目的 评估小儿扶脾颗粒联合乳酸菌素片治疗功能性消化不良患儿的临床疗效及安全性。方法 选取2024年5月—2025年7月在上海健康医学院附属崇明医院就诊并接受规范化治疗的功能性消化不良患儿共116例，采用简单随机法将所有患儿分为对照组（58例）和治疗组（58例）。对照组患儿口服乳酸菌素片，2片/次，3次/d。治疗组在对照组基础上口服小儿扶脾颗粒，1袋/次，3次/d。两组患儿连续治疗2周。观察两组患儿临床疗效，对比临床症状缓解时间，血清胃肠激素指标胃动素（MTL）、胃泌素（GAS）、生长抑素（SS）和血管活性肽（VIP）水平，餐后30、60 min的胃窦排空率。结果 治疗后，治疗组总有效率为94.83%，明显高于对照组的82.76%（P＜0.05）。治疗后，治疗组患儿餐后饱胀不适、早饱感、上腹痛和上腹烧灼感的缓解时间均明显短于对照组（P＜0.05）。治疗后，两组患儿血清MTL和GAS水平明显高于治疗前，而血清SS和VIP水平显著低于治疗前（P＜0.05），同时治疗组血清胃肠激素水平改善情况显著优于对照组（P＜0.05）。两组患儿进餐后30 min和进餐后60 min胃窦排空率均明显升高（P＜0.05），同时治疗组各时间点的胃窦排空率均显著高于对照组（P＜0.05）。结论 小儿扶脾颗粒联合乳酸菌素片能够有效治疗功能性消化不良患儿，在缩短临床缓解时间的同时，能够改善胃排空能力和胃肠激素水平，安全性高。

Objective To evaluate the clinical efficacy and safety of Xiao’er Fupi Granules combined with Lacidophilin Tablets in the treatment of children with functional dyspepsia. Methods A total of 116 children with functional dyspepsia who received standardized treatment in Chongming Hospital, Shanghai Health Medical College from May 2024 to July 2025 were enrolled. They were randomly divided into a control group and a treatment group using a simple randomization method, with 58 cases in each group. The control group was given oral Lacidophilin Tablets at a dose of 2 tablets per time, 3 times a day. On the basis of the control group, the treatment group was additionally administered oral Xiao’er Fupi Granules, 1 sachet per time, 3 times a day. Both groups received continuous treatment for 2 weeks. The clinical efficacy, remission time of clinical symptoms, serum levels of gastrointestinal hormones motilin (MTL), gastrin (GAS), somatostatin (SS), and vasoactive intestinal peptide (VIP), as well as antral emptying rates at 30 and 60 minutes after meals were observed and compared between the two groups. Results After treatment, the total effective rate of the treatment group was 94.83%, which was significantly higher than 82.76% of the control group (P < 0.05). After treatment, the recovery times of post-meal fullness and discomfort, early satiety, upper abdominal pain, and upper abdominal burning sensation in the treatment group were significantly shorter than those in the control group (P < 0.05). Compared with before treatment, serum levels of MTL and GAS were significantly increased, while serum levels of SS and VIP were significantly decreased in both groups after treatment (P < 0.05); notably, the improvement of serum gastrointestinal hormone levels in the treatment group was significantly superior to that in the control group (P < 0.05). In addition, the antral emptying rates at 30 and 60 minutes after meals were significantly increased in both groups (P < 0.05), and the antral emptying rates in the treatment group were significantly higher than those in the control group at both time points (P < 0.05). Conclusion Xiao’er Fupi Granules combined with Lacidophilin Tablets is effective in the treatment of children with functional dyspepsia. It can not only shorten the clinical remission time, but also improve gastric emptying function and regulate serum gastrointestinal hormone levels, with high safety.

R975

上海市卫生健康委员会卫生行业临床研究专项立项项目(202340126)