Os tres esquemas com antiacido (II, III e IV) foram superiores ao esquema I (controle), do qual diferiram de forma altamente significativa. Os esquemas II e IV foram iguais entre si e superiores ao esquema III

Efeito de antiacido contendo calcio sobre a secrecao gastrica de acido em pacientes com ulcera duodenal. / Effect of antacid containing calcium of gastric acid secretion, in patients with duodenal ulcer

O efeito de um antiacido contendo calcio, sobre a secrecao gastrica de acido, foi estudado em oito pacientes com ulcera duodenal. Os resultados demonstram que o antiacido contendo calcio na dose de 15 ml, correspondente a uma potencia antiacida de 49,5 mEq, nao provoca a estimulacao da secrecao gastrica acida, nas condicoes do teste, quando comparado com a dose equivalente de bicarbonato de sodio

Efeitos de diferentes esquemas terapeuticos de antiacidos sobre o pH do conteudo gastrico em pacientes com ulcera duodenal. / Effets of different therapeutic schedules of antacids on the pH of gastric contents in patients with duodenal ulcer

Foram estudados os efeitos de diferentes esquemas terapeuticos de antiacido sobre o pH do conteudo gastrico em l0 pacientes com ulcera duodenal. Os pacientes foram internados durante cinco dias, entubados com sonda nasogastrica e submetidos a tres esquemas terapeuticos de antiacido e um controle, sem antiacido. O antiacido-teste utilizado, era administrado em seis doses diarias e iguais, uma e tres horas apos o desjejum, almoco e jantar e a diferenca entre os esquemas estava na sua potencia antiacida (PA). O esquema I (controle), sem antiacido, o esquema II tinha uma PA equivalente a 132,96 mEq de CH1 0,1 N, o esquema III de 265,92 mEq e o esquema IV de 398,88 mEq. A cada hora, de 8 as 22 horas, obtinha-se uma aliquota do conteudo gastrico para determinacao potenciometrica do pH. Considerou-se como sucesso terapeutico a ocorrencia de pH do conteudo gastrico igual ou superior a 3,0. Verificouse que o esquema II nao diferiu significativamente do esquema controle; que o esquema III, teve um desempenho altamente significativo, em relacao ao esquema controle e significativo, em relacao ao esquema II; e que o esquema IV teve um desempenho semelhante ao esquema III, nao havendo diferenca entre eles. Conclui-se que o sucesso maximo na manutencao do pH do conteudo gastrico igual ou superior a 3,0, no periodo de 8 as 22 horas, foi alcancado com dose unitaria correspondente a 44,32 mEq de antiacido, equivalente a dois comprimidos do antiacido-teste