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[促黄体生成素释放激素类似物布舍瑞林(Hoe 766)单次及多次皮下注射治疗前列腺癌的临床经验:最佳皮下剂量的内分泌学研究]

[Clinical experience with single and multiple subcutaneous administration of LHRH analog Buserelin (Hoe 766) in prostatic carcinoma: endocrinological study of optimum subcutaneous doses].

作者信息

Niijima T, Isurugi K, Kawabe K, Kinoshita K, Asano M, Nakauchi K, Fujita K, Nishimura Y, Nitoh H, Yokoyama M

出版信息

Hinyokika Kiyo. 1988 Jul;34(7):1297-307.

PMID:2459944
Abstract

Seventy three patients with prostatic carcinoma (PC) and 7 patients with benign prostatic hypertrophy (BPH) in 12 institutes subcutaneously received single and multiple doses of Hoe 766, and clinical efficacy, safety and endocrine effects of drug were examined. In a single doses study, six doses were subcutaneously administered to 7 BPH and 3 with PC. Gonadotropin and testosterone levels in the blood were increased following all these doses. In a multiple study, 7 kinds of doses were given to 40 patients with PC. The optimum doses of subcutaneous injection was decided to be 500 x 3 micrograms/day based on gonadotropin and testosterone suppression. Objective response by NPCP's criteria was observed in 35.3% (complete response 5.9%, partial response 29.4%) following 3 months of Hoe 766 treatment. Adverse reactions were observed in 9 cases (12.8%): Treatment was discontinued in 3 cases (eruption in 2, nausea and vomiting in 1), and continued in 6 cases (8.6%) without any treatment required. Buserelin was thus considered to be an effective, safe drug to treat prostatic carcinoma.

摘要

12家机构的73例前列腺癌(PC)患者和7例良性前列腺增生(BPH)患者皮下接受了单剂量和多剂量的Hoe 766治疗,并对药物的临床疗效、安全性和内分泌效应进行了检查。在单剂量研究中,对7例BPH患者和3例PC患者皮下给予了6种剂量。所有这些剂量给药后,血液中的促性腺激素和睾酮水平均升高。在多剂量研究中,对40例PC患者给予了7种剂量。基于促性腺激素和睾酮抑制情况,皮下注射的最佳剂量确定为500×3微克/天。Hoe 766治疗3个月后,按照NPCP标准观察到客观缓解率为35.3%(完全缓解5.9%,部分缓解29.4%)。观察到9例(12.8%)出现不良反应:3例(2例皮疹、1例恶心和呕吐)停止治疗,6例(8.6%)继续治疗且无需任何处理。因此,布舍瑞林被认为是治疗前列腺癌的一种有效、安全的药物。

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