复方苦参注射液对局部晚期前列腺癌内分泌治疗耐药改善作用的临床研究

Clinical Study on Improvement Effect of Compound Kushen Injection(复方苦参注射液) on Endocrine Therapy Resistance for Locally Advanced Prostate Cancer

目的:观察复方苦参注射液对局部晚期前列腺癌患者内分泌治疗耐药的改善作用。方法:将70例局部晚期前列腺癌患者随机分为2组,对照组采用标准内分泌治疗,观察组在对照组治疗基础上联合复方苦参注射液治疗,共治疗3个月。观察2组患者治疗前及治疗1、2、3个月后PSA(前列腺特异性抗原)水平、治疗前及治疗3个月后疼痛评分、卡氏评分,并随访入组患者疾病无进展时间。结果:对照组随着内分泌治疗时间的延长,PSA有明显上升趋势,而观察组采用复方苦参注射液干预后PSA基本保持稳定,治疗前后未见明显差异,观察组与对照组比较有显著差异(P<0.05)。观察组中位疾病无进展时间为25.7个月,对照组20.3个月,2组比较统计学有明显差异(P=0.021)。观察组患者治疗后疼痛评分降低,卡氏评分提高,与治疗前及对照组比较统计学处理有明显差异(P<0.05)。结论:具有清热化湿解毒功效的复方苦参注射液可以改善局部前列腺癌内分泌治疗耐药,延长疾病无进展生存期,提高患者的生存质量。

Objective： To observe the effect of Compound Kushen Injection combining with endocrine therapy on locally advanced prostatic cancer. Methods： 70 patients who was suffering from locally advanced prostatic cancer were randomly divided into two groups： observation group in which 35 cases were treated by Compound Kushen Injection combining with endocrine therapy,control group in which 35 cases were only treated by endocrine therapy,with the course of 3 months. After three months,the serum PSA,the score of cancer pain,KPS and PFS were observed before and after treatment. Results： PSA level of the control group rapidly increased with the treatment time,the PSA growth of the observation group was delayed; compared with control group,the difference was significant（ P〈0. 05）. The median PFS of the observation group was 25. 7 months while that of the control group was 20. 3 months for which there was statistical difference of comparison（ P = 0. 21）. The NRS score of cancer pain in observation group was obviously decreased and KPS was improved after treatment（ P〈0. 05）; the improvement of observation group was more significant than that of the control group（ P〈0. 05）.Conclusion： The combined Compound Kushen Injection with endocrine therapy can alleviate endocrine therapy resistance on advanced prostatic cancer and prolong progression- free survival as well as improve quality of life.