通讯作者: 孙元水▲, 15658827828@163.com

DOI：10.12201/bmr.202611.00014

Clinical Efficacy of Hewei Jiedu Formula Combined with SOX Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

• 摘要：目的 探讨和胃解毒方联合替吉奥联合奥沙利铂（S-1 plus oxaliplatin，SOX）新辅助化疗治疗局部进展期胃癌的临床疗效及安全性。方法 纳入局部进展期胃癌患者72例，采用随机数字法分为对照组和治疗组，各36例。对照组脱落2例、治疗组脱落1例，最终对照组34例、治疗组35例纳入疗效分析。两组均接受SOX新辅助化疗2个周期，治疗组在此基础上加用和胃解毒方。比较两组肿瘤退缩分级（tumor regression grade，TRG）、实体瘤疗效评价标准（Response Evaluation Criteria in Solid Tumors，RECIST）1.1近期疗效、中医证候积分及治疗相关不良反应。结果 两组年龄、男性比例、体质量指数、临床分期、分化程度、卡氏功能状态评分、癌胚抗原及糖类抗原19-9等基线资料比较，差异均无统计学意义（P>0.05）。对照组TRG有效率为32.4%（11/34），治疗组为60.0%（21/35），治疗组高于对照组（χ²=5.301，P=0.021）。对照组客观缓解率和疾病控制率分别为14.7%和70.6%，治疗组分别为37.1%和94.3%，治疗组均高于对照组（χ²=4.503、6.741，P=0.034、0.009）。治疗后治疗组胃脘痛、纳呆、嗳气及乏力积分均低于对照组（P<0.05），中医证候总有效率高于对照组（71.4%比44.1%，χ²=5.280，P=0.022）。治疗组白细胞减少、中性粒细胞减少及恶心/呕吐发生率均低于对照组（P<0.05）。结论 和胃解毒方联合SOX新辅助化疗可提高局部进展期胃癌患者的病理退缩及影像学近期疗效，改善化疗期间中医证候，并减少部分骨髓抑制和胃肠道不良反应，具有一定的增效减毒作用。

  关键词： 胃肿瘤; 和胃解毒方; 新辅助化疗; SOX方案; 肿瘤退缩分级; 中医证候

   

  Abstract: Objective To investigate the efficacy and safety of Hewei Jiedu Formula combined with S-1 plus oxaliplatin (SOX) neoadjuvant chemotherapy in patients with locally advanced gastric cancer.Methods Seventy-two patients with locally advanced gastric cancer were randomly assigned to a control group and a treatment group, with 36 patients in each group. Two patients in the control group and one in the treatment group dropped out; 34 and 35 patients, respectively, were included in the efficacy analysis. Both groups received two cycles of SOX neoadjuvant chemotherapy, and the treatment group additionally received Hewei Jiedu Formula. Tumor regression grade (TRG), radiological response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, traditional Chinese medicine (TCM) syndrome scores, and treatment-related adverse events were compared.Results Baseline characteristics were comparable between groups (all P>0.05). The TRG response rate was 32.4% (11/34) in the control group and 60.0% (21/35) in the treatment group (χ²=5.301, P=0.021). Objective response rates were 14.7% and 37.1%, and disease control rates were 70.6% and 94.3% in the control and treatment groups, respectively (P=0.034 and P=0.009). After treatment, scores for epigastric pain, poor appetite, belching, and fatigue were lower in the treatment group (all P<0.05), and the overall TCM syndrome response rate was higher (71.4% vs 44.1%, P=0.022). Leukopenia, neutropenia, and nausea/vomiting occurred less frequently in the treatment group (all P<0.05).Conclusion Hewei Jiedu Formula combined with SOX neoadjuvant chemotherapy may enhance pathological and radiological responses, improve TCM syndrome symptoms, and reduce selected hematologic and gastrointestinal toxicities in patients with locally advanced gastric cancer.

  Key words: Stomach neoplasms; Weihe Jiedu Formula; Neoadjuvant chemotherapy; SOX regimen; Tumor regression grade; Traditional Chinese medicine syndrome

  提交时间：2026-11-08

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• 序号	提交日期	编号	操作
  1	2026-10-12	10.12201/bmr.202611.00014V1	下载

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