Xiaojing Cao, Lei Song, Jiarui Hou, Siyu Mao, Qiaolin Du, Fangping Cheng, Daning Feng, Jingyan Zhu, Qiuxia Chen, Xiaoyu Li, Jian Liu, Wenwei Ouyang, Xuchun Huang, Xiaoyun Wang
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引用次数: 0
Abstract
Objectives: This multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of Yangyin Shugan (YYSG) capsules in women with premature ovarian insufficiency (POI).
Methods: This study enrolled 548 Chinese women with POI (August 2016-June 2021) from 13 Guangdong hospitals. After screening, 333 participants were randomized (2:1) to receive YYSG capsules or placebo for 12 weeks. Primary outcomes included the modified Kupperman Index (KI) and serum basal follicle-stimulating hormone, basal E2, and anti-Müllerian hormone levels. Secondary outcomes included psychological status scores (Self-Rating Depression Scale, Self-Rating Anxiety Scale) and ovarian markers (antral follicle count, peak systolic velocity).
Results: YYSG demonstrated superior efficacy versus placebo across all endpoints (P < 0.01), including greater reductions in KI scores (-22.2 vs -6.0) and basal follicle-stimulating hormone levels (-23.7 vs -10.4 IU/L) and greater increases in anti-Müllerian hormone levels (2.5 vs 0.8 ng/mL). The YYSG group exhibited larger antral follicle count gains (4.3 vs 1.1 follicles) and bilateral peak systolic velocity improvements (left: 10.8 vs 4.9 cm/s; right: 10.0 vs 4.4 cm/s) and greater reductions in psychological scores (Self-Rating Depression Scale: -12.9 vs -1.3; Self-Rating Anxiety Scale: -15.7 vs -3.7).
Conclusions: YYSG capsules significantly improved ovarian reserve function and emotional disorders in women with POI, demonstrating good efficacy and safety. These findings support the potential application of YYSG capsules in clinical practice.
目的：本多中心、双盲、随机、安慰剂对照试验评价养阴舒肝胶囊（YYSG）治疗卵巢早衰（POI）的疗效和安全性。方法：本研究从广东13家医院招募548名中国POI女性（2016年8月- 2021年6月）。筛选后，333名参与者随机（2:1）接受YYSG胶囊或安慰剂12周。主要结果包括改良的Kupperman指数（KI）和血清基础促卵泡激素、基础E2和抗勒氏杆菌激素水平。次要结局包括心理状态评分（抑郁自评量表、焦虑自评量表）和卵巢指标（窦卵泡计数、峰值收缩速度）。结果：YYSG在所有终点均表现出优于安慰剂的疗效（P < 0.01），包括KI评分（-22.2 vs -6.0）和基础促卵泡激素水平（-23.7 vs -10.4 IU/L）的更大降低，抗勒氏杆菌激素水平（2.5 vs 0.8 ng/mL）的更大增加。YYSG组表现出更大的窦室卵泡计数增加（4.3 vs 1.1）和双侧峰值收缩速度改善(左：10.8 vs 4.9 cm/s；右：10.0 vs 4.4 cm/s)和更大程度的心理得分下降(抑郁自评量表：-12.9 vs -1.3；焦虑自评量表：-15.7 vs -3.7)。结论：YYSG胶囊可显著改善POI女性卵巢储备功能和情绪障碍，具有良好的疗效和安全性。这些发现支持了YYSG胶囊在临床实践中的潜在应用。
期刊介绍：
Menopause, published monthly, provides a forum for new research, applied basic science, and clinical guidelines on all aspects of menopause. The scope and usefulness of the journal extend beyond gynecology, encompassing many varied biomedical areas, including internal medicine, family practice, medical subspecialties such as cardiology and geriatrics, epidemiology, pathology, sociology, psychology, anthropology, and pharmacology. This forum is essential to help integrate these areas, highlight needs for future research, and enhance health care.
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