Abstract:

Objective　To evaluate the efficacy of Shenqu Xiaoshi oral liquid combined with Mosapride citrate in improving gastric motility indicators and alleviating symptoms in children with functional dyspepsia. Methods　This study was a randomized controlled trial. A total of 150 children with functional dyspepsia admitted to Baoji Maternal and Child Health Hospital from May 2021 to May 2023 were selected as the study objects, and were divided into a control group (75 cases) and an observation group (75 cases) by the random number table method. In the control group, 41 boys and 34 girls were (6.89±1.13) years old and the course of disease was (5.76±1.08) months. In the observation group, 44 boys and 31 girls were (7.10±1.22) years old and the course of disease was (5.85±1.13) months. The control group was treated with Mosapride citrate (for children under 7 years old, 2.5 mg each time, 3 times a day; for children ≥7 years old, 5.0 mg each time, 3 times a day), and the observation group was treated with Shenqu Xiaoshi oral liquid (for children under 5 years old, 5 ml each time, 3 times a day; for children ≥ 5 years old, 10 ml each time, 3 times a day) combined with Mosapride citrate for 2 weeks. The gastric motility indicators [antral contraction frequency (ACF), antral contraction amplitude (ACA), and motility index (MI)], intestinal flora (Escherichia coli, Enterococcus, Bifidobacterium, and Lactobacillus), symptom scores, and adverse reactions (dry mouth, diarrhea, dizziness, fatigue, and vomiting) were compared between the two groups before and two weeks after treatment. t test and χ² test were used. Results　After treatment, the ACF, ACA and MI levels in the observation group were (4.06±0.67) times/min, (52.43±5.24) mm, and (2.18±0.20), which were higher than those in the control group [(1.94±0.43) times/min, (49.54±4.95) mm, and (1.82±0.17)], with statistically significant differences (all P<0.05). After treatment, the counts of Bifidobacterium and Lactobacillus in the observation group were (9.78±1.23) CFU/g and (9.79±1.38) CFU/g, which were higher than those in the control group [(7.39±1.71) CFU/g and (6.89±1.44) CFU/g]; the counts of Escherichia coli and Enterococcus were (4.41±0.43) CFU/g and (3.85±0.37) CFU/g, which were lower than those in the control group [(7.33±1.22) CFU/g and (6.52±0.74) CFU/g], with statistically significant differences (all P<0.05). After treatment, the dimension scores of primary and secondary symptoms in the observation group were lower than those in the control group, with statistically significant differences (all P<0.05). The total incidence of adverse reactions in the observation group was higher than that in the control group [17.33% (13/75) vs. 10.67% (8/75)], but the difference was not statistically significant (χ²=1.384, P=0.239). Conclusion　The combined treatment of Shenqu Xiaoshi oral liquid and Mosapride citrate in children with functional dyspepsia can effectively improve their gastric motility indicators and intestinal flora, alleviate the symptoms of functional dyspepsia, and reduce the occurrence of adverse reactions, demonstrating good safety.

Key words:

Functional dyspepsia, Shenqu Xiaoshi oral liquid, Mosapride citrate, Gastric motility indicators, Symptom scores, Children

摘要：

目的　评估神曲消食口服液联合枸橼酸莫沙必利改善功能性消化不良患儿胃动力指标及缓解其症状的效果。方法　本研究为随机对照试验，选取在2021年5月至2023年5月期间宝鸡市妇幼保健院收治的150例功能性消化不良患儿作为研究对象，通过随机数字表法将患儿分为对照组（75例）和观察组（75例）。对照组男41例，女34例，年龄（6.89±1.13）岁，病程（5.76±1.08）个月；观察组男44例，女31例，年龄（7.10±1.22）岁，病程（5.85±1.13）个月。对照组患儿予以枸橼酸莫沙必利治疗（7岁以下的儿童，每次2.5 mg，每天3次；7岁及以上的儿童，每次5.0 mg，每天3次），观察组患儿予以神曲消食口服液（5岁以下的儿童，每次5 ml，每天3次；5岁及以上的儿童，每次10 ml，每天3次）联合枸橼酸莫沙必利治疗，持续治疗两周。比较两组患儿治疗前及治疗两周后胃动力指标［胃窦收缩频率（ACF）、胃窦收缩幅度（ACA）、运动指数（MI）］、肠道菌群（肠杆菌、肠球菌、双歧杆菌、乳杆菌）、症状积分及不良反应（口干、腹泻、头晕、乏力、呕吐）。采用t检验、χ²检验。结果　治疗后，观察组患儿ACF、ACA、MI水平分别为（4.06±0.67）次/min、（52.43±5.24）mm、（2.18±0.20），均高于对照组（1.94±0.43）次/min、（49.54±4.95）mm、（1.82±0.17），差异均有统计学意义（均P<0.05）；治疗后，观察组患儿双歧杆菌、乳杆菌数量分别为（9.78±1.23）CFU/g、（9.79±1.38）CFU/g，高于对照组（7.39±1.71）CFU/g、（6.89±1.44）CFU/g，肠杆菌、肠球菌数量分别为（4.41±0.43）CFU/g、（3.85±0.37）CFU/g，低于对照组（7.33±1.22）CFU/g、（6.52±0.74）CFU/g，差异均有统计学意义（均P<0.05）；治疗后，观察组患儿主次症各维度积分均低于对照组，差异均有统计学意义（均P<0.05）；观察组患儿的不良反应总发生率17.33%（13/75）高于对照组10.67%（8/75），但差异无统计学意义（χ²=1.384，P=0.239）。结论　对功能性消化不良患儿给予神曲消食口服液与枸橼酸莫沙必利联合治疗，能够有效改善其胃动力指标和肠道菌群，减轻功能性消化不良症状，减少不良反应，安全性较好。

关键词:

功能性消化不良, 神曲消食口服液, 枸橼酸莫沙必利, 胃动力指标, 症状积分, 儿童