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作 者:张新胜[1] 陶扬 张荣轩[2] 徐庆[1] 张永[1] 刘鹿[1] 刘钊[1] 陆大杰 刘英华[1] ZHANG Xin-sheng;TAO Yang;ZHANG Rong-xuan;XU Qing;ZHANG Yong;LIU Lu;LIU Zhao;LU Da-jie;LIU Ying-hua(Department of Nutrition,the First Medical Center of the Chinese PLA General Hospital,Beijing 100853,China;School of Parmaceutical Engineering&Life Science,Changzhou University,Changzhou 213164,China;Changzhou Vocational Institute of Engineering,Changzhou 213164,China)
机构地区:[1]解放军总医院第一医学中心营养科,北京100853 [2]常州大学制药与生命科学学院,江苏常州213164 [3]常州工程职业技术学院,江苏常州213164
出 处:《中国食物与营养》2019年第11期64-69,共6页Food and Nutrition in China
摘 要:目的:观察芦荟纯酰素膜片对更年期综合征患者的临床改善情况,重点观察芦荟纯酰素对受试者炎症指标、激素水平和更年期症状评分的影响,为芦荟纯酰素改善更年期综合征的临床应用提供科学依据。方法:采用随机对照双盲实验,2018年9-11月解放军总医院门诊招募更年期综合征女性受试者50名,并随机分成2组(干预组25人、对照组25人),分别舌下含服芦荟纯酰素膜片(6片/d)或干预物(6片/d),干预3个月后,比较两组之间及同组干预前后更年期自我综合评定结果、疲劳评定结果、GAD-7焦虑症评分、PHQ-9抑郁症、血清激素水平及抗氧化指标。结果:共46例受试者完成研究(对照组24例、干预组22例),失访率8%。与干预前比较,两组更年期自我综合评分、疲劳评分及雌激素水平有显著改善(P均<0.05);干预后,干预组较对照组更年期自我综合评分、雌激素水平及谷胱甘肽过氧化酶水平有显著改善(P均<0.05)。结论:芦荟纯酰素膜片能够改善更年期综合征症状,调节雌激素水平和增强机体抗氧化能力。Objective To observe the effect of Pure Material Acemannan Source(PMAS)on symptoms of climacteric syndrome,especially on antioxidant activity,hormone levels and climacteric syndrome Kupperman score.Method This was a single-center double-blinded randomized controlled trial performed at the Chinese People’s Liberty Army General Hospital.Totally fifty subjects with climacteric syndrome were recruited and randomly assigned into intervention group(PMAS,6 tablets/day,n=25)and control group(placebo,6 tablets/day,n=25)for three months.The primary outcome measures were Kupperman score,FS-14 score,GAD-7 score and PHQ-9 score,serum hormone level and antioxidant index.Secondary outcomes were regular biochemical tests,vitamin levels and adverse events.Result In total,46 patients(92%)completed the study.Comparison between pre-intervention and post-intervention revealed that both groups were able to enhance climacteric syndrome Kupperman score,improve FS-14 score and adjust serum estrogen level(P<0.05,respectively).Compared with control group in post-intervention,intervention group could improve climacteric syndrome Kupperman score,regulate serum estrogen level and increase serum glutathione(GSH)level(P<0.05,respectively).Conclusion PMAS can alleviate climacteric syndrome,regulate serum estrogen hormone,and enhance the ability of antioxidation in the menopausal women.
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