Page 109 - 《中国药房》2025年7期

健胃消食口服液治疗儿童功能性消化不良的疗效与安全性的

Meta分析 Δ

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戎 萍 1， 2＊ ，潘桂赟 ，魏 娟 ，李腾达 ，张喜莲 （1.天津中医药大学第一附属医院儿科，天津 300381；2.国
家中医针灸临床医学研究中心，天津 300381；3.山东大学齐鲁医院德州医院中医科，山东 德州 253000）
中图分类号 R725.7；R969.4 文献标志码 A 文章编号 1001-0408（2025）07-0867-07
DOI 10.6039/j.issn.1001-0408.2025.07.18

摘 要 目的 评价健胃消食口服液治疗儿童功能性消化不良（FD）的疗效与安全性，为该药临床应用提供循证依据。方法 计算
机检索中国知网、维普、万方、中国生物医学文献数据库、Cochrane Library及PubMed，检索时限均为建库起至2024年4月，收集健
胃消食口服液治疗儿童FD的随机对照试验。对照组使用常规西药（促胃肠动力药、抗酸或抑酸药），试验组单用或与常规西药（药
物剂量、疗程与对照组相同）联合使用健胃消食口服液。使用Cochrane风险偏倚评估工具6.1进行质量评价后，采用RevMan 5.3
软件进行Meta分析。结果 共纳入16篇文献，合计1 962例患儿。Meta分析结果显示，健胃消食口服液治疗儿童FD的临床总有
效率显著高于对照组[RR＝1.18，95%CI（1.13，1.22），P＜0.000 01]。本研究针对试验组的用法用量、疗程、联用与否以及常规西药
类别进行亚组分析，结果显示，试验组的临床总有效率均显著高于对照组。试验组患儿腹胀腹痛缓解时间[MD＝－2.54，95%CI
（－3.10，－1.98）]、食欲不振缓解时间[MD＝－2.12，95%CI（－2.63，－1.61）]、恶心呕吐缓解时间[MD＝－1.70，95%CI（－2.27，
－1.14）]、泛酸嗳气缓解时间[MD＝－1.61，95%CI（－2.44，－0.78）]均显著缩短（P＜0.05）。此外，与对照组相比，试验组患者胃泌
素水平[SMD＝1.63，95%CI（0.98，2.29）]、胃动素水平[SMD＝2.06，95%CI（1.58，2.54）]、胃窦排空率[MD＝5.99，95%CI（2.78，
9.21）]均明显升高，生长抑素水平[SMD＝－1.30，95%CI（－1.57，－1.02）]明显降低（P≤0.000 3）。结论 健胃消食口服液单用或联
用、不同疗程、不同用法用量对儿童FD均有效，安全性较高。
关键词 健胃消食口服液；功能性消化不良；儿童；餐后不适综合征；上腹痛综合征

Meta-analysis of the clinical efficacy and safety of Jianwei xiaoshi oral liquid in the treatment of functional
dyspepsia in children
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RONG Ping ，PAN Guiyun ，WEI Juan ，LI Tengda ，ZHANG Xilian （1. Dept. of Pediatrics， the First
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Affiliated Hospital of Tianjin University of Traditional Chinese Medicine， Tianjin 300381， China；2. National
Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion， Tianjin 300381， China；3. Dept.
of Traditional Chinese Medicine， Dezhou Hospital， Qilu Hospital of Shandong University， Shandong Dezhou
253000， China）
ABSTRACT OBJECTIVE To evaluate the clinical efficacy and safety of Jianwei xiaoshi oral liquid in the treatment of functional
dyspepsia （FD） in children， and provide evidence-based basis for clinical use of the drug. METHODS Retrieved from CNKI，
VIP， Wanfang， CBM， Cochrane Library and PubMed， randomized controlled trials （RCTs） about Jianwei xiaoshi oral liquid in the
treatment of FD in children were collected from the inception to Apr. 2024. The control group was treated with conventional western
drugs （including gastrointestinal motion-promoting， antacids or acid-suppressing drugs）， and the trial group was treated with
Jianwei xiaoshi oral liquid alone or combined with conventional Western drugs （drug dosage and course of treatment were the same
as the control group）. Meta-analysis was performed using RevMan 5.3 software after quality evaluation with the Cochrane risk bias
assessment tool 6.1. RESULTS Totally 16 literature were employed which included 1 962 patients. The results of meta-analysis
showed that the total clinical effective rate of Jianwei xiaoxi oral liquid in the treatment of FD in children of trial group was
significantly higher than that of the control group [RR＝1.18， 95%CI （1.13， 1.22）， P＜0.000 01]. In this study， subgroup analysis
was conducted on the usage and dosage， course of treatment， and combination or not in trial group， as well as the type of
conventional Western drugs. The results showed that the total clinical effective rate of trial group was significantly higher than that
of control group； the relief time of abdominal distension and abdominal pain in trial group [MD＝－2.54， 95%CI （－3.10，
－1.98）]， loss of appetite relief time [MD＝－2.12， 95%CI （－2.63， －1.61）]， nausea and vomiting relief time [MD＝－1.70，
95%CI （－2.27， －1.14）]， and belching relief time [MD＝－1.61， 95%CI （－2.44， －0.78）] were shorter than that of the control
group significantly （P＜0.05）. In addition， compared with
Δ 基金项目 国家中医药管理局青年岐黄学者支持项目（No.国中 control group， the levels of gastrin [SMD＝1.63， 95%CI
医药人教函〔2021〕204号） （0.98， 2.29）] and motilin [SMD＝2.06， 95%CI （1.58， 2.54）]
＊第一作者 主任医师，博士。研究方向：小儿脑病及常见病。 as well as gastric antral emptying rate [MD＝5.99， 95%CI
E-mail：erke2007@163.com （2.78， 9.21）] in trial group were increased significantly， while

中国药房 2025年第36卷第7期 China Pharmacy 2025 Vol. 36 No. 7 · 867 ·