他汀类药物联合全雄激素阻断一线治疗晚期前列腺癌:一项随机对照试验

Statins combined with complete androgen blockade as first-line treatment for advanced prostate cancer: A randomized controlled trial

目的 :评估他汀类药物联合全雄激素阻断一线治疗晚期前列腺癌的疗效和安全性。方法 :将46例初治晚期前列腺癌患者随机分为对照组(23例)和研究组(23例)。对照组患者接受醋酸戈舍瑞林缓释植入剂和比卡鲁胺治疗;研究组患者在醋酸戈舍瑞林缓释植入剂和比卡鲁胺治疗的基础上,口服辛伐他汀或阿托伐他汀。观察2组治疗前后血清前列腺特异性抗原(prostate-specific antigen,PSA)水平的变化,比较2组的客观有效率(objective response rate,ORR)和无进展生存(progression-free survival,PFS)情况,并进行安全性评价。结果 :治疗后9个月和1年时,研究组血清PSA水平明显低于对照组,差异均有统计学意义(P值均<0.05)。治疗后1年,研究组的ORR(78.3%)高于对照组(69.6%),但差异无统计学意义(P>0.05)。研究组的中位PFS(17.9个月)明显长于对照组(15.5个月),差异有统计学意义(P<0.05)。两组均未发生严重的不良反应。结论 :他汀类药物可以进一步提高全雄激素阻断治疗晚期前列腺癌的疗效,延长PFS,且不良反应较小,耐受性较好。

Obiective： To evaluate the clinical efficacy and safety of complete androgen blockade therapy combined with statins as first-line treatment of advanced prostate cancer. Methods： A total of 46 cases of randomly divided into two groups with goserelin and bicalutamide with goserelin, bicalutamide and advanced prostate cancer were ： control group （n = 23）, treated study group （n = 23）, treated simvastatin or atorvastatin. The pre- and post-treatment serum PSA levels in response rate （ORR）, progression-free surviva compared. the two groups were compared. The objective , and adverse reactions of the two groups were Results： After treatment for 9 months and 1 year, the serum PSA levels in the study group were significantly lower than those of the control group （both P 〈 0.05）. The ORR of the study group （78.3%） was higher than that of the control group （69.6%） after treatment for one year, but there was no significant difference between the two groups （P 〉 0.05）. The median PFS of the study group （1 7.9 months） was significantly longer than that of the control group （15.5 months） （P 〈 0.05）. No serious adverse effects were observed in the two groups. Conclusion： Treatment with statins can further blockade therapy for advanced prostate cancer, increase the efficacy of complete androgen prolong the PFS, and have good tolerance.