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目的观察醋酸戈舍瑞林缓释植入剂长期应用对前列腺癌患者去势后的临床疗效及安全性。方法 42例前列腺癌患者随机分为对照组及试验组,每组21例。双侧睾丸切除术后,对照组给予口服比卡鲁胺片50 mg qd;试验组在对照组基础上加用醋酸戈舍瑞林缓释植入剂3.60 mg,每28 d一次,腹前壁皮下注射。2组均持续治疗6个月。比较2组患者治疗前后血清前列腺特异性抗原、α-甲酰基辅酶A消旋酶水平、总有效率及安全性。结果治疗后,试验组和对照组的总有效率分别为90.48%(19/21例)和61.91%(13/21例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组患者血清前列腺特异性抗原(PSA)分别为(6.74±0.73),(13.27±1.17)μg·L-1;α-甲酰基辅酶A消旋酶(P504S)水平分别为(1.26±0.12),(1.85±0.21)μg·L-1,差异均有统计学意义(P<0.05)。试验组的药物不良反应主要有潮热4例,乏力2例,腹泻1例,乳房肿痛2例,对照组的药物不良反应主要有潮热3例,乏力3例,乳房肿痛2例。试验组和对照组的药物不良反应发生率分别为42.86%(9/21例)和38.09%(8/21例),差异无统计学意义(P>0.05)。结论醋酸戈舍瑞林缓释植入剂长期应用能够显著降低前列腺癌患者去势后患者的血清前列腺特异性抗原、α-甲酰基辅酶A消旋酶水平,提高临床疗效,安全性较高。
Objective To observe the clinical efficacy and safety of goserelin acetate sustained-release implants after castration in patients with prostate cancer. Methods 42 cases of prostate cancer were randomly divided into control group and experimental group, 21 cases in each group. After bilateral orchiectomy, the control group was given oral bicalutamide 50 mg qd; experimental group in the control group based on the addition of goserelin acetate sustained release implants 3.60 mg, once every 28 d, the anterior abdominal wall Subcutaneous injection. Both groups continued treatment for 6 months. The serum PSA, α-formyl CoA racemase, total effective rate and safety before and after treatment were compared between two groups. Results After treatment, the total effective rate was 90.48% (19/21 cases) and 61.91% (13/21 cases) in the experimental group and the control group, respectively. The difference was statistically significant (P <0.05). After treatment, the serum PSA levels in the test group and the control group were (6.74 ± 0.73) and (13.27 ± 1.17) μg · L -1, respectively. The levels of α-formyl CoA racemase (P504S) (1.26 ± 0.12) and (1.85 ± 0.21) μg · L-1, respectively, with statistical significance (P <0.05). Adverse drug reactions in the experimental group were mainly hot flashes in 4 cases, 2 cases of fatigue, 1 case of diarrhea, 2 cases of breast swelling and pain. The adverse drug reactions in the control group were mainly 3 cases of hot flashes, 3 cases of fatigue, breast swelling and pain in 2 cases. The incidences of adverse drug reactions in the experimental and control groups were 42.86% (9/21) and 38.09% (8/21) respectively, with no significant difference (P> 0.05). Conclusion Long-term application of Goserelin acetate sustained-release implants can significantly reduce the levels of serum prostate-specific antigen, α-formyl-CoA gyrase in patients with prostate cancer after castration, and improve the clinical efficacy and safety.