比卡鲁胺联合戈舍瑞林治疗晚期前列腺癌的临床疗效及安全性评价  

Clinical efficacy and safety of bicalutamide combine with goserelin in the treatment of advanced prostate cancer

作　　者：庞宽[1] 周泽光 黄英凡[2] 刘成倍[1] 徐伟[1] 

机构地区：[1]玉林市第一人民医院泌尿外科,广西玉林537000 [2]广西壮族自治区肿瘤防治研究所肿瘤科,南宁530000

出　　处：《中国临床药理学杂志》2016年第3期224-226,共3页The Chinese Journal of Clinical Pharmacology

基　　金：2015年度第二批广西医药卫生计划基金资助项目(Z2015581)

摘　　要：目的观察比卡鲁胺联合戈舍瑞林治疗晚期前列腺癌的临床疗效及安全性。方法将50例晚期前列腺癌患者随机分为试验组25例和对照组25例。试验组予以口服比卡鲁胺50 mg,qd+皮下注射戈舍瑞林3.6 mg,每4周1次;每月复查一次血清前列腺特异性抗原(PSA)含量,当血清PSA<0.2 ng·m L^(-1)时,停用两种药物,当PSA>4 ng·m L^(-1)时,开始新一轮治疗。对照组予以持续性给药,用量用法与试验组一样。2组患者治疗周期均为12个月。比较2组患者的临床疗效、治疗前及治疗3,6,9,12个月后的血清PSA值,以及不良反应的发生情况。结果治疗6,9,12个月后,试验组的有效缓解率明显高于对照组(P<0.05)。治疗3,6,9,12个月后,2组患者的血清PSA均较治疗前显著降低(P<0.05),但2组间各时点的血清PSA比较差异无统计学意义(P>0.05)。2组患者的主要不良反应均为去势综合征、血管收缩症、骨质疏松、肝毒性反应,但2组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论比鲁卡胺联合戈舍瑞林间歇性给药治疗晚期前列腺癌的临床疗效显著优于持续性给药,且不增加不良反应的发生率。Objective To evaluate the clinical efficacy and safety of bicalutamide combine with goserelin in the treatment of advanced prostate cancer. Methods Fifty cases of advanced prostate cancer patients were randomly divided into treatment group （25 cases） and control group （25 cases）. Treatment group was given oral biealutamide 50 rag, qd ＋ sub- cutaneous goserelin 3.6 mg, once 4 weeks, a monthly review of serum prostate - specific antigen （PSA） content, when the serum PSA 〈 0.2 ng- mL-l, disabled two drugs, when PSA〉4 ng＂ mL 1, begin a new round of treatment. Control group was given the continuous dosing, the same dosage and usage as the treatment group. The course of treatment for two groups was 12 months. Comparison of the clinical efficacy, serum PSA value and adverse drug reactions. Results After 6, 9, 12 months of treatment, the clinical efficacy of treatment group was significantly higher than that of control group （P 〈0.05）. After 3, 6, 9, 12 months of treatment, the serum PSA value was significantly lower than that of before treatment （P 〈 0. 05 ） , and there was no significant difference in serum PSA between the two groups at each time point （P 〉 0.05 ）. The main adverse drug reactions of the two groups were the castration syndrome, blood vessel contraction, osteoporosis, and liver toxicity, and the incidence rate of adverse drug reactions were not statistically different between the two groups （P 〉 0. 05）. Conclusion The clinical efficacy of intermittent administration for biealutamide combined with goserelin in the treatment of advanced prostate cancer was significantly better than the continuous dosing, without increasing the incidence of adverse drug reactions.

关 键 词：比卡鲁胺 戈舍瑞林 前列腺癌 临床疗效 安全性 

分 类 号：R737.21[医药卫生—肿瘤] R969.4[医药卫生—临床医学]