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Efficacy and Safety Investigation of Kuntai Capsule for the Add-back Therapy of Gonadotropin Releasing Hormone Agonist Administration to Endometriosis Patients： A Randomized,Double-blind, Blank-and Tibolone-controlled Study

引用

Chinese Medical Journal 2015年第4期128卷 427-432页

作者： Ji-Ming Chen Hong-Yan Gao Yi Ding Xia Yuan Qing Wang Qin Li Guo-Hua Jiang Department of Gynecology Third Affiliated Hospital of Soochow University Changzhou Jiangsu 213003 China Department of Gynecology Jintan Hospital Affiliated to Jiangsu University Jintan Jiangsu 213200 China

Background：As a Chinese Traditional Medicine product,Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal *** it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist （GnRH-a） *** purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule,on peri-menopausal symptoms in endometriosis （EMS） patients,with postoperative GnRH-a ***：Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study,and were randomly divided into Kuntai group,Tibolone group,or blank Control *** therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first GnRH-a injection,while Tibolone 2.5 mg qd,po for 12 weeks in Tibolone *** was no drug addition in Control *** complaints were evaluated by Kupperman menopausal index （KMI） and hot flash/sweating *** and renal functions,lipid profile,serum sex hormone levels and endometrial thickness were measured,and the frequency of adverse events in Kuntai and Tibolone groups was ***：（l） Before GnRH-a therapy,the baseline parameter results were comparable in the three groups （P ＞ 0.05）.（2） After GnRH-a therapy,KMI and hot flash/sweating scores in all the three groups increased significantly （P ＜ 0.05）.At the 4th week after GnRH-a therapy,KMI and hot flash/sweating score results were as follows：Control group ＞ Kuntai group ＞ Tibolone group （P ＜ 0.05）; at the 8th and 12th week after GnRH-a therapy,KMI and hot flash/sweating score in Control group were significantly higher than the other two groups （P ＜ 0.05）,and no significant difference was identified between Kuntai and Tibolone group （P ＞ 0.05）.（3） No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment （P ＞ 0.05）.（4） The posttherapeutic

关键词： Endometriosis Kuntai Capsule Kupperman menopausal Index peri-menopausal symptoms Tibolone

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