复方比黑马尔江胶囊治疗胃食管反流病的疗效与安全性研究

Efficacy and safety of compound Bihmarjan capsule in the treatment of gastroesophageal reflux disease

ObjectiveTo compare the clinical efficacy and safety of compound Bihmarjan capsule and esomeprazole magnesium enteric-coated tablets on gastroesophageal reflux disease. MethodsThis study was an open, randomized and positive controlled trial. 120 patients with gastroesophageal reflux disease were participated in this study. According to the random number table, the patient is randomly divided into three groups, namely, group A is the lower dose group of compound Bihmarjan capsules, group B is the high dose group of Bihmarjan capsules, and group C is the Esomeprazole Magnesium Enteric-coated Tablets group. Group A were given 2 g (5 capsules) of compound Bihmarjan capsules 3 times daily; group B were given 4 g (10 capsules) of compound Bihmarjan capsules 3 times daily; group C were given 40 mg of Esomeprazole Magnesium Enteric-coated Tablets once daily. They were on medication for 4 weeks. Follow up was done in second and fourth weeks of the study. The clinical efficacy and incidence of adverse events were analyzed. ResultsIn three groups,77.5%, 87.5% and 90% of patients reported significant improvement of clinical symptom on Gerd-Q score respectively. The total clinical efficacy of group A and group B was 84.75%, and the total incidence of adverse event was 2.5%. there was no significant difference between group B and C in the clinical efficacy (P＞0.05), when the clinical efficacy of group A was worse than other two group (P＜0.05). The incidence of adverse events in group A and B were lower than group C (P＜0.05). ConclusionThe clinical efficacy of high dose Bihmarjan capsules is similar to Esomeprazole and the incidences of adverse event is lower than control group. Bihmarjan capsules have therapeutic potentials in the treatment of gastroesophageal reflux disease.