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Split-dose menthol-enhanced PEG vs PEG-ascorbic acid for colonoscopy preparation 被引量:2
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作者 Ala I Sharara Ali H Harb +5 位作者 Fayez S Sarkis Jean M Chalhoub Rami Badreddine Fadi H Mourad Mahmoud Othman Omar Masri 《World Journal of Gastroenterology》 SCIE CAS 2015年第6期1938-1944,共7页
AIM:To compare the efficacy and palatability of 4L polyethylene glycol electrolyte(PEG)plus sugar-free menthol candy(PEG+M)vs reduced-volume 2 L ascorbic acid-supplemented PEG(Asc PEG).METHODS:In a randomized controll... AIM:To compare the efficacy and palatability of 4L polyethylene glycol electrolyte(PEG)plus sugar-free menthol candy(PEG+M)vs reduced-volume 2 L ascorbic acid-supplemented PEG(Asc PEG).METHODS:In a randomized controlled trial setting,ambulatory patients scheduled for elective colonoscopy were prospectively enrolled.Patients were randomized to receive either PEG+M or Asc PEG,both splitdosed with minimal dietary restriction.Palatability was assessed on a linear scale of 1 to 5(1=disgusting;5=tasty).Quality of preparation was scored by assignment-blinded endoscopists using the modified Aronchick and Ottawa scales.The main outcomes were the palatability and efficacy of the preparation.Secondary outcomes included patient willingness to retake the same preparation again in the future and completion of the prescribed preparation.RESULTS:Overall,200 patients were enrolled(100patients per arm).PEG+M was more palatable than Asc PEG(76%vs 62%,P=0.03).Completing the preparation was not different between study groups(91%PEG+M vs 86%Asc PEG,P=0.38)but more patients were willing to retake PEG+M(54%vs 40%respectively,P=0.047).There was no significant difference between PEG+M vs Asc PEG in adequate cleansing on both the modified Aronchick(82%vs77%,P=0.31)and the Ottawa scale(85%vs 74%,P=0.054).However,PEG+M was superior in the left colon on the Ottawa subsegmental score(score0-2:94%for PEG+M vs 81%for Asc PEG,P=0.005)and received significantly more excellent ratings than Asc PEG on the modified Aronchick scale(61%vs 43%,P=0.009).Both preparations performed less well in afternoon vs morning examinations(inadequate:29%vs 15.2%,P=0.02).CONCLUSION:4 L PEG plus menthol has better palatability and acceptability than 2 L ascorbic acidPEG and is associated with a higher rate of excellentpreparations;Clinicaltrial.gov identifier:NCT01788709. 展开更多
关键词 COLONOSCOPY BOWEL PREPARATION Efficacy tolerabilit
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利格列汀用于2型糖尿病患者的安全性和耐受性:17项随机对照临床研究的汇总分析 被引量:11
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作者 郝明 马雪菲 +1 位作者 林文简 匡洪宇 《中华糖尿病杂志》 CAS CSCD 北大核心 2019年第3期201-207,共7页
目的评估利格列汀作为单药、联合二甲双胍或联合二甲双胍+磺脲类治疗2型糖尿病(T2DM)患者的安全性和耐受性。方法汇总17项全球多中心随机临床研究,总共纳入4 789例T2DM患者数据进行汇总分析,筛选出基线时未接受降糖药或已接受二甲双胍... 目的评估利格列汀作为单药、联合二甲双胍或联合二甲双胍+磺脲类治疗2型糖尿病(T2DM)患者的安全性和耐受性。方法汇总17项全球多中心随机临床研究,总共纳入4 789例T2DM患者数据进行汇总分析,筛选出基线时未接受降糖药或已接受二甲双胍单药治疗或二甲双胍联合磺脲类药物的T2DM患者,分析其安全性数据,评估利格列汀的安全和耐受性。对符合纳入标准的随机对照研究中患者个体数据进行汇总分析,并根据原研究方案中的分类进行亚组分析。组间的连续性变量比较通过t检验或单因素方差分析进行。结果总共4 789例T2DM患者被纳入汇总分析,其中3 343例利格列汀组(包括单药、联合二甲双胍或联合二甲双胍+磺脲),1 446例为安慰剂组。利格列汀组和安慰剂组的总体不良事件发生率是相似的(52.4% vs 52.9%)。在低血糖发生率方面利格列汀组共发生229例低血糖事件,安慰剂组为59例,利格列汀组稍高于安慰剂组(OR=1.46, 95%CI 1.06~2.00),在背景治疗有磺脲类药物的患者中利格列汀组低血糖发生率稍高,其中利格列汀组207例,安慰剂组49例(OR=1.66,95%CI 1.17~2.34),而在背景治疗无磺脲类药物的患者中,两组低血糖发生率一致,利格列汀组22例,安慰剂组10例(OR=0.73,95%CI 0.33~1.61)。另外,总体患者中利格列汀组与安慰剂组的心血管疾病发生风险是相似的(OR=1.19, 95%CI 0.88~1.62)。同时不同基线治疗、年龄、预估肾小球滤过率或体质指数亚组中利格列汀组和安慰剂组的心血管疾病发生风险也相似(利格列汀组事件/患者总数为4.9%,安慰剂组事件/患者总数为4.3%)。此外,利格列汀组和安慰剂组中临床事件委员会确认的不良事件发生率都非常低(其中利格列汀组和安慰剂组中出现心血管死亡、心肌梗死或卒中复合性终点的患者比例均为0.2%,心血管死亡、心肌梗死、卒中或不稳定性心绞痛复合性终点的患者比例均为0.3%)。结论基于汇总分析的结果,利格列汀是T2DM患者的良好选择,安全性和耐受性良好。 展开更多
关键词 利格列汀 糖尿病 2型 安全性 耐受性
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