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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
Received:04 September 2024,
Revised:01 January 2025,
Accepted:2025-01-02,
Published:15 April 2025
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戎萍,潘桂赟,魏娟等.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[J].中国药房,2025,36(07):867-873.
RONG Ping,PAN Guiyun,WEI Juan,et al.Meta-analysis of the clinical efficacy and safety of Jianwei xiaoshi oral liquid in the treatment of functional dyspepsia in children[J].ZHONGGUO YAOFANG,2025,36(07):867-873.
戎萍,潘桂赟,魏娟等.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[J].中国药房,2025,36(07):867-873. DOI: 10.6039/j.issn.1001-0408.2025.07.18.
RONG Ping,PAN Guiyun,WEI Juan,et al.Meta-analysis of the clinical efficacy and safety of Jianwei xiaoshi oral liquid in the treatment of functional dyspepsia in children[J].ZHONGGUO YAOFANG,2025,36(07):867-873. DOI: 10.6039/j.issn.1001-0408.2025.07.18.
目的
2
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
2
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
2
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
2
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。
OBJECTIVE
2
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
2
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
2
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 control group, the levels of gastrin [SMD=1.63, 95%CI (0.98, 2.29)
]
and motilin [SMD=2.06, 95%CI (1.58, 2.54)
]
as well as gastric antral emptying rate [MD=5.99, 95%CI (2.78, 9.21)
]
in trial group were increased significantly, while the level of somatostatin was decreased significantly [SMD=-1.30, 95%CI (-1.57, -1.02)
]
(
P
≤0.000 3).
CONCLUSIONS
2
Jianwei xiaoshi oral liquid, whether used alone or in combination with other medications, and regardless of the treatment course or dosage and usage, is effective in treating FD in children, with good safety.
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