기능성 소화불량증 환자에서 mosapride의 상부 위장관 증상 및 위배출능에 대한 효과 = Effects of Mosapride on Upper Gastrointestinal Symptoms and Gastric Emptying in Patients with Functional Dyspepsia기능성 소화불량증 환자에서 mosapride의 상부 위장관 증상 및 위배출능에 대한 효과

국문 초록 (Abstract)

목적: Mosapride는 5-HT4 수용체 작용제로서, dopamine D2수용체 차단작용이 없는 새로운 위장관 운동촉진제이다. 본 연구에서는 기능성 소화불량증 환자에서 mosapride가 상부 위장관 증상 및 고형식의 위배출능에 미치는 효과를 알아보고자 하였다. 대상 및 방법: 3개의 3차 의료기관에 내원한 기능성 소화불량증 환자를 무작위 배정하여 시험약 mosapride 5mg과 대조약 domperidone 10 mg을 하루 3회, 2주간 투약하였고, 약물 투여 전후로 고형식의 위배출능, 자각증상을 평가하였다. 결과: 총 81명의 환자 중에서 75명이 2주간의 투약을 완료하였다. 자각증상 개선도 평가에서 중등도 효과 이상을 나타낸 비율은 mosapride 군이 84.6%, domperidone 군이 80.6%로 두 약물 모두 높은 개선 효과를 나타냈으며, 두 치료군 간에 유의한 차이는 없었다. 고형식 섭취 120분 후 mosapride 투여 전후의 위배출능은 각각 76.8±16.4%, 82.4±13.5%였으며( p=0.0023), domperidone 투여 전후의 위배출능은 각각 76.5±13.9%, 83.0±10.7%였다( p=0.0022). 그러나, 두 치료군 간에 위배출능 변화량에 대해서는 유의한 차이는 없었다. 안전성 평가에서 mosapride 군에서는 최소한 한 건 이상의 이상반응을 보고한 환자 비율이 11.9%로 domperidone 군(42.1%)에 비해서 유의하게 낮았으며(90% CI=-0.46~-0.15), 임상증상 이상반응, 혈액검사, 심전도 검사, 그리고 활력징후에 있어서도 임상적으로 유의한 변화를 유발하지 않았다. Domperidone 군은 39.5%에서 혈청 prolactin치의 상승이 있었다. 결론: Mosapride는 국내의 기능성 소화불량증 환자의 치료에 있어서 안전하면서도 유용하게 사용될 수 있는 위장운동 촉진제로 생각된다.

다국어 초록 (Multilingual Abstract)

Backgr ound/Aims: Mosapride is a new, prokinetic, 5-HT4 agonistic agent free of dopamine D2 receptor antagonist properties. The aim of this study was to evaluate the effects of mosapride on upper GI symptoms and gastric emptying in patients with functional dyspepsia. Methods: Eighty-one patients were randomly allocated to treatment with mosapride (5 mg t.i.d) (n=42) or domperidone (10 mg t.i.d) (n=39) in a single-blind, prospective, multicenter study. The changes in gastric emptying and symptom severity score after 2-week treatment were evaluated for the treatment efficacy. Results: The proportion of patients with symptom improvement more than 50% after medications was 84.6% in the mosapride-treated group and 80.6% in the domperidone-treated group, and this difference was not significant ( p=0.6426). In both groups, gastric emptying measured at 120 minutes after test meal was significantly accelerated after 2-week treatment compared with that of baseline. However, there was no significant difference between te two groups after 2-week treatment. Mosapride was well tolerated, and no serious adverse events were observed. Conclusions: Mosapride is a safe and useful drug for the treatment of patients with functional dyspepsia. (Kor J Neurogastr oenter ol Motil 2004;1:27-34)

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