| 乌灵胶囊治疗伴轻中度抑郁焦虑症状的老年功能性消化不良的多中心随机对照临床试验 |
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| 引用本文： | 陈洁,郑松柏,陈咸川,钟远,方宁远,潘志红,盛净,张玉,胡家安,董福轮,吴寒,应赛亚,张文俊.乌灵胶囊治疗伴轻中度抑郁焦虑症状的老年功能性消化不良的多中心随机对照临床试验[J].中国新药与临床杂志,2011(5). |
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| 作者姓名： | 陈洁 郑松柏 陈咸川 钟远 方宁远 潘志红 盛净 张玉 胡家安 董福轮 吴寒 应赛亚 张文俊 |
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| 作者单位： | 复旦大学附属华东医院;上海中医药大学附属岳阳医院;上海交通大学附属第六人民医院;上海交通大学医学院附属仁济医院;上海交通大学医学院附属新华医院;上海交通大学医学院附属第九人民医院;复旦大学附属华山医院;上海交通大学医学院附属瑞金医院;同济大学附属第十人民医院;上海交通大学附属第一人民医院;复旦大学附属中山医院;中国人民解放军第二军医大学附属长海医院; |
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| 摘 要： | 目的观察乌灵胶囊对伴轻、中度抑郁焦虑症状的功能性消化不良老年患者的疗效,并评估其临床应用的安全性。方法采用多中心、随机、阳性药物平行对照试验方法,以氟哌噻吨-美利曲辛为对照药物。266例功能性消化不良患者被随机分成试验组(145例)和对照组(121例)。试验组给予乌灵胶囊口服,3粒,每日3次;对照组给予氟哌噻吨-美利曲辛口服,1片,每日1次,疗程均为6wk。同时2组受试者均根据功能性消化不良分型及症状酌情给予抑酸、促动力、助消化药物。观察2组临床疗效、汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分及匹兹堡睡眠质量指数(PSQI)评分;根据副反应量表观察不良反应。结果试验组在治疗2、4及6 wk末的临床疗效与对照组相比均无显著差异(P>0.05);2组治疗6wk后与治疗前比较均有显著改善(P<0.01)。4、6wk末试验组的HAMD评分和HAMA评分的减分率均高于对照组。2组治疗6wk末PSQI评分与治疗前相比,均有显著改善(P<0.05),2组间PSQI评分的减分率无显著差异(P>0.05)。2组均无中、重度不良反应发生。结论乌灵胶囊治疗伴轻、中度抑郁焦虑症状的老年功能性消化不良患者的疗效较好,不良反应小,安全性好。
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| 关 键 词： | 消化不良 抑郁 焦虑 老年人 乌灵胶囊 氟哌噻吨-美利曲辛 随机对照试验 |
A multicenter clinical trial of Wuling capsule in treatment of functional dyspepsia with mild to moderate depression and anxiety in elderly |
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| CHEN Jie,ZHENG Song-bai,CHEN Xian-chuan,ZHONG Yuan,FANG Ning-yuan,PAN Zhi-hong,SHENG Jing,ZHANG Yu,HU Jia-an,DONG Fu-lun,WU Han,YING Sai-ya,ZHANG Wen-jun.A multicenter clinical trial of Wuling capsule in treatment of functional dyspepsia with mild to moderate depression and anxiety in elderly[J].Chinese Journal of New Drugs and Clinical Remedies,2011(5). |
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| Authors: | CHEN Jie ZHENG Song-bai CHEN Xian-chuan ZHONG Yuan FANG Ning-yuan PAN Zhi-hong SHENG Jing ZHANG Yu HU Jia-an DONG Fu-lun WU Han YING Sai-ya ZHANG Wen-jun |
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| Institution: | CHEN Jie,ZHENG Song-bai,CHEN Xian-chuan,ZHONG Yuan,FANG Ning-yuan,PAN Zhi-hong,SHENG Jing,ZHANG Yu,HU Jia-an,DONG Fu-lun,WU Han,YING Sai-ya,ZHANG Wen-jun (1.Huadong Hospital,Fudan University,SHANGHAI 200040,China,2.Yueyang Hospital,Shanghai University of Traditional Chinese Medicine,SHANGHAI 200437,3.The Sixth People's Hospital,Shanghai Jiaotong University,SHANGHAI 200233,4.Renji Hospital,School of Medcine,SHANGHAI 200001,5.Xinhua Hospital,S... |
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| Abstract: | AIM To evaluate the clinical efficacy and safety of Wuling capsule on functional dyspepsia with mild to moderate depression and anxiety in the elderly.METHODS A randomized,controlled multicenter clinical trial was conducted in 266 elderly patients with functional dyspepsia with mild to moderate depression and anxiety,who were randomly divided into trial group(n = 145) and control group(n = 121) to receive Wuling capsule 0.99 g po,tid or flupenthixol and melitracen 1 po,qd respectively for six weeks.All pati... |
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| Keywords: | dyspepsia depression anxiety aged Wuling capsule flupenthixol and melitracen randomized controlled trials |
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