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9.45毫克促性腺激素释放激素类似物布舍瑞林植入物用于前列腺局限性癌患者后睾酮抑制的持续时间:一项为期12个月的随访研究

Duration of testosterone suppression after a 9.45 mg implant of the GnRH-analogue buserelin in patients with localised carcinoma of the prostate a 12-month follow-up study.

作者信息

Pettersson Bill, Varenhorst Eberhard, Petas Anssi, Sandow Jürgen

机构信息

Department of Urology, Faculty of Health Sciences University Hospital, Linköping, Sweden.

出版信息

Eur Urol. 2006 Sep;50(3):483-9. doi: 10.1016/j.eururo.2006.03.001. Epub 2006 Mar 27.

Abstract

OBJECTIVES

(1) To determine the duration of androgen deprivation after a single buserelin implant 9.45 mg in the neoadjuvant setting in combination with curative radiation therapy of carcinoma of the prostate, and (2) to evaluate the time to recovery of gonadal function, and the incidence and duration of hypogonadal symptoms.

METHODS

We prospectively evaluated 21 men with carcinoma of the prostate who received one implant of 9.45 mg buserelin subcutaneously. Release of buserelin, changes in serum testosterone concentration, hot flushing and sexual function over a 12-month study period were recorded.

RESULTS

Testosterone was suppressed below the castration limit (0.58 ng/ml=2 nmol/l) for 224 days (range, 139-309). The mean time to first return of testosterone above the castration limit was 246 days (range, 168-344); 50% of pre-treatment value was reached after 285 days (range, 218-370). The prevalence of hot flushing was 19 of 21 patients (90%) at 12 weeks. At the end of the study period, serum testosterone had reached 80% (range, 33%-166%) of pre-treatment concentration, sexual interest was present in 52%, erection was possible in 60%, and hot flushing remained in 24%.

CONCLUSION

A single injection of 3-month buserelin implant 9.45 mg suppresses serum testosterone below the castration limit for at least 6 months. Testosterone secretion recovers by 8-12 months. Hypogonadal symptoms decreased with the restoration of serum testosterone secretion. These data are clinically relevant regarding the dose schedule for buserelin and the patient information provided.

摘要

目的

(1)确定在新辅助治疗中单次植入9.45mg布舍瑞林联合前列腺癌根治性放射治疗后雄激素剥夺的持续时间,以及(2)评估性腺功能恢复的时间、性腺功能减退症状的发生率和持续时间。

方法

我们前瞻性评估了21例接受单次皮下植入9.45mg布舍瑞林的前列腺癌男性患者。记录了12个月研究期内布舍瑞林的释放情况、血清睾酮浓度的变化、潮热和性功能。

结果

睾酮被抑制至去势水平以下(0.58ng/ml = 2nmol/l)达224天(范围139 - 309天)。睾酮首次回升至去势水平以上的平均时间为246天(范围168 - 344天);285天(范围218 - 370天)后达到治疗前值的50%。12周时,21例患者中有19例(90%)出现潮热。在研究期末,血清睾酮已达到治疗前浓度的80%(范围33% - 166%),52%的患者有性兴趣,60%的患者能够勃起,24%的患者仍有潮热。

结论

单次注射9.45mg、3个月缓释的布舍瑞林可使血清睾酮抑制至去势水平以下至少6个月。睾酮分泌在8 - 12个月恢复。随着血清睾酮分泌的恢复,性腺功能减退症状减轻。这些数据对于布舍瑞林的给药方案和所提供的患者信息具有临床相关性。

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