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OBJECTIVE: (1) To determine the prevalence of gastrointestinal (Gl) symptoms in patients with and without Helicobacter pylori infection and treated with non-steroidal anti-inflammatory drugs (NSAIDs) and (2) to estimate the impact of H. pylori eradication on these symptoms. METHODS: This was a multicentric, community-based, randomized, case-control study. Patients presenting with a rheumatic disorder motivating the prescription of an NSAID for at least 2 wks were stratified in two groups (H. pylori-positive and H. pylori-negative) by a serological doctor test and H. pylori-positive patients divided further into two subgroups, receiving either an eradication treatment (group 1) or a placebo (group 2).The main outcome measure was the prevalence of Gl symptoms estimated in groups 1 and 2 and in noninfected patients (group 3) at weeks 2, 6, and 12. RESULTS: Among H. pylori-negative patients (n = 145), Gl symptoms were present in 42.6%, 21.4%, and 10.0% at weeks 2, 6, and 12, respectively. In groups 1 and 2, Gl symptoms were present in 57.7% and 40.7%, respectively, at week 2 (p = 0.03); 24.7% and 23% at week 6 (p = 0.85); and 9.4% and 17.3% at week 12 (p = 0.13). The prevalence of Gl symptoms at week 2 was similar in group 2 and in the H. pylori-negative group (p = 0.77). The highest prevalence of symptoms at week 2 in group 1 was essentially due to diarrhea. The prevalence of Gl symptoms was the same for groups 1 and 3 at week 12, and higher in group 2, but the difference did not reach statistical significance. CONCLUSIONS: The short-term (6 wks) Gl tolerance of conventional NSAIDs does not differ whether or not the patients are infected by H. pylori. The tendency observed for the medium term (12 wks) deserves to be confirmed.

Background: Lansoprazole is a potent proton-pump inhibitor (PPI) of parietal cells, which reduces the secretion of gastric acid. Although human gastric lipase (HGL) is produced only by the chief cells of the stomach, the possibility that interactions may occur between lansoprazole and HGL has never been addressed so far in humans. The aim of this study was therefore to quantify the effects of lansoprazole on HGL secretion and intragastric lipolysis during the ingestion of test meals by healthy human volunteers. Methods: Six healthy volunteers were intubated twice with a gastric and a duodenal tube, before ingesting a standard liquid test meal alone (–PPI experiments) and after 7 days of lansoprazole treatment (+PPI experiments). The HGL concentration was assessed in gastric and duodenal samples by measuring the lipase activity using a pH-stat, and the lipolysis products were quantified by performing thin layer chromatography. The level of intragastric lipolysis was defined as the percentage acyl chains released from the meal triglycerides. The pyloric outputs of HGL and lipolysis products were calculated, based on the use of a non-absorbable marker added to the meal. Results: The pH of the gastric contents was significantly higher in the +PPI experiments than in the –PPI experiments (p < 0.05), since mean values of 4.3 ± 2.5 and 2.2 ± 1.6, respectively, were recorded at the end of the gastric emptying of the meal. The HGL concentrations recorded during the meal were found to be higher in the experiments with lansoprazole (p < 0.05) than in those without lansopra- zole, but the HGL secretion levels (–PPI: 15.4 ± 8.0 mg; +PPI: 19.0 ± 7.4 mg) and the intragastric lipolysis (–PPI: 24.0 ± 8.0%; +PPI: 23.6 ± 6.8%) were not significantly affected by lansoprazole (p > 0.05 in both cases). Conclusion: Lansoprazole affected neither the HGL secretion nor the intragastric lipolysis levels, although an increase was observed in the intragastric pH at the end of the gastric emptying of the meal. The HGL concentration increased, however, due to the decrease in the acid secretion process, resulting in less diluted gastric contents.

Les inhibiteurs de la pompe a protons a demi-dose ont modifie la prise en charge des patients presentant un RGO symptomatique. Il n'existe pas a ce jour d'etude comparative entre le lansoprazole et le cisapride aux dosages preconises par leurs AMM respectives.

Objectives: The eradication of Helicobacter pylori is recommended in duodenal ulcer disease. The aim of this randomized open trial was to evaluate and compare H. pylori eradication and safety after a dual therapy consisting of lansoprazole (30 mg b.i.d.) and amoxicillin (1 g b.i.d.) versus a triple therapy consisting of lansoprazole (30 mg b.i.d.), amoxicillin (1 g b.i.d.), and clarithromycin (500 mg b.i.d.) administered from day 1 to day 14. Methods : All patients with an ulcer received lansoprazole (30 mg) from day 15 to day 28. H. pylori status was determined from antral biopsies using histology, culture, and polymerase chain reaction (PCR) upon inclusion and 1-3 months after the end of the treatment. Results: Of the 50 patients included in the study, five did not adhere to the protocol. H. pylon eradication was obtained in 37.5% of the patients receiving lansoprazole-amoxicillin (n = 9/24) and in 95.2% of the patients receiving lansoprazole-amoxicillin.clarithromycin (n = 20/21, p < 0.0002). Minor side effects appeared in 8.3% of the cases during dual therapy (n = 2/24) and in 52% during triple therapy (n = 13/22, p < 0.001). These side effects consisted mainly of diarrhea and a metallic taste. Conclusion: Concommitant administration of double doses of lansoprazole with amoxicillin and clarithromycin is very efficacious against H. pylori infection compared with dual therapy.

Resume Cette etude multicentrique, randomisee, effectuee en double aveugle sur 2 groupes paralleles de patients, a compare l'efficacite et la tolerance du cefotiam hexetil (CTM) a la dose de 200 mg matin et soir, a celles de l'amoxicilline/acide clavulanique (AAC) a la dose de 1 g matin et soir sur une periode de dix jours de traitement, tous deux prescrits chez des adultes presentant une otite moyenne chronique. Le critere principal de jugement a ete la comparaison des reponses cliniques (guerison) en fin de traitement. Un prelevement rhinopharynge etait effectue a l'inclusion. Cent quatre vingt dix adultes ambullatoires (95 dans chaque groupe) vus en consultation par 43 oto-rhino-laryngologistes, ont ete inclus et traites entre octobre 1994 et septembre 1995. Il s'agissait de 103 hommes et 87 femmes, d'âge moyen (m ± ds) 49 ans ± 17. Les deux populations etaient comparables a l'inclusion en ce qui concerne les signes demographiques et cliniques. L'efficacite clinique dans l'analyse en intention de traiter, a montre en fin de traitement (J10), la guerison de 61 % des patients (57/94) du groupe cefotiam hexetil vs 65 % (61/94) du groupe amoxicilline/acide clavulanique (p = 0,55). Au suivi a distance (J30), une recidive a ete notee chez 6/65 patients (9 %) du groupe CTM et chez 2/67 patients (3 %) du groupe AAC (p = 0,30). L'analyse de la tolerance revele un nombre significativement plus eleve d'effets secondaires (p = 0,001) dans le groupe AAC (34/95, soit 36 %) que dans le groupe CTM (13/95, soit 14 %). Dans cette etude, l'efficacite du cefotiam hexetil 200 mg matin et soir pendant 10 jours a ete non significativement differente de celle de l'amoxicilline/acide clavulanique 1 g matin et soir pendant 10 jours, dans le traitement de l'otite moyenne chronique de l'adulte. La tolerance a ete significativement meilleure dans le groupe cefotiam hexetil.

Resume L'objectif de cette etude multicentrique, prospective, randomisee, en double aveugle, etait de comparer l'efficacite et la tolerance du cefotiam hexetil (CTM) a la dose de 400 mg matin et soir avec celles de l'amoxicilline/acide clavulanique (AAC) a la dose de 1 g matin et soir sur une periode de dix jours de traitement au cours d'une exacerbation de bronchite chronique. Cent cinquante sept patients adultes souffrant d'une exacerbation de bronchite chronique ont ete inclus par des pneumologues. Les deux populations etaient comparables a l'inclusion en ce qui concerne les donnees demographiques et la clinique. En fin de traitement, 92 % des patients du groupe cefotiam hexetil et 88 % du groupe amoxicilline/acide clavulanique etaient gueris apres analyse en intention de traiter, respectivement 96 % versus 94 % apres analyse en per protocol. Le nombre d'effets secondaires a ete moins frequent dans le groupe cefotiam hexetil (9 % versus 21 %). Cette difference etait statistiquement significative (p = 0,03). En conclusion, le cefotiam hexetil 400 mg matin et soir peut etre considere comme une bonne alternative therapeutique dans le traitement des exacerbations de bronchite chronique de l'adulte avec une efficacite equivalente et une tolerance meilleure que l'amoxicilline/acide clavulanique 1 g matin et soir.

Resume L'objectif de cette etude etait de comparer l'efficacite et la tolerance du cefotiam hexetil (CTM) a la dose de 200 mg matin et soir avec celles de l'amoxicilline/acide clavulanique (AAC) a la dose de 1 g matin et soir sur une periode de dix jours de traitement. Deux cent onze patients adultes souffrant d'une surinfection de sinusite chronique ont participe a cette etude multicentrique prospective en double aveugle, double placebo. Le diagnostic de sinusite evoque par les ORL sur l'observation de douleurs faciales, d'un ecoulement nasal purulent et/ou d'une obstruction, etait confirme par une radiographie des sinus. L'usage d'antibiotique ou de corticoides de facon concomitante ou pendant les 15 jours precedant l'inclusion representait l'un des criteres majeurs de non inclusion. L'analyse statistique a ete menee en Intention de Traiter (ITT) et en Per Protocol (PP). Les deux populations etaient comparables a l'inclusion en ce qui concerne les caracteristiques demographiques et cliniques. En fin de traitement, 82 % des patients du groupe cefotiam hexetil et 82 % du groupe amoxicilline/acide clavulanique etaient gueris apres analyse en ITT et respectivement 84 % versus 83 % apres analyse PP. Le nombre d'effets secondaires a ete moins frequent dans le groupe cefotiam hexetil (13 % versus 40 %). Cette difference etait statistiquement significative (p

Resume L'efficacite et la tolerance d'une nouvelle cephalosporine orale de troisieme generation, le cefotiam hexetil ** (CTM) a la dose de 200 mg matin et soir ont ete comparees avec celles du cefuroxime axetil *** (CFX) a la dose de 250 mg matin et soir sur une periode de dix jours de traitement. Cent vingt-cinq patients adultes ambulatoires souffrant d'otite moyenne chronique ont ete randomises par des ORL dans cette etude multicentrique prospective en double aveugle, double placebo. Le diagnostic d'otite est retenu sur l'observation d'une otorrhee, d'une hypoacousie et d'une perforation tympanique laissant sourdre un ecoulement plus ou moins purulent. L'usage d'antibiotique ou de corticoides de facon concomitante pendant les 15 jours precedant l'inclusion etait l'un des criteres majeurs de non inclusion. Cent vingt-cinq patients ont ete evalues pour l'analyse de l'efficacite (61 dans le groupe CTM et 64 dans le groupe CFX). Les deux populations etaient comparables a l'inclusion en ce qui concerne les signes demographiques et cliniques. Le taux de succes clinique en fin de traitement (guerison + amelioration) n'a pas ete significativement different entre les deux groupes (CTM : 67,2 % versus CFX : 69,8 %). A J30 le nombre de recidives n'est pas statistiquement different (CTM 4,2 % versus CFX 3,7 %). Le nombre d'effets secondaires a ete moins frequent dans le groupe CTM (11,5 % versus 15,9 %), difference non significative. En conclusion, CTM 200 mg matin et soir est aussi efficace et aussi bien tolere que CFX 250 mg matin et soir dans le traitement des otites moyennes chroniques de l'adulte.

Resume L'efficacite et la tolerance d'une nouvelle cephalosporine orale de troisieme generation, le cefotiam hexetil ** (CTM) a la dose de 200 mg matin et soir ont ete comparees avec celles du cefuroxime axetil *** (CFX) a la dose de 250 mg matin et soir sur une periode de dix jours de traitement. Quatre vingt-trois patients adultes ambulatoires souffrant d'otite moyenne aigue ont ete randomises par des ORL dans cette etude multicentrique prospective en double aveugle, double placebo. Le diagnostic d'otite est retenu sur l'observation d'une otalgie, d'une hypoacousie et d'une perforation tympanique laissant sourdre un ecoulement plus ou moins purulent. L'usage d'antibiotique ou de corticoides de facon concomitante pendant les 15 jours precedant l'inclusion etait l'un des criteres majeurs de non inclusion. Quatre vingt-deux patients ont ete evalues pour l'analyse de l'efficacite (38 dans le groupe CTM et 44 dans le groupe CFX). Les deux populations etaient comparables a l'inclusion en ce qui concerne les signes demographiques et cliniques, a l'exception des maladies associees (p = 0,03). Le taux de succes clinique en fin de traitement n'a pas ete significativement different entre les deux groupes (CTM : 95% versus CFX : 90 %). Le nombre d'effets secondaires a ete moins frequent dans le groupe CTM (8 % versus 23 %). En conclusion, CTM 200 mg matin et soir est aussi efficace et aussi bien tolere que CFX 250 mg matin et soir dans le traitement des otites moyennes aigues de l'adulte.

Objective:To compare the efficacy and safety of lansoprazole 30 mg and omeprazole 20 mg in the treatment of benign gastric ulcer.Patients and methods:A multicentre, randomized, comparative, double-blind study was conducted in two parallel groups. Patients with a single gastric ulcer over 5 mm in dia

Background The influence of the infection by Helicobacter pylori (Hp) on the gastro-intestinal (GI) tolerability of NSAIDs remains unknown. Objectives 1) to determine the prevalence of GI symptoms in patients treated with NSAIDs as they are or not infected by Hp, 2) to estimate the impact of Hp eradication on the prevalence of these symptoms. Methods Multicentric, randomised, double blind, placebo-controlled study. Selection: patients presenting with a degenerative articular disease motivating the prescription of an NSAID for a duration > = 2 weeks. Distribution of the patients in two groups Hp-positive and Hp-negative by a serologic fast digital test. Randomisation of Hp-positive patients in two subgroups, receiving an eradication treatment: lansoprazole 60 mg/d, amoxicilline 2 g/d and clarithromycine 1 g/d during 7 days (group 1), or a placebo (group 2). Prevalence of GI symptoms estimated in the 3 groups (group 3 = not infected patients) at 2, 6 and 12 weeks after the beginning of the treatment. Analysis in intention to treat. Results 330 patients; group 1: n = 93; group 2: n = 92; group 3: n = 145. The highest prevalence of GI symptoms in the group 1 at S2 was related to diarrhoea, main side effect of antibiotics (21,8% vs 4,6% in the group 2 and 5,6% in the group 3). The prevalence of GI symptoms at S6 was not different between the groups 2 and 3 (p = 0,77). After adjustment of the NSAIDs dosage received between S6 and S12, the prevalence of GI symptoms was the same between group 1 and e group 3 (9.4% and 10.0%). This prevalence was lower than in group 2 (17.3%). This difference was not significant because of the samples size, but the most frequent GI symptom identified in this group was pyrosis. Conclusion The GI tolerance of conventional NSAIDs does not differ whether or not patients are infected by Hp. Systematic Hp eradication in infected patients does not seem to improve the digestive tolerance of NSAIDs for the short-term; medium-term observed tendency deserves to be confirmed.

The primary objective of the present study was to evaluate the efficacy of 30 and 60 mg of lansoprazole administered in combination with two antibiotics for 7 or 10 days in eradicating Helicobacter pylori in duodenal ulcer patients.This multicenter double-blind study randomized for the lansoprazole dose was carried out by 325 gastroenterologists. The H. pylori-positive diagnosis was based on three antral biopsies (one for a rapid urease test and two for histological examination). Eradication was checked by a (13) C-urea breath test. Patients were given 30 or 60 mg of lansoprazole with 2 g of amoxicillin and 1 g of clarithromycin for 10 days or 7 days, followed by 30 mg of lansoprazole daily for 18 or 21 days, i.e. the total duration of antisecretory therapy was 28 days.Out of the 665 patients included, 620 were analyzed on the intent-to-treat basis and 567 on the per protocol basis. The eradication rates were significantly higher in the group receiving 60 mg of lansoprazole than in the 30 mg group in both the intent-to-treat analysis (P=0.003) and the per protocol analysis (P=0.006). In the intent-to-treat analysis 60 mg group, the rates (95% confidence intervals) in the 7-day and 10-day sub-groups were 82.5 (CI: 75.2 - 89.8) and 86.8% (CI: 82.2 - 91.4), respectively, and in the per protocol analysis 84.2 (CI: 76.9 - 91.5) and 91.5% (CI: 87.6 - 95.4), respectively. With either lansoprazole dose, the eradication rates seemed higher when therapy was administered for 10 days.The double dose of lansoprazole optimizes H. pylori eradication rates. The highest eradication rates were obtained after 10 days of therapy. Additional studies should be carried out to determine the optimal duration of triple therapy for eradicating H. pylori.

Helicobacter pylori associated gastritis responds to a variety of triple therapies. The combination of a proton pump inhibitor, amoxicillin and clarithromycin is particulary effective (1,2,3) and is one of the triple therapies recommended by the French conference of consensus. Amoxicillin and bismuth are among the most useful of the antimicrobial drugs that do not induce resistance in H. pylori. Currently, the triple therapy of asymptomatic gastritis does not seem to be suitable because of the cost and the risk of developping antibacterial resistance. However, a potential therapy using different metal salts could be envisaged for patients who do not have peptic ulcer. In fact, metals such as bismuth, silver or aluminium have been used in the treatment of gastritis for their topical activity but some of them have also bacteriostatic properties (4).

We evaluated the pituitary and gonadal suppression in 40 girls and nine boys treated with depot leuprorelin (3.75 mg sc if body weightor = 20 kg, 1.87 mg if body weight20 kg) every 28 days for central precocious puberty. Gonadal suppression was obtained in most of the children with this dose: 3 months after initiation of the treatment, 85% of children had a peak plasma luteinizing hormone response to gonadotropin-releasing hormone3 IU/l and the gonadal axis remained suppressed throughout the duration of the study (up to 24 months). Four patients required higher doses of leuprorelin to achieve suppression. In two girls, a cutaneous reaction to the drug was associated with incomplete suppression and the treatment had to be interrupted. Plasma leuprorelin levels tended to increase from day 3 to day 28 after injection. Residual leuprorelin levels measured 28 days after injection were stable during the first year of the study. We conclude that an initial dose of depot leuprorelin of 3.75 mg sc every 28 days is efficient in most children with central precocious puberty.

Efficacy and safety of a new oral third generation Cephalosporin, Cefotiam Hexetil (CTM) 200 mg bid were compared with those of Cefixime (CX) 200 mg bid over 10 day duration of treatment. One hundred and twenty two ambulatory adults suffering from chronic sinusitis were randomized by ENT specialists in this multicentre prospective double blind, doubled dummy study. Sinusitis diagnosis evocated in front of fascial pain, purulent nasal discharge and/or obstruction was confirmed with sinus X-ray. Use of antibiotics or corticosteroids concomitantly or 15 days prior inclusion represented one of the major exclusion criterion. One hundred and seventy one patients were evaluated for efficacy analysis (62 and 59 respectively in CTM and CX groups). Regarding demographic data, clinical and radiological signs, the two populations were comparable at inclusion excepted for sex and weight (female: 73% in CTM group versus 47% in CX group). The overall clinical success rate at the end of treatment (cure+improvement) was not significantly different between the two groups (CTM: 82% versus CX: 80%). The incidence of adverse events was less frequent in the CTM group (14.5% versus 19%). In conclusion, CTM 200 mg bid is as efficacious and as well tolerated as CX 200 mg bid in the treatment of chronic sinusitis in adults.

This paper aimed at evaluating the comparative efficacy of lansoprazole and omeprazole in reducing gastric acid secretion in patients suffering from Zollinger-Ellison syndrome.Nine patients with non-resected gastrinoma(s) an previously well controlled by omeprazole (mean dosage 75 +/- 12.4 (SEM) mg/day; extremes: 20-160 mg/day) underwent 24-hour intragastric pH-metry, baseline acid output before next dosing and serum gastrin dosages, receiving their usual therapy and thereafter lansoprazole at a weight equivalent posology (mean dosage 81.6 +/- 12.5 (SEM) mg/day; extremes: 30-165 mg/day).Lansoprazole maintained intragastric pH and basal acid output at therapeutic levels, but a discrete reacidification, that deserves confirmation on a larger group of patients, was observed between the meals.The possible long-term benefit of this phenomenon, especially on gastrinemia and the fundic ECL-cells density and gastric bacterial content, remains to be evaluated.

Lansoprazole, a new substituted benzimidazole, is an effective acid proton pump inhibitor acting by inhibiting selectively H+/K+ ATPase of the gastric parietal cell. This study was performed to assess the effect of successive 30, 60, 90 and 120 mg dosages of lansoprazole in 4 patients suffering from Zollinger-Ellison syndrome. The basal gastric acid output was markedly inhibited in comparison with baseline values (mean maximal reduction: 87%; extremes: 75-99%) and was dose-related. Lansoprazole inhibited pepsin output globally with a dose range effect between 30 and 90 mg/day. The treatment induced a rapid relief of clinical symptoms. No biological abnormality was noted. These data proved that lansoprazole is efficient for treating gastric acid hypersecretion in patients suffering from ZES.

This prospective, randomized study was carried out in the Orthopaedic Traumatology service, Hôpital Bichat, from March 1987 to June 1989 in order to compare the efficacy of an antibiotic prophylaxis either with cefotiam in "flash" administration or with cefazolin in continued administration (48 hours). This study included 207 patients undergoing a total hip or knee-joint replacement. The both groups (89 patients with cefotiam, 118 patients with cefazolin) were comparable with regard to all criteria. The general and local evolution did not show statistical significant difference in the occurrence of complications in the both groups. No infectious complication occurred after the operation for the two groups. Then, cefotiam, in "flash" administration (2 g with the anesthetic induction) proves to be as effective as a conventional antibiotic prophylaxis with cefazolin in the prevention of infectious complications in orthopaedic surgery.

The role of Lewis antigens in the pathogenic process is not well understood. The aim of this study was to determine whether the Lewis antigen expression of H. pylori differed in isolates obtained from symptomatic and asymptomatic individuals. Lewis antigen expression status was determined by ELISA, and confirmation of LPS 0 side chain production in isolates not expressing Lewis antigen phenotype was conducted by SDS-PAGE. Expression of Lewis antigens by H. pylori isolates of symptomatic and asymptomatic individuals differed significantly in three main categories: I) Type I Lewis antigens (Lea and Le) were not expressed at all by isolates from asymptomatic individuals, as compared with low level expression by isolates from symptomatic individuals; 2)incidence of LeX expression was significantly reduced in isolates from asymptomatic individuals; 3) an increased proportion of isolates from asymptomatic individuals did not express any Lewis antigens at all. The identification of differences between H. pylori isolated from symptomatic and asymptomatic individuals is the first step to understanding the potential role Lewis antigens may play in the pathogenicity of this bacteria. The decrease in the LeX expression by isolates from asymptomatic individuals is particularly interesting as this antigen has been noted to be expressed in higher proportions of H. pylori isolated from patients with peptic ulcer disease. The isolation of a high proportion of H. pylori that do not express any Lewis antigens in asymptomatic strains may also indicate a host-mediated cross reaction to the H. pylori Lewis antigens that may cause the pathology seen in some symptomatic patients.