香连化浊颗粒治疗慢性萎缩性胃炎伴肠上皮化生70例临床研究——一项随机、双盲、安慰剂对照试验  

Clinical Study on the Treatment of 70 Cases Chronic Atrophic Gastritis with Intestinal Metaplasia Using Xianglian Huazhuo Granules(香连化浊颗粒):A Randomized,Double-Blind,Placebo-Controlled Trial

作　　者：李子昱 张茂鹏 赵雯 李薇 盛时运 白海燕 杨倩 LI Ziyu;ZHANG Maopeng;ZHAO Wen;LI Wei;SHENG Shiyun;BAI Haiyan;YANG Qian(Hebei University of Chinese Medicine,Shijiazhuang,05001l;First Affiliated Hospital of Hebei University of Chinese Medicine)

机构地区：[1]河北中医药大学,河北省石家庄市050011 [2]河北中医药大学第一附属医院

出　　处：《中医杂志》2025年第5期473-479,共7页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局科技项目(GZY-KJS-2023-025);河北省重点研发计划(223777123D)。

摘　　要：目的观察香连化浊颗粒治疗慢性萎缩性胃炎伴肠上皮化生的临床疗效及可能作用机制。方法将140例慢性萎缩性胃炎伴肠上皮化生患者随机分为治疗组和对照组各70例。治疗组予香连化浊颗粒口服,每次12.5 g,每日2次;对照组予安慰剂口服,每次12.5 g,每日2次,疗程均为6个月。观察两组患者治疗前后中医症状积分、病理分型、消化系血清肿瘤标志物水平及血清胆汁酸(TBA)、白细胞介素23(IL-23)、Dickkopf相关蛋白1(DKK-1)水平,同时检测安全性指标并记录不良事件发生情况。治疗结束后评价中医证候疗效和病理分型疗效,并随访18个月,记录胃镜病理结果,与治疗结束时病理结果比较。结果对照组脱落2例,最终共纳入分析168例,其中治疗组70例,对照组68例。与本组治疗前比较,治疗组治疗后各中医症状积分及血清TBA、IL-23、DKK-1水平均降低,甲胎蛋白(AFP)、糖类抗原125(CA125)、糖类抗原199(CA199)水平均明显升高,对照组癌胚抗原(CEA)、CA125、CA199水平均明显升高(P<0.05或P<0.01),两组糖类抗原242(CA242)水平均明显降低(P<0.01)。治疗组治疗后各中医症状积分及血清TBA、IL-23、DKK-1水平均低于对照组(P<0.05)。治疗组治疗后中医证候疗效有效率为80.00%(56/70),对照组有效率为20.59%(14/68),治疗组显著优于对照组(P<0.05)。治疗组治疗后混合型肠上皮化生的病理分型疗效有效率为72.73%(8/11),对照组为46.15%(6/13),治疗组优于对照组(P<0.05)。两组均未见不良事件。1年以上复查胃镜病理患者共有40例,治疗组21例,其中11例肠上皮化生程度减轻,9例无明显变化,1例加重;对照组19例,其中4例肠上皮化生程度减轻,13例无明显变化,2例加重。两组均未发现癌变。治疗组随访胃镜病理结果肠上皮化生程度改善情况优于对照组(P<0.05)。结论香连化浊颗粒能明显改善慢性萎缩性胃炎伴肠上皮化生患者的临床症状,改善混合�Objective To observe the clinical efficacy and possible mechanisms of Xianglian Huazhuo Granules(香连化浊颗粒,XHG)in the treatment of chronic atrophic gastritis with intestinal metaplasia.Methods A total of 140 patients with chronic atrophic gastritis and intestinal metaplasia were randomly divided into a treatment group and a control group,with 70 cases in each group.The treatment group received 12.5 g of XHG orally,twice daily.The control group received 12.5 g of placebo orally,twice daily.Both groups were treated for 6 months.The traditional Chinese medicine(TCM)symptom scores,pathological types,serum tumor markers of the digestive system,and serum bile acids(TBA),interleukin-23(IL-23),and Dickkopf-related protein 1(DKK-1)levels were observed before and after treatment.Safety indicators and adverse events were recorded.After treatment,TCM syndrome efficacy and pathological types were evaluated,and patients were followed up for 18 months with gastric endoscopy and pathological results,which were compared with the results after treatment finished.Results Two patients dropped out in the control group,and a total of 168 cases were included in the final analysis,70 in the treatment group and 68 in the control group.The treatment group showed a significant reduction in TCM symptom scores,serum TBA,IL-23,and DKK-1 levels,and a significant increase in alpha-fetoprotein(AFP),carbohydrate antigen 125(CA125),carbohydrate antigen 199(CA199)levels;in the control group,carcinoembryonic antigen(CEA),CA125,CA199 levels significantly increased(P<0.05 or P<0.01);and carbohydrate antigen 242(CA242)level in both the treatment group and the control group decreased significantly(P<0.01).The treatment group had lower TCM symptom scores and lower levels of serum TBA,IL-23,and DKK-1 compared to the control group(P<0.05).The effective rate for TCM syndrome efficacy in the treatment group was 80.00%(56/70),significantly higher than the 20.59%(14/68)in the control group(P<0.05).The effective rate for pathological classification in

关 键 词：慢性萎缩性胃炎 肠上皮化生 肿瘤标志物 病理分型 随机对照试验 香连化浊颗粒 

分 类 号：R259[医药卫生—中西医结合]