解放军医药杂志
解放軍醫藥雜誌
해방군의약잡지
Medical & Pharmaceutical Journal of Chinese People's Liberation Army
2015年
9期
39-46
,共8页
陈硕%马建伟%徐丽梅%孟庆扬%韩琦
陳碩%馬建偉%徐麗梅%孟慶颺%韓琦
진석%마건위%서려매%맹경양%한기
微生态制剂%糖尿病,2型%Meta分析%系统评价%随机对照试验
微生態製劑%糖尿病,2型%Meta分析%繫統評價%隨機對照試驗
미생태제제%당뇨병,2형%Meta분석%계통평개%수궤대조시험
Micro-ecologic agents%Diabetes mellitus%type 2%Meta-analysis%System assessment%Randomized controlled trial
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、PubMed、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.
目的 應用meta分析繫統評價微生態製劑對2型糖尿病( diabetes mellitus, DM)患者糖化血紅蛋白、空腹血糖、空腹胰島素水平、氧化應激指標及炎性指標的影響. 方法 計算機檢索Cochrane圖書館、PubMed、EMBASE、Wiley、SCI、CNKI、VIP、CBM數據庫,按照Cochrane繫統評價方法查找微生態製劑治療2型DM的所有隨機對照試驗(RCT)文獻,對符閤納入標準的文獻進行數據提取和質量評價後,採用Rev-Man 5. 0軟件進行meta分析. 結果 最終共納入7篇RCT,研究質量相對較高,偏倚風險較低. meta分析結果顯示:①微生態製劑療程≥8週可有效降低2型DM患者糖化血紅蛋白水平[SMD= -0. 60,95% CI( -1. 05,-0. 15)];微生態製劑能有效降低2型DM患者空腹血糖[SMD= -0. 46,95% CI( -0. 86,-0. 05)]及空腹胰島素水平[SMD= -1. 01,95% CI( -2. 00,-0. 02)]. ②微生態製劑可提高2型DM患者穀胱甘肽過氧化物酶水平[SMD=2. 77,95% CI(0. 05,5. 48)]、降低超敏C反應蛋白(hs-CRP)水平[SMD= -2. 89,95% CI( -5. 04,-0. 74)]. 6篇RCT研究均報道微生態製劑治療期間無不良反應事件髮生,1篇無描述. 結論 現有證據支持微生態製劑作為輔助治療可在一定程度上有效控製2型DM患者血糖,改善機體的氧化應激狀態,降低全身低度炎性反應,且安全性較好,但其遠期療效及安全性有待開展更多高質量、大樣本、長期隨訪的RCT研究加以驗證.
목적 응용meta분석계통평개미생태제제대2형당뇨병( diabetes mellitus, DM)환자당화혈홍단백、공복혈당、공복이도소수평、양화응격지표급염성지표적영향. 방법 계산궤검색Cochrane도서관、PubMed、EMBASE、Wiley、SCI、CNKI、VIP、CBM수거고,안조Cochrane계통평개방법사조미생태제제치료2형DM적소유수궤대조시험(RCT)문헌,대부합납입표준적문헌진행수거제취화질량평개후,채용Rev-Man 5. 0연건진행meta분석. 결과 최종공납입7편RCT,연구질량상대교고,편의풍험교저. meta분석결과현시:①미생태제제료정≥8주가유효강저2형DM환자당화혈홍단백수평[SMD= -0. 60,95% CI( -1. 05,-0. 15)];미생태제제능유효강저2형DM환자공복혈당[SMD= -0. 46,95% CI( -0. 86,-0. 05)]급공복이도소수평[SMD= -1. 01,95% CI( -2. 00,-0. 02)]. ②미생태제제가제고2형DM환자곡광감태과양화물매수평[SMD=2. 77,95% CI(0. 05,5. 48)]、강저초민C반응단백(hs-CRP)수평[SMD= -2. 89,95% CI( -5. 04,-0. 74)]. 6편RCT연구균보도미생태제제치료기간무불량반응사건발생,1편무묘술. 결론 현유증거지지미생태제제작위보조치료가재일정정도상유효공제2형DM환자혈당,개선궤체적양화응격상태,강저전신저도염성반응,차안전성교호,단기원기료효급안전성유대개전경다고질량、대양본、장기수방적RCT연구가이험증.
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.
