中医肿瘤学杂志2026，Vol.8Issue(1)：29-37,9.DOI:10.19811/j.cnki.ISSN2096-6628.2026.01.004
加味参芪地黄汤联合新辅助内分泌治疗局部中高危前列腺癌的随机对照研究
Modified Shenqi Dihuang Decoction Combined with Neoadjuvant Endocrine Therapy for Localized Intermediate-to High-Risk Prostate Cancer:A Randomized Controlled Trial
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of modified Shenqi Dihuang Decoction(MSDD)combined with neoadjuvant endocrine therapy(NET)in the treatment of prostate cancer with spleen-kidney deficiency syndrome.Methods A total of 145 patients with localized intermediate-to high-risk prostate cancer manifesting as spleen-kidney deficiency syndrome were randomly assigned to either the experimental group or the control group in a 1∶1 ratio using a computer-generated randomization sequence.The experimental group received a combination of NET(abiraterone acetate,prednisone,and goserelin)and oral MSDD,while the control group received the same NET regimen with placebo.After three months of treatment,both groups underwent radical prostatectomy(RP).The main outcome measured was the rate of minimal residual disease(MRD).Secondary outcomes included the rate of pathological complete response(pCR),immune function indicators(CD4+and CD8+T-cell counts,and CD4+/CD8+),quality of life(EORTC QLQ-C30 and QLQ-PR25 questionnaires),and safety indicators(adverse events).Results A total of 20 cases were lost to follow-up,with a dropout rate of 13.8%,finally 62 patients in the experimental group and 63 in the control group were analyzed.The MRD rate was 38.7%in the experimental group and 17.5%in the control group(P=0.006).No significant difference in the pCR rate was observed between the two groups(P=0.187).The experimental group showed higher QLQ-C30 scores and lower QLQ-PR25 scores than those in the control group(all P＜0.001).The CD4+cell counts and CD4+/CD8+ratio was higher in the experimental group compared with the control group(P＜0.001),while there was no between-group difference in CD8+T-cell counts(P=0.192).The incidences of urinary incontinence,diarrhea,fatigue,and infection in the experimental group were significantly lower compared with the control group(P＜0.05).Most adverse events were mild in both groups.Conclusion The combination of MSDD and NET improves pathological response,reduce treatment-related adverse events,and improve quality of life in patients with localized intermediate-to high-risk prostate cancer manifesting as spleen-kidney deficiency syndrome.关键词
局部中高危前列腺癌/加味参芪地黄汤/新辅助内分泌治疗/根治性前列腺切除术/微小残留病灶率Key words
localized intermediate-to high-risk prostate cancer/modified Shenqi Dihuang Decoction/neoadjuvant endocrine therapy/radical prostatectomy/minimal residual disease rate分类
医药卫生引用本文复制引用
王韶婷,张童童,顾坚毅,徐东亮,占向阳,陈李琛,张杰翔,宋德鑫,巨夕冉,胡静岚,胡永红,琚官群..加味参芪地黄汤联合新辅助内分泌治疗局部中高危前列腺癌的随机对照研究[J].中医肿瘤学杂志,2026,8(1):29-37,9.基金项目
国家自然科学基金资助项目(编号:82174122) （编号:82174122）
上海市卫健委卫生学科带头人计划项目(编号:2022XD011). （编号:2022XD011）
