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长效促性腺激素释放激素类似物治疗转移性前列腺癌的有效性和安全性

Efficacy and safety of long-acting gonadotropin-releasing hormone analogue in the treatment for metastatic prostate cancer

摘要:

目的 评价长效促性腺激素释放激素类似物(GnRHa)曲普瑞林11.25 mg 3个月缓释剂型治疗转移性前列腺癌的安全性和有效性.方法 2004年1月至2006年3月对127例符合入选标准的患者进行随机、平行对照、多中心研究.65例接受曲普瑞林11.25 mg剂型治疗,62例患者接受常规剂型3.75 mg治疗,观察期3个月.观察治疗前后血清总前列腺特异性抗原(TPSA)、前列腺体积、睾酮、卵泡刺激素、黄体生成索、泌乳素和雌二醇水平,并对两组的变化情况进行比较.同时观察骨转移灶变化情况以及其他转移灶的变化情况.严密观察和记录治疗过程中的不良事件,进行安全性评价.结果 治疗后两组TPSA水平较治疗前均有明显的下降.但两组间差异无统计学意义(P=0.601).治疗结束时,研究组和对照组分别有78.6%和75.5的患者血清TPSA水平比基线值下降90%以上(P=0.700).治疗后两组患者前列腺体积均明显减小,但组间差异无统计学意义(P>0.05).治疗后两组患者血清睾酮达去势水平,两组比较其差异无统计学意义(P>0.05).两组不良事件发生率分别为13.8%和17.7%,组间差异无统计学意义(P=0.547).结论 曲普瑞林11.25mg治疗转移性前列腺癌疗效和安全性与曲普瑞林3.75 mg相似,是一种安全、有效的新型长效缓释GnRHa类药物.

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abstracts:

Objective To evaluate the efficacy and safety of gonadotropin-releasing hormone analogue (GnRHa) triptorelin 11.25 mg 3-month sustained release formulations in the treatment of metastatic prostate cancer. Methods From January 2004 to March 2006,a randomized, parallel-controlled,muhicentral clinical trial was conducted. One hundred and twenty-seven patients with documented metastatic prostate cancer were randomized to receive one injection of the 11.25 mg formulation triptorelin (n=65) or three injections at 28-day intervals of the 3.75 mg formulation (n=62). Changes from baseline of TPSA,prostate volume, testosterone, LH, FSH, PRL and estradiol were assessed over 3 months. Changes of the metastatic lesions were also observed and evaluated. The occurrences of adverse events were evaluated as well. Results After 3 months treatment, total PSA level decreased significantly from baseline both in 11.25 mg group and 3.75 mg group. At 30, 60 and 90 days, TPSA (median level) declined from 164.55 μg/Linto 11.34,4. 12,3.89 μg/L in 11.25 mg group, and from 101.38 μg/L into 6.88,2.41,2.57 μg/L in control group respectively. The patients ratio with over 90% decreasing from TPSA baseline were 78.6% and 75.5% respectively in two groups (P=0.700). Prostate volume were also decreased significantly in both groups, median volume declined from 48.0 mm3 into 21.5 mm3 in 11.25 mg group and from 45.0 mm3 into 21.0 mm3 in 3.75 mg group. No significant differences were found between the two groups in changes of TPSA (P=0.601) and prostate volume (P>0.05). Both formulations were able to induce castration levels, 0.31 μg/L in 11.25 mg group and 0.26 μg/L in 3.75 mg group (P>0.05). 13.8% and 17.7% of adverse events were recorded respectively in two groups, and no differences were found (P=0.47).Conclusion As a new long-acting sustained release formulation, triptorelin 11.25 mg is comparable to triptorelin 3.75 mg formulation in the aspect of efficacy and safety for the treatments of metastatic prostate cancer.

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