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坤泰胶囊联合激素治疗与单纯激素治疗对卵巢早衰患者的疗效:一项系统评价和Meta分析

Kuntai Capsule plus Hormone Therapy vs. Hormone Therapy Alone in Patients with Premature Ovarian Failure: A Systematic Review and Meta-Analysis.

作者信息

Liu Weiping, Nguyen Truong-Nam, Tran Thi Thu-Van, Zhou Shaohu

机构信息

The First Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.

Vietnam University of Traditional Medicine, Hanoi 100000, Vietnam.

出版信息

Evid Based Complement Alternat Med. 2019 Jun 26;2019:2085804. doi: 10.1155/2019/2085804. eCollection 2019.

Abstract

The aim of this study was to evaluate the efficacy and safety of Kuntai capsules (KTC) plus hormone therapy (HT) compared to HT alone for the treatment of premature ovarian failure (POF). Databases including PubMed, MEDLINE, Web of Science, China National Knowledge Infrastructure (CNKI), the Chinese BioMedical database (CBM), and the Wanfang database were searched up to October 2018 for randomized controlled trials (RCTs). After screening the studies, extracting the data, and assessing the study quality, Cochrane RevMan 5.3 software was used to conduct a meta-analysis. Twelve RCTs involving 1178 patients were included. Regarding the therapeutic effects, total effective treatment rate was higher for the KTC+HT groups compared to the HT-only groups. Furthermore, compared with HT, KTC+HR effectively altered endocrine indexes involving serum levels of luteinizing hormone (weighted mean difference []=-3.47, 95% CI [5.68, -1.26], =0.002]), follicle-stimulating hormone [=-8.15, 95% CI [-10.44, -5.86], <0.00001], estrogen [=17.21, 95% CI [10.16, 24.26], <0.00001], and anti-Müllerian hormone [=1.07, 95% CI [0.78, 1.36], <0.00001]; blood lipid indexes involving serum levels of triglyceride (=-0.55, 95% CI [-0.76, -0.43], <0.00001), total cholesterol (=-0.63, 95% CI [-0.74, -0.52], <0.00001), and low-density lipoprotein cholesterol (=-0.62, 95% CI [-0.75, -0.49], <0.00001); and B-ultrasound results involving ovarian resistance index (=-0.20, 95% CI [-0.35, -0.04], =0.01), perfusion index (=-0.41, 95% CI [-0.57, -0.24], <0.00001), peak systolic velocity (=2.43, 95% CI [1.52, 3.34], <0.00001), antral follicle count (=1.20, 95% CI [0.41, 2.00], =0.003), and mean ovarian diameter in the plane containing the longest axis of the ovary (=4.34, 95% CI [2.94, 5.74], <0.00001). There were no serious adverse events in either group. There is evidence that KTC+HT is more effective and safer than HT alone for treating POF. However, the trials had low methodological quality and small samples, so further standardized research is required.

摘要

本研究旨在评估坤泰胶囊(KTC)联合激素疗法(HT)与单纯激素疗法相比治疗卵巢早衰(POF)的疗效和安全性。检索了截至2018年10月的数据库,包括PubMed、MEDLINE、科学网、中国知网(CNKI)、中国生物医学数据库(CBM)和万方数据库,以查找随机对照试验(RCT)。在筛选研究、提取数据并评估研究质量后,使用Cochrane RevMan 5.3软件进行荟萃分析。纳入了12项涉及1178例患者的RCT。在治疗效果方面,KTC+HT组的总有效治疗率高于单纯HT组。此外,与HT相比,KTC+HR有效改变了内分泌指标,包括血清促黄体生成素水平(加权平均差[WMD]=-3.47,95%置信区间[CI][-5.68,-1.26],P=0.002)、促卵泡生成素[WMD=-8.15,95%CI[-10.44,-5.86],P<0.00001]、雌激素[WMD=17.21,95%CI[10.16,24.26],P<0.00001]和抗苗勒管激素[WMD=1.07,95%CI[0.78,1.36],P<0.00001];血脂指标,包括血清甘油三酯水平(WMD=-0.55,95%CI[-0.76,-0.43],P<0.00001)、总胆固醇(WMD=-0.63,95%CI[-0.74,-0.52],P<0.00001)和低密度脂蛋白胆固醇(WMD=-0.62,95%CI[-0.75,-0.49],P<0.00001);以及B超结果,包括卵巢阻力指数(WMD=-0.20,95%CI[-0.35,-0.04],P=0.01)、灌注指数(WMD=-0.41,95%CI[-0.57,-0.24],P<0.00001)、收缩期峰值流速(WMD=2.43,95%CI[1.52,3.34],P<0.00001)、窦卵泡计数(WMD=1.20,95%CI[0.41,2.00],P=0.003)以及包含卵巢最长轴平面的平均卵巢直径(WMD=4.34,95%CI[2.94,5.74],P<0.00001)。两组均未发生严重不良事件。有证据表明,KTC+HT治疗POF比单纯HT更有效、更安全。然而,这些试验的方法学质量较低且样本量较小,因此需要进一步进行标准化研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4735/6617870/6a87c1873efa/ECAM2019-2085804.001.jpg

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