ISSN 1674-3865  CN 21-1569/R
主管：国家卫生健康委员会
主办：中国医师协会
　　　辽宁省基础医学研究所
　　　辽宁中医药大学附属医院
中国中西医结合儿科学

中国中西医结合儿科学 ›› 2022, Vol. 14 ›› Issue (4): 319-322.

• 临床研究 • 上一篇    下一篇

山葡健脾颗粒治疗儿童功能性消化不良的随机对照多中心临床研究

  

  • 出版日期:2022-08-25 上线日期:2023-11-29

A randomized controlled multicenter clinical study of Shanpu Jianpi granules in the treatment of children with functional dyspepsia

  • Published:2022-08-25 Online:2023-11-29

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摘要： 目的 评价山葡健脾颗粒治疗儿童功能性消化不良症状与脾虚食滞证候改善作用，以及临床应用的安全性。方法 采用随机、对照、多中心、非劣效检验的设计方法。选择2022年2～7月辽宁中医药大学第一附属医院、辽宁省妇幼保健院、本溪满洲自治县中医院收治功能性消化不良患儿120例，随机分为观察组和对照组各60例。观察组口服山葡健脾颗粒，对照组口服双歧杆菌三联活菌肠溶胶囊，疗程2周。疗程结束后记录：(1)两组功能性消化不良症状积分综合总有效率；(2)两组中医证候疗效(总有效率);(3)两组功能性消化不良单项症状疗效；(4)两组不良反应发生率。结果 患儿失访脱落4例，其中观察组1例，对照组3例。观察组和对照组功能性消化不良症状综合总有效率分别为89.83%(53/59)和85.96%(49/57),提示观察组非劣于对照组。其他次要指标包括中医证候疗效、功能性消化不良单项症状疗效的组间比较差异均无统计学意义(P>0.05)。本次研究共报告3例临床不良事件，观察组1例(1.69%,1/59),对照组2例(3.51%,2/57),两组不良事件发生率比较差异无统计学意义(P>0.05)。结论 山葡健脾颗粒治疗功能性消化不良疾病症状的综合总有效率非劣于对照药双歧杆菌三联活菌肠溶胶囊，且能改善中医证候，临床应用安全性较好。 

关键词:

功能性消化不良, 积滞, 脾虚夹积证, 山葡健脾颗粒, 儿童

Abstract:

ObjectiveTo evaluate the effect of Shanpu Jianpi granules in improving the symptoms of functional dyspepsia and stagnation of spleen deficiency in children, and the safety of its clinical application.MethodsA randomized, controlled, multicenter, non-inferiority test design method was used. A total of 120 children with functional dyspepsia who were admitted to the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning Maternal and Child Health Hospital, and Benxi Manzhou Autonomous County Traditional Chinese Medicine Hospital from February 2022 to July 2022 were chosen and randomly divided into the observation group and the control group with 60 cases in each group. The observation group was given oral administration of Shanpu Jianpi granules, while the control group was given oral administration of Bifidobacterium triple viable enteric-coated capsules. The treatment lasted for 2 weeks. After the treatment course, record the following: (1) the comprehensive total effective rate of functional dyspepsia symptom scores in the two groups; (2) the curative effect of TCM syndromes in the two groups (total effective rate); (3) the curative effect of a single symptom of functional dyspepsia in the two groups; (4) the incidence of adverse reactions in the two groups.ResultsThe comprehensive total effective rate of functional dyspepsia symptom in the observation group and the control group was89.83%(53/59) and 85.96(49/57), suggesting that the observation group was not inferior to the control group. There was no statistical difference in other minor indexes between the two groups, including effect on traditional Chinese medicine syndrome and the curative effect on single symptom of functional dyspepsia (P>0.05). Altogether 3 adverse events were reported, one in the observation group (1.69%，1/59) and two in the control group (3.51%,2/57), and there was no statistical difference in the incidence of adverse events between the two groups.ConclusionShanpu Jianpi granules is not inferior to the control drug Bifidobacterium triple viable enteric-coated capsules in the treatment of FD symptoms, and can improve TCM syndromes, with good clinical safety.

Key words:

Functional dyspepsia, Stagnation, Spleen deficiency with accumulation syndrome, Shanpu Jianpi granule, Children