Clinical Efficacy Observation of Bushen Yiliu Formula in Treating Advanced Hormone-Sensitive Prostate Cancer Accompanied by Bone Metastasis of Kidney Deficiency Type
10.13359/j.cnki.gzxbtcm.2025.06.013
- VernacularTitle:补肾抑瘤方治疗肾虚型晚期激素敏感性前列腺癌骨转移的临床疗效观察
- Author:
Zibin ZHONG
1
;
Wenli LIN
;
Wenqiang QIU
;
Chiming GU
Author Information
1. 广州中医药大学第二临床医学院,广东 广州 510006
- Keywords:
hormone-sensitive prostate cancer;
bone metastasis;
Bushen Yiliu Formula;
prostate-specific antigen;
alkaline phosphatase
- From:
Journal of Guangzhou University of Traditional Chinese Medicine
2025;42(6):1385-1393
- CountryChina
- Language:Chinese
-
Abstract:
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.
