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 divided 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±7.5 vs 11.4±4.6, P <0.05), and Qmax (［10.9±4.3］ ml/s vs ［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 significant difference between the two groups in the improvement of the PSA level after treatment (P >0.05).
Conclusions: Qilan Capsules can significantly enhance the effect of androgen-deprivation therapy in the treatment of Qi-deficiency blood-stasis type of prostate cancer after castration though cannot obviously improve the PSA level.
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。.
Keywords: Qi-deficiency and blood stasis; clinical efficacy; prostate cancer; Qilan Capsules.