本文選題：消渴丸 + 2型糖尿病��； 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：1研究目的根據(jù)系統(tǒng)評(píng)價(jià)結(jié)果,綜合分析消渴丸治療2型糖尿病的臨床療效及安全性。2研究方法首先,計(jì)算機(jī)檢索中英文數(shù)據(jù)庫(kù),包括3個(gè)英文數(shù)據(jù)庫(kù),即:The Cochrane Library、Embase數(shù)據(jù)庫(kù)、Pubmed文獻(xiàn)數(shù)據(jù)庫(kù);和4個(gè)中文數(shù)據(jù)庫(kù),即:中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(CNKI)、萬(wàn)方數(shù)據(jù)知識(shí)服務(wù)平臺(tái)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)、重慶維普中文科技期刊全文數(shù)據(jù)庫(kù)(VIP),同時(shí)手動(dòng)檢索北京中醫(yī)藥大學(xué)圖書(shū)館數(shù)據(jù)庫(kù),收集消渴丸臨床療效的隨機(jī)對(duì)照試驗(yàn)。其次,根據(jù)納、排標(biāo)準(zhǔn)進(jìn)行文獻(xiàn)篩選,并使用Cochrane協(xié)作網(wǎng)偏倚風(fēng)險(xiǎn)評(píng)估工具(Cochrane Tools of Risk of Bias)對(duì)所納入的研究進(jìn)行方法學(xué)質(zhì)量評(píng)價(jià),同時(shí)提取數(shù)據(jù)資料。對(duì)數(shù)據(jù)資料進(jìn)行定性的描述性分析和定量的meta分析,并采用Cochrane協(xié)作網(wǎng)推薦的Revman5.3軟件進(jìn)行meta分析。最后對(duì)系統(tǒng)評(píng)價(jià)的結(jié)果進(jìn)行解釋和討論。3研究結(jié)果本系統(tǒng)評(píng)價(jià)共檢索出1441篇文獻(xiàn),最終納入14篇文獻(xiàn),共2269例患者。納入研究的對(duì)照類(lèi)型為消渴丸對(duì)照格列喹酮(1篇),消渴丸對(duì)照格列奇特(1篇),消渴丸對(duì)照二甲雙胍(4篇),消渴丸對(duì)照格列本脲(8篇)。在消渴丸對(duì)照格列喹酮的研究中,定性分析結(jié)果表明消渴丸較格列喹酮在改善臨床有效率、空腹血糖、餐后2小時(shí)血糖方面均具有優(yōu)勢(shì),且具有統(tǒng)計(jì)學(xué)差異。在消渴丸對(duì)照格列奇特的研究中,定性分析結(jié)果表明消渴丸與格列奇特在改善臨床有效率、空腹血糖、餐后2小時(shí)血糖及糖化血紅蛋白方面均無(wú)顯著性差異。在消渴丸對(duì)照二甲雙胍的研究中,對(duì)4項(xiàng)研究的臨床有效率進(jìn)行定性分析,其中2項(xiàng)研究表明消渴丸優(yōu)于二甲雙胍,且具有顯著性差異;在空腹血糖方面,2項(xiàng)研究的定性分析表明在療程≤1月時(shí),消渴丸較二甲雙胍具有一定的優(yōu)勢(shì),另2項(xiàng)研究的meta分析結(jié)果表明在治療療程1月時(shí),試驗(yàn)組與對(duì)照組結(jié)果無(wú)顯著性差異;在餐后2小時(shí)血糖方面,對(duì)3項(xiàng)研究定性分析,其中2項(xiàng)研究表明消渴丸優(yōu)于二甲雙胍,且有顯著性差異。在消渴丸對(duì)照格列本脲的研究中,對(duì)報(bào)告臨床有效人數(shù)的4項(xiàng)研究進(jìn)行定性分析,其中2項(xiàng)研究表明消渴丸較格列本脲在改善臨床有效率方面具有優(yōu)勢(shì),并具有顯著性差異;在空腹血糖方面,對(duì)未使用安慰劑的5項(xiàng)研究定性描述,其中1項(xiàng)研究表明消渴丸優(yōu)于格列本脲,3項(xiàng)研究無(wú)顯著性差異,1項(xiàng)研究表明格列本脲優(yōu)于消渴丸。對(duì)使用安慰劑的2項(xiàng)研究進(jìn)行meta分析,結(jié)果表明消渴丸與格列本脲無(wú)顯著性差異;在餐后2小時(shí)血糖方面,對(duì)6項(xiàng)研究進(jìn)行定性描述,其中1項(xiàng)研究表明消渴丸優(yōu)于格列本脲,4項(xiàng)研究無(wú)顯著性差異,1項(xiàng)研究表明格列本脲優(yōu)于消渴丸。在去除1項(xiàng)異質(zhì)性的可能來(lái)源后,對(duì)同質(zhì)性較好的幾項(xiàng)研究進(jìn)行meta分析,結(jié)果表明消渴丸在降低餐后2小時(shí)血糖上優(yōu)于格列本脲,且具有統(tǒng)計(jì)學(xué)意義;在空腹胰島素方面,對(duì)未使用安慰劑的2項(xiàng)研究定性分析,發(fā)現(xiàn)消渴丸在降低空腹胰島素上優(yōu)于格列本脲,并有統(tǒng)計(jì)學(xué)意義。對(duì)使用安慰劑的2項(xiàng)研究進(jìn)行meta分析,發(fā)現(xiàn)試驗(yàn)組與對(duì)照組結(jié)果無(wú)顯著性差異;在糖化血紅蛋白方面,5項(xiàng)研究的meta分析結(jié)果提示消渴丸對(duì)比格列本脲在改善糖化血紅蛋白時(shí)無(wú)顯著性差異;在胰島β細(xì)胞功能指數(shù)方面,對(duì)1項(xiàng)研究定性分析,提示消渴丸較格列本脲在改善胰島β細(xì)胞功能上無(wú)顯著性差異;在胰島素敏感指數(shù)方面,對(duì)未使用安慰劑的1項(xiàng)研究定性描述,發(fā)現(xiàn)消渴丸優(yōu)于格列本脲,并具有顯著性差異。對(duì)使用安慰劑的2項(xiàng)研究進(jìn)行meta分析,結(jié)果表明消渴丸對(duì)比格列本脲在改善胰島素敏感性指數(shù)方面無(wú)顯著性差異;在總膽固醇方面,3項(xiàng)研究的meta分析結(jié)果提示消渴丸對(duì)比格列本脲在降低總膽固醇方面無(wú)顯著性差異;在甘油三酯方面,3項(xiàng)研究的meta分析結(jié)果提示消渴丸對(duì)比格列本脲在降低甘油三酯方面無(wú)顯著性差異;在中醫(yī)癥狀改善方面,2項(xiàng)研究的定性分析表明治療組優(yōu)于對(duì)照組,2項(xiàng)研究的meta分析表明消渴丸在改善口渴喜飲、倦怠乏力、多食易饑、氣短懶言癥狀上優(yōu)于格列本脲,且具有統(tǒng)計(jì)學(xué)差異。在安全性方面,7項(xiàng)研究說(shuō)明了不良反應(yīng)情況,其中1項(xiàng)研究明確表明未發(fā)生不良反應(yīng),6項(xiàng)研究報(bào)告了不良反應(yīng)。在低血糖發(fā)生率方面,4項(xiàng)研究的meta分析結(jié)果表明消渴丸發(fā)生低血糖的風(fēng)險(xiǎn)低與格列本脲,且具有統(tǒng)計(jì)學(xué)意義。4研究結(jié)論消渴丸較西醫(yī)口服降糖藥在改善臨床有效率、糖脂代謝方面具有很大潛力,在改善中醫(yī)氣陰兩虛的主要癥狀及降低低血糖發(fā)生率方面具有一定優(yōu)勢(shì)。但由于本系統(tǒng)評(píng)價(jià)的局限性,尚不能得出確切結(jié)論,仍需要開(kāi)展設(shè)計(jì)良好的多中心、大樣本的隨機(jī)雙盲對(duì)照試驗(yàn)。消渴丸治療2型糖尿病隨機(jī)對(duì)照試驗(yàn)的文獻(xiàn)質(zhì)量有待進(jìn)一步提高,尤其是在樣本量的估算、隨機(jī)方案的隱匿、盲法的實(shí)施等方面需引起重視。
[Abstract]:1 the purpose of the study is to analyze the clinical efficacy and safety of Xiaoke pill in the treatment of type 2 diabetes based on the results of the system. First, the computer retrieval of the Chinese and English database, including 3 English databases, namely, The Cochrane Library, Embase database, Pubmed literature database, and the Chinese academic journals, namely: Chinese academic periodicals. The text database (CNKI), Wanfang Data knowledge service platform, Chinese biomedical literature database (CBM), Chongqing VIP Chinese science and technology periodical full text database (VIP), and manual retrieval of the library database of Beijing University of Chinese Medicine, collect the clinical efficacy of Xiaoke pill as a control experiment. We use the Cochrane Tools of Risk of Bias (Cochrane of Risk of Bias) to evaluate the methodological quality of the integrated research and extract the data. The qualitative descriptive analysis and quantitative meta analysis of the data are carried out, and meta analysis is carried out by the Revman5.3 software recommended by the Cochrane collaboration network. The results of the unified evaluation were explained and discussed in the.3 study. 1441 documents were retrieved and 14 papers were included, and 2269 cases were included. The control types included Xiaoke pill control gliziazone (1), Xiaoke pill control glenquide (1), Xiaoke pill control metformin (4), Xiaoke pill contrast glibenclamide (8) In the study of Xiaoke pill control gliquazone, qualitative analysis showed that Xiaoke pill was superior to glitazone in improving clinical efficiency, fasting blood glucose and 2 hours postprandial blood glucose, and had statistical differences. In the study of Xiaoke pill contrast glicet, the results of the definite analysis showed that Xiaoke pill and glitazer were improved. There was no significant difference in clinical efficiency, fasting blood glucose, 2 hours postprandial blood glucose and glycated hemoglobin. In the study of metformin, the clinical efficiency of the 4 studies was qualitatively analyzed, and 2 of them showed that Xiaoke pills were superior to metformin and had significant differences; 2 studies on fasting blood glucose The qualitative analysis showed that the Xiaoke pill had a certain advantage over the metformin when the course of treatment was less than January. The results of the meta analysis of the other 2 studies showed that there was no significant difference between the experimental group and the control group in the course of the course of treatment in January. In the 2 hours after the meal, 3 studies were qualitatively analyzed, and 2 of them showed that Xiaoke pills were superior to metformin. There were significant differences. In the study of Xiaoke pill contrast glibenclamide, 4 studies on the number of clinical effective people were qualitatively analyzed. 2 of them showed that Xiaoke pills were superior to glenoureuon in improving clinical efficiency and had significant differences. In the field of fasting blood glucose, 5 studies on the unused placebo were determined. 1 studies showed that 1 studies showed that Xiaoke pills were superior to glibenclamide. There were no significant differences in 3 studies. 1 studies showed that glibenclamide was superior to Xiaoke pill. 2 studies of placebo were analyzed. The results showed that there was no significant difference between Xiaoke pills and glibenclamide, and 6 studies were qualitatively described in 2 hours postprandial blood glucose. 1 studies showed that Xiaoke pills were superior to glibenclamide, and there were no significant differences in 4 studies. 1 studies showed that glibenclamide was superior to Xiaoke pill. After removing the possible sources of 1 heterogeneity, a few studies with better homogeneity were analyzed by meta. The results showed that Xiaoke pill was superior to glibenclamide at 2 hours after the meal. Study significance; on fasting insulin, a qualitative analysis of 2 studies without a placebo showed that Xiaoke pill was superior to glibenclamide in reducing fasting insulin and was statistically significant. Meta analysis of 2 studies using placebo showed that there was no significant difference between the experimental group and the control group; in glycosylated hemoglobin, 5 The results of meta analysis in the study showed that there was no significant difference between Xiaoke pill and glibenclamide in improving glycosylated hemoglobin. In the aspect of islet beta cell function index, there was no significant difference in the improvement of islet beta cell function by the 1 studies, which showed that Xiaoke pill was more than glenimourea in improving the function of islet beta cells. The 1 studies of the placebo were qualitatively described and found that Xiaoke pills were superior to glibenclamide and had significant differences. The results of meta analysis on 2 studies using placebo showed that there was no significant difference in the improvement of insulin sensitivity index between Xiaoke pills and glibenclamide. In the total bile steroids, the results of meta analysis in the 3 studies suggested thirst. There was no significant difference in the reduction of total cholesterol in the pill compared with glibenclamide. In the triglyceride, the results of meta analysis in the 3 studies showed that there was no significant difference in reducing triglyceride by the Xiaoke pill compared with glibenclamide. In the improvement of TCM symptoms, the qualitative analysis of the 2 studies showed that the treatment group was superior to the control group and the 2 study was meta The analysis showed that Xiaoke pill was better than glipenourea in improving thirst and thirsty drink, fatigue, hunger and hunger and shortness of breath, and there were statistical differences. In safety, 7 studies showed adverse reactions, 1 of which clearly showed no adverse reactions, 6 studies reported adverse reactions. The incidence of hypoglycemia was in the incidence of hypoglycemia. The results of meta analysis in the 4 studies show that the risk of hypoglycemia in Xiaoke pill is low and glibenclamide, and it has statistical significance.4 research conclusion that Xiaoke pill is more effective in improving clinical efficiency than western medicine, and has great potential in glycolipid metabolism. It can improve the main symptoms of Qi Yin deficiency of TCM two and reduce the incidence of hypoglycemia. But because of the limitations of the system evaluation, there is no definite conclusion, and we still need to carry out a well designed multi center and large sample randomized double blind controlled trial. The literature quality of the randomized controlled trial of Xiaoke pill in the treatment of type 2 diabetes needs to be further improved, especially in the estimation of sample size and the concealment of random schemes. Attention should be paid to the implementation of blind law and so on.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R259

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