黑升麻类药物莉芙敏治疗更年期症状临床疗效观察  

Efficacy of remifemin for controll of climacteric symptoms.

作　　者：李轶琳[1] 崔满华[2] 高双[1] 

机构地区：[1]大庆油田总医院妇产科,大庆163001 [2]吉林大学第二医院妇产科

出　　处：《现代妇产科进展》2011年第6期462-465,共4页Progress in Obstetrics and Gynecology

摘　　要：目的:研究黑升麻(black cohosh)异丙醇提取物莉芙敏治疗更年期症状的有效性。方法:以随机、双盲对照方法,入组40～55岁围绝经期妇女89例,其中12例中断治疗,77例入组。莉芙敏组45例,口服莉芙敏片28mg,每天2次,连续用药12周;安慰剂组32例。以Kupperman绝经期指数(KM I)总分为主要疗效指标,在治疗前、治疗第4、12周时进行观察、以肝功(谷草转氨酶及谷丙转氨酶)、血脂4项(总胆固醇、高密度脂蛋白、低密度脂蛋白、甘油三酯)、血清中促卵泡生成素(FSH)、雌二醇(E2)、子宫内膜厚度、阴道脱落细胞成熟值评分(VM I),进行用药前后比较。结果:(1)用药前两组各指标之间无统计学差异(P>0.05);(2)治疗4周时,莉芙敏组KM I评分为12.46±6.96,安慰剂组为19.63±11.09;治疗12周时,莉芙敏组KM I评分为6.37±4.16,安慰剂组为17.41±11.61,两组差异有统计学意义(P<0.005)。莉芙敏组KM I评分和潮热次数明显低于安慰剂组;(3)高密度脂蛋白(HDL)安慰剂组从基线水平60.20±16.37降至第12周56.63±12.67,莉芙敏组由58.32±11.64上升至59.74±10.54,差异有统计学意义(P=0.04)。GOT及GPT、FSH、E2在12周的莉芙敏治疗后无显著变化;(4)莉芙敏组与安慰剂组在治疗前后12周,对子宫内膜厚度均无影响。结论:在不能给予或拒绝激素替代疗法的更年期妇女中,莉芙敏(56mg/d)能够有效、安全改善妇女的围绝经期症状。Objective：To investigate the efficacy of remifemin（isopropanolic extract of cimicifuga racemosa） on climacteric symptoms in a randomized clinical study.Hormone parameters,lipid profiles,the endometrial thickness and the vaginal mature index（VMI） were evaluated.Methods：89 perimenopausal women at range of 40~55 years old were enrolled in randomized and double blind study.From the initial 89 participants,77 completed the trial（45 in the remifemin group,32 in the placebo group）.They were divided into remifemin group and placebo group.The therapeutic strategy was remifemin 28mg bid po for 12 weeks.Climacteric complaints were evaluated by the Kupperman Index（KMI） initially and 4 and 12 weeks following treatment.Liver function（GOT and GPT）,total cholesterol,HDL-cholesterol,LDL-cholesterol and triglyceride levels,serum estradiol,FSH,the thickness of endometrium and vaginal mature index were measured before and after treatment.Results：（1）Baseline characteristics were not significantly different between the two groups.（2）KMI score decreased from 26.46±10.64 to 12.46±6.96 and 6.37±4.16 at 4 and 12 weeks in remifemin group.It decreased from 25.38±10.16 to 19.63±11.09 and 17.14±11.61 at 4 and 12 weeks in placebo group.（3）HDL levels decreased in the control group from 60.20±16.37 to 56.63±12.67,and increased in the remifemin group from 58.32±11.64 to 59.74±10.54,this was statistically significant（P=0.04）.GOT,GPT,FSH and E2 were not significantly different after 12 weeks treatment.（4）In comparison of thickness of endometrium before and at 12 weeks treatment,no remarkable changes were observed between groups.Conclusion：The study suggested that remifemin is one effective and safe agent to women with climacteric symptom.It has been recommended that women with estrogen-sensitive cancers seek remifemin as an alternative method for alleviating menopausal symptoms.

关 键 词：黑升麻 莉芙敏 更年期综合征 激素替代疗法 

分 类 号：R749.5[医药卫生—神经病学与精神病学]