Buckler H M, Kalsi P K, Cantrill J A, Anderson D C
University Department of Medicine, Hope Hospital, Salford, UK.
Clin Endocrinol (Oxf). 1995 May;42(5):445-50. doi: 10.1111/j.1365-2265.1995.tb02660.x.
The aim of the study was to review our long-term use of subcutaneous oestradiol (E2) implant therapy for the treatment of climacteric symptoms in post-menopausal women. On the grounds that the aim is to restore premenopausal serum E2 levels, our declared clinical policy is not to repeat implants even in the presence of symptoms if serum E2 levels are > 400 pmol/l. Therapy was with 50 mg E2 implants inserted subcutaneously in the lower abdominal wall.
All women who had attended the gynaecological/endocrinological clinic who had received subcutaneous E2 implants for the relief of climacteric symptoms between December 1981 and 1992 were included.
Between December 1981 and December 1992, 275 women received a total of 759 50 mg E2 implants. The median length of implant therapy was 34.2 months (range 3.7-109.5 months), and the median number of implants per patient was 4 and ranged from 1 to 13. One hundred and twenty-nine women had more than four implants and their mean recorded serum E2 level was 425 +/- 187 (mean +/- SD) pmol/l; the mean level over the first 24 months of therapy was 408 +/- 157 pmol/l. This was not different from the mean value of the remaining period of therapy (439 +/- 168 pmol/l). Following the second implant there was no significant progressive rise in serum E2 with time and implant number and the mean E2 level per patient was no higher in those patients who received implants more frequently. The mean time between the first two implants was 9.7 +/- 0.4 months and between subsequent ones was 11.7 +/- 0.5 months. After the first two implants there was no progressive change in this interval with time.
This study shows that effective, safe and sympathetic management of women with oestrogen deficient symptoms may be achieved by use of two criteria to determine re-treatment; the return of symptoms, and a serum E2 level no higher than 400 pmol/l. Once therapy is established, E2 implants may need to be prescribed only on an annual basis. There appears to be no justification for giving E2 implants more frequently as this policy achieves satisfactory (physiological) premenopausal E2 levels and good symptomatic relief without any evidence for accumulation of E2 or 'tachyphylaxis'.
本研究旨在回顾我们长期使用皮下雌二醇（E2）植入疗法治疗绝经后女性更年期症状的情况。基于恢复绝经前血清E2水平的目标，我们宣称的临床策略是，即使出现症状，若血清E2水平>400 pmol/l，也不再重复植入。治疗采用50 mg E2植入物，经皮下插入下腹壁。
纳入1981年12月至1992年期间在妇科/内分泌科门诊接受皮下E2植入以缓解更年期症状的所有女性。
1981年12月至1992年12月期间，275名女性共接受了759次50 mg E2植入。植入治疗的中位时长为34.2个月（范围3.7 - 109.5个月），每位患者植入的中位次数为4次，范围为1至13次。129名女性植入次数超过4次，其记录的血清E2平均水平为425±187（均值±标准差）pmol/l；治疗前24个月的平均水平为408±157 pmol/l。这与治疗剩余时间的均值（439±168 pmol/l）无差异。第二次植入后，血清E2水平并未随时间和植入次数显著逐步升高，且植入更频繁的患者其每位患者的平均E2水平也未更高。前两次植入的平均间隔时间为9.7±0.4个月，后续植入之间的平均间隔时间为11.7±0.5个月。前两次植入后，该间隔时间并未随时间逐步变化。
本研究表明，通过使用两个标准来确定再次治疗，即症状复发和血清E2水平不高于400 pmol/l，可实现对雌激素缺乏症状女性的有效、安全且人性化管理。一旦确立治疗方案，E2植入物可能仅需每年开具一次。没有理由更频繁地给予E2植入物，因为该策略可实现令人满意的（生理性的）绝经前E2水平并有效缓解症状，且没有任何证据表明E2会蓄积或出现“快速耐受性”。
