复方阿嗪米特肠溶片联合依托必利治疗功能性消化不良腹胀

Compound azintamide enteric-coated tablet plus itopride for the treatment of abdominal distension in patients with functional dyspepsia

目的观察复方阿嗪米特肠溶片联合依托必利治疗功能性消化不良(FD)腹胀的效果。方法155例以腹胀为主诉的FD患者随机分为治疗组(78例,复方阿嗪米特肠溶片+依托必利)和对照组(77例,依托必利),分别每天3次给予复方阿嗪米特肠溶片(2片,餐后立即口服)和/或依托必利(50mg,餐前30min口服)共2周。观察各组治疗前后腹胀积分变化、腹胀改善总有效率及药物副作用。结果治疗2周末时治疗组腹胀积分明显低于对照组(P<0.05),腹胀改善总有效率为94.9%,明显高于对照组(P<0.01)。治疗过程中各组均未出现严重药物副作用。结论复方阿嗪米特肠溶片联合依托必利能迅速缓解FD患者腹胀症状,两者之间具有一定协同作用,具有较好安全性。

Objective To investigate the efficacy of compound azintamide enteric - coated tablet plus itopride for the treatment of abdominal distension in patients with functional dyspepsia （FD）. Methods A total of 155 patients with the chief complaint of abdominal distension were randomized to treatment group （ n = 78 ） treated with eompound azintamide enteric - coated tablet plus itopride and control group （ n = 77 ） treated with itopride. Compound azintamide formulated as enteric - coated tablet was administered orally 2 tablets tid immediately after meal while itopride was administered orally 50 mg tid 30rain before meal for 2 weeks. Changes of abdominal distension score, the total effective rates in improvement of abdominal distension, and drug side effects before and after treatment were observed. Results After 2 weeks treatment, the mean abdominal distension score in treatment group were significantly lower than that in control group （ P 〈 0.05 ）. The total effective rate of the improvement of abdominal distension was 94.9%, significantly higher than that in control group （ P 〈 0.01 ）. No severe drug side effects were noted in each group during the treatment. Conclusion The abdominal distension caused by FD can be quickly relieved after treatment with compound azintamide enterie- coated tablet combined with itopride. The two drugs show synergistic effect and good safety.