和颜悦颗粒治疗早发性卵巢功能不全残留卵泡复苏的疗效及安全性：一项多中心、随机、双盲、安慰剂对照试验方案

Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol.

作者信息

Peng Yin, Liu Jian, Li Yang, Nie Guangning, Cheng Fangping, Feng Daning, Du Qiaolin, Huang Jian, Yang Hongyan

机构信息

The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, People's Republic of China.

Department of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.

出版信息

BMC Complement Med Ther. 2025 Feb 11;25(1):46. doi: 10.1186/s12906-025-04803-3.

DOI:10.1186/s12906-025-04803-3

PMID:39934764

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11817039/

Abstract

BACKGROUND

Premature ovarian insufficiency (POI), a condition impacting women under 40, is rising globally, posing significant risks to fertility, bone health, and cardiovascular function. Conventional hormone replacement therapy (HRT) alleviates symptoms but fails to restore ovarian function. Our prior studies have demonstrated that the Huyang Yangkun (HYYK) formula effectively supports menstrual cycle frequency and alleviates menopause-related symptoms in POI patients. This study aims to evaluate the efficacy and safety of the HYYK formula, a traditional Chinese medicine (TCM) approach, in enhancing residual follicle activity in POI patients.

METHODS

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 102 women with POI, who will be randomly assigned to receive either the HYYK formula or a placebo for 24 weeks. Primary outcomes will be assessed through Hoogland and Skouby scores (indicative of residual follicle activity) and menstrual cycle regularity. Secondary outcomes include hormone levels (AMH, FSH, LH, E2), ovarian volume, antral follicle count, and clinical symptom scales, such as the Greene Scale and the Female Sexual Function Index. Safety assessments will involve routine physical exams and adverse event monitoring.

DISCUSSION

This is the first multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy of TCM in stimulating residual follicle recovery in POI patients. The trial rigorously investigates the potential of the HYYK formula as a therapeutic alternative for POI, aiming to deliver high-quality evidence that supports the use of TCM in POI management. This study will concentrate on stimulating residual follicle development in POI patients, offering a viable approach to delaying ovarian decline and generating compelling clinical evidence.

TRIAL REGISTRATION

Chinese Clinical Trials.gov ChiCTR2100049604 Registered on August 6, 2021 ( http://www.chictr.org.cn ).

摘要

背景

卵巢早衰（POI）是一种影响40岁以下女性的疾病，在全球范围内呈上升趋势，对生育能力、骨骼健康和心血管功能构成重大风险。传统激素替代疗法（HRT）可缓解症状，但无法恢复卵巢功能。我们之前的研究表明，护养养坤（HYYK）方有效地支持了POI患者的月经周期频率，并缓解了与绝经相关的症状。本研究旨在评估一种中医方法——HYYK方在增强POI患者残余卵泡活性方面的疗效和安全性。

方法

这项多中心、随机、双盲、安慰剂对照试验将招募102名POI女性，她们将被随机分配接受HYYK方或安慰剂治疗24周。主要结局将通过霍格兰德和斯科比评分（指示残余卵泡活性）以及月经周期规律性进行评估。次要结局包括激素水平（AMH、FSH、LH、E2）、卵巢体积、窦卵泡计数以及临床症状量表，如格林量表和女性性功能指数。安全性评估将包括常规体格检查和不良事件监测。

讨论

这是第一项多中心、随机、双盲、安慰剂对照研究，旨在调查中医在刺激POI患者残余卵泡恢复方面的疗效。该试验严格研究了HYYK方作为POI治疗替代方案的潜力，旨在提供高质量证据支持中医在POI管理中的应用。本研究将专注于刺激POI患者残余卵泡发育，提供一种可行的方法来延缓卵巢衰退并产生令人信服的临床证据。