比较复方比黑马尔江胶囊与艾司奥美拉唑镁肠溶片对胃食管反流病的临床疗效。

本研究为开放性、随机、阳性对照试验。预计纳入120例胃食管反流病患者。按照随机数字表法，将患者随机分为3组，即A组为复方比黑马尔江胶囊低剂量组，B组为复方比黑马尔江胶囊高剂量组，C组为艾司奥美拉唑镁肠溶片组。A组给予复方比黑马尔江胶囊一次2 g（5粒）、3次/d；B组给予复方比黑马尔江胶囊一次4 g（10粒）、3次/d；C组给予艾司奥美拉唑镁肠溶片40 mg，1次/d，疗程为4周。服药第2周和第4周各随访一次。对比分析3组治疗方案的临床疗效以及不良反应发生率。计数资料采用（

在三组中，A组有效率为77.5%，B组有效率为87.5%，C组有效率为90.0%，A和B组临床总有效率82.5%，总不良反应发生率2.5%；C组的不良反应总发生率7.5%。高剂量复方比黑马尔江胶囊与艾司奥美拉唑镁肠溶片疗效比较无统计学差异（P＞0.05），低剂量复方比黑马尔江胶囊与艾司奥美拉唑镁肠溶片疗效比较有统计学差异（P＜0.05），艾司奥美拉唑镁肠溶片的疗效优于复方比黑马尔江胶囊。不良反应总发生率比较，复方比黑马尔江胶囊组低于艾司奥美拉唑镁肠溶片组，差异有统计学意义（P＜0.05）。

与艾司奥美拉唑相比，采用高剂量复方比黑马尔江胶囊对胃食管反流病进行治疗，不仅临床疗效与艾司奥美拉唑镁肠溶片相近，还可进一步降低不良反应发生率，确保临床药物治疗的安全性，值得临床推广。

To compare the clinical efficacy and safety of compound Bihmarjan capsule and esomeprazole magnesium enteric-coated tablets on gastroesophageal reflux disease.

This 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.

In 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).

The 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.