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应用双盲法观察国产雌二醇控释贴片治疗卵巢功能低落104例(用药组),采用空白贴片治疗卵巢功能低落72例(对照组),并结合促黄体生成激素(LH)、促卵泡激素(FSH)、雌二醇(E_2)测定,阴道壁脱落细胞成熟指数(MI)和子宫内膜组织学检查综合评价药效。结果表明:用药组贴片对卵巢功能低落所致的潮热、出汗、阴道干涩、头晕、情绪波动及失眠等6项主要临床表现,有显著疗效,有效率分别为97.9%、97.5%、93.7%、77.0%、76.2%及75.0%,且随用药时间延长疗效递增,与对照组比较,差异有显著意义。对LH、FSH释放的抑制作用,在用药的第10天即已出现。在整个用药期间,MI升高,血清E_2水平轻度升高,浓度平稳。部分患者行子宫内膜组织学检查,未见明显的由于雌激素作用引起的内膜增殖反应。
Double-blind observation of domestic estradiol controlled release patch treatment of 104 cases of ovarian dysfunction (medication group), the use of blank patch treatment of 72 cases of ovarian dysfunction (control group), combined with luteinizing hormone (LH), and promote Follicle-stimulating hormone (FSH), estradiol (E2), vaginal wall exfoliated cell maturation index (MI) and endometrial histology were evaluated comprehensively. The results showed that there were significant effects on the six major clinical manifestations of hot flashes, sweating, vaginal dryness, dizziness, mood swings and insomnia caused by low ovarian function in the treatment group. The effective rates were 97.9%, 97 .5%, 93.7%, 77.0%, 76.2% and 75.0%, respectively, and the therapeutic effect was prolonged with the prolongation of drug use time. Compared with the control group, the difference was significant. Inhibition of LH, FSH release, the tenth day of administration that has emerged. During the whole period of treatment, MI increased, serum E_2 level increased slightly and the concentration was stable. Some patients underwent endometrial histological examination, no significant intimal hyperplasia due to estrogen effects.