复合凝乳酶胶囊治疗儿童功能性消化不良临床研究

Clinical study on the efficacy and safety of composite milk clotting enzyme capsules in children with functional dyspepsia

目的 观察使用复合凝乳酶胶囊治疗儿童功能性消化不良的效果及药物的安全性.方法 采用多中心、随机开放的临床试验方法,纳入2012年2月至2013年3月广东省4家三级甲等医院门诊收治的符合罗马Ⅲ标准诊断为功能性消化不良的患儿,观察并比较治疗1周及2周的总症状积分变化及药物相关不良反应,治疗效果根据总症状积分下降程度分为显效、有效及无效;并以疗效相差大于10％为优效标准对治疗1周及2周的有效性做非劣检验.结果 共有201例患儿纳入观察,196例完成2周治疗.治疗2周显效率、总有效率分别为68.88％、87.76％,明显高于治疗1周的显效率（27.04％）和总有效率（76.02％）（U=2.935,P＜0.05）.治疗2周后和1周后症状积分改善率的差值、症状积分下降的差值及显效率变化差值的95％可信区间（95％ CI）下限均大于10％,治疗2周疗效优于治疗1周疗效.试验期间未见明显药物相关不良反应.结论 服用复合凝乳酶胶囊治疗消化不良对各症状改善明显.治疗2周较治疗1周的效果明显,无明显不良反应.

9 Objective To evaluate the efficacy and safety of composite milk clotting enzyme capsules in children with functional dyspepsia.Methods A multicenter,randomized,open-label clinical trial was carried out in 4Guangzhou hospitals during Feb.2012 to Mar.2013.Children with functional dyspepsia on basis of Rome Ⅲ criteria were enrolled and treated with composite milk clotting enzyme capsules.Total symptom score and drug-related adverse reactions were evaluated after one-week and two-week therapy.The treatment outcome were divided into very effective,fairly effective and ineffective according to the symptom score changes.Superiority test was done for effectiveness of the treatment based on efficacy difference by 10% regarded as superiority.Results Two hundred and one children were enrolled.One hundred and ninety-six children completed the study as planned.After two-week therapy,better effective rate and total effective rate were 68.88% and 87.76%,higher than those of one-week therapy （27.04%,76.02%） （U =2.935,P 〈 0.05）.The lower limits of 95 % confidence interval of difference in symptoms improve rate,better efficacy rate and symptom score decrease rate between two-week and one-week therapy were more than 10%,and two-week therapy was superior to one-week therapy.No significant drug-related adverse reaction was found during the study.Conclusions Composite milk clotting enzyme capsules can improve functional dyspepsia symptoms significantly.The effectiveness of two-week of treatment is better than that of one-week treatment.No obvious drug-related adverse reaction is observed.