30.雌二醇氮芥

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第163页(4062字)

【中文释文】:

(磷酸雌二醇氮芥)

〔成分〕

1粒胶囊含相当于140mg磷酸雌二醇氮芥的磷酸雌二醇氮芥二钠盐。

1支注射剂含相当于150mg或300mg磷酸雌二醇氮芥的磷酸雌二醇氮芥甲葡糖胺盐。

〔性质〕

雌二醇氮芥是一种细胞生长抑制制剂,用于治疗进展期的前列腺癌。除了它具有抑制细胞生长作用外,还有很微弱的雌激素作用。本品对前列腺组织有特异的亲合力,对前列腺癌细胞抑制作用强。由于其副作用小,因而可长期用药。大量临床研究表明雌二醇氮芥是治疗原发性和耐雌二醇的前列腺癌的有效药物。

〔适应证〕

进展期的前列腺癌,特别是激素治疗无效者及分化差的前列腺癌。

〔副作用〕

胃肠道反应如恶心、呕吐,部分病人出现血小板减少、白细胞减少、转氨酶升高,但这些现象在停药1~2周后均会逆转。部分病例乳房女性化。

静脉注射可能会引起局部血栓性静脉炎及短暂的会阴部疼痛。

〔剂量〕

胶囊:除特殊情况外,一般每次口服2~3粒,每日2次,用药3~4周无效应停药。

注射剂:治疗开始时为300mg/d,静脉注射,连续用药3周。然后维持治疗,即300mg静脉注射,每周2次或2~3粒胶囊口服,每日2次。

静脉注射时必须缓慢注射,并选用细针头。

用药3~4周无效应停药。

〔注意〕

雌二醇氮芥胶囊不能与奶或牛奶制品同服,以免减少药物吸收。

〔注射液的配制〕

将8ml稀释剂缓慢加入药瓶中,勿振荡,以免起泡沫。切勿将盐水作为稀释剂。

〔贮存〕

雌二醇氮芥胶囊及注射剂均应贮于不超过25℃环境中。

〔包装〕

每瓶100粒

150mg×10瓶(带10支稀释剂)

300mg×10瓶(带10支稀释剂)

〔生产厂家〕

瑞典

【外文释文】:

(estramustine phosphate)

Composition

1 capsule contains:

Estramustine phosphate di-sodium salt equivalent to Estramustine phosphate 140 mg

1 vial contains:

Estramustine phosphate methylglucamine salt equivalent to Estramustine phosphate 150 or 300mg

Properties

Estracyt is a cytostatic compound effective in the treatment of advanced prostatic carcinoma.Besides its cytostatic action estracyt has low estrogen effects.Estracyt has a specific affinity for prostatic tissue and effect on prostatic cancer cells.Because of the low frequency of serious side effects,long time therapy is possible.Extensive clinical trials have shown thatestracyt is effective in the treatment of primary and estrogen resistant prostatic carcinoma.

Indications

Prostatic carcinoma in advanced stages,especially hormone refractory cases and when carcinomas are poorly differentiated.

Side effects

Gastro-intestinal disturbances such as nausea and vomiting.In a few cases thrombocytopenia,leukopenia and elevated transaminases have been noted but were reversible in all cases upon discontinuation of the treatment for 1-2 weeks.In addition,a few cases of gynaecomastia have been observed.Intravenous injection has produced local thrombophlebitis and brief perineal pain.

Dosage

Capsules:

Unless otherwise prescribed,2-3 capsules twice a day.

If there is no effect after 3-4 weeks,the treatment can be discontinued.

Injections:

The treatment can also start with i.v.injections of 300 mg daily for 3 weeks.Then continue the therapy with i.v.injections of 300 mg twice a week or 2-3 capsules twice a day.

The injections must be given intravenously slowly and carefully with a fine neede.

If there is no effect after 3-4 weeks,the treatment can be discontinued.

Precautions

Estracyt capsules must not be given with meals containing milk or milk products which decrease the absorbtion of Estracyt.

Preparation of the solution:

8 ml diluent should be added slowly to the vial containing the drug substance but without shaking to avoid frothing.

saline must not be used as a diluent.

Storage

Estracyt capsules and ampoules should be stored at max 25℃。

Package

Bottles of 100 capsules

Vials 10 × 150mg(with 10 ampoules of diluent)

Vials 10 × 300mg(with 10 ampoules of diluent)

Manufacturer

Aktiebolaget Leo Helsingborg Sweden

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