Zhou Yuan-zheng, Sun Li-zhou, Lin Jin-fang, Yang Xin, Zhang Li-jia, Qiao Jie, Wang Ze-hua, Xu Yan-xue, Xiong Zheng-ai, Lin Shou-qing
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Zhonghua Fu Chan Ke Za Zhi. 2011 May;46(5):345-9.
To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese healthy women.
Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned into estradiol and drospirenone (observation group, n = 183) or placebo group (n = 61) by the ratio of 3:1 for 16 weeks in this randomized multi-center double-blind placebo-controlled study. During the trial, the follow-up visits were conducted at week 4, 8, 12, 16 of treatment and 2 weeks after treatment respectively. Height, weight, vital signs, hot flushes, other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit, while the clinical global impression scale was assessed at 16 weeks as well.
It showed that hot flushes were reduced significantly more in observation group than that in placebo group (P < 0.01), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from baseline respectively, which reached significant difference (P < 0.05). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0.05). After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P < 0.01). During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48.9% (87/178) in observation group and 10.7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183). The level of serum potassium was in the normal range in observation group mostly.Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related.
Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.
研究雌二醇屈螺酮片（安吉丽娜）治疗绝经后中国健康女性绝经症状的有效性和安全性。
在这项随机、多中心、双盲、安慰剂对照研究中，将244例有中度至重度潮热的绝经后中国健康女性按3:1的比例随机分为雌二醇屈螺酮组（观察组，n = 183）或安慰剂组（n = 61），治疗16周。试验期间，分别在治疗的第4、8、12、16周及治疗后2周进行随访。每次随访时观察身高、体重、生命体征、潮热、其他相关绝经症状及阴道出血情况，同时在第16周评估临床总体印象量表。
结果显示，尽管两种治疗均有效，但观察组潮热减少幅度显著大于安慰剂组（P < 0.01）。观察组和安慰剂组总潮热平均严重程度指数绝对值分别较基线下降了-0.6±0.5和-0.4±0.4，差异有统计学意义（P < 0.05）。然而，观察组和安慰剂组中度至重度潮热平均严重程度指数绝对值分别较基线下降了-0.6±0.8和-0.3±0.6，差异无统计学意义（P > 0.05）。治疗16周后，雌二醇屈螺酮在中度至重度出汗、阴道干燥及临床总体印象量表方面的疗效也显著优于安慰剂（P < 0.01）。试验期间，观察组血压稳定。观察组阴道出血发生率高于安慰剂组，尤其是在第4至8周时，观察组48.9%（87/178）的患者出现阴道出血，安慰剂组为10.7%（6/56）。尽管观察组每个周期（28天）的累积闭经率低于安慰剂组，但随着治疗时间延长逐渐升高。观察组最常见的不良事件是乳房压痛，占12.0%（22/183）。观察组血清钾水平大多在正常范围内。同时，其他不良事件发生率较低。本试验报告的严重不良事件经评估与研究药物无关或不太可能与研究药物有关。
雌二醇屈螺酮片能有效缓解绝经后中国健康女性的绝经症状，是一种安全性和有效性高的新型激素替代治疗方案。
