中国全科医学 ›› 2022, Vol. 25 ›› Issue (14): 1765-1771.DOI: 10.12114/j.issn.1007-9572.2022.01.003

所属专题: 儿科最新文章合集

• 医学循证 • 上一篇    下一篇

肠炎宁颗粒治疗小儿消化不良有效性和安全性的系统评价与Meta分析

张蕾, 吕健, 谢雁鸣*()   

  1. 100700 北京市,中国中医科学院中医临床基础医学研究所
  • 收稿日期:2021-11-14 修回日期:2022-02-13 出版日期:2022-03-25 发布日期:2022-04-07
  • 通讯作者: 谢雁鸣
  • 张蕾,吕健,谢雁鸣.肠炎宁颗粒治疗小儿消化不良有效性和安全性的系统评价与Meta分析[J].中国全科医学,2022,25(14):1765-1771. [www.chinagp.net]
    作者贡献:张蕾负责文献数据的收集、整理,完成文献数据分析并完成论文初稿的写作;吕健对数据整理及分析过程中遇到的技术问题提供指导,绘制森林图;谢雁鸣提出本研究的主要目标,规划研究整体,指导论文写作,对文章整体负责。
  • 基金资助:
    国家重点研发计划项目(2018YFC1707400)

Effectiveness and Safety of Changyanning Granules in the Treatment of Dyspepsia in Children: a Systematic Review and Meta-analysis

Lei ZHANG, Jian LYU, Yanming XIE*()   

  1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2021-11-14 Revised:2022-02-13 Published:2022-03-25 Online:2022-04-07
  • Contact: Yanming XIE
  • About author:
    ZHANG L, LYU J, XIE Y M. Effectiveness and safety of Changyanning Granules in the treatment of dyspepsia in children: a systematic review and Meta-analysis[J]. Chinese General Practice, 2022, 25 (14) : 1765-1771.

摘要: 背景 小儿消化不良(即小儿功能性消化不良)是儿科临床常见病症,复发率较高,严重的小儿消化不良会影响儿童营养摄入,进而影响儿童身体生长发育乃至心理健康。 目的 对肠炎宁颗粒治疗小儿消化不良的有效性和安全性进行系统评价。 方法 计算机检索中文数据库:中国知网、万方数据知识服务平台、维普网、中国生物医学数据库,外文数据库:PubMed,The Cochrane Libarary,EMBase,Web of Science;检索时间从建库起至2021年5月,筛选出肠炎宁颗粒治疗小儿消化不良的随机对照试验(RCT),试验组使用肠炎宁颗粒或肠炎宁颗粒联合西医常规治疗(金双歧或吗丁啉);对照组为中成药常规治疗(小儿喜食片)或西医常规治疗(金双歧或吗丁啉),且不含肠炎宁颗粒,用药剂量、给药方式和疗程不限;主要结局指标为显效率,次要结局指标为不良反应发生率、临床症状消失时间。应用Cochrane Handbook 5.1评价标准和RevMan 5.3评价软件对最终纳入的研究进行Meta分析。 结果 共纳入6项研究进行Meta分析,包含1 150例患儿,试验组575例,对照组575例。Meta分析结果显示:肠炎宁颗粒治疗小儿消化不良的显效率高于中成药常规治疗〔RR=1.57,95%CI(1.27,1.94),P<0.000 1〕;肠炎宁颗粒+西医常规治疗小儿消化不良的显效率高于西医常规治疗〔RR=1.60,95%CI(1.13,2.26),P=0.008〕;肠炎宁颗粒治疗小儿消化不良的不良反应发生率低于中成药常规治疗〔RR=0.18,95%CI(0.09,0.37),P<0.000 01〕;肠炎宁颗粒联合西医常规治疗小儿消化不良的不良反应发生率与单用西医常规治疗比较,差异无统计学意义(P>0.05);肠炎宁颗粒联合西医常规治疗小儿消化不良临床症状消失时间短于单用西医常规治疗(P<0.05)。 结论 基于现有数据和方法,肠炎宁颗粒单用或联合西医常规治疗可提高显效率、缩短临床症状消失时间,且不良反应发生率相对较低。但由于纳入研究质量不高,欲得到更有力的证据,还需采用大样本、设计严谨、符合国际规范的临床试验方案提高证据质量级别。

关键词: 消化不良, 儿童, 肠炎宁颗粒, 治疗结果, 随机对照试验, 不良反应, 系统评价, Meta分析

Abstract:

Background

Dyspepsia (namely, the functional dyspepsia) in children, is a common pediatric disease that has a high recurrence rate. Severe dyspepsia will affect the nutritional intake of children, and may further impair their physical development and even mental health.

Objective

To systematically review the effectiveness and safety of Changyanning Granules in the treatment of dyspepsia in children.

Methods

We searched databases of CNKI, WanFang Data, CQVIP, and SinoMed for randomized controlled trials (RCTs) in Chinese and searched databases of PubMed, The Cochrane Libarary, EMBase, Web of Science for relevant RCTs in English from inception to May 2021. Regarding children with dyspepsia treated by Changyanning Granules or Changyanning Granules in combination with routine western treatment〔Live Combined Bifidobacterium and Lactobacillus Tablets (LCBLT) or Motilium Tablets (MT) 〕 (experimental group) compared with those treated with Xiaoer Xishi Pian (a Chinese patent medicine) or routine western treatment (LCBLT or MT) regardless of dosage, administration route and duration of treatment. We used response rate as the primary outcome indicator, and incidence of adverse reactions and clinical symptoms disappearing time as secondary outcome indicators. We used the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1) and RevMan 5.3 for conducting the meta-analysis.

Results

Six RCTs were included, involving 1 150 cases (575 in the experimental group and 575 in the control group) . Meta-analysis showed that Changyanning Granules were superior to Xiaoer Xishi Pian in terms of overall response rate〔RR=1.57, 95%CI (1.27, 1.94) , P<0.000 1〕 with lower incidence of adverse reactions〔RR=0.18, 95%CI (0.09, 0.37) , P<0.000 01〕. Compared with LCBLT or MT, Changyanning Granules with LCBLT or MT produced higher overall response rate〔RR=1.60, 95%CI (1.13, 2.26) , P=0.008〕, and shortened the clinical symptom disappearing time (P<0.05) , but showed no significant difference in the incidence of adverse reactions (P>0.05) .

Conclusion

For children with dyspepsia, available evidence has demonstrated that using Changyanning Granules alone, or in combination with LCBLT or MT, could improve the overall response rate, shorten the clinical symptoms disappearing time with relatively low incidence of adverse reactions. However, due to low quality of included RCTs, our conclusion needs to be further verified by RCTs meeting the international standards with a large sample size, and rigorous design.

Key words: Dyspepsia, Child, Changyanning granules, Treatment outcome, Randomized controlled trial, Adverse reaction, Systematic reviews, Meta-analysis