Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (9): 1039-1045.
DOI: 10.19803/j.1672-8629.20230153

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Jinghuaweikang capsules combined with quadruple therapy in the treatment of Helicobacter pylori associated gastritis: a systematic evaluation and meta-analysis

LIU Qian1, HU Jing1, LI Bo1#, YANG Xiaojing2,*   

  1. 1Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Chinese Medicine, Beijing Evidence-based Chinese Medicine Center, Beijing 100010, China;
    2Department of Traditional Chinese Medicine, Eighth Medical Center, PLA General Hospital, Beijing 100091, China
  • Received:2023-03-21 Online:2023-09-15 Published:2023-09-14

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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

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