Fraser Ian S, Parke Susanne, Mellinger Uwe, Machlitt Andrea, Serrani Marco, Jensen Jeffrey
University of Sydney, Sydney, New South Wales, Australia.
Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258-69. doi: 10.3109/13625187.2011.591456.
To evaluate the efficacy of oestradiol valerate/dienogest (E2V/DNG) for the treatment of heavy and/or prolonged menstrual bleeding without organic pathology based on the analysis of data from two identically designed double-blind, randomised studies.
Women aged ≥ 18 years with heavy and/or prolonged menstrual bleeding were randomised to E2V/DNG (n = 269) or placebo (n = 152) for 196 days. Objective changes in menstrual blood loss (MBL) volume were assessed using the alkaline haematin method.
After six months of treatment, median MBL decreased by 88% with E2V/DNG compared with 24% with placebo. The greatest reduction was achieved at the first withdrawal bleed after treatment initiation and it was sustained with no loss of effect throughout treatment.
E2V/DNG was more effective than placebo in reducing MBL in women with heavy and/or prolonged menstrual bleeding without organic pathology. The reduction was largely achieved as early as the first withdrawal bleed, with further gradual improvement throughout treatment.
基于两项设计相同的双盲随机研究数据的分析，评估戊酸雌二醇/地诺孕素（E2V/DNG）治疗无器质性病变的月经过多和/或经期延长的疗效。
年龄≥18岁、有月经过多和/或经期延长的女性被随机分为E2V/DNG组（n = 269）或安慰剂组（n = 152），治疗196天。采用碱性高铁血红素法评估月经失血量（MBL）的客观变化。
治疗6个月后，E2V/DNG组MBL中位数下降了88%，而安慰剂组下降了24%。最大降幅出现在治疗开始后的首次撤药性出血时，且在整个治疗过程中持续存在，疗效无损失。
在治疗无器质性病变的月经过多和/或经期延长的女性中，E2V/DNG在减少MBL方面比安慰剂更有效。这种减少在首次撤药性出血时就基本实现，在整个治疗过程中进一步逐渐改善。
