微生态制剂治疗2型糖尿病临床随机对照研究的meta分析及系统评价  

A Meta-analysis and System Assessment of Micro-ecologic Agents in Treatment of Type 2 Diabetes Mellitus Patients by Randomised Control Trial

作　　者：陈硕[1] 马建伟[1] 徐丽梅[1] 孟庆扬[1] 韩琦[1] 

机构地区：[1]北京空军总医院中医科,100142

出　　处：《解放军医药杂志》2015年第9期39-46,共8页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

基　　金：首都医学发展基金(SF-2009-I-13);首都临床特色应用研究课题(Z121107001012011)

摘　　要：目的应用meta分析系统评价微生态制剂对2型糖尿病(diabetes mellitus,DM)患者糖化血红蛋白、空腹血糖、空腹胰岛素水平、氧化应激指标及炎性指标的影响。方法计算机检索Cochrane图书馆、Pub Med、EMBASE、Wiley、SCI、CNKI、VIP、CBM数据库,按照Cochrane系统评价方法查找微生态制剂治疗2型DM的所有随机对照试验(RCT)文献,对符合纳入标准的文献进行数据提取和质量评价后,采用Rev-Man 5.0软件进行meta分析。结果最终共纳入7篇RCT,研究质量相对较高,偏倚风险较低。meta分析结果显示:1微生态制剂疗程≥8周可有效降低2型DM患者糖化血红蛋白水平[SMD=-0.60,95%CI(-1.05,-0.15)];微生态制剂能有效降低2型DM患者空腹血糖[SMD=-0.46,95%CI(-0.86,-0.05)]及空腹胰岛素水平[SMD=-1.01,95%CI(-2.00,-0.02)]。2微生态制剂可提高2型DM患者谷胱甘肽过氧化物酶水平[SMD=2.77,95%CI(0.05,5.48)]、降低超敏C反应蛋白(hs-CRP)水平[SMD=-2.89,95%CI(-5.04,-0.74)]。6篇RCT研究均报道微生态制剂治疗期间无不良反应事件发生,1篇无描述。结论现有证据支持微生态制剂作为辅助治疗可在一定程度上有效控制2型DM患者血糖,改善机体的氧化应激状态,降低全身低度炎性反应,且安全性较好,但其远期疗效及安全性有待开展更多高质量、大样本、长期随访的RCT研究加以验证。Objective To evaluate the effects of micro-ecologic agents on levels of glycated hemoglobin （HbA1c）, fasting plasma glucose （FPG） and fasting serum insulin, and oxidative stress and inflammatory indexes in pa-tients with type 2 diabetes mellitus （ DM ） using meta-analysis. Methods The papers of randomized controlled trials （ RCT） were searched from Cochrane Library, PubMed, EMbase, Wiley, SCI, CNKI, VIP and CBM databases. The da-ta extraction and quality evaluation were performed for the selected papers, and then meta-analysis was performed using Rev-Man 5. 0 software. Results A total of 7 RCTs were included in this study with good study quality and little misregis-tration risk. The results of meta-analyses,showed that the HbA1c levels of patients with type 2 DM significantly decreased when the therapeutic time was equal or more than 8 weeks [SMD= -0. 60, 95% CI （ -1. 05 to -0. 15）], and levels of FPG [SMD= -0. 46, 95% CI （ -0. 86 to -0. 05）] and fasting serum insulin [SMD= -1. 01, 95% CI （ -2. 00 to -0. 02）] could be also effectively decreased after treatment of micro-ecologic agents. The levels of glutathion peroxi-dase [SMD=2. 77,95% CI （0. 05 to 5. 48）] of patients with type 2 DM effectively increased, and hs-CRP levels [SMD= -2. 89, 95% CI （ -5. 04 to -0. 74）] were effectively decreased after treatment of micro-ecologic agents. There was no adverse events in 6 RCTs during the treatment, and there was no report about adverse events in 1 RCT. Conclusion The adjunctive therapy with micro-ecologic agents may effectively control blood glucose, improve the oxida-tive stress state and decrease the systemic low-grade inflammatory reaction in a certain extent with good safety for patients with type 2 DM, but long-term efficacy and safety need to be verified by more RCTs with better quality, larger samples and long-term follow-up.

关 键 词：微生态制剂 糖尿病 2型 META分析 系统评价 随机对照试验 

分 类 号：R587.1[医药卫生—内分泌]