目的 观察二陈丸联合多潘立酮治疗痰湿型功能性消化不良的临床疗效。方法 利用组间匹配原则将2023年2月—2024年12月上海中医药大学附属市中医医院收治的功能性消化不良患儿120例，分为对照组和治疗组，每组各60例。对照组患儿饭前15～20 min口服多潘立酮片，10 mg/次，3次/d。治疗组在对照组基础上口服二陈丸，3～6岁患儿30 mg/kg，2次/d；7～12岁患儿2～3 g/次，3次/d；＞12岁患儿6 g/次，3次/d。两组患儿均连续治疗2周。观察两组患儿临床疗效，比较治疗前后两组患儿临床症状缓解时间，中医证候积分，生活质量，胃泌素（GAS）、生长抑素（SS）和胃动素（MTL）水平。结果 治疗后，治疗组总有效率明显优于对照组（96.67% vs 91.67%，P＜0.05），治疗组食欲不振、恶心呕吐、反酸嗳气、腹痛腹胀均较对照组缓解早（P＜0.05）；治疗后，治疗组主症次症证候积分、尼平消化不良生活质量指数（NDLQI）评分下降幅度大于对照组（P＜0.05），SS下降幅度与GAS、MLT升高幅度均大于对照组（P＜0.05）；治疗组复发率低于对照组，差异具有统计学意义（P＜0.05）。结论 在一般治疗基础上，二陈丸联合多潘立酮治疗痰湿型功能性消化不良患儿，利于缓解痰湿型功能性消化不良患儿不适症状，改善患儿胃肠激素，提高临床疗效，促进胃肠动力恢复，提高生活质量，且安全性尚可，短时间内的复发率较低，值得推荐用于临床功能性消化不良患儿。

Objective To observe the clinical efficacy of Erchen Pills combined with domperidone in treatment of functional dyspepsia of phlegm-turbid stagnation type in children. Methods Children (120 cases) with phlegm-turbid stagnation type in Shanghai Municipal Hospital of Traditional Chinese Medicine from February 2023 to December 2024 were divided into control and treatment group using the inter-group matching principle, and each group had 60 cases. Children in the control group were po administered with Domperidone Tablets 15 — 20 min before meals, 10 mg/time, three times daily. Children in the treatment group were po administered with Erchen Pills on the basis of the control group, 30 mg/kg for 3 — 6 years old children, twice daily, 2 — 3 g/kg for 7 — 12 years old children, 6 g/kg for more than 12 years old children, three times daily. Children in two groups were treated for 2 weeks. After treatment, the clinical evaluations were evaluated, and the clinical symptom relief time, TCM syndrome scores, quality of life (NDLQI), gastrointestinal hormone parameters SS, GAS and MLT levels in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was better than that in the control group (96.67% vs 91.67%, P < 0.05). After treatment, loss of appetite, nausea and vomiting, acid reflux and belching, abdominal pain and abdominal distension in the treatment group were all relieved earlier than in the control group (P < 0.05). After treatment, the decrease in main and secondary syndrome scores and NDLQI scores in the treatment group were greater than that in the control group (P < 0.05), and the decrease in SS and the increase in GAS and MLT were greater than that in the control group (P < 0.05). After treatment, the recurrence rate in the treatment group was lower than that in the control group with statistical significance (P < 0.05). Conclusion For children with phlegm-dampness type functional dyspepsia, on the basis of general treatment, the combination of Domperidone Tablets and Erchen Pills is beneficial to relieve the discomfort symptoms of children with phlegm-dampness type functional dyspepsia, improve the gastrointestinal hormones, enhance the clinical efficacy, promote the recovery of gastrointestinal motility, improve the quality of life, and the safety is acceptable, with a relatively low recurrence rate in a short period of time. It is worthy of being recommended for implementation in children with clinical functional dyspepsia.

R975;R985

第五批全国中医临床优秀人才研修项目（国中医药人教函[2022]1 号）