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一项随机试验,比较每12周注射一次的10.8毫克戈舍瑞林长效注射剂与每4周注射一次的3.6毫克戈舍瑞林长效注射剂在晚期前列腺癌患者中的安全性和有效性。荷兰东南部泌尿外科合作组。

A randomised trial comparing the safety and efficacy of the Zoladex 10.8-mg depot, administered every 12 weeks, to that of the Zoladex 3.6-mg depot, administered every 4 weeks, in patients with advanced prostate cancer. The Dutch South East Cooperative Urological Group.

作者信息

Dijkman G A, Debruyne F M, Fernandez del Moral P, Plasman J W, Hoefakker J W, Idema J G, Sykes M

机构信息

St. Ignatius Hospital, Department of Urology, Breda, The Netherlands.

出版信息

Eur Urol. 1995;27(1):43-6. doi: 10.1159/000475122.

Abstract

A new longer-acting depot formulation containing 10.8 mg Zoladex administered every 12 weeks was compared to the 3.6-mg Zoladex depot administered every 28 days, in a randomised trial in patients with advanced prostatic carcinoma in which pharmacodynamic efficacy and safety were assessed. Effective induction of mean serum testosterone suppression into the surgically castrate range by 21 days and maintenance of suppression for the duration of therapy was achieved with both the 3.6-mg and the 10.8-mg depot formulations. The Zoladex 10.8-mg depot was well tolerated both locally and systemically. This new formulation which is equivalent to three successive 3.6-mg depots will provide a more convenient dosing regime for both patient and doctor in this indication.

摘要

在一项针对晚期前列腺癌患者的随机试验中,对一种每12周注射一次、含10.8毫克诺雷得的新型长效储库制剂与每28天注射一次、含3.6毫克诺雷得的储库制剂进行了比较,评估了其药效学疗效和安全性。3.6毫克和10.8毫克的储库制剂均能在21天内有效诱导平均血清睾酮抑制至手术去势范围,并在治疗期间维持抑制效果。10.8毫克的诺雷得储库制剂在局部和全身均耐受性良好。这种相当于连续三次注射3.6毫克储库制剂的新制剂,将为该适应症的患者和医生提供更方便的给药方案。

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