目的 评价莉芙敏片与利维爱治疗妇女围绝经期症状的疗效和安全性.方法 采用随机、双盲、平行对照的研究方法,纳入40～60岁的绝经期妇女110例,按1:1比例分配至莉芙敏组和利维爱组,每组各55例.莉芙敏组口服片剂20 mg,2次/d,利维爱组口服片剂1.25 mg/d;均连续用药12周.以Kupperman绝经期指数(KMI)总分为主要疗效评价指标,以KMI各单项指标作为次要疗效评价指标,在治疗前及治疗4、12周时进行观察,以肝肾功能、血常规等实验室检查项目及不良事件作为安全性指标,对用药前后进行组间、组内比较.结果 (1)KMI总分:治疗前KMI总分莉芙敏组为(22±6)分,利维爱组为(23±5)分;治疗4周时,KMI总分莉芙敏组为(9±7)分,利维爱组为(10±8)分;治疗12周时,KMI总分莉芙敏组为(8±4)分,利维爱组为(7±5)分.治疗后第4、12周时,两组KMI总分较治疗前均有明显下降,差异有统计学意义(P＜0.05);治疗后各时间点两组KMI总分比较,差异均无统计学意义(P＞0.05).(2)KMI各单项指标:两组内治疗前与治疗4周、12周时各项症状评分比较,差异有统计学意义(P＜0.05);但治疗后各时间点各指标组间比较,差异无统计学意义(P＞0.05).(3)安全性及疗效:莉芙敏组无一例阴道出血,利维爱组阴道出血10例(18.2%,10/55);莉芙敏组乳房胀痛8例(14.5%,8/55),利维爱组20例(36.4%,20/55);治疗前子宫内膜厚度莉芙敏片组为(2.5±1.1)mm,利维爱组为(2.7±1.1)mm,治疗12周时,子宫内膜厚度莉芙敏组为(2.7±1.2)mm,利维爱组为(3.8±2.1)mm,治疗前与治疗12周时比较,莉芙敏组子宫内膜厚度无明显增厚,而利维爱组子宫内膜厚度明显增加.结论 莉芙敏片能够有效、安全地改善妇女的围绝经期症状,其疗效与利维爱相似,不良事件发生率低于利维爱.%Objective To investigate the efficacy and safety of Remifemin ( isopropanolie extract of eimicifuga racemo-sa ) and Livial in treating perimenopausal syndromes. Methods One hundred and ten postmenopausal women aged 40 ~ 60 were enrolled in a randomized and double - blinded study. They were equally divided into the Remifemin and the Livial group ( 55 cases each ). The regimen was Remifemin 20 mg ( bid p. O. ) for 12 weeks for the Remifemin group and Livial 1. 25 mg ( qd p. O. ) for 12 weeks for the Livial group. The observation and comparision were made before the treatment, after 4 weeks and 12 weeks of the treatment respectively, both within and between the two groups, with total score of Kupperman menopause index ( KMI ) as the major evaluating index, single item scores of KMI as the second, laboratory tests and adverse events at baseline as the safety indice. Results ( 1 ) Total score of KMI: Total score of KMI was ( 22 ± 6 ) in the Remifemin group and ( 23 ± 5 ) in the Livial group at baseline, ( 9 ± 7 ) in the Remifemin group and ( 10 ± 8 ) in the Livial group at the timepoint of 4 weeks, and ( 8 ± 4 ) in the Remifemin group and ( 7 ± 5 ) in the Livial group at the timepoint of 12 weeks. There is no statistical significance with Total KMI scores between the two groups at various timepoints ( P >0. 05 ). ( 2 ) Single item scores: Single item scores of KMI were significantly different within each group before, 4 weeks after and 12 weeks after treatment ( P <0. 05 ), however no differences were found between the two groups at both timepoints after treatment ( P >0. 05 ). (3) Safety and Efficacy: No cases of vaginal bleeding were observed in the Remifemin group, while 10 cases of vaginal bleeding were noted in the Livial group (18. 2% , 17/ 55 ). The incidence of breast swelling was 14. 5% ( 8/55 ) in the Remifemin group and 36. 4% ( 20/55 ) in the Livial group. Before treatment, the thickness of endometrium was ( 2. 5 ± 1. 1 ) mm in the Remifemin group and ( 2. 7 ± 1. 1 ) mm in the Livial group; at the timepoint of 12 weeks, the thickness of endometrium was ( 2. 7 ± 1. 2 ) mm in the Remifemin group and ( 3. 8 ± 2. 1 ) mm in the Livial group. In comparison with the thickness of endometrium before treatment, no remarkable changes were observed in the Remifemin group while significant increase in endometrium thickness was noted in the Livial group after 12 weeks of treatment. Conclusion Remifemin is an effective and safe agent to manage climacteric symptoms. It displays similar therapeutic effects and lower incidence of adverse reactions when compared with Livial.
展开▼
