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目的比较伊托必利与莫沙必利治疗功能性消化不良的疗效和安全性。方法采用开放随机对照试验,将106例功能性消化不良患者随机分为两组,试验组53例,予伊托必利50mg,饭前服,每天3次;对照组53例,予莫沙必利5mg,饭前服,每天3次,疗程2周。观察症状变化和不良反应,比较治疗前和治疗后上腹各症状积分,进行疗效评估。结果试验组上腹胀、餐后饱胀、早饱、上腹痛、食欲下降、嗳气和恶心等症状消失或明显改善,积分明显降低(P<0·01),疗效与莫沙必利相似(P>0·05)。两组药物不良反应发生率分别为7·5%和9·4%,差异无显著意义(P>0·05)。结论伊托必利治疗功能性消化不良近期疗效与莫沙必利相似,安全性好。
Objective To compare the efficacy and safety of itoprime and mosapride in the treatment of functional dyspepsia. Methods A total of 106 patients with functional dyspepsia were randomly divided into two groups according to an open randomized controlled trial. 53 patients in the experimental group were treated with itop 50mg, and 3 times a day before meals. In the control group, 53 patients were given mosapride Lee 5mg, before meals, 3 times a day, treatment for 2 weeks. Observed changes in symptoms and adverse reactions, compared before and after treatment of upper abdominal symptoms score, the efficacy evaluation. Results The symptoms such as abdominal distension, postprandial fullness, postpartum fullness, upper abdominal pain, appetite decreased, belching and nausea disappeared or significantly improved, and the scores were significantly lower (P <0.01) and the effect was similar to that of mosapride > 0 · 05). Adverse drug reactions in both groups were 7.5% and 9.4%, respectively, with no significant difference (P> 0.05). Conclusion The efficacy of Itopride in treating functional dyspepsia is similar to mosapride, and its safety is good.