【摘要】 目的 探讨加味参芪地黄汤联合新辅助内分泌治疗（neoadjuvant endocrine therapy,NET）应用于脾肾两虚型局部中高危前列腺癌的临床疗效和安全性。方法 采用计算机生成的随机序列表将145例脾肾两虚型局部中高危前列腺癌受试者按1∶1比值分为试验组和对照组，试验组给予NET（醋酸阿比特龙加泼尼松联合戈舍瑞林）联合口服加味参芪地黄汤，对照组予相同NET联合口服安慰剂，两组均于治疗3个月后行根治性前列腺切除术（radical prostatectomy,RP）。主要结局指标为微小残留病灶（minimal residual disease,MRD）率。次要结局指标包括病理完全缓解（pathological complete response,pCR）率，免疫功能指标（CD4~+、CD8~+T细胞计数及CD4~+/CD8~+比值），生活质量（EORTC QLQ-C30及QLQ-PR25量表评分），安全性指标（不良事件）。结果 共20例脱落（脱落率13.8%），最终纳入试验组62例，对照组63例。试验组MRD率为38.7%，对照组为17.5%(P=0.006)。两组pCR率差异无统计学意义（P=0.187）。试验组QLQ-C30评分高于对照组（P<0.001），且QLQ-PR25评分比对照组低（P<0.001）。试验组的CD4~+T细胞计数及CD4~+/CD8~+比值高于对照组（P<0.001），而CD8~+T细胞数量两组间无差异（P=0.192）。试验组相较于对照组在尿失禁、腹泻、疲劳及感染等方面的发生率低（P<0.05），且两组不良事件程度均较轻。结论 加味参芪地黄汤联合NET可改善脾肾两虚型局部中高危前列腺癌患者的病理反应，减少治疗相关的不良反应，提高生活质量。更多还原

【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 receiv7ed 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.更多还原