荆花胃康胶丸联合四联疗法治疗幽门螺旋杆菌相关性胃炎的系统评价及Meta分析

doi:10.19803/j.1672-8629.20230153

摘要/Abstract

摘要： 目的探讨荆花胃康胶丸联合四联疗法对幽门螺旋杆菌（Hp）相关性胃炎的有效性与安全性。方法检索PubMed、Cochrane Library、Embase、SinoMed、中国知网、万方数据和维普网数据库,检索时间为建库至2022年5月19日,纳入荆花胃康胶丸联合四联疗法治疗Hp相关性胃炎患者的随机对照研究,以临床有效率（显效、有效均视作有效）、Hp根除率为主要结局指标,消化道症状改善、炎症因子[白细胞介素-6（IL-6）,C反应蛋白（CRP）,肿瘤坏死因子（TNF-α）]、不良反应发生率为次要结局指标提取并合并数据。使用GRADE证据质量分级系统进行单个结局指标的质量评价,使用Revman 5.4.1进行Meta分析,Cochrane协作网偏倚风险评估工具进行单个研究的质量评价。结果 10篇随机对照研究、1 181例患者被纳入最终分析。Meta分析结果显示：荆花胃康胶丸联合四联疗法治疗Hp相关性胃炎其临床有效率（RR=1.20,95%CI 1.12~1.30,P<0.000 01）、Hp根除率（RR=1.16,95%CI 1.10~1.23,P<0.000 01）、消化道症状改善（SMD=-1.74,95%CI -2.85~-0.62,P=0.002）、炎症因子IL-6（SMD=-3.68,95%CI -5.72~-1.64,P=0.000 4）、炎症因子CRP（SMD=-2.09,95%CI -2.44~-1.73,P<0.000 01）、炎症因子TNF-α（SMD=-2.58,95%CI -3.11~-2.06,P<0.000 01）、不良反应发生率（RR=0.89,95%CI 0.60~1.32,P=0.55）。结论在治疗Hp相关性胃炎时,荆花胃康胶丸和四联疗法联用在临床有效率、Hp根除率、消化道症状缓解、炎症因子的改善等方面效果优于单用四联疗法,中西联用方案和单用四联方案在不良反应方面无区别。由于目前临床研究质量不高,以上结论尚需更多高质量临床研究进一步证明。

关键词: 幽门螺旋杆菌, 荆花胃康胶丸, 四联疗法, 慢性胃炎, Meta分析, 有效性, 安全性

Abstract: Objective To explore the efficacy and safety of Jinhuaweikang capsules combined with quadruple therapy in the treatment of patients with Helicobacter pylori (Hp) associated gastritis. Methods Cochrane Library, EMBASE, PubMed, Sinomed, CNKI, Wanfang data and VIP databases were searched for articles published between inception and May 19, 2022 about Hp associated gastritis patients treated with Jinhuaweikang capsules combined with quadruple therapy. The therapeutic effect was compared with those treated with quadruple therapy alone. The data was retrieved and integrated with the clinical effective rate (markedly effective and effective) and Hp eradication rate as the main indicators of outcomes and with the improvement of digestive tract-related symptoms, inflammatory factor (IL-6,CRP and TNF-α) and adverse reactions were secondary indicators of outcomes. The bias risk assessment tool of the Cochrane collaborative network was used to evaluate the quality of an individual study,the grade evidence quality grading system was adopted to evaluate the quality of an individual index of outcomes, and Revman 5.4.1 software was used to analyze data and test heterogeneity. Results Ten RCTs and 1 181 patients were included. Meta analysis results showed that when Jinhuaweikang capsules were combined with quadruple therapy to treat Hp associated gastritis patients, the clinical effective rate was (RR=1.20, 95%CI 1.12-1.30, P<0.000 01), Hp eradication rate was (RR=1.16, 95%CI 1.10-1.23, P<0.000 01), the improvement of digestive tract-related symptoms was (SMD=-1.74, 95%CI -2.85--0.62, P=0.002), IL-6 was (SMD=-3.68, 95%CI -5.72--1.64, P=0.000 4), CRP was (SMD=-2.09, 95%CI -2.44--1.73, P<0.000 01), TNF-α was (SMD=-2.58, 95%CI -3.11--2.06, P<0.000 01) and rate of adverse reactions was (RR=0.89, 95%CI 0.60-1.32, P=0.55). Conclusion In the treatment of Hp associated gastritis, the combination of Jinhuaweikang capsules with quadruple therapy is more effective than quadruple therapy alone in terms of the Hp eradication rate, the improvement of digestive tract-related symptoms and inflammatory factors. Due to the low quality of clinical studies, more high-quality clinical studies are needed to verify the above conclusions.

Key words: Helicobacter pylori (Hp), Jinhuaweikang capsule, quadruple therapy, gastritis, Meta analysis, efficacy, safety

中图分类号:

R975

刘倩, 胡晶, 李博, 杨小静. 荆花胃康胶丸联合四联疗法治疗幽门螺旋杆菌相关性胃炎的系统评价及Meta分析[J]. 中国药物警戒, 2023, 20(9): 1039-1045.

LIU Qian, HU Jing, LI Bo, YANG Xiaojing. Jinghuaweikang capsules combined with quadruple therapy in the treatment of Helicobacter pylori associated gastritis: a systematic evaluation and meta-analysis[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1039-1045.

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