【目的】 观察补肾抑瘤方（由淫羊藿、女贞子、墨旱莲、重楼等中药组成）治疗肾虚型晚期激素敏感性前列腺癌伴骨转 移的临床疗效。【方法】 采用前瞻性随机对照试验，将2022年1月至2024年2月期间在广东省中医院接受治疗的45例肾虚型 晚期激素敏感性前列腺癌骨转移患者随机分为观察组23例和对照组22例。所有患者均给予全雄激素阻断治疗联合骨保护治 疗，在此基础上，观察组患者给予中药补肾抑瘤方加减治疗，治疗周期为6个月。观察2组患者治疗3、6个月后的疾病控制 率（DCR）、客观缓解率（ORR）以及治疗前和治疗3、6个月后的中医证候积分、Karmofsky功能状态（KPS）评分、疼痛数字评 估量表（NRS）评分和血清总前列腺特异抗原（tPSA）、碱性磷酸酶（ALP）水平的变化情况以评估补肾抑瘤方的临床疗效；观察 2组患者治疗前和治疗3、6个月后的血清谷丙转氨酶（ALT）、谷草转氨酶（AST）、肌酐（Scr）水平的变化情况以评估补肾抑瘤 方的临床安全性。【结果】（1）骨转移灶肿瘤负荷情况：治疗 3个月后，2组均无完全缓解病例；治疗 6个月后，仅观察组有 1 例完全缓解病例。治疗 3 个月后，观察组的 ORR 和 DCR 分别为 21.74%（5/23）、95.65%（22/23），对照组分别为 22.73% （5/22）、95.45%（21/22），组间比较，差异均无统计学意义（P＞0.05）。治疗 6个月后，观察组的 ORR 和 DCR 分别为 60.87% （14/23）、95.65%（22/23），均明显高于对照组的22.73%（5/22）、68.18%（15/22），差异均有统计学意义（P＜0.05）。（2）临床症 状改善情况：治疗3个月和6个月后，2组患者的中医证候积分和疼痛NRS评分均较治疗前明显降低（P＜0.01），KPS评分均 较治疗前明显提高（P＜0.01），且除治疗3个月后的中医证候积分外，观察组在治疗3个月和6个月后对中医证候积分和疼痛 NRS评分的下降幅度及对KPS评分的提高幅度均明显优于对照组（P＜0.01）。（3）肿瘤相关标志物情况：2组患者治疗3个月后 的血清tPSA水平和治疗6个月后的血清tPSA、ALP水平均较治疗前明显降低（P＜0.05或P＜0.01），且观察组在治疗3个月和 6个月后对血清 tPSA水平的降低幅度均明显优于对照组（P＜0.05或 P＜0.01），而 2组患者治疗 3个月和 6个月后的血清 ALP 水平比较，差异均无统计学意义（P＞0.05）。（4）安全性指标情况：治疗3个月和6个月后，2组患者的血清ALT、AST、Scr水 平均较治疗前无显著变化，差异均无统计学意义（P＞0.05）。【结论】 补肾抑瘤方联合内分泌治疗肾虚型晚期激素敏感性前列 腺癌伴骨转移患者疗效确切，可以有效降低骨转移灶肿瘤负荷，提高肿瘤客观缓解率；同时，能够改善患者临床症状，降 低患者疼痛NRS评分，提高患者生活质量；并能有效降低患者血清tPSA、ALP水平，其疗效明显优于单纯内分泌治疗。

Objective To observe the clinical efficacy of Bushen Yiliu Formula （mainly composed of Epimedii Folium，Ligustri Lucidi Fructus，Ecliptae Herba，and Paridis Rhizoma） in treating advanced hormone-sensitive prostate cancer accompanied by bone metastasis of kidney deficiency type. Methods A prospective randomized controlled trial was conducted on 45 patients with advanced hormone-sensitive prostate cancer accompanied by bone metastasis of kidney deficiency type，who received treatment at Guangdong Provincial Hospital of Chinese Medicine from January 2022 to February 2024. The patients were randomly divided into an observation group （23 cases） and a control group （22 cases）. All patients received complete androgen blockade therapy combined with bone-protective therapy. Additionally， the observation group was treated with the modified Bushen Yiliu Formula for 6 months. The clinical efficacy of Bushen Yiliu Formula was evaluated with the disease control rate （DCR） and objective response rate （ORR） after 3 and 6 months of treatment，and with the changes in the TCM syndrome scores，Karnofsky Performance Status （KPS） scores，Numerical Rating Scale （NRS） pain scores，and serum levels of total prostate-specific antigen （tPSA） and alkaline phosphatase （ALP） before treatment and after 3 and 6 months of treatment. Changes in serum alanine aminotransferase （ALT）， aspartate aminotransferase （AST），and creatinine （Scr） levels before treatment and after 3 and 6 months of treatment were observed to assess the clinical safety of the formula. Results （1） After 3 months of treatment，both groups had no complete remission cases. After 6 months，the observation group hand only one complete remission case. After 3 months of treatment， the ORR and DCR in the observation group were 21.74% （5/23） and 95.65% （22/23），respectively，compared to 22.73% （5/22） and 95.45% （21/22） in the control group. The intergroup comparison showed that there were no significant differences between the two groups （P＞0.05）. After 6 months of treatment，the ORR and DCR in the observation group were 60.87% （14/23） and 95.65% （22/23），respectively，significantly higher than those in the control group [22.73% （5/22） and 68.18% （15/22），respectively]，with statistically significant differences （P＜ 0.05）.（2） After 3 and 6 months of treatment，TCM syndrome scores and NRS pain scores in both groups were significantly decreased （P＜0.01）， and KPS scores were significantly increased （P＜0.01）. Except for TCM syndrome scores after 3 months of treatment， the observation group had stronger effect on decreasing TCM syndrome scores and NRS pain scores and on increasing KPS scores after 3 and 6 months of treatment than the control group （P＜0.01）.（3） The serum level of tumor-related marker tPSA after 3 months of treatment， and serum tPSA and ALP levels after 6 months of treatment were significantly decreased in both groups compared to the baseline level （P＜0.05 or P＜0.01）. The observation group had stronger effect on decreasing serum tPSA level after 3 and 6 months compared to the control group （P＜0.05 or P＜0.01）. However，no significant differences of serum ALP level were observed between the two groups after 3 and 6 months of treatment （P＞0.05）.（4） Serum levels of safety indicators of ALT，AST，and Scr showed no significant changes in either group after 3 or 6 months of treatment compared to the baseline level （P＞0.05）. Conclusion Bushen Yiliu Formula combined with endocrine therapy exerts certain efficacy for the treatment of advanced hormone-sensitive prostate cancer accompanied by bone metastasis of kidney deficiency type. The combined therapy is effective in reducing tumor burden of bone metastases， improving objective response rates， alleviating clinical symptoms， decreasing NRS pain scores， enhancing quality of life，and effectively lowering serum tPSA and ALP levels. Its efficacy is significantly superior to endocrine therapy alone.

R273.372

国家中医药管理局全国名老中医药专家传承工作室建设项目（编号：国中医药人教函[2022]75号）； 广州市市校（院）联合资助项目 （编号：202201020350）； 广东省中医院拔尖人才项目（编号：BJ2022YL04）；广东省中医院院内专项（围手术期研究专项）（编号： YN2023WSSQ03）