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两种经皮雌二醇替代疗法治疗绝经后症状的多中心对照研究。

A comparative multicenter study of two transdermal estradiol replacement therapies in the treatment of postmenopausal symptoms.

作者信息

Van Leusden H A, Albertyn G, Verlaine C, Van Ruymbeke J

机构信息

Rijnstate EG Hospital, Arnhem, The Netherlands.

出版信息

Int J Fertil Menopausal Stud. 1993 Jul-Aug;38(4):210-8.

PMID:8401679
Abstract

OBJECTIVE

Comparison of the effects of treatment of two transdermal therapeutic systems for estrogen replacement therapy with regard to efficacy, tolerability, and acceptance.

DESIGN

Open randomized.

SETTING

Multicenter.

PATIENTS AND INTERVENTIONS

A study population of 104 postmenopausal women was randomized on a 1:1 basis to treatment with one of two estradiol patches, System (Cilag) and Estraderm (Ciba-Geigy).

OUTCOME MEASURES

Systolic and diastolic BP, hot flushes, night sweating, fatigue, insomnia, depression, nervousness, headache, vaginal discomfort (efficacy variables); bleeding, dermatological symptoms, comfort and adhesiveness of patch, and other possible causes of discontinuation (tolerability); general evaluation by patient (acceptance).

RESULTS

Considering all efficacy variables, 53% of Systen and 46% of Estraderm patients found the therapy satisfactory. Tolerability was somewhat higher in the Systen group. Adhesiveness of the patch was significantly better for Systen. Overall, 79% of Systen patients and 62% of Estraderm patients evaluated treatment as "good" or "very good." The majority of patients in both groups found the patch very comfortable or only slightly obtrusive.

摘要

目的

比较两种用于雌激素替代疗法的透皮治疗系统在疗效、耐受性和接受度方面的治疗效果。

设计

开放随机试验。

地点

多中心。

患者和干预措施

104名绝经后女性的研究人群按1:1比例随机分配,接受两种雌二醇贴片之一的治疗,即系统贴片(西拉格公司)和雌二醇透皮贴片(汽巴-嘉基公司)。

观察指标

收缩压和舒张压、潮热、盗汗、疲劳、失眠、抑郁、紧张、头痛、阴道不适(疗效变量);出血、皮肤症状、贴片的舒适度和粘性,以及其他可能导致停药的原因(耐受性);患者的总体评价(接受度)。

结果

考虑所有疗效变量,53%使用系统贴片的患者和46%使用雌二醇透皮贴片的患者认为治疗效果令人满意。系统贴片组的耐受性略高。系统贴片的粘性明显更好。总体而言,79%使用系统贴片的患者和62%使用雌二醇透皮贴片的患者将治疗评价为“好”或“非常好”。两组中的大多数患者都觉得贴片非常舒适或只是稍有妨碍。

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