芪蓝胶囊对去势后气虚血瘀型前列腺癌患者临床增效作用研究  

Qilan Capsules plus androgen-deprivation therapy for Qi-deficiency blood-stasis type of prostate cancer after castration

作　　者：常德贵[1] 李响[2] 邹建华[3] 俞旭君[1] 潘晓放[1] 吴天浪[4] 李广森[4] 陈文英[4] 陈承[4] 

机构地区：[1]成都中医药大学,四川成都610041 [2]四川大学华西医院泌尿外科,四川成都610041 [3]四川省人民医院泌尿外科,四川成都610072 [4]成都中医药大学附属医院男科,四川成都610072

出　　处：《中华男科学杂志》2017年第7期646-651,共6页National Journal of Andrology

基　　金：四川省中医药管理局重大疑难疾病防治研究项目(2012-A-095);四川省教育厅重大培育项目(14CZ0010)~~

摘　　要：目的:观察中药芪蓝胶囊对去势后行内分泌治疗的前列腺癌患者(气虚血瘀型)的临床增效作用。方法:采用随机、对照、双盲的方法,分别从成都中医药大学附属医院、四川大学华西医院和四川省人民医院3家医疗中心各取82例去势后前列腺癌患者(气虚血瘀型),共246例。随机分为试验组(芪蓝胶囊联合去势及雄激素拮抗剂)和对照组(安慰剂联合去势及雄激素拮抗剂)各123例。芪蓝胶囊每日3次,每次4粒,去势治疗为手术去势或戈舍瑞林3.6 mg,每4周1次,皮下注射,雄激素拮抗剂比卡鲁胺50 mg,每日1次,口服。安慰剂为外观和芪蓝胶囊一致的淀粉制剂。观察比较两组患者治疗前以及治疗6个月后国际前列腺症状评分(IPSS)、中医症侯评分、最大尿流率(Qmax)及血清PSA水平。结果:试验组和对照组治疗后在分级证候疗效(87.7%vs 67.9%,P<0.05)、总有效率上(86.0%vs 71.6%,P<0.05)比较,两组间差异有统计学意义。试验组在中医症侯评分[治疗前(17.1±5.1)分,治疗后(8.3±4.0)分]、IPSS[(治疗前(17.7±7.5)分,治疗后(11.4±4.6)分]及Qmax[治疗前(10.9±4.3)ml/s,治疗后(14.7±3.7)ml/s]等方面疗效优于对照组[治疗前(16.8±5.2)分,治疗后(11.5±5.2)分;治疗前(17.8±6.7)分,治疗后(14.6±5.8)分;治疗前(11.0±4.3)ml/s,治疗后(12.0±4.1)ml/s],差异有统计学意义(P<0.05);试验组在PSA改善例数上与对照组相比不具有统计学意义(P>0.05)。结论:芪蓝胶囊对去势术后气虚血瘀型前列腺癌患者治疗安全有效,对去势后抗雄激素治疗有增效作用,但对血清PSA值的干预作用不明显。Objective： To observe the synergistic effect of Qilan Capsules in the treatment of the patient with Qi-deficiency blood-stasis type of prostate cancer receiving androgen-deprivation therapy after castration. Methods： This randomized controlled double-blind study included 246 cases of Qi-deficiency blood-stasis type of prostate cancer after castration, which were randomly divid- ed into an experiment and a control group of equal number to be treated with Qilan Capsules ＋ androgen-deprivation and placebo ＋ androgen-deprivation, respectively. After 6 months of treatment, we compared the International Prostate Symptoms Scores （ IPSS）, TCM Symptoms Scores （TCMSS）, maximal urine flow rate （Qmax）, and the level of serum prostate-specific antigen （PSA） between the two groups of patients. Results： Statistically significant differences were observed between the experiment and control groups in the syndrome classification-based efficacy （87.7% vs 67.9%, P 〈 0.05） and total effectiveness rate （86.0% vs 71.6%, P 〈 0.05）. Compared with the baseline, the experiment group showed remarkable improvement after treatment in TCMSS （17.1 ±5.1 vs 8.3±4.0, P 〈0.05）, IPSS （17.7 ±7.5vs11.4±4.6, P 〈0.05）, andQmax （[10.9±4.3] ml/svs [14.7 ±3.7] ml/s, P 〈 0.05）, and so did the control group （ 16.8 ~ 5.2 vs 11.5 ± 5.2, 17.8 ± 6.7 vs 14.6 ± 5.8, and [ 11.0 ± 4.3 ] ml/s vs [ 12.0 ± 4.1 ] ml/s, P 〈 0.05 ）. The above three parameters were even more markedly improved in the former than in the latter group （P 〈 0.05 ）. However, there was no statistically signifieant difference between the two groups in the improvement of the PSA level after treatment （P 〉 0.05 ）. Conclusion ： Qilan Capsules ean significantly enhanee the effect of androgen-deprivation therapy in the treatment of Qi-de- fieieney blood-stasis type of prostate cancer after eastration though eannot obviously improve the PSA level.

关 键 词：芪蓝胶囊 气虚血瘀 前列腺癌 临床疗效 

分 类 号：R273[医药卫生—中西医结合]