复方参芪软胶囊治疗儿童功能性消化不良的随机对照试验

Randomized Controlled Trials on Compound Shenqi Soft Capsules in Children with Functional Dyspepsia

目的:评价复方参芪软胶囊对儿童功能性消化不良(FD)的疗效。方法:采用分层随机平行组对照非盲法设计,将功能性消化不良患儿按年龄分层后随机入组。观察组给予复方参芪软胶囊,对照组给予复方参芪颗粒。1个月为一疗程。比较观察组与对照组在改善腹痛、腹胀、食少早饱、嗳气反酸、恶心呕吐等方面的临床疗效,并监测两组患者儿的胃电指标变化。结果:复方参芪软胶囊能明显改善患儿腹痛、腹胀、食少早饱、嗳气反酸、恶心呕吐等临床症状,能明显增加正常胃电节律,减少过缓胃电节律,与治疗前比较有显著性差异(P<0.05);在改善腹痛、腹胀、食少早饱,减少胃动过缓方面,与复方参芪颗粒比较有显著性差异(P<0.05);观察组总有效率为91.9%,对照组总有效率为78.3%,两组比较有显著性差异(P<0.05)。结论:复方参芪软胶囊治疗儿童功能性消化不良疗效满意,不良反应少见,适合临床推广应用。

Objective：To evaluate the clinical effects of compound Shenqi soft capsules in the children with functional dyspepsia（FD）.Methods：A stratified random,parallel,control and non-blind design was used,and the children with FD were randomly divided into groups after stratified by age.The children in the trial group were given compound Shenqi soft capsules,one capsule for the children with age under three and two capsules for the children with age over three,tid.The control group was treated with compound Shenqi granules,half a bag for the children with age under three and 1 bag for the children with age over three,tid.The treatment course was one month.The two groups were compared by the symptoms of bellyache,abdominal distension,early satiety,belching and nausea.The electrogastrogram was analyzed in two groups.Results：Compound Shenqi soft capsules could improve the symptoms of ballyache,abdominal distension,early satiety,belching and nausea obviously,increase normal rhythm and reduce bradygastria obviously,and there were significant differences compared with those before the treatment（P〈0.05）.The trial group was better than the control group in the improvement of ballyache,abdominal ditension,early satiety and bradygastria,and the difference was significant（P〈0.05）.The total effective rate of the trial group was 91.9%,while that of the control group was78.3%,and the difference was statistically significant（P〈0.05）.Conclusion：The clinical effect of compound Shenqi soft capsules is satisfied without any adverse reaction during the test,suggesting the capsules are suitable for clinical application.