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学科主题泌尿外科学
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
其他题名Efficacy and safety of long-acting gonadotropin-releasing hormone analogue in the treatment for metastatic prostate cancer
李宁忱1; 宋毅1; 姜昊文1; 丁强1; 甘卫东1; 郭宏骞1; 孙则禹1; 胡志全1; 叶章群1; 魏强1; 那彦群1
关键词前列腺肿瘤 肿瘤转移 Prostatic Neoplasms 抗肿瘤药 Neoplasm Metaatasis 激素 Antineoplasfic Agents Hormonal
刊名中华外科杂志
2008
DOI10.3321/j.issn:0529-5815.2008.21.016
46期:21页:1653-1657
收录类别中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型Journal Article
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. 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.
语种中文
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文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/45231
专题北京大学第一临床医学院_泌尿外科
作者单位1.北京大学第一医院北京大学泌尿外科研究所,100034
2.复旦大学附属华山医院泌尿外科
3.南京大学医学院附属鼓楼茨院泌尿外科
4.华中科技大学同济医学院附属同济医院泌尿外科
5.四川大学华西医院泌尿外科
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李宁忱,宋毅,姜昊文,等. 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[J]. 中华外科杂志,2008,46(21):1653-1657.
APA 李宁忱.,宋毅.,姜昊文.,丁强.,甘卫东.,...&那彦群.(2008).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.中华外科杂志,46(21),1653-1657.
MLA 李宁忱,et al."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".中华外科杂志 46.21(2008):1653-1657.
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