Combination therapy of tripterygium glycosides plus valsartan in diabetic nephropathy treatment: A systematic review and meta-analysis
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摘要
Objective: To assess the efficacy and safety of the combination therapy of Chinese herbal medicines,tripterygium glycosides, plus valsartan for the treatment of diabetic nephropathy(DN).Methods: A comprehensive research of 12 electronic databases was performed. Data of the included studies were extracted and analyzed independently by two authors, and were synthesized using Review Manager(version 5.2) and Stata(version 12.0).Results: A total of 12 randomized controlled trials(RCTs) involving 829 patients were included. Pooled results showed that the combination therapy significantly increased total efficacy of DN patients [RR = 1.35,95% CI(1.22, 1.50), P < 0.001], the level of serum albumin [Mean difference(MD) = 3.87, 95% CI(3.12,4.62), P < 0.001], and significantly decreased 24 h urinary protein level [MD =-0.97, 95% CI(-1.19,-0.76), P < 0.001], urinary albumin-excretion rate [MD =-145.53, 95% CI(-227.95,-63.11), P < 0.001],and urinary β2-microglobuli level [MD =-11.86, 95% CI(-13.02,-10.69), P < 0.001]. No significant differences were found in levels of serum creatinine [MD =-0.26, 95% CI(-7.52, 7.00), P > 0.05), blood urea nitrogen [MD = 0.25, 95% CI(-0.23, 0.74), P > 0.05], and endogenous creatinine clearance rate[MD =-0.43, 95% CI(-3.48, 2.62), P > 0.05]. However, tripterygium glycosides plus valsartan seemed to exert higher adverse reaction rate than valsartan monotherapy [MD = 3.41, 95% CI(1.34, 8.66), P < 0.05].There were no publication bias for all of the pooled effect sizes.Conclusion: Combination therapy of tripterygium glycosides plus valsartan may be effective for the treatment of DN. However, the safety of the combination therapy need to be further confirmed.
Objective: To assess the efficacy and safety of the combination therapy of Chinese herbal medicines,tripterygium glycosides, plus valsartan for the treatment of diabetic nephropathy(DN).Methods: A comprehensive research of 12 electronic databases was performed. Data of the included studies were extracted and analyzed independently by two authors, and were synthesized using Review Manager(version 5.2) and Stata(version 12.0).Results: A total of 12 randomized controlled trials(RCTs) involving 829 patients were included. Pooled results showed that the combination therapy significantly increased total efficacy of DN patients [RR = 1.35,95% CI(1.22, 1.50), P < 0.001], the level of serum albumin [Mean difference(MD) = 3.87, 95% CI(3.12,4.62), P < 0.001], and significantly decreased 24 h urinary protein level [MD =-0.97, 95% CI(-1.19,-0.76), P < 0.001], urinary albumin-excretion rate [MD =-145.53, 95% CI(-227.95,-63.11), P < 0.001],and urinary β2-microglobuli level [MD =-11.86, 95% CI(-13.02,-10.69), P < 0.001]. No significant differences were found in levels of serum creatinine [MD =-0.26, 95% CI(-7.52, 7.00), P > 0.05), blood urea nitrogen [MD = 0.25, 95% CI(-0.23, 0.74), P > 0.05], and endogenous creatinine clearance rate[MD =-0.43, 95% CI(-3.48, 2.62), P > 0.05]. However, tripterygium glycosides plus valsartan seemed to exert higher adverse reaction rate than valsartan monotherapy [MD = 3.41, 95% CI(1.34, 8.66), P < 0.05].There were no publication bias for all of the pooled effect sizes.Conclusion: Combination therapy of tripterygium glycosides plus valsartan may be effective for the treatment of DN. However, the safety of the combination therapy need to be further confirmed.
Objective: To assess the efficacy and safety of the combination therapy of Chinese herbal medicines,tripterygium glycosides, plus valsartan for the treatment of diabetic nephropathy(DN).Methods: A comprehensive research of 12 electronic databases was performed. Data of the included studies were extracted and analyzed independently by two authors, and were synthesized using Review Manager(version 5.2) and Stata(version 12.0).Results: A total of 12 randomized controlled trials(RCTs) involving 829 patients were included. Pooled results showed that the combination therapy significantly increased total efficacy of DN patients [RR = 1.35,95% CI(1.22, 1.50), P < 0.001], the level of serum albumin [Mean difference(MD) = 3.87, 95% CI(3.12,4.62), P < 0.001], and significantly decreased 24 h urinary protein level [MD =-0.97, 95% CI(-1.19,-0.76), P < 0.001], urinary albumin-excretion rate [MD =-145.53, 95% CI(-227.95,-63.11), P < 0.001],and urinary β2-microglobuli level [MD =-11.86, 95% CI(-13.02,-10.69), P < 0.001]. No significant differences were found in levels of serum creatinine [MD =-0.26, 95% CI(-7.52, 7.00), P > 0.05), blood urea nitrogen [MD = 0.25, 95% CI(-0.23, 0.74), P > 0.05], and endogenous creatinine clearance rate[MD =-0.43, 95% CI(-3.48, 2.62), P > 0.05]. However, tripterygium glycosides plus valsartan seemed to exert higher adverse reaction rate than valsartan monotherapy [MD = 3.41, 95% CI(1.34, 8.66), P < 0.05].There were no publication bias for all of the pooled effect sizes.Conclusion: Combination therapy of tripterygium glycosides plus valsartan may be effective for the treatment of DN. However, the safety of the combination therapy need to be further confirmed.
引文
Alberti,K.G.,&Zimmet,P.Z.(1998).Definition,diagnosis and classification of diabetes mellitus and its complications.Part 1:Diagnosis and classification of diabetes mellitus provisional report of a WHO consultation.Diabetic Medicine,15(7),539-553.
Cai,X.P.(2012).Treatment of diabetic nephropathy with ARB combined with tripterygium glycosides.Journal of Clinical Medicine in Practice,16(23),112-114.
Chi,Y.X.(2014).Application of tripterygium glycosides combined with valsartan in the treatment of diabetic nephropathy.Diabetes New World,12,20.
Ge,Y.,Xie,H.,Li,S.,Jin,B.,Hou,J.,Zhang,H.,Shi,M.,&Liu,Z.(2013).Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract:A prospective,randomized,controlled clinical trial.Journal of Translational Medicine,11,134-142.
Goldbach-Mansky,R.,Wilson,M.,Fleischmann,R.,Olsen,N.,Silverfield,J.,Kempf,P.,Kivitz,A.,Sherrer,Y.,Pucino,F.,Csako,G.,Costello,R.,Pham,T.H.,Snyder,C.,van der Heijde,D.,Tao,X.,Wesley,R.,&Lipsky,P.E.(2009).Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis:A randomized trial.Annals of Internal Medicine,151(4),229-240.
Hong,Y.,Gui,Z.,Cai,X.,&Lan,L.(2016).Clinical efficacy and safety of tripterygium glycosides in treatment of stage IV diabetic nephropathy:A meta-analysis.Open Med(Wars),11(1),611-617.
Ji,W.,Chen,Y.J.,Zhao,X.,Guo,Y.K.,Zhong,L.Y.,Li,H.G.,Wang,D.,&Song,Y.N.(2015).Beneficial effects of tripterygium glycosides tablet on biomarkers in patients with ankylosing spondylitis.Molecular Medicine Reports,12(1),684-690.
Jiang,X.(2015).Clinical observation of tripterygium glycosides combined with telmisartan in treatment of diabetic nephropathy.Drugs&Clinic,30(8),987-990.
Jin,Y.H.,Wang,G.H.,Sun,Y.R.,Li,Q.,Zhao,C.,Li,G.,Si,J.H.,Li,Y.,Lu,C.,&Shang,H.C.(2016).A critical appraisal of the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing interventions:A systematic review of reviews.BMJ Open,6(11),E011514-E011529.
Kato,M.,Wang,M.,Chen,Z.,Bhatt,K.,Oh,H.J.,Lanting,L.,Deshpande,S.,Jia,Y.,Lai,J.Y.,O’Connor,C.L.,Wu,Y.,Hodgin,J.B.,Nelson,R.G.,Bitzer,M.,&Natarajan,R.(2016).An endoplasmic reticulum stress-regulated lncRNA hosting a microRNA megacluster induces early features of diabetic nephropathy.Nature Communications,7,12864-12879.
Li,H.,Guo,F.,Luo,Y.C.,Zhu,J.P.,&Wang,J.L.(2015).Efficacy of tripterygium glycosides tablet in treating ankylosing spondylitis:a systematic review and meta-analysis of randomized controlled trials.Clinical Rheumatology,34(11),1831-1838.
Li,J.(2011).Clinical observation of tripterygium glycosides combined with valsartan in the treatment of diabetic nephropathy.Chinese Community Physician,13(23),43.
Liu,Q.D.(2015).Effect of valsartan combined with tripterygium glycosides on reducing proteinuria.Journal of Practical Diabetes,11(5),56-57.
Mogensen,C.E.,Christensen,C.K.,&Vittinghus,E.(1983).The stages in diabetic renal disease.With emphasis on the stage of incipient diabetic nephropathy.Diabetes,32(Suppl 2),64-78.
Moher,D.,Liberati,A.,Tetzlaff,J.,&Altman,D.G.(2009).Preferred reporting items for systematic reviews and meta-analyses:The PRISMA statement.BMJ,339,B2535-B2542.
Pu,Y.,Zou,Q.W.,&Pu,M.(2013).Effect of valsartan dispersible tablets and tripterygium glycosides in treating 78 cases of diabetic nephropathy with proteinuria.Jilin Medical,34(28),5789-5791.
Raphaela,Goldbach-Mansky,Mildred,Wilson,Roy,Fleischmann,Nancy,Olsen,Joel,Silverfield,Phillip,Kempf,Alan,Kivitz,Yvonne,Sherrer,Frank,Pucino,Gyorgy,Csako,Rene,Costello,Tuyet,Hang Pham,Christopher,Snyder,van der Heijde,Désirée,Xuelian,Tao,Robert,Wesley,&Peter E.,Lipsky(2009).Comparison of Tripterygium wilfordii Hook F Versus Sulfasalazine in the Treatment of Rheumatoid Arthritis:A Randomized Trial.Annals of Internal Medicine,151(4),229-W51.
Remuzzi,G.,Ruggenenti,P.,&Benigni,A.(1997).Understanding the nature of renal disease progression.Kidney International,51(1),2-15.
Song,M.A.(2014).Effect of valsartan dispersible tablets and tripterygium glycosides on proteinuria in diabetic nephropathy.China Medical Engineering,22(10),154-156.
Viberti,G.,&Wheeldon,N.M.(2002).Microalbuminuria reduction with valsartan in patients with type 2 diabetes mellitus:A blood pressure-independent effect.Circulation,106(6),672-678.
Wang,M.(2016).Clinical effect of tripterygium glycosides tablets combined with valsartan on diabetic nephropathy.Diabetes New World,9,31-32.
Wang,M.L.,&Zhang,C.(2012).Clinical observation of valsartan combined with tripterygium glycosides in the treatment of proteinuria in type 2 diabetic nephropathy.Chin J of Clinical Rational Drug Use,5(8),84-85.
Wu,S.B.,Cao,Z.D.,Zhang,W.,&Q.,Q.(2012).Clinical observation of tripterygium glycosides combined with valsartan in treating large amount of protein diabetic diabetic nephropathy.Modern Journal of Integrated Traditional Chinese and Western Medicine,21(4),394-395.
Wu,W.,Yang,J.J.,Yang,H.M.,Huang,M.M.,Fang,Q.J.,Shi,G.,Mao,Z.M.,Han,W.B.,Shen,S.M.,&Wan,Y.G.(2017).Multi-glycoside of Tripterygium wilfordii Hook.f.attenuates glomerulosclerosis in a rat model of diabetic nephropathy by exerting anti-microinflammatory effects without affecting hyperglycemia.International Journal of Molecular Medicine,40(3),721-730.
Xu,C.,Qi,A.R.,Fu,B.,&Zhou,L.(2016).Clinical observation on treating diabetic nephropathy during IV period with the tripterygium glycosides tablets.Clinical Journal of Traditional Chinese Medicine,8(17),95-96.
Xu,Z.,Diao,Z.,Liu,R.,&Liu,W.(2017).Molecular mechanism of smurf2 in regulating the expression of SnoN in diabetic nephropathy.Molecular Medicine Reports,15(5),2560-2566.
Zhang,M.,Wang,S.A.,&Liu,L.X.(2014).Immunosuppression of tripterygium glycosides via TLR-NF-κB signaling pathway.Chinese Traditional and Herbal Drugs,45(9),1288-1292.
Zhao,R.Y.,Tang,B.S.,Shi,X.L.,Lu,S.K.,Ye,Q.K.,&Lin,Y.Q.(2011).Clinical observation on 46 cases of diabetic nephropathy treated by tripterygium glycosides combined with valsartan.Chinese Journal of Integrated Traditional and Western Medicine on Nephrology,12(9),811-813.
Zhou,C.L.(2013).Clinical effect of tripterygium glycosides combined with valsartan on diabetic nephropathy.For All Health,7(3),94-95.
Cai,X.P.(2012).Treatment of diabetic nephropathy with ARB combined with tripterygium glycosides.Journal of Clinical Medicine in Practice,16(23),112-114.
Chi,Y.X.(2014).Application of tripterygium glycosides combined with valsartan in the treatment of diabetic nephropathy.Diabetes New World,12,20.
Ge,Y.,Xie,H.,Li,S.,Jin,B.,Hou,J.,Zhang,H.,Shi,M.,&Liu,Z.(2013).Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract:A prospective,randomized,controlled clinical trial.Journal of Translational Medicine,11,134-142.
Goldbach-Mansky,R.,Wilson,M.,Fleischmann,R.,Olsen,N.,Silverfield,J.,Kempf,P.,Kivitz,A.,Sherrer,Y.,Pucino,F.,Csako,G.,Costello,R.,Pham,T.H.,Snyder,C.,van der Heijde,D.,Tao,X.,Wesley,R.,&Lipsky,P.E.(2009).Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis:A randomized trial.Annals of Internal Medicine,151(4),229-240.
Hong,Y.,Gui,Z.,Cai,X.,&Lan,L.(2016).Clinical efficacy and safety of tripterygium glycosides in treatment of stage IV diabetic nephropathy:A meta-analysis.Open Med(Wars),11(1),611-617.
Ji,W.,Chen,Y.J.,Zhao,X.,Guo,Y.K.,Zhong,L.Y.,Li,H.G.,Wang,D.,&Song,Y.N.(2015).Beneficial effects of tripterygium glycosides tablet on biomarkers in patients with ankylosing spondylitis.Molecular Medicine Reports,12(1),684-690.
Jiang,X.(2015).Clinical observation of tripterygium glycosides combined with telmisartan in treatment of diabetic nephropathy.Drugs&Clinic,30(8),987-990.
Jin,Y.H.,Wang,G.H.,Sun,Y.R.,Li,Q.,Zhao,C.,Li,G.,Si,J.H.,Li,Y.,Lu,C.,&Shang,H.C.(2016).A critical appraisal of the methodology and quality of evidence of systematic reviews and meta-analyses of traditional Chinese medical nursing interventions:A systematic review of reviews.BMJ Open,6(11),E011514-E011529.
Kato,M.,Wang,M.,Chen,Z.,Bhatt,K.,Oh,H.J.,Lanting,L.,Deshpande,S.,Jia,Y.,Lai,J.Y.,O’Connor,C.L.,Wu,Y.,Hodgin,J.B.,Nelson,R.G.,Bitzer,M.,&Natarajan,R.(2016).An endoplasmic reticulum stress-regulated lncRNA hosting a microRNA megacluster induces early features of diabetic nephropathy.Nature Communications,7,12864-12879.
Li,H.,Guo,F.,Luo,Y.C.,Zhu,J.P.,&Wang,J.L.(2015).Efficacy of tripterygium glycosides tablet in treating ankylosing spondylitis:a systematic review and meta-analysis of randomized controlled trials.Clinical Rheumatology,34(11),1831-1838.
Li,J.(2011).Clinical observation of tripterygium glycosides combined with valsartan in the treatment of diabetic nephropathy.Chinese Community Physician,13(23),43.
Liu,Q.D.(2015).Effect of valsartan combined with tripterygium glycosides on reducing proteinuria.Journal of Practical Diabetes,11(5),56-57.
Mogensen,C.E.,Christensen,C.K.,&Vittinghus,E.(1983).The stages in diabetic renal disease.With emphasis on the stage of incipient diabetic nephropathy.Diabetes,32(Suppl 2),64-78.
Moher,D.,Liberati,A.,Tetzlaff,J.,&Altman,D.G.(2009).Preferred reporting items for systematic reviews and meta-analyses:The PRISMA statement.BMJ,339,B2535-B2542.
Pu,Y.,Zou,Q.W.,&Pu,M.(2013).Effect of valsartan dispersible tablets and tripterygium glycosides in treating 78 cases of diabetic nephropathy with proteinuria.Jilin Medical,34(28),5789-5791.
Raphaela,Goldbach-Mansky,Mildred,Wilson,Roy,Fleischmann,Nancy,Olsen,Joel,Silverfield,Phillip,Kempf,Alan,Kivitz,Yvonne,Sherrer,Frank,Pucino,Gyorgy,Csako,Rene,Costello,Tuyet,Hang Pham,Christopher,Snyder,van der Heijde,Désirée,Xuelian,Tao,Robert,Wesley,&Peter E.,Lipsky(2009).Comparison of Tripterygium wilfordii Hook F Versus Sulfasalazine in the Treatment of Rheumatoid Arthritis:A Randomized Trial.Annals of Internal Medicine,151(4),229-W51.
Remuzzi,G.,Ruggenenti,P.,&Benigni,A.(1997).Understanding the nature of renal disease progression.Kidney International,51(1),2-15.
Song,M.A.(2014).Effect of valsartan dispersible tablets and tripterygium glycosides on proteinuria in diabetic nephropathy.China Medical Engineering,22(10),154-156.
Viberti,G.,&Wheeldon,N.M.(2002).Microalbuminuria reduction with valsartan in patients with type 2 diabetes mellitus:A blood pressure-independent effect.Circulation,106(6),672-678.
Wang,M.(2016).Clinical effect of tripterygium glycosides tablets combined with valsartan on diabetic nephropathy.Diabetes New World,9,31-32.
Wang,M.L.,&Zhang,C.(2012).Clinical observation of valsartan combined with tripterygium glycosides in the treatment of proteinuria in type 2 diabetic nephropathy.Chin J of Clinical Rational Drug Use,5(8),84-85.
Wu,S.B.,Cao,Z.D.,Zhang,W.,&Q.,Q.(2012).Clinical observation of tripterygium glycosides combined with valsartan in treating large amount of protein diabetic diabetic nephropathy.Modern Journal of Integrated Traditional Chinese and Western Medicine,21(4),394-395.
Wu,W.,Yang,J.J.,Yang,H.M.,Huang,M.M.,Fang,Q.J.,Shi,G.,Mao,Z.M.,Han,W.B.,Shen,S.M.,&Wan,Y.G.(2017).Multi-glycoside of Tripterygium wilfordii Hook.f.attenuates glomerulosclerosis in a rat model of diabetic nephropathy by exerting anti-microinflammatory effects without affecting hyperglycemia.International Journal of Molecular Medicine,40(3),721-730.
Xu,C.,Qi,A.R.,Fu,B.,&Zhou,L.(2016).Clinical observation on treating diabetic nephropathy during IV period with the tripterygium glycosides tablets.Clinical Journal of Traditional Chinese Medicine,8(17),95-96.
Xu,Z.,Diao,Z.,Liu,R.,&Liu,W.(2017).Molecular mechanism of smurf2 in regulating the expression of SnoN in diabetic nephropathy.Molecular Medicine Reports,15(5),2560-2566.
Zhang,M.,Wang,S.A.,&Liu,L.X.(2014).Immunosuppression of tripterygium glycosides via TLR-NF-κB signaling pathway.Chinese Traditional and Herbal Drugs,45(9),1288-1292.
Zhao,R.Y.,Tang,B.S.,Shi,X.L.,Lu,S.K.,Ye,Q.K.,&Lin,Y.Q.(2011).Clinical observation on 46 cases of diabetic nephropathy treated by tripterygium glycosides combined with valsartan.Chinese Journal of Integrated Traditional and Western Medicine on Nephrology,12(9),811-813.
Zhou,C.L.(2013).Clinical effect of tripterygium glycosides combined with valsartan on diabetic nephropathy.For All Health,7(3),94-95.