坤泰胶囊改善GnRH-a所致围绝经期症状的前瞻性随机对照研究  

Effects of Kuntai capsule on GnRH-a-induced perimenopause symptoms:a prospective randomized controlled study

作　　者：丁淼[1] 王良岸[1] 李扬志[1] 陈冬梅[1] 廖德华 方玲玲 谢小倩 谢梅青[1] DING Miao;WANG Liang-an;LI Yang-zhi;CHEN Dong-mei;LIAO De-hua;FANG Ling-ling;XIE Xiao-qian;XIE Mei-qing.(Department of Reproductive Endocrinology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,China)

机构地区：[1]中山大学孙逸仙纪念医院生殖内分泌科,广东广州510120

出　　处：《中国实用妇科与产科杂志》2019年第4期462-465,共4页Chinese Journal of Practical Gynecology and Obstetrics

摘　　要：目的评估坤泰胶囊对促性腺激素释放激素激动剂(gonadotrophin releasing hormone agonist,GnRH-a)所引起的围绝经期症状及内分泌激素水平的改善情况。方法选择2015年6月至2016年3月于中山大学孙逸仙纪念医院妇科就诊的子宫肌瘤、子宫腺肌病或者中重度子宫内膜异位症且需要接受GnRH-a治疗的患者共99例,随机分为观察组(坤泰组)和对照组(替勃龙组)。于月经期第2～4天或手术后撤退性出血第2～4天注射第一支GnRHa,以后每28 d注射1次。从注射第1针GnRHa开始服用坤泰胶囊或替勃龙,两组同时口服钙尔奇D-600和阿法迪三。记录患者的Kupperman评分,血清性激素(FSH和E2)水平及安全性等指标。结果 GnRH-a治疗中应用坤泰胶囊使大部分患者的绝经症状维持在轻度水平,Kupperman评分升高平缓;且在治疗第8周时坤泰组疗效优于替勃龙(P<0.05)。观察组中患者感觉异常、焦躁和皮肤蚁走感等症状改善较为明显。同时,观察组血清FSH和E2水平均较治疗前明显下降(P<0.05),且与替勃龙组疗效相当。两组均未出现严重不良反应。结论在GnRH-a短期治疗中,坤泰胶囊对GnRH-a引起的绝经症状有良好的缓解作用,具有安全性高,不良反应少的特点。Objective To evaluate the effect of Kuntai capsule on the gonadotrophin releasing hormone agonist(GnRH-a)-induced perimenopaus symptoms and the sex hormone levels.Methods A total of 99 patients with uterine fibroids,adenomyosis or moderate to severe endometriosis who needed the treatment of GnRH-a at Sun Yat-sen Memorial Hospital of Sun Yat-sen University from June 2015 to March 2016 were collected and randomly divided into research group(Kuntai capsule)and control group(Tibolone).GnRH-a was injected once every 28 days and first injection of GnRH-a was administered on the 2 nd to 4 th day of menstrual period or retraction bleeding after surgery.Kuntai capsule or Tibolone was orally taken beginning from the first GnRH-a injection,and the co-administration of Caltrate D-600 and alfacalcidol was given in both groups.The Kupperman scores,sex hormone levels including folliclestimulating hormone(FSH)and estrogen(E2),and adverse events were recorded.Results Kuntai capsule kept the perimenopause symptoms at mild level with the slow increase of Kupperman scores,whose effect was significantly superior to Tibolone(P<0.05)after 8 weeks of treatment,especially in paresthesia,nervousness,and formication.The FSH and E2 levels in both Kuntai and Tibolone groups were obviously decreased when compared with the pre-treatment(P<0.05),and these hormone levels in Kuntai group were comparable to those in Tibolone group.No adverse events occurred in either group.Conclusion In the short-term treatment of GnRH-a,Kuntai capsule exhibits significant alleviating effects on perimenopause symptoms caused by GnRH-a with high safety and few adverse reactions.

关 键 词：促性腺激素释放激素激动剂 反向添加疗法 围绝经期 坤泰胶囊 子宫内膜异位症 子宫肌瘤 

分 类 号：R711.51[医药卫生—妇产科学]