临床传统医学和药理学（英文）2026，Vol.7Issue(2)：10-22,13.DOI:10.1016/j.ctmp.2026.200283
健脾活血汤逆转慢性萎缩性胃炎肠化萎缩的临床疗效:一项随机对照试验
Clinical effect of Jianpi Huoxue Decoction in reversing intestinal metaplasia and atrophy in chronic atrophic gastritis:A randomized controlled trial
摘要
Abstract
Background:Chronic atrophic gastritis(CAG),characterized by gastric mucosal atrophy and intestinal metaplasia,is a well-established precancerous lesion.Modern medicine currently lacks specific therapies to reverse these pathological changes.Traditional Chinese Medicine(TCM)posits that its core pathogenesis involves"spleen-stomach deficiency as the root cause and blood stasis in the stomach collaterals as the manifestation".Guided by this theory,this study employs the principle of"fortifying the spleen and replenishing qi to consolidate the root,and promoting blood circulation to remove stasis to unblock the collaterals"as the fundamental treatment approach.It aims to evaluate the clinical efficacy of the empirical formula Jianpi Huoxue Decoction(literally"Spleen-Fortifying and Blood-Activating Decoction")in combination with conventional Western medicine. Objective:This study aimed to evaluate the clinical efficacy of supplementing conventional Western medicine with Jianpi Huoxue Decoction in the treatment of chronic atrophic gastritis. Methods:This study was designed as a prospective randomized controlled clinical trial.The research followed the Consort 2025 statement,from September 2023 to September 2025,patients diagnosed with CAG were recruited and randomly assigned to a treatment group or a control group.The control group received conventional West-ern medicine treatment including folic acid tablets,vitamin C tablets,and symptomatic therapy.In addition to the same regimen administered to the control group,the treatment group received oral administration of Jianpi Huoxue Decoction.The treatment duration for both groups was three months.Clinical efficacy,TCM syndrome scores,histopathological grades of gastric mucosal atrophy and intestinal metaplasia(evaluated using Operative Link on Gastritis Assessment and Operative Link on Gastric Intestinal Metaplasia Assessment staging systems),and gastric secretion function indicators(PG I,PG Ⅱ,PGR,and G-17)were assessed and compared before and after treatment.The study protocol was approved by the Institutional Ethics Committee of Linping District Hos-pital of Traditional Chinese Medicine,Hangzhou,Zhejiang Province,China(Approval number:2023050607).The clinical trial protocol has been registered with the Chinese Clinical Trial Registry(ChiCTR)under the Inter-national Traditional Medicine Clinical Trial Registration Platform on February 9th,2026(registration number:ITMCTR2026000326,URL:https://itmctr.ccebtcm.org.cn/mgt/project/view/2020823963730575360). Results:After 3 months of treatment,the overall clinical effective rate was significantly higher in the treatment group than in the control group(93.1％vs.65.5％,P=0.005).The treatment group also showed greater im-provement in major TCM syndrome scores,including epigastric pain,abdominal fullness,and acid regurgitation(P＜0.05).Histopathological evaluation demonstrated that the treatment group achieved a higher rate of gastric mucosal atrophy improvement compared with the control group(80％vs.46.7％,P＜0.05).Moreover,regression from high-stage atrophy was more frequent in the treatment group(57.9％vs.25.0％,P＜0.05).Although the overall improvement rate of intestinal metaplasia did not differ significantly between groups,the regression rate from high-stage intestinal metaplasia was significantly higher in the treatment group(52.4％vs.20.8％,P＜0.05).In terms of gastric function,patients in the treatment group showed significant increases in pepsinogen Ⅰ(PG Ⅰ)and the pepsinogen ratio(PGR),along with a trend toward normalization of gastrin-17 levels,all of which were significantly better than those observed in the control group(P＜0.001). Conclusion:Jianpi Huoxue Decoction demonstrates a synergistic effect when combined with conventional Western medicine.This integrated regimen not only effectively alleviates clinical symptoms in patients with CAG but also exerts a significant regression effect on gastric mucosal atrophy and intestinal metaplasia.These findings suggest that the combination of TCM and Western medicine can effectively intervene in disease progression,offering a promising clinical strategy for managing CAG.关键词
慢性萎缩性胃炎/健脾活血方/中医药/病理逆转/中西医结合/肠化生Key words
Chronic atrophic gastritis/Jianpi Huoxue decoction/Traditional Chinese medicine/Pathological reversal/Integrated Chinese and Western medicine/Intestinal metaplasia引用本文复制引用
岑刚,石荣珍,Tae-Young Choi,程时峰,凌鹏,王鑫炜,汪瑶,蒋群,来杰锋..健脾活血汤逆转慢性萎缩性胃炎肠化萎缩的临床疗效:一项随机对照试验[J].临床传统医学和药理学（英文）,2026,7(2):10-22,13.基金项目
This study was supported by the Hangzhou Health Science and Tech-nology Planning Project(No.B20231026)and the Traditional Chinese Medicine Clinical Research Project of Zhejiang Association of Tradi-tional Chinese Medicine(No.HQYTZY-2025-015). （No.B20231026）
