辛伐他汀应用于晚期前列腺癌的疗效及安全性研究

目的:评估晚期前列腺癌全雄阻断联合辛伐他汀治疗的临床疗效及安全性。方法:87例符合入选标准的晚期前列腺癌患者随机分为对照组和治疗组。对照组43例,去势手术+口服氟他胺250 mg,3次/d;治疗组44例,去势手术+口服氟他胺250 mg,3次/d,同时口服辛伐他汀20 mg,2次/d。分别记录术后1个月、3个月、6个月和1年前列腺特异性抗原(PSA)值,国际前列腺症状(IPSS)评分,生活质量(QOL)评分,术后6月和1年远处转移情况。结果:术后6个月、1年治疗组血清PSA、IPSS评分、QOL评分均显著低于对照组,差异有统计学意义(P<0.05)。从术后3个月开始辛伐他汀对晚期前列腺癌的PSA抑制作用较强,PSA下降速率治疗组大于对照组,而对照组从术后6个月开始PSA值开始上升,同治疗组有相反趋势;治疗组术后1年远处转移率15.9%明显低于对照组的34.9%(χ2=4.381,P<0.05)。两组治疗中均无严重不良事件发生。结论:辛伐他汀增加了晚期前列腺癌全雄阻断的疗效,改善了患者的排尿症状,提高了生活质量,不良反应小。

Efficacy and safety of simvastatin in the treatment of advanced prostate cancer

Objective: To evaluate the clinical efficacy and safety of the complete androgen deprivation therapy combined with simvastatin for treatment of advanced prostate cancer.Methods: A total of 87 cases of advanced prostate cancer were randomly divided into two groups :the control group 43 cases(surgical castration+flutamide 250 mg.po.tid)and the treatment group 44 cases(surgical castration combined with flutamide 250 mg.po.tid.plus simvastatin 20 mg.po.bid).Serum PSA levels,IPSS score and QOL score were detected 1,3,6,12 months after treatment,postoperative distant metastasis were detected after treatment of six months and one year,the drugs safety evaluation also included.Results: Serum PSA levels,IPSS score and QOL score in the treatment group were much lower than the control group after operation six months and one year with significant difference(P<0.05).After three months of treatment the inhibition of PSA by simvastatin were stronger,the decrease of PSA in the treatment group was greater,while the opposite direction of PSA appeared in the control group after six months.The probability of postoperative distant metastasis was much lower in the treatment group after one year(χ2=4.381,P<0.05).No serious safety issues were identified during treatment.Conclusion: Simvastatin as an adjuvant combined with the complete androgen deprivation therapy improved the effect on advanced prostate cancer,the symptoms of urination,the quality of life and had little side effect.