黑升麻制剂治疗妇科恶性肿瘤术后绝经相关症状的初步研究  

A pilot study of Cimicifuga racemosa for the treatment of menopausal symptoms in women surviving gynecological malignant tumors

作　　者：田秦杰[1] 徐苓[1] 沈铿[1] 高庆蕾 郭红燕[3] 谭世桥[4] 张丙忠[5] 陈亦乐[6] 张国楠[7] 董武[8] 朱丽荣[9] 郑虹[10] 张淑兰[11] 王新宇[12] 张绍芬[13] 

机构地区：[1]中国医学科学院,北京协和医学院,北京协和医院妇产科,北京100730 [2]武汉同济医院妇产科,武汉430030 [3]北京大学第三医院妇产科,北京100191 [4]四川大学华西第二医院妇产科,成都610041 [5]中山大学孙逸仙纪念医院妇产科,广州510120 [6]湖南省肿瘤医院,长沙410006 [7]四川省肿瘤医院,成都610041 [8]辽宁省人民医院妇产科,沈阳110016 [9]北京大学第一医院妇产科,北京100034 [10]北京大学临床肿瘤学院,北京肿瘤医院暨北京市肿瘤防治研究所,北京100142 [11]中国医科大学盛京医院妇产科,沈阳110004 [12]浙江大学医学院附属妇产科医院妇瘤科,杭州310006 [13]复旦大学附属妇产科医院,上海200011

出　　处：《生殖医学杂志》2011年第3期167-173,共7页Journal of Reproductive Medicine

基　　金："十一五"国家科技支撑计划(妇科恶性肿瘤患者术后激素补充治疗的应用研究)(2008BAI57B04)

摘　　要：目的探讨黑升麻治疗妇科恶性肿瘤术后绝经症状的疗效和安全性。方法本研究是在中国8个省市13所大型医院进行的多中心、前瞻性、开放性、平行、病例对照研究。妇科恶性肿瘤术后出现绝经相关症状[Kupperman绝经指数(KMI)≥15分]的妇女根据自己的愿望分为不用药对照组和使用莉芙敏片研究组,观察期3个月,评估治疗前后症状评分改变,记录副反应,同时进行常规妇科肿瘤的术后监测。结果 97例患者符合入选条件,其中对照组46例,平均年龄(47.0±7.4)岁(25～58岁),平均入组时间为术后18.0个月(1～36个月),3个月后的KMI无显著变化,基线及3个月后的KMI平均分值分别为(23.2±4.8)和(23.4±5.8),无显著性差异(P=0.650)。莉芙敏研究组51例,平均年龄(41.5±5.4)岁(28～53岁),平均入组时间为术后7.6个月(0.5～82个月),KMI平均总分由治疗前的(26.5±6.7)分下降为治疗3月后的(19.2±5.8)分,有非常显著性差异(P<0.001)。治疗前后两组患者均未有肿瘤复发的体征,研究组亦无严重副反应。结论妇科恶性肿瘤治疗后会长期存在雌激素缺乏相关的绝经症状,黑升麻可有效缓解其绝经症状,改善生活质量,是一种非雌激素治疗选择,3个月治疗期间未发现肿瘤复发风险的增加。Objective： To explore the efficacy and safety of black cohosh （Cimicifuga racemosa, Remifemin ） for the treatment of menopausal symptoms in women surviving gynecological malignant tumors. Methods： This is a muhicenter, prospective, open, parallel, case-control clinical trial hold in 13 centers of 8 cities in China. Women of gynecological malignant tumors suffering from menopausal symptoms with Kupperman menopause index （KMI） ≥15 after bilateral oophrectomies or radiochemical therapy were divided into control group （without using any special drug） and study group （with treatment of Remifemin ） according to women＇s own desire. Remifemin 20 mg （b. i. d） was used in study group for 3 months （1 course of treatment）. The KMI and symptoms of each participant were evaluated before and after 3-month study and any side effects were recorded and signs of gynecological tumor were monitored. Results： The total number of enrolled women was 97, of which 46 were in control group with mean age of 47.0±7.4 （25-58） yrs and mean interval of 18.0 （1-36） months after surgery. The KMIs in control group before and after 3 months of treatment were 23.2±4.8 and 23.4±5.8, respectively, and there was no significant change （P= 0. 650）. There were 51 women in study group with mean age of 41. 5±5.4 （28-53） yrs and mean interval of 7.6 （0.5 82） months after operation. The KMI in study group was significantly reduced from 26.5 ± 6.7 before treatment to 19.2±5.8 after 3-month treatment of Remifemin （P〈0. 001）. There were no signs of tumor recurrence in the patients of either group and no report of severe side effects in study group after 3-month study. Conclusions： The estrogen deficiency-related menopausal symptoms after bilateral oophrectomies will last a long period resulting in reduced quality of life in gynecological malignant survivors. Black cohosh is a useful non-estrogenic treatment for the menopausal symptoms and does not increase risk of tumor recurrence during th

关 键 词：妇科恶性肿瘤 绝经症状 Kupperman绝经指数 黑升麻(莉芙敏片) 

分 类 号：R[医药卫生]