Clinical trial and safety of long term application of goserelin acetate implant on prostate cancer patients after castration
10.13699/j.cnki.1001-6821.2017.14.008
- VernacularTitle: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与安全性
- Author:
Yun-Feng XIE
1
;
Yi-Ming HUANG
Author Information
1. 内江市第一人民医院泌尿外科
- Keywords:
goserelin acetate implant;
prostate cancer;
castration;
prostate specific antigen
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(14):1314-1316
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical efiicacy and safety of long term application of goserelin acetate implant on prostate cancer patients after castration.Methods Forty-two patients with prostate cancer were randomly divided into the control group (n =21) and treatment group (n =21).After bilateral orchiectomy,the control group was orally given bicalutamide tablets 50 mg qd;on the basis of the control group,the treatment group received subcutaneous abdomen injection of goserelin acetate implant 3.6 mg every 28 d.Serum prostate specific antigen (PSA),α-methylacyl coenzyme A racemase (P504S) levels,total effective rate and safety between the two groups before and after treatment were compared.Results After treatment,the total effective rate in the treatment and control groups were 90.48％ (19/21 cases) and 61.91％ (13/21 cases),respectively,and significant difference was found between the two groups (P ＜ 0.05).After treatment,the serum levels of PSA in treatment and control groups were (6.74 ±0.73),(13.27 ± 1.17) μg · L-1,respectively;the P504S were (1.26 ± 0.12),(1.85 ± 0.21) μg · L-1,respectively.Significant differences were found in the indices above between the two groups (P ＜ 0.05).The adverse drug reactions in treatment group were hot flashes(4 cases),fatigue(2 cases),diarrhea(1 case) and breast swelling(2 cases);The adverse reactions in control group were hot flashes (3 cases),fatigue(3 cases) and breast swelling(2 cases);The adverse reaction rates in treatment and control group were 42.86％ (9/21 cases) and 38.09％ (8/21 cases),respectively,and no significant difference was found between the two groups (P ＞ 0.05).Conclusion The goserelin acetate implant could significantly reduce the serum levels of PSA and P504S in prostate cancer patients after castration,exerting considerable clinical efficacy and safety.
