Van Leusden H A, Albertyn G, Verlaine C, Van Ruymbeke J
Rijnstate EG Hospital, Arnhem, The Netherlands.
Int J Fertil Menopausal Stud. 1993 Jul-Aug;38(4):210-8.
Comparison of the effects of treatment of two transdermal therapeutic systems for estrogen replacement therapy with regard to efficacy, tolerability, and acceptance.
Open randomized.
Multicenter.
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).
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).
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.
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。
开放随机试验。
多中心。
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）。
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）。
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。
