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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 efficacy of compound Shenqi soft capsule in children with functional dyspepsia (FD). Methods: Stratified randomized parallel group control non-blinded design, functional dyspepsia children stratified by age randomized into the group. The observation group was given Compound Shenqi Soft Capsule while the control group was given Compound Shenqi Granules. 1 month for a course of treatment. The clinical efficacy of the observation group and the control group in improving abdominal pain, abdominal distension, eating less early fullness, belching acid reflux, nausea and vomiting were compared. The changes of gastric electrical parameters in both groups were also monitored. Results: Shenqi Soft Capsule can significantly improve clinical symptoms such as abdominal pain, abdominal distension, hypo-early-appetite, nausea and vomiting, nausea and vomiting, can significantly increase the normal gastric electrical rhythm and reduce the gastric nocturnal electrical rhythm, compared with before treatment There was a significant difference (P <0.05); in improving abdominal pain, abdominal distension, eating less early fullness, reducing gastric motility slow, compared with the compound Shenqi particles were significantly different (P <0.05); the total effective rate was 91.9% in the control group, and 78.3% in the control group. There was significant difference between the two groups (P <0.05). Conclusion: The compound Shenqi soft capsule is effective in treating functional dyspepsia in children with rare adverse reactions and is suitable for clinical popularization and application.