“健脾利湿化瘀方”联合治疗激素敏感性前列腺癌的真实世界研究  

Real-world study on the treatment of hormone-sensitive prostate cancer with Jianpi Lishi Huayu Decoction

作　　者：牟睿宇 李小江[1,2] 郭姗琦 陆莹[1,2] 贾春鑫 王琮 田汇川 王亮 贾英杰 Ruiyu Mou;Xiaojiang Li;Shanqi Guo;Ying Lu;Chunxin Jia;Cong Wang;Huichuan Tian;Liang Wang;Yingjie Jia(Department of Oncology,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;Na-tional Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Department of Integrated Chinese and Western Medicine,Tianjin Medical University Cancer Institute&Hospital,Tianjin 300600,China;Department of Urinary Surgery,Tianjin Medical University General Hospital,Tianjin 300052,China)

机构地区：[1]天津中医药大学第一附属医院肿瘤科,天津市300381 [2]国家中医针灸临床医学研究中心 [3]天津医科大学肿瘤医院中西医结合科 [4]天津医科大学总医院泌尿外科

出　　处：《中国肿瘤临床》2023年第11期561-566,共6页Chinese Journal of Clinical Oncology

基　　金：天津市教委科研计划项目(编号:2022KJ174)资助。

摘　　要：目的:观察“健脾利湿化瘀方”联合雄激素受体抑制剂/雄激素合成抑制剂+促性腺激素释放激素激动剂(MAB)治疗激素敏感性前列腺癌(hormone-sensitive prostate cancer,HSPC)的临床疗效。方法:选取2019年11月至2021年6月于天津中医药大学第一附属医院、天津医科大学总医院就诊的HSPC患者100例,随机分为治疗组和对照组各50例,对照组接受MAB治疗,治疗组在对照组基础上给予“健脾利湿化瘀方”。主要观察指标为中位无进展生存期(median progression-free survival,mPFS)、前列腺特异性抗原(prostate specific antigen,PSA);次要观察指标为血清睾酮、中医临床症状评分、肿瘤生存质量调查表(EORTC QLQ-C30)、KPS功能状态评分。结果:治疗组较对照组可延长mPFS 4个月(16个月vs.12个月)、明显降低PSA水平、改善中医临床症状、改善QLQ-C30、提高KPS评分(均P<0.05)。亚组预后因素分析显示,治疗前KPS评分90分组、PSA最低值≤1 ng/mL、PSA下降≥90%的患者在治疗组中获益更显著。结论:“健脾利湿化瘀方”联合MAB治疗延长患者的m PFS,更好地降低PSA水平,实现PSA的深度应答,降低血清睾酮至去势水平,延长激素敏感时间,改善中医临床症状,提高患者的生存质量。Objective:To observe the clinical effect of the"Jianpi Lishi Huayu Decoction"combined with androgen receptor inhibitor or androgen synthesis inhibitors+gonadotropin-releasing hormone agonist(MAB)regime in the treatment of hormone-sensitive prostate cancer(HSPC).Methods:One hundred patients with HSPC who visited First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and Tianjin Medical University General Hospital from November 2019 to June 2021 were randomly assigned into the treatment and control groups(50 patients each).Patients in the control group were treated with MAB regime,while those in the treatment group were treated with MAB and the"Jianpi Lishi Huayu Decoction".The main outcome measures were median progression-free survival(mPFS)and prostate specific antigen(PSA)levels.Secondary outcome measures were serum testosterone levels,traditional Chinese medicine(TCM)clinical symptom score,EORTC QLQ-C30,and KPS score.Results:Compared with patients in the control group,those in the treatment group had a longer mPFS by 4 months(16 months vs.12 months),had significantly reduced PSA levels(P<0.05),showed improved TCM clinical symptom score(P<0.05),showed improved QLQ-C30(P<0.05),and had improved KPS score(P<0.05).Prognostic factor analysis of subgroups showed that patients with KPS grade 90,PSA minimum≤1 ng/mL,and PSA decrease≥90%before treatment benefitted more significantly from the combined treatment of"Jianpi Lishi Huayu Decoction"and MAB.Conclusions:The use of"Jianpi Lishi Huayu Decoction"combined with MAB can prolong the mPFS of patients,reduce the level of PSA,achieve the deep response of PSA,reduce the level of serum testosterone to that seen in individuals who have undergone castration,and prolong the time of hormone sensitivity.Improvement in the TCM clinical symptom score of patients with HSPC following this treatment is synonymous with the improvement in the quality of life of these patients.

关 键 词：健脾利湿化瘀方 激素敏感性前列腺癌 最大雄激素阻断治疗 临床研究 

分 类 号：R737.25[医药卫生—肿瘤]