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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。
Objective To observe the clinical efficacy and side effects of estrogen and progesterone compound preparation (nocodazole) for controlling menstrual cycle and relieving the symptoms associated with menopause. Methods The open, multicenter and self-controlled clinical research methods were used to observe the menopausal or premenopausal women with menopausal symptoms or menopausal symptoms. A total of 153 cases were enrolled, 146 cases completed the observation. The estrogen and progesterone compound preparation used by Novate’s law, with 17β estradiol and norethindrone acetate two components, continuous treatment of three cycles. Menopausal symptoms were assessed using the Greene score before treatment, at 1, 2, and 3 months of treatment. Results After treatment, the scores of psychological symptoms, physical symptoms and vasomotor symptoms were significantly decreased. The total score of symptoms decreased from 19 ± 9 before treatment to 10 ± 7 at 1 month and 6 ± 6 at 2 months. 5 ± 10 at 3 months. At 1 month, 2 months and 3 months, 95.4%, 96.7% and 98.6% of the patients had regular menstruation. The incidences of irregular bleeding were 3.3%, 2.7% and 0.7% respectively. Amenorrhoea were 1.3%, 0.7% and 0.7%. Among the side effects, the incidence of breast swelling was 9.6% (14 cases), 38.2% (58 cases) at 1 month, 36.7% (55 cases) at 2 months and 21.9% (32 cases) at 3 months. Five cases (3.3%) had digestive tract reactions at 1 month, 2 cases (1.3%) at 2 months and 1 case (0.7%) at 3 months. No other serious side effects, medication compliance is better, the withdrawal rate is low (4.6%). Conclusions Sequential combined application of estrogen and progesterone can significantly relieve menopausal symptoms and adjust the menstrual cycle. Adverse reactions, compliance is good.