江西中医药大学学报
江西中醫藥大學學報
강서중의약대학학보
Journal of Jiangxi University of Traditional Chinese Medicine
2015年
4期
35-40
,共6页
黄少桐%刘霞%刘红宁%陈晓凡
黃少桐%劉霞%劉紅寧%陳曉凡
황소동%류하%류홍저%진효범
参芪降糖颗粒%2型糖尿病%气阴两虚证%系统评价%Meta分析%随机对照试验( RCT)
參芪降糖顆粒%2型糖尿病%氣陰兩虛證%繫統評價%Meta分析%隨機對照試驗( RCT)
삼기강당과립%2형당뇨병%기음량허증%계통평개%Meta분석%수궤대조시험( RCT)
Shenqi Jiangtang Granule%2 Diabetes Mellitus%Qi-yin Deficiency%Systematic Review%Meta-analysis%Randomized Controlled Trial( RCT)
目的:系统评价目前参芪降糖颗粒治疗2型糖尿病气阴两虚证患者的疗效和安全性。方法:计算机检索Cochrane Librar-y、PubMed、WHO ICTRP、CNKI、VIP、CBM、Wanfang Data和中国优秀硕士、博士学位毕业论文数据库的文献,检索时限均为从建库至2014年11月11日,由两名研究者按照纳入和排除标准独立进行文献筛选、资料提取、质量评价并交叉核对后,采用Rev-Man5.2软件进行Meta分析。结果:共纳入8个随机对照试验,合计772例。各纳入研究的方法学质量总体中等。 Meta分析结果显示:(1)有效率指标:共纳入的6个研究,实验组(联合组、单用组)治疗2型糖尿病气阴两虚证患者效果优于对照组,差异有统计学意义,分别为[OR=4.52,95%CI(2.44,8.37),P<0.00001]、[OR=5.60,95%CI(2.33,13.45),P<0.00001]。(2)空腹血糖(FBG):共纳入的6个研究,实验组(联合组、单用组)降低2型糖尿病气阴两虚证患者FBG的疗效优于对照组,差异有统计学意义,分别为[MD=-2.29,95%CI(-2.67,-1.91)]、[MD=-1.97,95%CI(-2.80,-1.15)]。(3)餐后2小时血糖(2hPBG):共纳入的6个研究,实验组(联合组、单用组)降低2型糖尿病气阴两虚证患者2hPBG的疗效优于对照组,差异有统计学意义,分别为[MD=-2.21,95%CI(-2.69,-1.74)]、[MD=-1.46,95%CI(-2.32,-0.60)]。(4)不良反应:2个研究治疗组出现1例低血糖反应,对照组8例,两组比较有显著性差异(P<0.05);1个研究治疗组出现了2例低血糖反应,对照组16例,两组比较有显著性差异( P<0.05);1个研究治疗组在用药期间3例出现轻度腹泻。结论:参芪降糖颗粒对2型糖尿病气阴两虚证患者疗效确切,且不良反应少,值得临床应用。然而目前参芪降糖颗粒治疗2型糖尿病气阴两虚证临床研究的方法学和报告质量尚低,因此有必要进行大样本、多中心、随机、双盲的对照试验,以进一步证实其临床上的疗效和安全性。
目的:繫統評價目前參芪降糖顆粒治療2型糖尿病氣陰兩虛證患者的療效和安全性。方法:計算機檢索Cochrane Librar-y、PubMed、WHO ICTRP、CNKI、VIP、CBM、Wanfang Data和中國優秀碩士、博士學位畢業論文數據庫的文獻,檢索時限均為從建庫至2014年11月11日,由兩名研究者按照納入和排除標準獨立進行文獻篩選、資料提取、質量評價併交扠覈對後,採用Rev-Man5.2軟件進行Meta分析。結果:共納入8箇隨機對照試驗,閤計772例。各納入研究的方法學質量總體中等。 Meta分析結果顯示:(1)有效率指標:共納入的6箇研究,實驗組(聯閤組、單用組)治療2型糖尿病氣陰兩虛證患者效果優于對照組,差異有統計學意義,分彆為[OR=4.52,95%CI(2.44,8.37),P<0.00001]、[OR=5.60,95%CI(2.33,13.45),P<0.00001]。(2)空腹血糖(FBG):共納入的6箇研究,實驗組(聯閤組、單用組)降低2型糖尿病氣陰兩虛證患者FBG的療效優于對照組,差異有統計學意義,分彆為[MD=-2.29,95%CI(-2.67,-1.91)]、[MD=-1.97,95%CI(-2.80,-1.15)]。(3)餐後2小時血糖(2hPBG):共納入的6箇研究,實驗組(聯閤組、單用組)降低2型糖尿病氣陰兩虛證患者2hPBG的療效優于對照組,差異有統計學意義,分彆為[MD=-2.21,95%CI(-2.69,-1.74)]、[MD=-1.46,95%CI(-2.32,-0.60)]。(4)不良反應:2箇研究治療組齣現1例低血糖反應,對照組8例,兩組比較有顯著性差異(P<0.05);1箇研究治療組齣現瞭2例低血糖反應,對照組16例,兩組比較有顯著性差異( P<0.05);1箇研究治療組在用藥期間3例齣現輕度腹瀉。結論:參芪降糖顆粒對2型糖尿病氣陰兩虛證患者療效確切,且不良反應少,值得臨床應用。然而目前參芪降糖顆粒治療2型糖尿病氣陰兩虛證臨床研究的方法學和報告質量尚低,因此有必要進行大樣本、多中心、隨機、雙盲的對照試驗,以進一步證實其臨床上的療效和安全性。
목적:계통평개목전삼기강당과립치료2형당뇨병기음량허증환자적료효화안전성。방법:계산궤검색Cochrane Librar-y、PubMed、WHO ICTRP、CNKI、VIP、CBM、Wanfang Data화중국우수석사、박사학위필업논문수거고적문헌,검색시한균위종건고지2014년11월11일,유량명연구자안조납입화배제표준독립진행문헌사선、자료제취、질량평개병교차핵대후,채용Rev-Man5.2연건진행Meta분석。결과:공납입8개수궤대조시험,합계772례。각납입연구적방법학질량총체중등。 Meta분석결과현시:(1)유효솔지표:공납입적6개연구,실험조(연합조、단용조)치료2형당뇨병기음량허증환자효과우우대조조,차이유통계학의의,분별위[OR=4.52,95%CI(2.44,8.37),P<0.00001]、[OR=5.60,95%CI(2.33,13.45),P<0.00001]。(2)공복혈당(FBG):공납입적6개연구,실험조(연합조、단용조)강저2형당뇨병기음량허증환자FBG적료효우우대조조,차이유통계학의의,분별위[MD=-2.29,95%CI(-2.67,-1.91)]、[MD=-1.97,95%CI(-2.80,-1.15)]。(3)찬후2소시혈당(2hPBG):공납입적6개연구,실험조(연합조、단용조)강저2형당뇨병기음량허증환자2hPBG적료효우우대조조,차이유통계학의의,분별위[MD=-2.21,95%CI(-2.69,-1.74)]、[MD=-1.46,95%CI(-2.32,-0.60)]。(4)불량반응:2개연구치료조출현1례저혈당반응,대조조8례,량조비교유현저성차이(P<0.05);1개연구치료조출현료2례저혈당반응,대조조16례,량조비교유현저성차이( P<0.05);1개연구치료조재용약기간3례출현경도복사。결론:삼기강당과립대2형당뇨병기음량허증환자료효학절,차불량반응소,치득림상응용。연이목전삼기강당과립치료2형당뇨병기음량허증림상연구적방법학화보고질량상저,인차유필요진행대양본、다중심、수궤、쌍맹적대조시험,이진일보증실기림상상적료효화안전성。
Objective:To systematically review the effect and safety of the current system of Shenqi Jiangtang Granule for 2 Diabetes Mel-litus of Qi-yin Deficiency.Methods:Such database as Cochrane Library,PubMed,CBM, WanFang Data, CNKI and VIP were electron-ically searched from inception to November 11st, 2014.Result:8 randomized controlled trials( RCTs) about 772 cases are included in this article,the quality of each study was generally medium.The results of Meta analysis show that:(1) The total effective rate:6 ran-domized controlled trials are included, the total effective rate of treatment groups ( joint group, group) is higher than the control groups for 2 Diabetes Mellitus of Qi-yin deficiency, difference is statistically significant, just as follows:[ OR=4.52,95%CI(2.44,8.37) , P<0.000 01],[OR=5.60,95%CI(2.33,13.45),P<0.000 01];(2)Fasting blood glucose(FBG):6 randomized controlled trials are included,the total curative effect of treatment groups about reducing FBG is better than the control groups,difference is statistically significant, just as follows:[MD=-2.29,95%CI(-2.67,-1.91)],[MD=-1.97,95%CI( -2.80,-1.15)];(3)2h Postpran-dial blood glucose (PBG):6 randomized controlled trials are included,the total curative effect of treatment groups about reducing 2hPBG is better than the control groups ,difference is statistically significant, just as follows:[ MD=-2.21,95%CI( -2.69,-1.74)],[MD=-1.46,95%CI( -2.32,-0.60)];(4)There is 1 hypoglycemia reaction occurrenced in treatment group of one RCT, while 8 cases develope hypoglycemia reaction in control group,there is significant difference between the two groups(P<0.05);there are 2 hypoglycemia reactions occurrenced in treatment group of another RCT, while 16 cases develope hypoglycemia reaction in control group,there is significant difference between the two groups(P<0.05);there are 3 cases about mild diarrhea in treatment group of one RCT during the period of medication.Conclusion Shenqi Jiangtang Granule is effective and safe for 2 Diabetes Mellitus of Qi-yin Deficiency,which is recommended in clinical application.However, the current clinical studies on Shenqi Jiangtang Granule for 2 Diabetes Mellitus of Qi-yin Deficiency are low in methodology and reporting quality, so it is necessary to design multicenter, strictly randomized and double-blind randomized control trials with large samples, to further confirm the clinical curative effect and safety.