目的 探讨雌二醇屈螺酮片(其他名称:安今益)用于伴有绝经相关症状的绝经后妇女的临床疗效和安全性.方法 采用多中心、双盲、随机、安慰剂对照的研究方法,将244例伴有中重度潮热症状的绝经后妇女,按3∶1比例随机分为治疗组(服用雌二醇屈螺酮片,183例)和安慰剂组(61例),连续服药16周,在服药的4、8、12、16周及服药结束后2周进行随访,观察身高、体质量、生命体征、潮热及其他绝经相关症状改善情况和阴道出血等,并在服药16周时进行临床疗效评价.结果 与治疗前比较,治疗后16周治疗组和安慰剂组总潮热平均严重程度指数下降的绝对值分别为-0.6±0.5和-0.4 ±0.4,两组比较,差异有统计学意义(P＜0.05);但治疗组和安慰剂组治疗后中重度潮热平均严重程度指数下降的绝对值分别为-0.6±0.8和-0.3±0.6,两组比较,差异无统计学意义(P＞0.05).治疗后16周时,治疗组妇女中重度出汗、阴道干涩等症状的缓解以及总体临床疗效均显著优于安慰剂组,差异有统计学意义(P＜0.01).整个治疗过程中,治疗组妇女的血压基本稳定.治疗中发生阴道出血治疗组为48.9%(87/178),安慰剂组为10.7%(6/56),尤其在治疗的第4～8周发生率最高.虽然治疗组的每个周期(28 d)累积无阴道出血率低于安慰剂组,但随着治疗时间的延长,治疗组的累积无阴道出血率逐渐升高.治疗组的不良事件主要是乳房胀痛,占12.0%(22/183).治疗组患者血钾无异常升高,无明显其他不良事件发生.整个治疗过程中发生的严重不良事件均与试验药物无关或可能无关.结论 雌二醇屈螺酮片可有效缓解绝经后妇女的绝经相关症状,是安全有效的新型激素补充治疗药物.%Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned 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.Results 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. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.
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