南京中医药大学学报2025，Vol.41Issue(6)：822-831,10.DOI:10.14148/j.issn.1672-0482.2025.0822
胃炎通络颗粒治疗脾虚瘀阻型慢性萎缩性胃炎的多中心随机双盲双模拟临床对照研究
Efficacy of Weiyan Tongluo Granules in Patients with Chronic Atrophic Gastritis of Spleen Deficiency and Blood Stasis Type:A Multi-Center,Double-Blind,Double-Dummy,Randomized Controlled Trial
摘要
Abstract
OBJECTIVE To evaluate the efficacy and safety of Weiyan Tongluo Granules in treating chronic atrophic gastritis(CAG)and explore its potential mechanisms.METHODS From June 2020 to December 2022,100 CAG patients with spleen defi-ciency and blood stasis syndrome were enrolled and randomly divided into a trial group(n=50)and a control group(n=50)using a random number table.The trial group received Weiyan Tongluo Granules plus a folic acid placebo,while the control group received fo-lic acid tablets plus a traditional Chinese medicine granule placebo.The treatment course for both groups was 24 weeks,with 8 and 10 dropouts in the trial and control groups,respectively.Post-treatment comparisons included OLGA/OLGIM staging reversal rates,low-grade intraepithelial neoplasia regression rate,SSDPRO-CG(Patient-Reported Outcome Scale for Chronic Gastritis in Spleen-Stomach Diseases)scores,TCM syndrome scores,and safety indicators.Serum levels of PG I,PGⅡ,PGR,and G-17 were measured via ELISA before and after treatment.Gastric mucosal p-NF-κB and CDX2 protein expression levels were analyzed by Western blot,while mRNA levels of IL-1β,IL-6,VIL1,and MUC2 were quantified via qPCR.RESULTS After treatment,the trial group showed sig-nificantly higher OLGA and OLGIM stage reversal rates than the control group(P<0.05,P<0.01),though no significant difference was observed in low-grade intraepithelial neoplasia regression.Both groups exhibited significant improvements in physiological domain scores and total SSDPRO-CG scores(P<0.01),with the trial group outperforming the control group in physiological,independence,psychological domains,and total scores(P<0.05,P<0.01).TCM syndrome scores(total and sub-items:gastric distension,pain,poor appetite,bloating)decreased significantly in both groups(P<0.01),while the trial group showed greater reductions in loose stools and dull complexion(P<0.01).After-treatment,the trial group had significantly lower TCM syndrome scores than the control group(P<0.05,P<0.01).Serum PG I,PGⅡ,PGR,G-17,gastric mucosal p-NF-κB,CDX2,and IL-1β,IL-6,VIL1,MUC2 mRNA levels improved significantly in the trial group(P<0.05,P<0.01),while the control group improved only in PGⅡ(P<0.05,P<0.01).The trial group's improvements in these biomarkers surpassed the control group's(P<0.05,P<0.01).No treatment-related adverse events occurred in either group.CONCLUSION Weiyan Tongluo Granules ameliorate gastric mucosal pathology,clinical symptoms,psychological state,and quality of life in CAG patients without significant adverse effects.Its mechanism may involve sup-pressing the NF-κB pathway to reduce IL-1β and IL-6 expression,downregulating CDX2 to inhibit VIL1 and MUC2 transcription,thereby reversing the vicious cycle of inflammation-intestinal metaplasia.关键词
胃炎通络颗粒/慢性萎缩性胃炎/脾虚瘀阻证/多中心/随机对照试验/NF-κB/CDX2Key words
Weiyan Tongluo Granules/chronic atrophic gastritis/spleen deficiency with blood stasis syndrome/multicenter/ran-domized controlled trial/NF-κB/CDX2分类
医药卫生引用本文复制引用
江晓涛,严艳花,郑君辉,文艺,刘凤斌,李培武,林洁,邹雨杉,杨泽虹,潘静琳,熊哲锟,王昌龙,黄远程,王姝烨..胃炎通络颗粒治疗脾虚瘀阻型慢性萎缩性胃炎的多中心随机双盲双模拟临床对照研究[J].南京中医药大学学报,2025,41(6):822-831,10.基金项目
国家自然科学基金面上项目(82474404,82474408,82104602) （82474404,82474408,82104602）
广东省自然科学基金面上项目(2023A1515011019,2024A1515012532) （2023A1515011019,2024A1515012532）
国家重点研发计划"中医药现代化"重点专项(2023YFC3503602) （2023YFC3503602）
广州中医药大学中医学学科中医基础理论研究"揭榜挂帅"项目(2022JB04) （2022JB04）
广州市科技计划项目市校(院)企联合项目(2024A03J0408,202102010422) （院）
广州中医药大学"双一流"与高水平大学学科后备人才培育项目(中医学二级学科:中医内科学) （中医学二级学科:中医内科学）
国家中医药传承创新中心科研专项(2022ZD01) （2022ZD01）
