Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial.
Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial.
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补肾活血颗粒治疗卵巢早衰的有效性和安全性：随机、双盲、安慰剂对照、多中心临床试验研究方案。
DOI：
10.1186/s13063-021-05838-w
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发表时间：
2021-12-04
期刊：
影响因子：
2.5
通讯作者：
Weibo-Zhao
中科院分区：
文献类型：
--
作者：
Cao Y;Peijuan-Wang;Lu Y;Chen Y;Chen S;Weibo-Zhao
卵巢早衰（POI）严重影响育龄妇女的生活质量、内分泌功能和生育能力。目前，激素替代疗法治疗POI存在一定的局限性，要么疗效低，要么副作用大。补肾活血（BSHX）在缓解POI患者临床症状、改善健康状况方面具有重要作用。这项安慰剂对照、随机、双盲、多中心临床试验方案旨在评估BSHX治疗女性POI的有效性和安全性。我们计划从中国的四家参与医院招募150名患有POI的妇女。参与者将按1:1的比例随机接受口服BSHX或BSHX安慰剂。所有参与者将治疗3个月，并随访3个月。主要观察指标为基于总症状变化的问卷得分，即中国版的绝经期特异性生活质量量表（CMS）（聂刚，杨华，刘健，赵超，王霞，绝经24(5):546-554,2017）。CMS将在干预前、随机分组后3个月和6个月对所有参与者进行测量。其他测量包括血清性激素水平、抗<s:1>勒氏杆菌激素（AMH）水平、卵巢峰值收缩速度（PSV; cm/s）和窦卵泡计数（AFC）。本研究通过对大鼠血清中雌二醇（E2）、促黄体生成素（LH）、促卵泡生成素（FSH）等性激素水平的变化，评价中药对激素的调节作用。这些指标将在干预前和随机分组后3个月测量。本研究已获江苏省中西医结合医院研究伦理委员会（2019LWKY014）批准。所有参与者将在随机分组前提供书面知情同意书。这项研究的结果将提交给学术会议和同行评议的期刊。ChiCTR1900028451。2019年12月22日注册，网址：https://www.chictr.org.cn/index.aspx。在线版本包含补充资料，下载地址：10.1186/s13063-021-05838-w。
Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization. This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals. ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx. The online version contains supplementary material available at 10.1186/s13063-021-05838-w.
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DOI：
10.1097/gme.0b013e3181ace49b
发表时间：
2009-11
期刊：
Menopause (New York, N.Y.)
影响因子：
--
作者：
Geller SE;Shulman LP;van Breemen RB;Banuvar S;Zhou Y;Epstein G;Hedayat S;Nikolic D;Krause EC;Piersen CE;Bolton JL;Pauli GF;Farnsworth NR
通讯作者：
Farnsworth NR
DOI：
10.1097/gme.0000000000000784
发表时间：
2017-05
期刊：
Menopause (New York, N.Y.)
影响因子：
--
作者：
Nie G;Yang H;Liu J;Zhao C;Wang X
通讯作者：
Wang X
影响因子：
39.2
作者：
Cheng, Chung-wah;Wu, Tai-xiang;Bian, Zhao-xiang
通讯作者：
Bian, Zhao-xiang
DOI：
10.13703/j.0255-2930.2017.10.008
发表时间：
2017-10-12
期刊：
Zhongguo zhen jiu = Chinese acupuncture & moxibustion
影响因子：
--
作者：
Jiang, Duosheng;Zhang, Yingchun;Wu, Song
通讯作者：
Wu, Song
影响因子：
6.7
作者：
Sullivan, Shannon D.;Sarrel, Philip M.;Nelson, Lawrence M.
通讯作者：
Nelson, Lawrence M.