目的 探讨保和口服液联合西沙必利治疗小儿功能性消化不良的临床研究。方法 选取2019年2月—2021年2月在郑州大学附属儿童医院诊治的138例小儿功能性消化不良患儿，根据随机数字表法分为对照组和治疗组，每组各69例。对照组口服西沙必利混悬液，稀释成1 mg/mL，0.2 mg/kg，2次/d。治疗组患儿在对照组基础上口服保和口服液，10 mL/次，2次/d。两组患儿连续治疗7 d。观察两组患者临床疗效，比较治疗前后两组患者临床症状缓解时间，血浆胃泌素（GAS）、胃动素（MTL）、5-羟色胺（5-HT）和一氧化氮（NO）水平，血清炎性因子白细胞介素-10（IL-10）、白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）和干扰素-γ（IFN-γ）水平及不良反应。结果 治疗后，治疗组患儿总有效率为98.55%，明显高于对照组的85.51%（P＜0.05）。治疗后，治疗组患儿临床症状恶心呕吐、腹胀、腹痛、厌食缓解时间均早于对照组（P＜0.05）。治疗后，两组患儿GAS、MTL水平明显升高，而5-HT和NO水平明显降低（P＜0.05），且治疗组患儿GAS、MTL、5-HT、NO水平明显好于对照组（P＜0.05）。治疗后，两组血清炎性因子IL-10水平明显升高，而IL-6、TNF-α和IFN-γ水平明显降低（P＜0.05），且治疗组患儿血清炎性因子水平明显好于对照组（P＜0.05）。治疗组患儿不良反应发生率明显低于对照组（P＜0.05）。结论 保和口服液与西沙必利联合治疗小儿功能性消化不良疗效明显，临床症状缓解快，能改善胃肠激素水平，降低炎性反应，药物不良反应小。

Objective To investigate the curative effect of Baohe Oral Liquid combined with cisapride in treatment of children with functional dyspepsia.Methods Children (138 cases) with functional dyspepsia in Children's Hospital Affiliated to Zhengzhou University from February 2019 to February 2021 were divided into control and treatment group according to random number table method, and each group had 69 cases. Children in the control group were po administered with Cisapride Suspension, which was diluted to 1 mg/mL, 0.2 mg/kg, twice daily. Children in the treatment group were po administered with Baohe Oral Liquid on the basis of the control group, 10 mL/time, twice daily. Children in two groups were treated for 7 d. After treatment, the clinical evaluation was evaluated, the relief time of clinical symptom, the levels of GAS, MTL, 5-HT, and NO, the levels of serum inflammatory factors, and adverse reactions in two groups before and after treatment were compared.Results After treatment, the clinical effective rate of the treatment group was 98.55%, which was significantly higher than that of the control group (85.51%) (P < 0.05). After treatment, the relief time of nausea and vomiting, abdominal distension, abdominal pain and anorexia in the treatment group was earlier than that in the control group (P < 0.05). After treatment, the levels of GAS and MTL in two groups were significantly increased, while the levels of 5-HT and NO were significantly decreased, and the levels of GAS, MTL, 5-HT, and NO in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the level of serum inflammatory factors IL-10 was significantly increased, while the levels of IL-6, TNF-α, and IFN-γ were significantly decreased in two groups, and the level of serum inflammatory factors in the treatment group was significantly better than that in the control group (P < 0.05). The incidence of adverse reactions in the treatment group was significantly lower than that in the control group (P < 0.05).Conclusion The curative effect of Baohe Oral Liquid combined with cisapride in treatment of children with functional dyspepsia is obvious, which can quickly relieve the clinical symptoms, improve the level of gastrointestinal hormone, reduce the inflammatory reaction, and the adverse drug reaction is small.

R975

河南省医学科技攻关计划省部共建项目（SBGJ202002125）