CYP3A5基因型與腎移植患者他克莫司血藥濃度關系的系統評價_《中國循證醫學雜志》

作者：

付生軍 ^1,2,3,4 , 劉靜 ⁵ , 李濤 ^1,2,3,4 , 王志平 ^1,2,3,4 ,  楊立 ^1,2,3,4

1. 蘭州大學泌尿外科研究所（蘭州 730030）；2. 蘭州大學第二醫院泌尿外科（蘭州 730030）；3 甘肅省泌尿系統疾病臨床醫學中心（蘭州 730030）；4. 甘肅省泌尿系統疾病研究重點實驗室（蘭州 730030）；5. 蘭州大學第二醫院肝病科(蘭州 730030）;

關鍵詞：

他克莫司 CYP3A5 Meta分析系統評價

DOI：

10.7507/1672-2531.20130247

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目的　系統評價CYP3A5基因型與腎移植術后他克莫司（FK506）血藥濃度的關系。
方法　計算機檢索PubMed（1966.1～2013.7）、Sciverse（1823.1～2013.7）、The Cochrane Library（2013年第7期）、CNKI（1994.1～2013.7）、VIP（1989.1-2013.7）、CBM（1978.1～2013.7）及WanFang Data（1995.1～2013.7），查找關于CYP3A5基因型與腎移植術后他克莫司（FK506）血藥濃度/劑量關系的文獻。根據納入與排除標準篩選文獻、提取資料和評價質量后，采用RevMan 5.2軟件進行Meta分析。
結果　共納入12篇文獻，包含956例對象。Meta分析結果顯示：在腎移植術后7天［MD=54.61，95%CI（–67.67，–41.54），P lt;0.000 01］、1個月［MD= –74.84，95%CI（–83.39，–66.29），P lt;0.000 01］、3個月［MD= –96.09，95%CI（–107.55，–84.64），P lt;0.000 01］、6個月［MD= –107.30，95%CI（–125.65，–88.95），P lt;0.000 01］和1年［MD= –78.32，95%CI（–123.02，–33.61），P=0.000 6］，攜帶CYP3A5 3/3基因型患者的FK506 血藥濃度/劑量值明顯較攜帶其他基因型患者高；而攜帶1/1患者的FK506 血藥濃度/劑量值較低。
結論　腎移植術后FK506血藥濃度/劑量值與CYP3A5基因型相關。因此在腎移植術后應用FK506作為免疫抑制治療時，有必要對患者進行CYP3A5基因型檢測，以指導臨床治療。

引用本文： 付生軍,劉靜,李濤,王志平,楊立. CYP3A5基因型與腎移植患者他克莫司血藥濃度關系的系統評價. 中國循證醫學雜志, 2013, 13(12): 1440-1445. doi: 10.7507/1672-2531.20130247 復制

1. 侯明明, 高菲, 宋洪濤. 腎移植術后2組免疫抑制劑用藥方案的成本一效果分析. 中國藥房, 2009, 20(5): 331.

2. 陳偉, 胡志德, 吳麗娟, 等. mdr1基因C3435T多態性與口服FK506后血藥濃度關系的實驗研究. 第三軍醫大學學報, 2006, 28(19): 1971-1972.

3. Ninova D, Covarrubias M, Rea DJ, et al. Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-beta1 and alpha-smooth muscle actin. Transplantation, 2004, 78(3): 338-434.

4. 張海燕, 張小明, 吳小麗, 等. CYP3A5基因多態性對中國腎移植受者他克莫司血藥濃度和療效的影響. 器官移植, 2011, 2(6): 328-331.

5. Miao LY, Huang CR, Hou JQ, et al. Association study of ABCB1 and CYP3A5 gene polymorphisms with sirolimus trough concentration and dose requirements in Chinese renal transplant recipients. Biopharm Drug Dispos, 2008, 29(1): 1-5.

6. Chen JS, Li LS, Cheng DR, et al. Effect of CYP3A5 genotype on renal allograft recipients treated with tacrolimus. Transplant Proc, 2009, 41(5): 1557-1561.

7. Kim IW, Noh H, Ji E, et al. Identification of factors affecting tacrolimus level and 5-year clinical outcome in kidney transplant patients. Basic Clin Pharmacol Toxicol, 2012, 111(4): 217-223.

8. Singh R, Srivastava A, Kapoor R, et al. Impact of CYP3A5 and CYP3A4genepolymorphisms on doserequirement of calcineurininhibitors, cyclosporine and tacrolimus, in renalallograftrecipients of NorthIndia. Naunyn Schmiedebergs Arch Pharmacol, 2009, 380(2): 169-177.

9. Cho JH, Yoon YD, Park JY, et al. Impact of cytochrome P450 3A and ATP-binding cassette subfamily B member 1 polymorphisms on tacrolimus dose-adjusted trough concentrations among Korean renal transplant recipients. Transplant Proc, 2012, 44(1): 109-114.

10. Gervasini G, Garcia M, Macias RM, et al. Impact of genetic polymorphisms on tacrolimus pharmacokinetics and the clinical outcome of renal transplantation. Transpl Int, 2012, 25(4): 471-480.

11. Provenzani A, Notarbartolo M, Labbozzetta M, et al. Influence of CYP3A5 and ABCB1 gene polymorphisms and other factors on tacrolimus dosing in Caucasian liver and kidney transplant patients. Int J Mol Med, 2011, 28(6): 1093-1102.

12. Zhang X, Liu ZH, Zheng JM, et al. Influence of CYP3A5 and MDR1 polymorphisms on tacrolimus concentration in the early stage after renal transplantation. Clin Transplant, 2005, 19(5): 638-643.

13. Li L, Li CJ, Zheng L, et al. Tacrolimusdosing in Chineserenal transplantrecipients: a population-basedpharmacogeneticsstudy. Eur J Clin Pharmacol, 2011, 67(8): 787-795.

14. Ferraris JR, Argibay PF, Costa L, et al. Influence of CYP3A5 polymorphism on tacrolimus maintenance doses and serum levels after renal transplantation: age dependency and pharmacological interaction with steroids. Pediatr Transplant, 2011, 15(5): 525-532.

15. 孫華賓, 劉燕, 王道虎. 腎移植受者CYP3A5基因多態性對他可莫司代謝的影響. 國際醫藥衛生導報, 2009, 15(3): 5-7.

16. Zhang G, Zhang Y, Su Z. CYPSI: a structure-basedinterface for cytochromeP450s and ligands in Arabidopsisthaliana. BMC Bioinformatics, 2012, 13: 332.

17. 王若倫, 葉曉光, 葉麗卡, 等. 細胞色素P450 3A5基因多態性的研究進展. 中國藥房, 2008, 19(4): 304-306.

18. Kuehl P, Zhang J, Lin Y, et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of po1ymorphic CYP3A5 expression. Nat Genet, 2001, 27(4): 383-391.

19. 孫陽洋, 何軍, 邱橋成, 等. 細胞色素P4503A亞家族多肽5基因多態性對腎移植患者術后他克莫司血藥濃度的影響. 中華實驗外科雜志, 2013, 4(4): 848-851.

20. Thervet E, Anglicheau D, King B, et al. Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients. Transplantation, 2003, 76(8): 1233-1235.

21. Wu P, Ni X, Wang M, et al. Polymorphisms in CYP3A5*3 and MDR1, and haplotype modulate response to plasma levels of tacrolimus in Chinese renal transplant patients. Ann Transplant, 2011, 16(1): 54-60.

22. Hirano K, Naito T, Mino Y, et al. Impact of CYP3A5 genetic polymorphism on cross-reactivity in tacrolimus chemiluminescent immunoassay in kidney transplant recipients. Clin Chim Acta, 2012, 414: 120-124.

23. Pashaee N, Bouamar R, Hesselink DA, et al. CYP3A5 genotype is not related to the intrapatient variability of tacrolimus clearance. Ther Drug Monit, 2011, 33(3): 369-371.

24. Kamdem LK, Streit F, Zanger UM, et al. Contribution of CYP3A5 to the in vitro hepatic clearance of tacrolimus. Clin Chem, 2005, 51(8): 1374-1381.

25. Quteineh L, Verstuyft C, Furlan V, et al. Influence of CYP3A5 genetic polymorphism on tacrolimus daily dose requirements and acute rejection in renal graft recipients. Basic Clin Pharmacol Toxicol, 2008, 103(6): 546-552.

1. 侯明明, 高菲, 宋洪濤. 腎移植術后2組免疫抑制劑用藥方案的成本一效果分析. 中國藥房, 2009, 20(5): 331.

2. 陳偉, 胡志德, 吳麗娟, 等. mdr1基因C3435T多態性與口服FK506后血藥濃度關系的實驗研究. 第三軍醫大學學報, 2006, 28(19): 1971-1972.

3. Ninova D, Covarrubias M, Rea DJ, et al. Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-beta1 and alpha-smooth muscle actin. Transplantation, 2004, 78(3): 338-434.

4. 張海燕, 張小明, 吳小麗, 等. CYP3A5基因多態性對中國腎移植受者他克莫司血藥濃度和療效的影響. 器官移植, 2011, 2(6): 328-331.

5. Miao LY, Huang CR, Hou JQ, et al. Association study of ABCB1 and CYP3A5 gene polymorphisms with sirolimus trough concentration and dose requirements in Chinese renal transplant recipients. Biopharm Drug Dispos, 2008, 29(1): 1-5.

6. Chen JS, Li LS, Cheng DR, et al. Effect of CYP3A5 genotype on renal allograft recipients treated with tacrolimus. Transplant Proc, 2009, 41(5): 1557-1561.

7. Kim IW, Noh H, Ji E, et al. Identification of factors affecting tacrolimus level and 5-year clinical outcome in kidney transplant patients. Basic Clin Pharmacol Toxicol, 2012, 111(4): 217-223.

8. Singh R, Srivastava A, Kapoor R, et al. Impact of CYP3A5 and CYP3A4genepolymorphisms on doserequirement of calcineurininhibitors, cyclosporine and tacrolimus, in renalallograftrecipients of NorthIndia. Naunyn Schmiedebergs Arch Pharmacol, 2009, 380(2): 169-177.

9. Cho JH, Yoon YD, Park JY, et al. Impact of cytochrome P450 3A and ATP-binding cassette subfamily B member 1 polymorphisms on tacrolimus dose-adjusted trough concentrations among Korean renal transplant recipients. Transplant Proc, 2012, 44(1): 109-114.

10. Gervasini G, Garcia M, Macias RM, et al. Impact of genetic polymorphisms on tacrolimus pharmacokinetics and the clinical outcome of renal transplantation. Transpl Int, 2012, 25(4): 471-480.

11. Provenzani A, Notarbartolo M, Labbozzetta M, et al. Influence of CYP3A5 and ABCB1 gene polymorphisms and other factors on tacrolimus dosing in Caucasian liver and kidney transplant patients. Int J Mol Med, 2011, 28(6): 1093-1102.

12. Zhang X, Liu ZH, Zheng JM, et al. Influence of CYP3A5 and MDR1 polymorphisms on tacrolimus concentration in the early stage after renal transplantation. Clin Transplant, 2005, 19(5): 638-643.

13. Li L, Li CJ, Zheng L, et al. Tacrolimusdosing in Chineserenal transplantrecipients: a population-basedpharmacogeneticsstudy. Eur J Clin Pharmacol, 2011, 67(8): 787-795.

14. Ferraris JR, Argibay PF, Costa L, et al. Influence of CYP3A5 polymorphism on tacrolimus maintenance doses and serum levels after renal transplantation: age dependency and pharmacological interaction with steroids. Pediatr Transplant, 2011, 15(5): 525-532.

15. 孫華賓, 劉燕, 王道虎. 腎移植受者CYP3A5基因多態性對他可莫司代謝的影響. 國際醫藥衛生導報, 2009, 15(3): 5-7.

16. Zhang G, Zhang Y, Su Z. CYPSI: a structure-basedinterface for cytochromeP450s and ligands in Arabidopsisthaliana. BMC Bioinformatics, 2012, 13: 332.

17. 王若倫, 葉曉光, 葉麗卡, 等. 細胞色素P450 3A5基因多態性的研究進展. 中國藥房, 2008, 19(4): 304-306.

18. Kuehl P, Zhang J, Lin Y, et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of po1ymorphic CYP3A5 expression. Nat Genet, 2001, 27(4): 383-391.

19. 孫陽洋, 何軍, 邱橋成, 等. 細胞色素P4503A亞家族多肽5基因多態性對腎移植患者術后他克莫司血藥濃度的影響. 中華實驗外科雜志, 2013, 4(4): 848-851.

20. Thervet E, Anglicheau D, King B, et al. Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients. Transplantation, 2003, 76(8): 1233-1235.

21. Wu P, Ni X, Wang M, et al. Polymorphisms in CYP3A5*3 and MDR1, and haplotype modulate response to plasma levels of tacrolimus in Chinese renal transplant patients. Ann Transplant, 2011, 16(1): 54-60.

22. Hirano K, Naito T, Mino Y, et al. Impact of CYP3A5 genetic polymorphism on cross-reactivity in tacrolimus chemiluminescent immunoassay in kidney transplant recipients. Clin Chim Acta, 2012, 414: 120-124.

23. Pashaee N, Bouamar R, Hesselink DA, et al. CYP3A5 genotype is not related to the intrapatient variability of tacrolimus clearance. Ther Drug Monit, 2011, 33(3): 369-371.

24. Kamdem LK, Streit F, Zanger UM, et al. Contribution of CYP3A5 to the in vitro hepatic clearance of tacrolimus. Clin Chem, 2005, 51(8): 1374-1381.

25. Quteineh L, Verstuyft C, Furlan V, et al. Influence of CYP3A5 genetic polymorphism on tacrolimus daily dose requirements and acute rejection in renal graft recipients. Basic Clin Pharmacol Toxicol, 2008, 103(6): 546-552.

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亞洲健康人群CYP2C19等位基因發生率的合并分析

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痰熱清注射液治療手足口病療效評價的Meta分析

1資料與方法

1.1一般資料

1.2方法

1.3察指標和判定標準

1.4統計學方法

2結果

2.1兩組患者療效比較

2.2兩組患者換藥次數、導管留置時間、治愈時間比較

2.3兩組患者治療前后血清PCT、CRP、WBC水平比較

3討論

《中國循證醫學雜志》

CYP3A5基因型與腎移植患者他克莫司血藥濃度關系的系統評價

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1.	侯明明, 高菲, 宋洪濤. 腎移植術后2組免疫抑制劑用藥方案的成本一效果分析. 中國藥房, 2009, 20(5): 331.
2.	陳偉, 胡志德, 吳麗娟, 等. mdr1基因C3435T多態性與口服FK506后血藥濃度關系的實驗研究. 第三軍醫大學學報, 2006, 28(19): 1971-1972.
3.	Ninova D, Covarrubias M, Rea DJ, et al. Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-beta1 and alpha-smooth muscle actin. Transplantation, 2004, 78(3): 338-434.
4.	張海燕, 張小明, 吳小麗, 等. CYP3A5基因多態性對中國腎移植受者他克莫司血藥濃度和療效的影響. 器官移植, 2011, 2(6): 328-331.
5.	Miao LY, Huang CR, Hou JQ, et al. Association study of ABCB1 and CYP3A5 gene polymorphisms with sirolimus trough concentration and dose requirements in Chinese renal transplant recipients. Biopharm Drug Dispos, 2008, 29(1): 1-5.
6.	Chen JS, Li LS, Cheng DR, et al. Effect of CYP3A5 genotype on renal allograft recipients treated with tacrolimus. Transplant Proc, 2009, 41(5): 1557-1561.
7.	Kim IW, Noh H, Ji E, et al. Identification of factors affecting tacrolimus level and 5-year clinical outcome in kidney transplant patients. Basic Clin Pharmacol Toxicol, 2012, 111(4): 217-223.
8.	Singh R, Srivastava A, Kapoor R, et al. Impact of CYP3A5 and CYP3A4genepolymorphisms on doserequirement of calcineurininhibitors, cyclosporine and tacrolimus, in renalallograftrecipients of NorthIndia. Naunyn Schmiedebergs Arch Pharmacol, 2009, 380(2): 169-177.
9.	Cho JH, Yoon YD, Park JY, et al. Impact of cytochrome P450 3A and ATP-binding cassette subfamily B member 1 polymorphisms on tacrolimus dose-adjusted trough concentrations among Korean renal transplant recipients. Transplant Proc, 2012, 44(1): 109-114.
10.	Gervasini G, Garcia M, Macias RM, et al. Impact of genetic polymorphisms on tacrolimus pharmacokinetics and the clinical outcome of renal transplantation. Transpl Int, 2012, 25(4): 471-480.
11.	Provenzani A, Notarbartolo M, Labbozzetta M, et al. Influence of CYP3A5 and ABCB1 gene polymorphisms and other factors on tacrolimus dosing in Caucasian liver and kidney transplant patients. Int J Mol Med, 2011, 28(6): 1093-1102.
12.	Zhang X, Liu ZH, Zheng JM, et al. Influence of CYP3A5 and MDR1 polymorphisms on tacrolimus concentration in the early stage after renal transplantation. Clin Transplant, 2005, 19(5): 638-643.
13.	Li L, Li CJ, Zheng L, et al. Tacrolimusdosing in Chineserenal transplantrecipients: a population-basedpharmacogeneticsstudy. Eur J Clin Pharmacol, 2011, 67(8): 787-795.
14.	Ferraris JR, Argibay PF, Costa L, et al. Influence of CYP3A5 polymorphism on tacrolimus maintenance doses and serum levels after renal transplantation: age dependency and pharmacological interaction with steroids. Pediatr Transplant, 2011, 15(5): 525-532.
15.	孫華賓, 劉燕, 王道虎. 腎移植受者CYP3A5基因多態性對他可莫司代謝的影響. 國際醫藥衛生導報, 2009, 15(3): 5-7.
16.	Zhang G, Zhang Y, Su Z. CYPSI: a structure-basedinterface for cytochromeP450s and ligands in Arabidopsisthaliana. BMC Bioinformatics, 2012, 13: 332.
17.	王若倫, 葉曉光, 葉麗卡, 等. 細胞色素P450 3A5基因多態性的研究進展. 中國藥房, 2008, 19(4): 304-306.
18.	Kuehl P, Zhang J, Lin Y, et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of po1ymorphic CYP3A5 expression. Nat Genet, 2001, 27(4): 383-391.
19.	孫陽洋, 何軍, 邱橋成, 等. 細胞色素P4503A亞家族多肽5基因多態性對腎移植患者術后他克莫司血藥濃度的影響. 中華實驗外科雜志, 2013, 4(4): 848-851.
20.	Thervet E, Anglicheau D, King B, et al. Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients. Transplantation, 2003, 76(8): 1233-1235.
21.	Wu P, Ni X, Wang M, et al. Polymorphisms in CYP3A5*3 and MDR1, and haplotype modulate response to plasma levels of tacrolimus in Chinese renal transplant patients. Ann Transplant, 2011, 16(1): 54-60.
22.	Hirano K, Naito T, Mino Y, et al. Impact of CYP3A5 genetic polymorphism on cross-reactivity in tacrolimus chemiluminescent immunoassay in kidney transplant recipients. Clin Chim Acta, 2012, 414: 120-124.
23.	Pashaee N, Bouamar R, Hesselink DA, et al. CYP3A5 genotype is not related to the intrapatient variability of tacrolimus clearance. Ther Drug Monit, 2011, 33(3): 369-371.
24.	Kamdem LK, Streit F, Zanger UM, et al. Contribution of CYP3A5 to the in vitro hepatic clearance of tacrolimus. Clin Chem, 2005, 51(8): 1374-1381.
25.	Quteineh L, Verstuyft C, Furlan V, et al. Influence of CYP3A5 genetic polymorphism on tacrolimus daily dose requirements and acute rejection in renal graft recipients. Basic Clin Pharmacol Toxicol, 2008, 103(6): 546-552.

《中國循證醫學雜志》

CYP3A5基因型與腎移植患者他克莫司血藥濃度關系的系統評價

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