当归补血汤对缓解更年期症状的疗效观察

E. Wong, A. Cheung, C. Haines, C. C. Wang, C. Wong, K. Tsim, William K. F. Cheng, P. Leung
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摘要

目的进一步探讨当归补血汤这一简单的中药方剂对改善绝经期妇女生活质量的疗效和安全性。方法进行第三次临床试验,观察大剂量DBT的临床疗效,为期12周。采用标准的绝经期特异性生活质量(MENQOL)评估表进行评估。安全性被定义为没有直接的雌激素效应,血清炎症细胞因子。值得注意的是,在更年期研究中,已知与雌激素反应直接相关的白细胞介素IL-6、IL-8和肿瘤坏死因子TNF-α被监测。结果第三次临床试验表明MENQOL的四个领域总体改善,进一步证明了前两次试验中DBT的疗效。与雌激素活性相关的三种细胞因子的连续检测没有显示出上升或下降的趋势。三种细胞因子的随机行为反应间接表明DBT改善MENQOL独立于雌激素活性。结论三项临床试验均证实了DBT治疗绝经期综合征的疗效。DBT中含有的“植物雌激素”是否具有与雌激素相似的生物活性的不确定性,通过确认没有观察到严格的雌激素生物活性,减轻了不确定性。通过对DBT的实验室平台研究,进一步明确了安全性问题,不仅表明DBT与雌激素的作用缺乏相似性,而且证实了两种草药在经典配方中的结合价值。
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The Efficacy of Herbal Supplement Danggui Buxue Tang for Relieving Menopausal Symptoms
Objectives This study aimed to further explore the efficacy and safety of Danggui Buxue Tang (DBT), a simple herbal formula, for improving the quality of life of women suffering from menopausal symptoms. Methods A third clinical trial to determine the clinical efficacy of high-dose DBT for a period of 12 weeks was carried out. The standard Menopause-Specific Quality of Life (MENQOL) assessment chart was used for the evaluation. Safety was defined as an absence of direct estrogenic effects, serum inflammatory cytokines. Notably, interleukin IL-6, IL-8 and tumor necrosis factor TNF-α, known to be directly related to estrogenic reactions in menopause studies, were monitored. Results The third clinical trial indicated an overall improvement in the four domains of MENQOL, offering further proof of the efficacy of DBT demonstrated in the two previous trials. The serial checks of the three cytokines related to estrogen activities did not show either upward or downward trends. The haphazard behavior reactions of the three cytokines offered indirect indications that DBT improved the MENQOL independently from estrogen activities. Conclusions The three clinical trials using DBT to relieve menopausal syndrome have offered solid evidence for its efficacy. The uncertainty regarding whether the “phytoestrogen” contained in DBT had bioactivities similar to estrogen was alleviated through the confirmation that no strict estrogenic bioactivities were observed. The issue of safety was further clarified via laboratory platform studies on DBT, which not only showed the lack of similarity with estrogen actions but also confirmed the value of combining the two herbs in the classic formula.
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