不同雄激素阻断方案治疗晚期前列腺癌患者疗效的临床研究  

Clinical study on efficacy of different androgen deprivation regimens in the treatment of advanced prostate cancer

作　　者：罗怀景 张婷婷 董兴模 林超禄 余丰 LUO Huai-jing;ZHANG Ting-ting;DONG Xing-mo;LIN Chao-lu;YU Feng(Department of Urology,Longyan First Hospital Afiliated to Fujian Medical University,Longyan 364000,Fujian Province,China;Department of Ultrasound,Longyan First Hospital Afiliated to Fujian Medical University,Longyan 364000,Fujian Province,China)

机构地区：[1]福建医科大学附属龙岩第一医院泌尿外科,福建龙岩364000 [2]福建医科大学附属龙岩第一医院超声科,福建龙岩364000

出　　处：《中国临床药理学杂志》2024年第4期519-523,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 对比间歇性雄激素阻断(IAD)治疗与持续性雄激素阻断(CAD)治疗晚期前列腺癌患者的效果及对预后影响。方法 将晚期前列腺癌患者按照队列法分为试验组(86例)和对照组(62例)。试验组采取IAD方案,即皮下注射戈舍瑞林3.6 mg(每28 d注射1次),联合口服氟他胺250 mg(tid),或联合比卡鲁胺口服,每次50 mg(qd);对照组采取CAD方案治疗,即双侧睾丸切除术联合持续氟他胺或比卡鲁胺口服,用法用量同试验组。2组观察随访时间均≥9个月。比较治疗后2组疗效、血清总睾酮(TT)、前列腺特异性抗原(PSA)及血管内皮生长因子(VEGF)水平,评价患者治疗药物不良反应、生存质量[前列腺癌治疗与功能评价(FACT-P)问卷]及疾病进展情况。结果 治疗后9个月,试验组和对照组客观缓解率(ORR)分别为30.99%(22例/71例)和29.09%(16例/55例),疾病进展率(DCR)分别为71.83%(51例/71例)和69.09%(38例/55例),差异均无统计学意义(均P>0.05)。试验组和对照组血清TT分别为(25.53±9.44)和(22.51±8.28)ng·dL^(-1),PSA分别为(4.48±1.02)和(4.32±0.95)ng·mL^(-1),VEGF分别为(121.03±35.26)和(118.65±33.42)pg·mL^(-1),差异均无统计学意义(均P>0.05);试验组和对照组潮热发生率分别为21.13%和56.36%,乳房肿痛分别为16.90%和34.55%,骨质疏松分别为8.45%和25.45%,差异均有统计学意义(均P<0.05);试验组和对照组FACT-P中身体状况得分分别为(24.15±4.22)和(20.28±3.71)分,生活状况得分分别为(20.28±2.94)和(17.81±2.84)分,前列腺特异性(PCS)模块得分分别为(33.21±6.32)和(28.42±5.43)分,差异均有统计学意义(均P<0.05)。试验组和对照组的累计无进展生存率分别为61.97%和58.18%,差异无统计学意义(P>0.05)。结论 IAD与CAD治疗晚期前列腺癌疗效及对患者预后影响相当,但前者治疗药物不良反应更少,有助于提高患者生存质量。Objective To compare the application effect of intermittent androgen deprivation(IAD) and continued androgen deprivation(CAD)on advanced prostate cancer and influence on prognosis.Methods The patients with advanced prostate cancer were divided into treatment group(86 cases) and control group(62 cases) according to the cohort method.The treatment group was given IAD regimen(subcutaneous injection of 3.6 mg goserelin once every 28 days) combined with oral administration of flutamide(250 mg every 3 times a day) or combined with oral administration of bicalutamide(50 mg once a day),and the control group was treated with CAD regimen(bilateral orchiectomy combined with continuous flutamide or bicalutamide orally,with the same dosage as the treatment group).The observation follow-up time of both groups was≥9 months.Efficacy,serum total testosterone(TT),prostate specific antigen(PSA) and vascular endothelial growth factor(VEGF) were compared between the two groups after treatment,and the side effects of treatment,quality of life[Functional Assessment of Cancer Therapy-Prostate(FACT-P)] and disease progression were evaluated.Results At 9 months after treatment,the objective response rates(ORR) in treatment group and control group were 30.99%(22 cases/71 cases) and 29.09%(16 cases/55 cases),and the disease control rates(DCR) were 71.83%(51cases/71 cases) and 69.09%(38 cases/55 cases) respectively(P>0.05).Serum TT levels in treatment group and control group were(25.53±9.44) and(22.51±8.28) ng · dL^(-1),PSA levels were(4.48±1.02) and(4.32±0.95) ng·mL^(-1),and VEGF levels were(121.03±35.26) and(118.65±33.42) pg · mL^(-1) respectively(all P>0.05).The incidence rates of hot flash in treatment group and control group were 21.13% and 56.36%,the incidence rates of breast swelling pain were 16.90% and 34.55%,and the incidence rates of osteoporosis were 8.45%and 25.45% respectively(all P <0.05).The scores of physical condition of FACT-P in treatment group and control group were(24.15±4.22) and(20.28±3.71) points,the sco

关 键 词：前列腺癌 间歇性雄激素阻断 持续性雄激素阻断 安全性 预后 

分 类 号：R97[医药卫生—药品]