目的 观察"健脾利湿化瘀法"治疗中晚期前列腺癌内分泌治疗后部分雄激素缺乏综合征的改善情况及临床疗效。方法 选取符合纳排标准60例中晚期前列腺癌患者，随机分为治疗组30例和对照组30例，对照组行间歇内分泌治疗（全雄激素阻断），治疗组在对照组基础上联合"健脾利湿化瘀方"化裁治疗。研究终点为发展为去势抵抗性前列腺癌的时间，比较两组中老年男子睾酮部分缺乏症状自我测量表（ISS量表）评分、疾病无进展生存期、前列腺特异性抗原（PSA）、血清睾酮、国际前列腺症状评分（I-PSS）及中医临床症状评分。结果 观察两组患者中位无进展生存期可达23个月，与对照组19个月相比差异无统计学意义；治疗后治疗组ISS总评分、体能症状评分、血管舒缩症状评分、精神心理症状评分较治疗前明显降低，且低于对照组评分（P<0.05）；治疗后治疗组ISS评分有效率（73.33%）明显高于对照组（16.67%）；两组患者治疗后PSA水平均显著下降且治疗组（2.13±0.58）ng/mL优于对照组（5.30±1.40）ng/mL（P<0.05）；两组患者治疗后血清睾酮较治疗前差异无统计学意义；治疗组与对照组治疗后I-PSS评分、中医临床症状评分均较治疗前改善，且治疗组优于对照组（P<0.05），治疗后治疗组I-PSS评分有效率（96.67%）、中医临床症状评分改善率（76.67%），优于对照组（73.33%、26.67%）。结论 "健脾利湿化瘀法"联合内分泌治疗一方面能延长激素依赖性前列腺癌进展为去势抵抗性前列腺癌的时间，提高临床疗效，降低肿瘤标志物水平，稳定睾酮水平，并且能改善内分泌治疗后部分雄激素缺乏综合征，尤其在改善体能症状、血管舒缩症状、精神心理症状方面具有明显的优势，明显减轻内分泌治疗后出现的不良反应，另一方面能更好地改善临床症状，降低I-PSS评分、中医临床症状评分等，提高患者的生活质量，充分发挥中医药减毒增效的作用。

Objective To observe the improvement of androgen deficiency syndrome after endocrine therapy by "Jianpi Lishi Huayu Method" for advanced prostate cancer and its clinical effect. Methods A total of 60 patients with advanced prostate cancer were randomly divided into observation group (30 cases) and control group (30 cases). The control group was treated with intermittent endocrine therapy (androgen blocking). The treatment group was treated with "Jianpi Lishi Huayu Decoction" on the basis of the control group. The end point of the study was the time to develop castration-resistant prostate cancer. ISS scale scores, disease progression-free survival, PSA, serum testosterone, I-PSS and TCM clinical symptom scores were compared between the two groups. Results The median progression-free survival time of the patients in the observation group was 23 months, and there was no significant difference between the two groups. After treatment, the total ISS score, physical symptoms score, vasomotor symptoms score and psychosocial symptoms score in the observation group were significantly lower than those before treatment, and lower than those in the control group (P<0.05). After treatment, the effective rate of ISS score in the observation group (73.33%) was significantly higher than that in the control group (16.67%); The PSA level in both groups decreased significantly after treatment, and the PSA level in the observation group (2.13±0.58) ng/mL was better than that in the control group (5.30±1.40) ng/mL (P<0.05); There was no significant difference in serum testosterone between the two groups after treatment. After treatment, the I-PSS score and TCM clinical symptom score of the observation group and the control group were improved, and the observation group was better than the control group (P<0.05). After treatment, the effective rate of the I-PSS score of the observation group (96.67%) and the improvement rate of TCM clinical symptom score (76.67%) were better than those of the control group (73.33%, 26.67%). Conclusion On one hand, "invigorating spleen, draining dampness and removing blood stasis" method combined with endocrine therapy can prolong the time for hormone-dependent prostate cancer to develop into castrated resistant prostate cancer, improve clinical efficacy, reduce the level of tumor markers, stabilize the level of testosterone, and improve some androgen deficiency syndrome after endocrine therapy, especially in ovariectomized resistant prostate cancer. It has obvious advantages in improving physical symptoms, vasomotor symptoms and psycho-psychological symptoms. It can obviously alleviate adverse reactions after endocrine therapy. On the other hand, it can better improve clinical symptoms, reduce I-PSS scores and TCM clinical symptoms scores, improve the quality of life of patients, and give full play to the role of reducing TCM toxicity and increasing synergism efficiency.

R28;R737

国家中医药管理局中医药科技研究专项（2019XZZX-ZL007）；天津市自然科学基金（19JCZDJC37000）；天津市教委项目（2019YJSB138）