序贯联合应用雌孕激素调节月经周期与缓解绝经相关症状的临床研究

Clinical studies on efficacy of trisequens in adjusting menstrual cycle and menopausal symptoms during perimenopause

目的观察雌孕激素复方制剂(诺康律)用于控制月经周期与缓解绝经相关症状的临床疗效与副作用。方法采取开放、多中心、自身对照临床研究方法,观察对象为有绝经相关症状或同时有月经紊乱的绝经过渡期或绝经早期妇女。共入组153例,完成观察146例。所用的雌孕激素复方制剂诺康律,含17β雌二醇与醋酸炔诺酮两种成分,连续治疗3个周期。分别在治疗前、治疗1、2、3个月时采用Greene评分进行绝经相关症状评分。结果治疗后心理症状、躯体症状和血管舒缩症状等评分指标均有显著降低,症状总分从治疗前19±9降低至1个月时的10±7,2个月时的6±6,3个月时的5±10。在用药1个月、2个月和3个月时,95.4%、96.7%和98.6%的人出现规律性月经;不规则出血发生率分别为3.3%、2.7%和0.7%;闭经者分别为1.3%、0.7%和0.7%。副作用中,治疗前乳房胀发生率9.6%(14例),治疗1个月时38.2%(58例),2个月时36.7%(55例),3个月时21.9%(32例)。治疗1个月时消化道反应5例(3.3%),2个月时2例(1.3%),3个月时1例(0.7%)。无其他严重副作用发生,用药依从性较好,退出率低(4.6%)。结论序贯联合应用雌孕激素能够显著缓解绝经相关症状,调整月经周期。不良反应少,依从性好。

Objectives To observe efficacy of trisequens (a compound of estrogen plus progestin) in managing menopausal symptoms and irregular menstruation and its adverse effects.Methods An open, multiple-center, self-control clinical study was conducted and 153 women subjects at menopausal transition and early menopausal period who had menopausal symptoms or/and irregular menstruation were recruited. Trisequens, containing 17β-estradiol and/or northisterone acetate, was prescribed to all the subjects, one tablet/day continuously for 3 month. Menopausal symptoms were evaluated using Greene scale before the study, and the 1st, 2nd and 3rd month after treatment. Incidence of vaginal bleeding and other adverse effects were recorded during the follow-up period. In addition, causes of their clinic visits and educational background were obtained by questionnaires.Results Follow-up was completed in 146 of 153 participants. Scores of psychologic and somatic symptoms and vasomotor symptoms by Greene scale decreased significantly after treatment than those before treatment. Overall score of symptoms decreased to 10±7, 6±6 and 5±10 one, three and six month after treatment, respectively, from 19±9 before treatment. Regular menstruation could be observed in 95.4%, 96.7% and 98.6% of the subjects one, three and six months after treatment, respectively, and irregular bleeding was observed in 3.3%, 2.7% and 0.7% of them, and amenorrhea in 1.3%, 0.7% and 0.7% of them, respectively. Breast tenderness could be found in 14 cases (9.6%) before treatment, and in 58 (38.2%), 55 (36.7%) and 32 (21.9%) of them one, two and three months after treatment, respectively. Gastrointestinal reactions could be seen in five (3.3%), two (1.3%) and one (0.7%) of them one, two and three months after treatment, respectively. No other severe adverse reactions were found. The overall compliance with the treatment was good, only with 4.6%of them dropout.Conclusions Trisequens is effective to relieve menopausal symptoms and to adjust menstruation, with good compliance and less adverse effects.