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中醫(yī)藥治療慢性心力衰竭臨床隨機(jī)對照研究結(jié)局指標(biāo)相關(guān)問題的探討

發(fā)布時間:2018-06-08 06:25

  本文選題:慢性心力衰竭 + 結(jié)局指標(biāo); 參考:《河南中醫(yī)藥大學(xué)》2016年碩士論文


【摘要】:目的:通過檢索關(guān)于中醫(yī)藥治療慢性心衰臨床隨機(jī)對照研究的相關(guān)文獻(xiàn),分析研究中存在的問題,尤其是心衰結(jié)局指標(biāo)的選擇和應(yīng)用的問題,為以后的中醫(yī)臨床研究提供思路和借鑒。方法:檢索中國知網(wǎng)數(shù)據(jù)庫、重慶維普數(shù)據(jù)庫和萬方數(shù)據(jù)資源系統(tǒng)收錄的中醫(yī)臨床隨機(jī)對照研究文獻(xiàn),以“心衰”、“心力衰竭”、“心功能不全”為“主題”、“篇名”、“關(guān)鍵詞”,以“2014年”為抽樣年份,通過下載文獻(xiàn)題錄,閱讀文獻(xiàn)摘要,篩選出中醫(yī)臨床隨機(jī)對照研究,提取相關(guān)信息,包括研究中心數(shù)量、方案注冊、倫理審核、知情同意、結(jié)局指標(biāo)的選擇和評價(jià)方法等,進(jìn)行分析。結(jié)果:共檢索到606篇相關(guān)文獻(xiàn),通過初步篩選,最終納入281篇,總樣本量24662例;颊吣挲g在18-98歲,病程在3月至41年不等;基礎(chǔ)疾病主要包括冠心病,其次為肺源性心臟病、高原性心臟病、風(fēng)濕性心臟病和擴(kuò)張型心肌病;NYHA心功能分級為Ⅱ-Ⅳ級者9612例(占38.97%),Ⅱ-Ⅲ級者4557例(占18.48%),Ⅲ-Ⅳ級者3124例(占12.67%),Ⅰ-Ⅳ級者1045例(占4.24%),Ⅳ級者408例(占1.65%);干預(yù)類型為中成藥者14930例(占60.54%),其中采用中藥針劑者9787例(占39.68%),采用口服制劑者5045例(占20.46%),干預(yù)類型為自擬方者9732例(占39.46%);中醫(yī)證型出現(xiàn)頻率高者依次為陽虛證(2923例,占11.85%)、氣虛血瘀證(2479例,占10.05%)、氣陽兩虛證(1742例,占7.06%)、氣陰兩虛證(1403例,占5.69%)、陰陽兩虛證(72例,占0.29%);共收集到慢性心衰的療效評價(jià)指標(biāo)45個,包括心臟彩超、心功能分級、臨床癥狀、BNP、NT-pro BNP、中醫(yī)證候、6分鐘步行試驗(yàn)、生存量表等,出現(xiàn)頻率最高的療效評價(jià)指標(biāo)組合為“心臟彩超+心功能分級”。結(jié)論:心臟彩超、心功能分級、臨床癥狀、中醫(yī)證候、BNP、6分鐘步行試驗(yàn)、NT-pro BNP、生存質(zhì)量等是慢性心力衰竭療效評價(jià)最常選用的指標(biāo);慢性心衰中醫(yī)臨床隨機(jī)對照研究的設(shè)計(jì)、結(jié)局指標(biāo)的選擇和使用有待規(guī)范。
[Abstract]:Objective: to search the literature on randomized controlled clinical study on the treatment of chronic heart failure with traditional Chinese medicine, and to analyze the problems in the study, especially the choice and application of the outcome index of heart failure. For the future clinical research of TCM to provide ideas and reference. Methods: to search the literature of Chinese medicine clinical randomized controlled study collected by Chinese knowledge Network Database, Chongqing Weipu Database and Wanfang data Resource system. The subjects were Heart failure, Heart failure, and the title was "Heart failure", "Heart failure" and "Heart failure". "key words", taking "2014" as the sampling year, through downloading the bibliography, reading the abstract of the literature, screening out the randomized controlled study of TCM clinical, extracting relevant information, including the number of research centers, the registration of the project, the ethics audit, and so on. Informed consent, the selection of outcome indicators and evaluation methods, etc. Results: a total of 606 related literatures were retrieved, and by preliminary screening, 281 articles were included, with a total sample size of 24662 cases. The age of the patients ranged from 18 to 98 years, and the course of disease ranged from 3 months to 41 years. The underlying diseases mainly included coronary heart disease, followed by pulmonary heart disease and high altitude heart disease. There were 9612 cases (38.97 cases) with rheumatic heart disease and dilated cardiomyopathy, 4557 cases (18.4848) with grade 鈪,

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