健脾益肾方治疗脾肾两虚型前列腺癌雄激素剥夺治疗后癌因性疲乏疗效观察  

Efficacy of decoction for fortifying spleen and replenishing kidney on cancer-related fatigue in prostate cancer with syndrome of spleen-kidney deficiency after androgen deprivation therapy

作　　者：刘利红 谢佳琪 魏永强 丁家森 张泽家 程鹏伃 纪荣富 高瞻[1] 曾凡雄[1] LIU Lihong;XIE Jiaqi;WEI Yongqiang;DING Jiasen;ZHANG Zejia;CHENG Pengyu;JI Rongfu;GAO Zhan;ZENG Fanxiong(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]北京中医药大学,北京100029

出　　处：《现代中西医结合杂志》2025年第6期764-769,844,共7页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：中国中医科学院科技创新工程课题(CI2021A02204);中国中医科学院西苑医院提升中医药临床循证证据级别研究专项(XYZX0201-05)。

摘　　要：目的评价健脾益肾方治疗脾肾两虚型前列腺癌雄激素剥夺治疗(ADT)后癌因性疲乏的有效性与安全性。方法采用随机、双盲、安慰剂对照研究方法,将2022年8月—2024年1月就诊于中国中医科学院西苑医院泌尿外科且辨证为脾肾两虚型的40例前列腺癌ADT后癌因性疲乏患者随机分为2组,试验组给予健脾益肾方颗粒剂冲服,对照组给予健脾益肾方安慰剂颗粒剂冲服,均连续服用12周。比较2组患者治疗前及治疗2周、4周、6周、8周、10周、12周末的简明疲乏量表(BFI)评分、简化版扩展性前列腺癌复合指数量表(EPIC-26)评分、中老年男性症状量表(AMS)评分,检测2组患者治疗前及治疗12周后血清前列腺特异性抗原(PSA)、睾酮(T)水平及安全性指标(血常规、尿便常规+隐血、心电图、肝功能、肾功能),记录2组患者不良反应发生情况。结果与治疗前比较,试验组治疗6周、8周、10周、12周末BFI评分和治疗10周、12周末AMS评分均明显降低(P均<0.05),治疗6周、8周、10周、12周末EPIC-26评分均明显升高(P均<0.05);对照组治疗后各时间点BFI评分、EPIC-26评分、AMS评分均无明显变化(P均>0.05)。治疗后组间比较,试验组治疗12周末BFI评分明显低于对照组(P<0.05),2组治疗后各时间点EPIC-26评分、AMS评分比较差异均无统计学意义(P均>0.05)。治疗12周后2组血清PSA、T水平均有降低趋势,但与治疗前比较和治疗后组间比较差异均无统计学意义(P均>0.05)。2组各有1例患者因服药后出现腹泻症状而退出研究,未见其他不良反应。结论健脾益肾方可减轻脾肾两虚型前列腺癌ADT后癌因性疲乏患者疲乏程度和雄激素缺乏相关不良反应,提高患者生活质量,且安全。Objective It is to evaluate the efficacy and safety of decoction for fortifying spleen and replenishing kidney in the treatment of cancer-related fatigue(CRF)in prostate cancer with syndrome of spleen-kidney deficiency after androgen deprivation therapy(ADT).Methods A randomized,controlled,double-blind,placebo-controlled study was performed,in which 40 CRF patients with prostate cancer after ADT,and differentiated as syndrome of spleen-kidney deficiency in the Department of Urology,Xiyuan Hospital of China Academy of Chinese Medical Sciences from August 2022 to January 2024 were randomly divided into experimental group and control group.The experimental group was given granules of decoction for fortifying spleen and replenishing kidney by oral administration,while the control group was given placebo granules of decoction for fortifying spleen and replenishing kidney by oral administration,both groups were continuously treated for 12 weeks.The scores of Brief Fatigue Inventory(BFI),Expanded Prostate Cancer Index Composite(EPIC-26),Aging Male Symptoms(AMS)of patients in the two groups before treatment and after treatment for 2,4,6,8,10 and 12 weeks were compared,the serum levels of prostate-specific antigen(PSA),testosterone(T),safety indicators(blood routine,urine and stool routine+occult blood,ECG,liver function and renal function)of patients in the two groups were detected before and after treatment for 12 weeks,the occurrence of adverse reactions in the two groups was recorded.Results Compared with before treatment,the BFI scores after treatment for 6,8,10 and 12 weeks and AMS scores after treatment for 10 and 12 weeks were significantly decreased,while the EPIC-26 scores after treatment for 6,8,10 and 12 weeks were significantly increased in the experiment group(all P<0.05);there was no obvious changes in the BFI scores,EPIC-26 scores and AMS scores at all time points after treatment in the control group(all P>0.05).The BFI score after treatment for 12 weeks in the experimental group was significantly lower th

关 键 词：前列腺癌 健脾益肾方 脾肾两虚 癌因性疲乏 

分 类 号：R737.25[医药卫生—肿瘤]