多西他赛注射液联合比卡鲁胺片治疗中晚期前列腺癌的临床研究

Clinical trial of docetaxel injection combined with bicalutamide tablets in the treatment of intermediate and advanced prostate cancer

目的观察多西他赛注射液联合比卡鲁胺片治疗中晚期前列腺癌的临床疗效及安全性。方法将148例中晚期前列腺癌患者随机分为对照组和试验组,每组74例。对照组予以比卡鲁胺片每次50 mg,qd,口服;试验组在对照组治疗的基础上,予以75 mg·m-2多西他赛,静脉滴注1 h,每4周1次。2组患者均治疗12个月。比较2组患者的临床疗效、血清前列腺特异性抗原(PSA)、磷脂酰肌醇蛋白聚糖3(GPC-3)、腺激肽释放酶2(h K2),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为89.19%(66例/74例)和43.24%(32例/74例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的PSA分别为(9.57±1.24)和(27.58±3.06)ng·m L^(-1),GPC-3分别为(68.43±8.31)和(102.18±10.57)pg·m L^(-1),h K2分别为(31.29±3.98)和(58.47±7.43)ng·L^(-1),差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应均以去势综合征、乳房胀痛和胃肠道反应为主,试验组和对照组的总药物不良反应发生率分别为25.68%和16.22%,差异无统计学意义(P>0.05)。结论多西他赛注射液联合比卡鲁胺片治疗中晚期前列腺癌的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of docetaxel injection combined with bicalutamide tablets in the treatment of intermediate and advanced prostate cancer. Methods A total of 148 patients with intermediate and advanced prostate cancer were randomly divided into control and treatment groups with 74 cases per group. Control group received bicalutamide tablets 50 mg per time,qd,orally. Treatment group received 75 mg · m-2 docetaxel,intravenous drip for 1 h,once four weeks,on the basis of control group. Two groups were treated for 12 months. The clinical efficacy,serum prostatic specific antigen（ PSA）,glypican-3（ GPC-3）,human kallikrein 2（ h K2） and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were89. 19%（ 66 cases/74 cases） and 43. 24%（ 32 cases/74 cases） with significant difference（ P 0. 05）. After treatment,the main indexes in treatment and control groups were compared： PSA were（ 9. 57 ± 1. 24）and（ 27. 58 ± 3. 06） ng · m L^（-1）,GPC-3 were（ 68. 43 ± 8. 31） and（ 102. 18 ± 10. 57） pg·m L^（-1）,h K2 were（ 31. 29 ± 3. 98） and（ 58. 47 ± 7. 43） ng·L^（-1）,the differences were statistically significant（ all P 0. 05）. The adverse drug reactions of two groups were castration syndrome,breast distention and gastrointestinal reaction. The total incidences of adverse drug reactions in the treatment and control groups were25. 68% and 16. 22% without significant difference（ P 0. 05）. Conclusion Docetaxel injection combined with bicalutamide tablets has a definitive clinical efficacy in the treatment of intermediate and advanced prostate cancer,without increasing the incidence of adverse drug reactions.