消渴丸治疗2型糖尿病疗效与安全性的系统评价

发布时间：2018-04-26 23:42

本文选题：消渴丸 + 2型糖尿病　；参考：《北京中医药大学》2017年硕士论文

【摘要】：1研究目的根据系统评价结果,综合分析消渴丸治疗2型糖尿病的临床疗效及安全性。2研究方法首先,计算机检索中英文数据库,包括3个英文数据库,即:The Cochrane Library、Embase数据库、Pubmed文献数据库;和4个中文数据库,即:中国学术期刊全文数据库(CNKI)、万方数据知识服务平台、中国生物医学文献数据库(CBM)、重庆维普中文科技期刊全文数据库(VIP),同时手动检索北京中医药大学图书馆数据库,收集消渴丸临床疗效的随机对照试验。其次,根据纳、排标准进行文献筛选,并使用Cochrane协作网偏倚风险评估工具(Cochrane Tools of Risk of Bias)对所纳入的研究进行方法学质量评价,同时提取数据资料。对数据资料进行定性的描述性分析和定量的meta分析,并采用Cochrane协作网推荐的Revman5.3软件进行meta分析。最后对系统评价的结果进行解释和讨论。3研究结果本系统评价共检索出1441篇文献,最终纳入14篇文献,共2269例患者。纳入研究的对照类型为消渴丸对照格列喹酮(1篇),消渴丸对照格列奇特(1篇),消渴丸对照二甲双胍(4篇),消渴丸对照格列本脲(8篇)。在消渴丸对照格列喹酮的研究中,定性分析结果表明消渴丸较格列喹酮在改善临床有效率、空腹血糖、餐后2小时血糖方面均具有优势,且具有统计学差异。在消渴丸对照格列奇特的研究中,定性分析结果表明消渴丸与格列奇特在改善临床有效率、空腹血糖、餐后2小时血糖及糖化血红蛋白方面均无显著性差异。在消渴丸对照二甲双胍的研究中,对4项研究的临床有效率进行定性分析,其中2项研究表明消渴丸优于二甲双胍,且具有显著性差异;在空腹血糖方面,2项研究的定性分析表明在疗程≤1月时,消渴丸较二甲双胍具有一定的优势,另2项研究的meta分析结果表明在治疗疗程1月时,试验组与对照组结果无显著性差异;在餐后2小时血糖方面,对3项研究定性分析,其中2项研究表明消渴丸优于二甲双胍,且有显著性差异。在消渴丸对照格列本脲的研究中,对报告临床有效人数的4项研究进行定性分析,其中2项研究表明消渴丸较格列本脲在改善临床有效率方面具有优势,并具有显著性差异;在空腹血糖方面,对未使用安慰剂的5项研究定性描述,其中1项研究表明消渴丸优于格列本脲,3项研究无显著性差异,1项研究表明格列本脲优于消渴丸。对使用安慰剂的2项研究进行meta分析,结果表明消渴丸与格列本脲无显著性差异;在餐后2小时血糖方面,对6项研究进行定性描述,其中1项研究表明消渴丸优于格列本脲,4项研究无显著性差异,1项研究表明格列本脲优于消渴丸。在去除1项异质性的可能来源后,对同质性较好的几项研究进行meta分析,结果表明消渴丸在降低餐后2小时血糖上优于格列本脲,且具有统计学意义;在空腹胰岛素方面,对未使用安慰剂的2项研究定性分析,发现消渴丸在降低空腹胰岛素上优于格列本脲,并有统计学意义。对使用安慰剂的2项研究进行meta分析,发现试验组与对照组结果无显著性差异;在糖化血红蛋白方面,5项研究的meta分析结果提示消渴丸对比格列本脲在改善糖化血红蛋白时无显著性差异;在胰岛β细胞功能指数方面,对1项研究定性分析,提示消渴丸较格列本脲在改善胰岛β细胞功能上无显著性差异;在胰岛素敏感指数方面,对未使用安慰剂的1项研究定性描述,发现消渴丸优于格列本脲,并具有显著性差异。对使用安慰剂的2项研究进行meta分析,结果表明消渴丸对比格列本脲在改善胰岛素敏感性指数方面无显著性差异;在总胆固醇方面,3项研究的meta分析结果提示消渴丸对比格列本脲在降低总胆固醇方面无显著性差异;在甘油三酯方面,3项研究的meta分析结果提示消渴丸对比格列本脲在降低甘油三酯方面无显著性差异;在中医症状改善方面,2项研究的定性分析表明治疗组优于对照组,2项研究的meta分析表明消渴丸在改善口渴喜饮、倦怠乏力、多食易饥、气短懒言症状上优于格列本脲,且具有统计学差异。在安全性方面,7项研究说明了不良反应情况,其中1项研究明确表明未发生不良反应,6项研究报告了不良反应。在低血糖发生率方面,4项研究的meta分析结果表明消渴丸发生低血糖的风险低与格列本脲,且具有统计学意义。4研究结论消渴丸较西医口服降糖药在改善临床有效率、糖脂代谢方面具有很大潜力,在改善中医气阴两虚的主要症状及降低低血糖发生率方面具有一定优势。但由于本系统评价的局限性,尚不能得出确切结论,仍需要开展设计良好的多中心、大样本的随机双盲对照试验。消渴丸治疗2型糖尿病随机对照试验的文献质量有待进一步提高,尤其是在样本量的估算、随机方案的隐匿、盲法的实施等方面需引起重视。
[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.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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