Dispeptik hastalarda Helicobacter pylori eradikasyonu için 14 günlük ranitidin bizmut sitrat vs lansoprazol tabanlı üçlü tedavi; çok merkezli, randomize, prospektif çalışma
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Date
2013
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info:eu-repo/semantics/openAccess
Abstract
Giriş ve Amaç: Proton pompa inhibitörü ve ranitidin bizmut sitrat bazlı üçlü tedavi rejimleri Helikobakter pilori eradikasyonun- da ilk basamak tedavi olarak önerilir. Çok merkezli prospektif, randomize bir çalışma ile bu iki tedavi rejiminin etkinlik ve tolere edilebilirliğini araştırmayı amaçladık. Gereç ve Yöntem: On beş çalışma merkezinden dispeptik yakınmaları olan hastalar seçil- di. Hem histolojik hem de hızlı üreaz testi ile Helikobakter pilori pozitifliği tanımlanan hastalar belirlendi. Hastalar 14 gün bo- yunca günde ikişer defa olmak üzere ya ranitidin bizmut sitrat 400 mg + amoksisilin 1 g + klaritromisin 500 mg ya da lansopra- zol 30 mg + amoksisilin 1 g + klaritromisin 500 mg kullanacak şekilde randomize edildi. Tedavi süresince yan etkiler kaydedildi. Tedavi bitiminden 6 hafta sonra 13C üre nefes testi ile Helikobakterin eradike olup olmadığına bakıldı. Etkinlik intension to treat ve per protocol analizleri ile değerlendirildi. Bulgular: 279 hasta randomizasyona uygundu (123 erkek, 156 kadın). Per protocol analizinde (247 hasta) ranitidin bizmut sitrat bazlı tedavinin ve lansoprazol bazlı tedavinin eradikasyon oranları sırasıyla %74,6 ve %69,2 idi (p>0,05). Intension to treat analizinde ise (279 hasta) ranitidin bizmut sitrat bazlı tedavinin ve lansoprazol bazlı te- davinin eradikasyon oranları sırasıyla %65,1 ve %63,6 idi (p>0.05). Her iki tedavide iyi tolere edildi ve anlamlı bir yan etki gözlen- medi. Sonuç: Ranitidin bizmut sitrat bazlı tedavi klasik proton pompa inhibitörlü tedavi kadar etkin ve tolere edilebilirdir. Ama her iki tedavi de önerilebilir eradikasyon oranlarına ulaşamamıştır.
Background/aims: Proton-pump inhibitor- and ranitidine bismuth citrate-based triple regimens are the two recommended first- line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treat- ments in a prospective, multi-centric, randomized study. Materials and Methods: Patients with dyspeptic complaints were recrui- ted from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients we- re randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13C urea breath test was performed 6 weeks after termination of treatment to as- sess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. Results: Two hun- dred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate- and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was ob- served during the study. Conclusion: Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classi- cal proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.
Background/aims: Proton-pump inhibitor- and ranitidine bismuth citrate-based triple regimens are the two recommended first- line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treat- ments in a prospective, multi-centric, randomized study. Materials and Methods: Patients with dyspeptic complaints were recrui- ted from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients we- re randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13C urea breath test was performed 6 weeks after termination of treatment to as- sess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. Results: Two hun- dred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate- and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was ob- served during the study. Conclusion: Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classi- cal proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.
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Cerrahi
Journal or Series
Turkish Journal of Gastroenterology
WoS Q Value
Scopus Q Value
Volume
24
Issue
4
