2型糖尿病患者沙格列汀5mg/d单药和联合治疗与尿路感染和上呼吸道感染发病风险相关性META分析
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- 英文论文题名：Association Between Saxagliptin 5mg/d and Urinary Tract Infections or Upper Respiratory Tract Infection As Monotherapy Or As Combination Therapy in Type 2 Diabetes Patients:A Meta-Analysis
- 论文作者：黄文辉 ; 费燕 ; 许小鑫 ; 侯幸赟
- 英文论文作者：HUANG Wen-hui ; FEI-Yan ; XU Xiao-xin ; HOU Xing-yun ; Dept.of Pharmacy ; No.175 Hospital of PLA ; Dept.of Pharmacy ; Changzheng Hospital Affiliated to Second Military Medical University
- 年：2016
- 作者机构：解放军第175医院药学科;第二军医大学附属长征医院药学部;
- 论文关键词：沙格列汀5mg/d ; 尿路感染 ; 上呼吸道感染 ; 发病风险 ; Meta分析
- 英文论文关键词：saxagliptin 5mg/d ; urinary tract infection ; upper respiratory tract infection ; risk ; Meta-analysis
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R587.1
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：8
- 文件大小：1255k
- 原文格式：O
- 会议级别：全国
摘要
目的:系统评价沙格列汀常规剂量5mg/d治疗2型糖尿病与尿路感染和上呼吸道感染发病的相关性。方法:计算机检索Cochrane Library(2015年第4期)、PubMed(1978~2015.12)、EMbase(1974~2015.12)、CNKI(1978~2015.12)、VIP(1989~2015.12)、CBM(1978~2015.12)、网上图书馆(Elsevier Science-Science Direct,Nature Publishing Group,Oxford University Press,Science,Wiley-Blackwell and Springer Link)建库至2015年12月的所有文献资料。按照Cochrane系统评价方法查找沙格列汀5mg/d治疗2型糖尿病发生尿路感染或上呼吸道感染的所有随机对照试验(RCT),进行数据提取和质量评价后,采用RevMan 5.3软件进行Meta分析。结果:共纳入16个研究。Meta分析结果显示:沙格列汀5mg/d尿路感染的发病风险与安慰剂组相似,差异无统计学意义[RR=1.13,95%CI(0.93,1.37),P=0.23];沙格列汀5mg/d上呼吸道感染的发病风险与安慰剂组相似,其差异无统计学意义[RR=1.10,95%CI(0.90,1.34),P=0.35];而且沙格列汀5mg/d联合二甲双胍与单药二甲双胍治疗2型糖尿病上呼吸道感染的发病风险相似,差异亦无统计学意义[RR=1.16,95%CI(0.82,1.65),P=0.40]。结论:沙格列汀常规剂量5mg/d单药和联合治疗2型糖尿病不增加尿路感染和上呼吸道感染的风险。但其远期安全性有待开展更多高质量、大样本、长期随访的RCT加以验证。
Objective To systematically review the correlation between saxagliptin 5mg/d and urinary tract infection or upper respiratory tract infection in type 2 diabetes patients.Methods The following databases as The Cochrane Library(Issue 4,2015),PubMed(1978 to December 2015),EMbase(1974 to December 2015),CNKI(1978 to December 2015),VIP(1989 to December 2015),CBM(1978 to December 2015),Online library(Elsevier Science-Science Direct,Nature Publishing Group,Oxford University Press,Science,Wiley-Blackwell and Springer Link)(until December 2015) were searched.The quality of included randomized controlled trials(RCTs) was assessed according to the Cochrane Collaboration system review,and then meta-analysis was performed using RevMan 5.3.Results A total of 16 RCTs were included.The results of meta-analyses showed that the risk of urinary tract infection or upper respiratory tract infection between saxagliptin 5mg/d and the placebo group is similar(RR=1.13,95%CI 0.93 to 1.37,P=0.23) and(RR=1.10,95%CI 0.90 to 1.34,P=0.35).Saxagliptin 5mg/d added to metformin also had no difference in the risk of upper respiratory tract infection with metformin monotherapy in type2 diabetes patients(RR=1.16,95%CI 0.82 to 1.65,P=0.40).Conclusion Saxagliptin 5mg once daily did not increase the risk of urinary tract infection or upper respiratory tract infection in type 2 diabetes patients.But its long-term safety still need to be confirmed by performing more high quality,large sample RCTs with longterm follow-up.
Objective To systematically review the correlation between saxagliptin 5mg/d and urinary tract infection or upper respiratory tract infection in type 2 diabetes patients.Methods The following databases as The Cochrane Library(Issue 4,2015),PubMed(1978 to December 2015),EMbase(1974 to December 2015),CNKI(1978 to December 2015),VIP(1989 to December 2015),CBM(1978 to December 2015),Online library(Elsevier Science-Science Direct,Nature Publishing Group,Oxford University Press,Science,Wiley-Blackwell and Springer Link)(until December 2015) were searched.The quality of included randomized controlled trials(RCTs) was assessed according to the Cochrane Collaboration system review,and then meta-analysis was performed using RevMan 5.3.Results A total of 16 RCTs were included.The results of meta-analyses showed that the risk of urinary tract infection or upper respiratory tract infection between saxagliptin 5mg/d and the placebo group is similar(RR=1.13,95%CI 0.93 to 1.37,P=0.23) and(RR=1.10,95%CI 0.90 to 1.34,P=0.35).Saxagliptin 5mg/d added to metformin also had no difference in the risk of upper respiratory tract infection with metformin monotherapy in type2 diabetes patients(RR=1.16,95%CI 0.82 to 1.65,P=0.40).Conclusion Saxagliptin 5mg once daily did not increase the risk of urinary tract infection or upper respiratory tract infection in type 2 diabetes patients.But its long-term safety still need to be confirmed by performing more high quality,large sample RCTs with longterm follow-up.
引文
[1]DEACON C F,NAUCK M A,TOFT-NIELSEN M et al.Both siibcutaneously and intravenously administered glucagon-like peptideⅠare rapidly degraded from the NH2-terminus in typeⅡdiabetic patients and in healthy subjects[J]Diabetes.1995,44(9):1126-1131.
[2]MARJOLEIN,J,WILLEMEN,PHARMD,et al.Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections:A Disproportionality Analysis in the World Health Organization VigiBase[J].DIABETES CARE,2011,34(2):369-374.
[3]Higgins J,Green S.Cochrane handbook for systematic reviews of interventions version 5.0.2[updated September 2009].The Cochrane Collaboration.2009.
[4]Rosenstock J,Hansen L et al.Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy:arandomized double-blind trial of saxagliptin plus dapagliflozin addition versus singleaddition of saxagliptin or dapagliflozin to metformin.Diabetes Care.2015 Mar;38(3):376-83.
[5]Barnett AH Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin.Curr Med Res Opin.2012 Apr;28(4):513-23.
[6]Frederich R et al.The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type2 diabetes mellitus:a randomized controlled trial.Diabetol Metab Syndr.2012 Jul 24;4(1):36.
[7]Rosenstock J et al.GIucose-Iowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2diabetes.Diabetes Obes Metab.2008 May;10(5):376-86.
[8]Chacra AR et al.Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared withuptitration of sulphonylurea in patients with type 2 diabetes:a randomised controlled trial.Int J Clin Pract.2009 Sep;63(9):1395-406.
[9]Rosenstock J Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.Diabet Med.2013Dec;30(12):1472-6.
[10]Karyekar C Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes.Postgrad Med.2011Jul;123(4):63-70.
[11]Hollander P et al.Saxagliptin Added to a Thiazolidinedione Improves Glycemic Control in.Patients with Type 2 Diabetes and Inadequate Control on Thiazolidinedione Alone J Clin Endocrinol Metab.2009 Dec;94(12):4810-9.
[12]Rosenstock J et al.Effect of saxagliptin monotherapy in treatment-nai've patients with type 2 diabetes.Curr Med Res Opin.2009Oct;25(10):2401-ll.
[13]Cook W et al.Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular diseasehistory and cardiovascular risk factors:analysis of 3 clinical trials.Postgrad Med.2014 Oct;126(6):19-32.
[14]Iqbal N et al.Long-term safety and tolerability of saxagliptin add-on therapy in older patients(aged>65 years)with type 2 diabetes.Clin Interv Aging.2014 Sep 4;9:1479-87.
[15]Sjostrand M et al.Saxagliptin improves glycemic control by modulating postprandial glucagon and C-peptide levels in Chinesepatients with type 2 diabetes.Di abetes Res Clin Pract.2014 Aug;105(2):185-91.
[16]Moses RG et al.A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2diabetes and inadequate glycaemic control on metformin plus a sulphonylurea.Diabetes Obes Metab.2014 May;16(5):443-50.
[17]Bamett AH et al.Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus:52-week safety and efficacy.Clin Drug Investig.2013 Oct;33(10):707-17.
[18]Yang W et al.Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus:arandomized controlled trial.Diabetes Res Clin Pract.2011 Nov;94(2):217-24.
[19]De Fronzo RA et al.The efficacy and safety of saxagliptin when added to metformin therapy in patients withinadequately controlled type2 diabetes with metformin alone.Diabetes Care.2009 Sep;32(9):1649-55.
[20]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Januvia.London,UK,CHMP,2009.
[21]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Galvus.London,UK,CHMP,2007.
[22]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Onglyza.London,UK,CHMP,2010
[23]De Meester I,Scharpe S,Lambeir AM.Dipeptidyl peptidases and related proteins:multifaceted markers and therapeutic targets.Clin Chem Lab Med 2009;47:245-7.
[24]Gorrell MD,Gysbers V,McCaughan GW.CD26:a multifunctional integral membrane and secreted protein of activated lymphocytes.Scand J Immunol 2001;54:249-64.
[25]P.C.M.van Poppel,M.S.Gresnigt.P,Smits,M,G,Netea,C.J.Tack.The dipeptidyl peptidase-4 inhibitor vildagliptin does not affect ex vivo cytokine response and lymphocyte function in patients with type 2 diabetes mellitus[J].Diabetes Research and Clinical Practice,2014,103(3):395-401.
[2]MARJOLEIN,J,WILLEMEN,PHARMD,et al.Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections:A Disproportionality Analysis in the World Health Organization VigiBase[J].DIABETES CARE,2011,34(2):369-374.
[3]Higgins J,Green S.Cochrane handbook for systematic reviews of interventions version 5.0.2[updated September 2009].The Cochrane Collaboration.2009.
[4]Rosenstock J,Hansen L et al.Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy:arandomized double-blind trial of saxagliptin plus dapagliflozin addition versus singleaddition of saxagliptin or dapagliflozin to metformin.Diabetes Care.2015 Mar;38(3):376-83.
[5]Barnett AH Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin.Curr Med Res Opin.2012 Apr;28(4):513-23.
[6]Frederich R et al.The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type2 diabetes mellitus:a randomized controlled trial.Diabetol Metab Syndr.2012 Jul 24;4(1):36.
[7]Rosenstock J et al.GIucose-Iowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2diabetes.Diabetes Obes Metab.2008 May;10(5):376-86.
[8]Chacra AR et al.Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared withuptitration of sulphonylurea in patients with type 2 diabetes:a randomised controlled trial.Int J Clin Pract.2009 Sep;63(9):1395-406.
[9]Rosenstock J Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.Diabet Med.2013Dec;30(12):1472-6.
[10]Karyekar C Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes.Postgrad Med.2011Jul;123(4):63-70.
[11]Hollander P et al.Saxagliptin Added to a Thiazolidinedione Improves Glycemic Control in.Patients with Type 2 Diabetes and Inadequate Control on Thiazolidinedione Alone J Clin Endocrinol Metab.2009 Dec;94(12):4810-9.
[12]Rosenstock J et al.Effect of saxagliptin monotherapy in treatment-nai've patients with type 2 diabetes.Curr Med Res Opin.2009Oct;25(10):2401-ll.
[13]Cook W et al.Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular diseasehistory and cardiovascular risk factors:analysis of 3 clinical trials.Postgrad Med.2014 Oct;126(6):19-32.
[14]Iqbal N et al.Long-term safety and tolerability of saxagliptin add-on therapy in older patients(aged>65 years)with type 2 diabetes.Clin Interv Aging.2014 Sep 4;9:1479-87.
[15]Sjostrand M et al.Saxagliptin improves glycemic control by modulating postprandial glucagon and C-peptide levels in Chinesepatients with type 2 diabetes.Di abetes Res Clin Pract.2014 Aug;105(2):185-91.
[16]Moses RG et al.A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2diabetes and inadequate glycaemic control on metformin plus a sulphonylurea.Diabetes Obes Metab.2014 May;16(5):443-50.
[17]Bamett AH et al.Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus:52-week safety and efficacy.Clin Drug Investig.2013 Oct;33(10):707-17.
[18]Yang W et al.Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus:arandomized controlled trial.Diabetes Res Clin Pract.2011 Nov;94(2):217-24.
[19]De Fronzo RA et al.The efficacy and safety of saxagliptin when added to metformin therapy in patients withinadequately controlled type2 diabetes with metformin alone.Diabetes Care.2009 Sep;32(9):1649-55.
[20]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Januvia.London,UK,CHMP,2009.
[21]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Galvus.London,UK,CHMP,2007.
[22]Committee for Medicinal Products for Human Use.European Public Assessment Report(EPAR)for Onglyza.London,UK,CHMP,2010
[23]De Meester I,Scharpe S,Lambeir AM.Dipeptidyl peptidases and related proteins:multifaceted markers and therapeutic targets.Clin Chem Lab Med 2009;47:245-7.
[24]Gorrell MD,Gysbers V,McCaughan GW.CD26:a multifunctional integral membrane and secreted protein of activated lymphocytes.Scand J Immunol 2001;54:249-64.
[25]P.C.M.van Poppel,M.S.Gresnigt.P,Smits,M,G,Netea,C.J.Tack.The dipeptidyl peptidase-4 inhibitor vildagliptin does not affect ex vivo cytokine response and lymphocyte function in patients with type 2 diabetes mellitus[J].Diabetes Research and Clinical Practice,2014,103(3):395-401.