目的 探讨开胃理脾丸联合多潘立酮治疗功能性消化不良的临床疗效。方法 选择2020年7月—2022年8月河南中医药大学第三附属医院收治的116例功能性消化不良患者，随机分为对照组（58例）和治疗组（58例）。对照组患者口服多潘立酮片，1片/次，3次/d。在对照组的基础上，治疗组口服开胃理脾丸，2丸/次，3次/d。两组患者治疗14 d。观察两组患者临床疗效，比较治疗前后两组患者症状改善时间，胃肠激素一氧化氮（NO）、血清胃动素（MTL）和血清胃泌素（GAS）水平，血清白细胞介素-6（IL-6）、降钙素基因相关肽（CGRP）、肿瘤坏死因子-α（TNF-α）和神经肽S受体1（NPSR1）水平，及不良反应情况。结果 治疗后，治疗组临床有效率（98.28%）明显高于对照组（84.48%，P＜0.05）。经治疗，治疗组症状改善时间明显早于对照组（P＜0.05）。治疗后，两组患者NO、IL-6和TNF-α水平明显降低，而MTL、GAS、CGRP和NPSR1水平明显升高（P＜0.05），且治疗组这些指标水平明显优于对照组（P＜0.05）。治疗后，治疗组不良反应总发生率（5.17%）明显低于对照组（12.07%，P＜0.05）。结论 开胃理脾丸联合多潘立酮治疗功能性消化不良效果确切，可有效改善症状，增强胃肠活力及动力，能降低胃肠炎性反应，有效降低患者焦虑状态。

Objective To investigate the clinical study of Kaiwei Lipi Pills combined with domperidone in treatment of functional dyspepsia. Methods Patient (116 cases) with functional dyspepsia in the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from July 2020 to August 2022 were randomly divided into control (58 cases) and treatment (58 cases) group. Patient in the control group was po administered with Domperidone Tablets, 1 tablet/time, three times daily. Patient in the treatment group were po administered with Kaiwei Lipi Pills on the basis of the control group, 2 pills/time, three times daily. Patient in two groups were treated for 14 weeks. After treatment, the clinical evaluation was evaluated, and the improvement time of symptom, gastrointestinal hormone of NO, MTL and GAS, the levels of serum CGRP, NPSR1, IL-6 and TNF-α, adverse reaction in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group (98.28%) was significantly higher than that of the control group (84.48%, P < 0.05). After treatment, the improvement time of symptom in the treatment group was significantly earlier than that in the control group (P < 0.05). After treatment, the levels of NO, IL-6 and TNF-α were significantly decreased, while the levels of MTL, GAS, CGRP and NPSR1 were significantly increased in two groups (P < 0.05), and the level of these indexes in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the adverse incidence in the treatment group (5.17%) was significantly lower than that in the control group (12.07%, P < 0.05). Conclusion Kaiwei Lipi Pills combined with domperidone in treatment of functional dyspepsia has a definite therapeutic effect, which can effectively improve symptoms, enhance gastrointestinal vitality and motility, reduce gastrointestinal inflammatory reaction and effectively reduce the anxiety state.

R975

河南省医学科技攻关计划（LHGJ20210728）