麦考酚钠肠溶片与吗替麦考酚酯胶囊_省略_制剂对肾移植患者酶酚酸暴露的影响_许亮

中国组织工程研究与临床康复第15卷第53期 2011–12–31出版

Journal of Clinical Rehabilitative Tissue Engineering Research December 31, 2011 Vol.15, No.53 ISSN 1673-8225 CN 21-1539/R CODEN: ZLKHAH

9901 First Department of Urology, PLA Transplantation Center, the 309 Hospital of Chinese PLA, Beijing 100091, China

Xu Liang★, Master, Atteding physician, First Department of Urology, PLA Transplantation Center, the 309 Hospital of Chinese PLA, Beijing 100091, China

xul351@ Correspondence to: Cai Ming, Doctor, Chief physician, First Department of Urology, PLA Transplantation Center, the 309 Hospital of Chinese PLA, Beijing 100091, China caiming@ Received: 2011-10-20 Accepted: 2011-11-14

解放军第309医院全军器官移植中心泌尿一科，北京市 100091

许亮★，男，1983年生，安徽省舒城县人，硕士，主治医师，主要从事器官移植、泌尿外科临床与基础研究。xul351@

通讯作者：蔡明，医学博士，主任医师，解放军第309医院全军器官移植中心泌尿一科，北京市 100091 caiming@

中图分类号:R318

文献标识码:B

文章编号:1673-8225 (2011)53-09901-04

收稿日期：2011-10-20修回日期：2011-11-14 (20111020006/YJ·C)

麦考酚钠肠溶片与吗替麦考酚酯胶囊联合质子泵抑制剂对肾移植患者

酶酚酸暴露的影响★

许亮，蔡明，金海龙，王强，许晓光，石炳毅

Effect of Myfortic and CellCept combined with proton pump inhibitor on mycophenolic acid in kidney transplantation patients

Xu Liang, Cai Ming, Jin Hai-long, Wang Qiang, Xu Xiao-guang, Shi Bing-yi

Abstract

BACKGROUND: The absorption and metabolism places in vivo of Myfortic are different with classic immunosuppressant

CellCept, this is due to the combination with related drugs and results in the different clinical effects.

OBJECTIVE: To explore the effect of Myfortic and CellCept combined with proton pump inhibitor (PPI) on mycophenolic acid in

kidney transplantation patients.

METHODS: Seventeen patients with Myfortic and 16 patients with CellCept who were treated in the 309 Hospital of Chinese PLA

as study group during May 2010 to May 2011. Myfortic/CellCept+ciclosporin/Tacrolimus+steroid hormone was regarded as the immunosuppressive regimen, 540 mg Myfortic and 750 mg CellCept was injected once every 12 hours.

RESULTS AND CONCLUSION: The kidney function of the patients was recovered to normal in Myfortic and CellCept groups.

The average peak time, peak concentration, half life period and the area under the curve of the mycophenolic acid in Myfortic

group were higher than those in the CellCept group (P < 0.05). It indicates that the therapeutic efficacy of Myfortic combined with

PPI on mycophenolic acid in kidney transplantation patients is better than that of CellCept.

Xu L, Cai M, Jin HL, Wang Q, Xu XQ, Shi BY.Effect of Myfortic and CellCept combined with proton pump inhibitor on

mycophenolic acid in kidney transplantation patients. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu. 2011;15(53):

9901-9904. [ ]

摘要

背景：麦考酚钠肠溶片与经典的免疫抑制剂吗替麦考酚酯胶囊在体内吸收代谢场所有所不同，与相关药物的联合应用造成

了二者在代谢水平的差异，从而可能导致临床疗效的差异。

目的：探讨麦考酚钠肠溶片与吗替麦考酚酯胶囊联合质子泵抑制剂的临床应用对肾移植患者酶酚酸暴露的影响。

方法：选取2010-05/2011-05于解放军第309医院全军器官移植中心应用麦考酚钠肠溶片患者17例和应用吗替麦考酚酯

胶囊患者16例为研究对象，采用麦考酚钠肠溶片/吗替麦考酚酯胶囊+环孢素/他克莫司+类固醇激素的免疫抑制方案，麦考

酚钠肠溶片540 mg 12 h给药1次，吗替麦考酚酯胶囊750 mg 12 h给药1次。

结果与结论：麦考酚钠肠溶片组和吗替麦考酚酯胶囊组患者肾移植后肾功能均恢复正常。麦考酚钠肠溶片组酶酚酸平均达

峰时间、平均达峰浓度、平均半衰期和均平均药-时曲线下面积高于吗替麦考酚酯胶囊组(P < 0.05)，说明麦考酚钠肠溶片

临床联合应用质子泵抑制剂对肾移植患者酶酚酸暴露的治疗效果优于吗替麦考酚酯胶囊。

关键词：麦考酚钠；肾移植；质子泵抑制剂；吗替麦考酚酯；酶酚酸

doi:10.3969/j.issn.1673-8225.2011.53.006

许亮，蔡明，金海龙，王强，许晓光，石炳毅.麦考酚钠肠溶片与吗替麦考酚酯胶囊联合质子泵抑制剂对肾移植患者酶酚

酸暴露的影响[J].中国组织工程研究与临床康复，2011，15(53):9901-9904.

[ ]

0 引言

随着移植免疫学的不断发展，以吗替麦考酚酯胶囊联合类固醇和钙神经蛋白抑制剂类药物的经典三联免疫抑制方案已经深得移植学者们的认可[1]，麦考酚钠肠溶片作为与吗替麦考酚酯胶囊同根同源的新型免疫抑制剂在国内的出现也引起了移植学者们的广泛兴趣。肾移植后由于手术应激、大剂量激素的应用，约10%以上患者出现较为严重的消化道并发症，且51%以上发生在移植后第1年[2-3]。临床上针对胃黏膜损伤的危险因素，约有90%的患者在围手术期使用质子泵抑制剂(proton pump inhibitor, PPI)，如泮托拉唑、奥美拉唑等药物抑制胃酸分泌，保护胃黏膜[4-7]。吗替麦考酚酯胶囊在胃内的代谢过程高度依赖胃内酸性环境[8]，而麦考酚钠肠溶片是在肠道碱性环境下释放吸收。因此在联合PPI的应用过程中，吗替麦考酚酯胶囊是否会因为胃壁细胞泌酸功能的抑制，造成代谢、吸收障碍，从而造成药物暴露量的不足，增加移植物排斥的风险。本文拟观察吗替麦考酚酯胶囊联合PPI的的临床应用对肾移植患者酶酚酸暴露的影响。

1 对象和方法

设计：前瞻性随机对照研究。