Panay N, Versi E, Savvas M
Department of Obstetrics and Gynaecology, University Hospital Lewisham, London.
BJOG. 2000 Aug;107(8):1012-6. doi: 10.1111/j.1471-0528.2000.tb10405.x.
Randomised, double-blind investigation.
Forty-four women, who had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy.
The women were randomised to receive either 25 mg (n = 20) or 50 mg (n = 24) oestradiol implants. Follow up consisted of prospective symptom enquiry and hormone assays.
Primary: climacteric symptom control: duration and effectiveness; secondary: serum oestradiol and follicle stimulating hormone levels.
Serum oestradiol was significantly higher and serum follicle stimulating hormone significantly lower after the fourth month of treatment in women receiving 50 mg implants. No significant difference in symptom control was noted in the two groups. The mean duration of symptom control was similar in the two groups: 5.9 months (SD 2.4) in those receiving 50 mg oestradiol and 5.6 months (SD 2.3) in those receiving 25 mg.
The higher level, 50 mg oestradiol implants does not result in better control of symptoms nor in longer periods of symptom control compared with 25 mg oestradiol implants. In order to maximise compliance, 25 mg oestradiol implants should therefore be the treatment of choice for women with normal bone density seeking relief of climacteric symptoms.
随机双盲研究。
44名接受了全腹子宫切除术和双侧输卵管卵巢切除术的女性。
将这些女性随机分为接受25毫克(n = 20)或50毫克(n = 24)雌二醇植入剂两组。随访包括前瞻性症状询问和激素测定。
主要指标:更年期症状控制:持续时间和有效性;次要指标:血清雌二醇和卵泡刺激素水平。
接受50毫克植入剂的女性在治疗第四个月后血清雌二醇显著升高,血清卵泡刺激素显著降低。两组在症状控制方面未观察到显著差异。两组症状控制的平均持续时间相似:接受50毫克雌二醇的为5.9个月(标准差2.4),接受25毫克的为5.6个月(标准差2.3)。
与25毫克雌二醇植入剂相比,50毫克较高剂量的雌二醇植入剂在症状控制方面并未带来更好的效果,也未使症状控制期更长。因此,为了最大程度提高依从性,对于寻求缓解更年期症状且骨密度正常的女性,25毫克雌二醇植入剂应作为首选治疗方法。