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鼻内用雌二醇:新剂型。鼻内雌激素给药系统:不过是个噱头。

Intranasal estradiol: new formulation. Intranasal oestrogen delivery system: just a gimmick.

出版信息

Prescrire Int. 2002 Dec;11(62):163-5.

PMID:12469692
Abstract

(1) Many oral and transdermal (patch and gel) estradiol preparations are already available for controlling menopausal symptoms due to oestrogen deficiency. (2) Marketing authorization has now been granted in Europe for an intranasal delivery system, which produces a high, brief plasma estradiol peak. (3) According to two clinical trials, the symptomatic effects of 300 micrograms of estradiol daily by the intranasal route is similar to that of 50 micrograms /day transdermally (unblinded trial) and 2 mg/day orally (double-blind trial). (4) The most frequent side effects are intranasal reactions (in approximately 50% of patients), breast pain (30-40% of patients), and metrorrhagia (approximately 7% of cycles). (5) The long-term consequences of such high plasma estradiol peaks, including the risk of breast cancer, are unknown. (6) Intranasal estradiol is not reimbursed in France, unlike other oestrogen preparations for use in menopausal women. (7) In practice, oral and transdermal delivery systems, with which we have lengthy experience, are adequate for relieving menopausal symptoms. The intranasal route offers no proven advantage, and its long-term risks are unknown.

摘要

(1)许多口服和经皮(贴片和凝胶)雌二醇制剂已可用于控制因雌激素缺乏引起的更年期症状。(2)一种鼻内给药系统现已在欧洲获得上市许可,该系统可产生高且短暂的血浆雌二醇峰值。(3)根据两项临床试验,经鼻途径每日给予300微克雌二醇的症状缓解效果与经皮每日50微克(非盲法试验)和口服每日2毫克(双盲试验)相似。(4)最常见的副作用是鼻内反应(约50%的患者)、乳房疼痛(30 - 40%的患者)和子宫出血(约7%的周期)。(5)如此高的血浆雌二醇峰值的长期后果,包括患乳腺癌的风险,尚不清楚。(6)与用于绝经后女性的其他雌激素制剂不同,法国不报销鼻内雌二醇。(7)实际上,我们有长期经验的口服和经皮给药系统足以缓解更年期症状。鼻内途径没有已证实的优势,其长期风险尚不清楚。

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