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Meðferð á meltingarónotum með súkralfati : tvíblind rannsókn

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Authors
Hallgrímur Guðjónsson
Einar Oddsson
Sigurður Björnsson
Ólafur Gunnlaugsson
Ásgeir Theodórs
Tómas Árni Jónasson
Bonnevie, Olaf
Bjarni Þjóðleifsson
Issue Date
1994-04-01

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Læknablaðið 1994, 80(4):149-53
Abstract
The object of the study was to assess fhe efficacy of sucralfate in the treatment of non-ulcer dyspepsia (NUD). The diagnosis of NUD was made by exclusion. All patients underwent an upper gastrointestinal endoscopy and abdominal ultrasound and blood tests were done as clinically indicated. Patients with a history of peptic ulcer disease were not included. Symptomatic assessment was done at the beginning and at the end of the study. The patients registered their most prominent dyspeptic symptoms, whether they improved, were unchanged or worse. The study was double blind. Placebo or sucralfate 1 gm. q.i.d. was given for 3 weeks. Over a 2 year period 104 patients were included in the study, 56 received sucralfate and 48 placebo. Nine patients were excluded because of poor compliance or side effects, 6 from the sucralfate group and 3 from the placebo group. The sucralfate and placebo groups were comparable in symptom and clinical parameters. Global assessment of symptoms showed that in the sucralfate group 34 improved (68%), 11 were unchanged and 5 were worse. In the placebo group 31 improved (69%), 11 were unchanged and 3 were worse. There was no statistical difference between the groups. The three week course of sucralfate 1 gm q.i.d. in patients with non-ulcer dyspepsia did not show symptomatic improvement over placebo.
Markmið rannsóknarinnar var að meta gagnsemi súkralfats í meðferð meltingarónota. Allir sjúklingarnir voru magaspeglaðir. Auk þess var ómun af kviðarholi og blóðrannsókn gerð hjá þeim sem ástæða þótti til. Sjúklingar með sögu um sár í maga eða skeifugörn voru ekki teknir með. Einkenni sjúklinganna voru metin bæði í upphafi og við lok rannsóknarinnar. Sjúklingarnir skráðu þau tvö einkenni sin sem voru mest áberandi, hvort þau voru betri, óbreytt eða verri við lok meðferðar, miðað við upphaf. Rannsóknin var tvíblind og var geíið ýmist lyfleysa eða súkralfat 1 g fjórum sinnum á dag í þrjár vikur. Alls voru 104 sjúklingar teknir inn í rannsóknina, 56 fengu súkralfat og 48 lyfleysu. Níu sjúklingar féllu út vegna slælegrar lyfjatöku eða aukaverkana, sex úr súkralfathópnum og þrír úr lyfleysuhópnum. Hóparnir voru í aðalatriðum sambærilegir. Mat á einkennum í lok meðferðar sýndi að í súkralfathópnum höfðu 34 (68%) hlotið bata, 11 voru óbreyttir og fimm verri. Í lyfleysuhópnum hafði 31 (69%) hlotið bata, 11 voru óbreyttir og þremur hafði versnað. Enginn marktækur munur var á milli hópanna. Þessi þriggja vikna meðferð með súkralfati 1 g fjórum sinnum á dag hjá sjúklingum með meltingarónot gaf því ekki betri árangur en lyfleysa.
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