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[胃脘痛病证双灵胃痛颗粒治疗的系统评价与Meta分析]

[Systematic review and Meta-analysis of Biling Weitong Granules in treatment of stomach ache disorder].

作者信息

Zhang Le, Wu Xue, Jing Cheng-Yang, Dai Ze-Qi, Li Miao-Miao, Tang Xu-Dong, Liao Xing

机构信息

Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2023 Apr;48(8):2249-2259. doi: 10.19540/j.cnki.cjcmm.20221222.501.

Abstract

This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P<0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P<0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P<0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P<0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger's test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.

摘要

本研究旨在评价荜铃胃痛颗粒治疗胃脘痛病证的有效性和安全性。从中文和英文电子数据库以及试验注册平台中检索自数据库建立至2022年6月10日以胃脘痛病证为主要症状的荜铃胃痛颗粒治疗消化系统疾病的随机对照试验(RCT)。两名研究者根据筛选标准进行文献筛选和数据提取。采用Cochrane偏倚风险工具(v 2.0)评估纳入研究的偏倚风险。使用RevMan 5.4和R 4.2.2进行分析,采用固定效应模型或随机效应模型进行汇总估计。主要结局指标为视觉模拟评分(VAS)和胃脘痛病证症状评分。次要结局指标为临床治愈率、幽门螺杆菌(Hp)根除率及不良反应/事件。共纳入27项RCT,样本量为2 902例。Meta分析结果显示,与传统西药治疗或安慰剂相比,荜铃胃痛颗粒可改善VAS评分(标准化均数差[SMD]=-1.90,95%置信区间[CI][-2.18,-1.61],P<0.000 01)、胃脘痛病证症状评分(SMD=-1.26,95%CI[-1.71,-0.82],P<0.000 01)、临床治愈率(相对危险度[RR]=1.85,95%CI[1.66,2.08],P<0.000 01)及Hp根除率(RR=1.28,95%CI[1.20,1.37],P<0.000 01)。安全性评价显示,荜铃胃痛颗粒主要不良事件包括恶心呕吐、皮疹、腹泻、食欲不振、口苦,未报告严重不良事件。Egger检验无统计学意义,表明无发表偏倚。结果表明,荜铃胃痛颗粒治疗以胃脘痛病证为主要症状的消化系统疾病,可改善患者的VAS评分和胃脘痛病证症状评分,缓解胃脘痛病证,提高临床治愈率和Hp根除率,安全性良好,无严重不良反应。然而,原始研究质量较低,存在一定局限性。未来研究应采用统一规范的结局指标检测方法和评价标准,注重研究设计与实施的严谨性,突出药物临床安全性,为临床应用提供更可靠的临床证据支持。

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