Smith R N, Studd J W, Zamblera D, Holland E F
Department of Obstetrics and Gynaecology, Chelsea and Westminster Hospital, London, UK.
Br J Obstet Gynaecol. 1995 Jun;102(6):475-84. doi: 10.1111/j.1471-0528.1995.tb11321.x.
To determine the efficacy of a 100 micrograms twice weekly dose of Estraderm TTS compared with a 200 micrograms dose in the treatment of severe PMS, and to determine the overall acceptability of the treatment. To determine the serum oestradiol levels produced by the two doses of Estraderm and to discover whether the lower dose suppresses ovulation.
Main: randomised, prospective, comparative study. Subsidiary: cross-sectional and prospective.
Premenstrual syndrome clinic in teaching hospital.
Women with severe PMS confirmed by prospective daily symptom recording.
Estraderm TTS at a dose of either 100 or 200 micrograms twice weekly continuously with either dydrogesterone 10 mg or medroxyprogesterone acetate 5 mg, from day 17 to day 26 of each cycle.
Main: change in total, exponentially smoothed, average maximum score (total-ESAmax) of 10 common premenstrual syndrome symptoms derived from Trigg's trend analysis and patient satisfaction. Subsidiary: plasma oestradiol and day 21 progesterone levels.
Main: no difference in change in total-ESAmax between Estraderm 100 micrograms and 200 micrograms groups. Greater drop-out rate and greater incidence of side effects attributed to oestrogen in higher dosage group. Satisfaction rate of 45% to 57% at eight months. Subsidiary: 1. Mean (95% CI) oestradiol level of 300 pmol/l (255 to 345) with Estraderm 100 micrograms and 573 (494 to 693) with Estraderm 200 micrograms; 2. Estraderm 100 micrograms suppresses mid-luteal progesterone from a mean (95% CI) of 35.5 (28.4 to 42.7) to 3.4 (2.4 to 4.5).
Estraderm TTS 100 micrograms twice weekly is as effective as 200 micrograms twice weekly in reducing symptom levels in severe premenstrual syndrome but is better tolerated. Estraderm 100 micrograms suppresses ovulation and results in a mean plasma oestradiol level similar to that observed in a spontaneous cycle.
确定每周两次、每次100微克剂量的雌二醇透皮贴剂（Estraderm TTS）与200微克剂量相比，在治疗严重经前综合征（PMS）中的疗效，并确定该治疗的总体可接受性。确定两种剂量的Estraderm产生的血清雌二醇水平，并探究较低剂量是否抑制排卵。
主要：随机、前瞻性、对照研究。辅助：横断面研究和前瞻性研究。
教学医院的经前综合征诊所。
通过前瞻性每日症状记录确诊为严重PMS的女性。
在每个周期的第17天至第26天，每周两次连续使用100或200微克剂量的Estraderm TTS，并联合10毫克地屈孕酮或5毫克醋酸甲羟孕酮。
主要：源自Trigg趋势分析的10种常见经前综合征症状的总指数平滑平均最高得分（total-ESAmax）变化及患者满意度。辅助：血浆雌二醇和第21天孕酮水平。
主要：100微克Estraderm组和200微克Estraderm组在total-ESAmax变化方面无差异。高剂量组的脱落率更高，且因雌激素导致的副作用发生率更高。八个月时的满意度为45%至57%。辅助：1. 100微克Estraderm组的平均（95%可信区间）雌二醇水平为300皮摩尔/升（255至345），200微克Estraderm组为573（494至693）；2. 100微克Estraderm可将黄体中期孕酮从平均（95%可信区间）35.5（28.4至42.7）降至3.4（2.4至4.5）。
每周两次、每次100微克的Estraderm TTS在降低严重经前综合征症状水平方面与每周两次、每次200微克的效果相同，但耐受性更好。100微克Estraderm可抑制排卵，并使平均血浆雌二醇水平与自然周期中观察到的水平相似。
