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中华肝脏外科手术学电子杂志 ›› 2015, Vol. 04 ›› Issue (03): 176 -180. doi: 10.3877/cma.j.issn.2095-3232.2015.03.011

所属专题: 文献

临床研究

他克莫司缓释胶囊在肝移植术后患者中的应用价值
许世磊1, 张英才1, 王庆亮2, 杨卿1, 汪国营1, 刘波2, 陈文捷3, 杨扬1,(), 陈规划1   
  1. 1. 510630 广州,中山大学附属第三医院肝移植中心
    2. 510530 广州,中山大学附属第三医院岭南医院普通外科
    3. 广东省肝脏疾病研究重点实验室
  • 收稿日期:2015-03-12 出版日期:2015-06-10
  • 通信作者: 杨扬
  • 基金资助:
    国家自然科学基金(81170451,81301331); 广东省科技计划项目(2011B031800103); 广东省自然科学基金重点项目(9251008901000025); 广州市科技计划重点项目(2011Y1-00033)

Application value of Tacrolimus sustained-release capsules in patients after liver transplantation

Shilei Xu1, Yingcai Zhang1, Qingliang Wang2, Qing Yang1, Guoying Wang1, Bo Liu2, Wenjie Chen3, Yang Yang1,(), Guihua Chen1   

  1. 1. Liver Transplantation Center, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
    2. Department of General Surgery, Lingnan Hospital, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510530, China
    3. Guangdong Provincial Key Laboratory of Liver Disease, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
  • Received:2015-03-12 Published:2015-06-10
  • Corresponding author: Yang Yang
  • About author:
    Corresponding author: Yang Yang, Email:
目的

探讨他克莫司缓释胶囊在肝移植术后患者中的应用价值。

方法

回顾性研究2011年1月至2013年12月在中山大学附属第三医院接受诊治的48例肝移植术后患者临床资料。所有患者均签署知情同意书,符合医学伦理学规定。其中男43例,女5例;平均年龄(45±12)岁。根据术后有否应用他克莫司缓释胶囊将患者分为缓释组(18例)和对照组(30例)。两组患者术后早期均采用他克莫司+甲泼尼龙二联免疫抑制方案。缓释组术后20 d开始改用等剂量他克莫司缓释胶囊。比较两组患者他克莫司血药浓度谷值的变化及排斥反应和不良反应的发生率。两组他克莫司血药浓度谷值比较采用t检验;排斥反应及不良反应发生率比较采用χ2检验或Fisher确切概率法。

结果

缓释组患者血药浓度谷值逐渐下降并于30 d趋于稳定,对照组血药浓度谷值波动较大。缓释组60 d时血药浓度谷值为(7±2) μg/L,明显低于对照组的(10±1) μg/L(t=-15.61,P<0.05)。缓释组排斥反应的发生率为0(0/18),明显低于对照组的7%(2/30) (P<0.05)。缓释组肺炎、消化道症状、高血糖、睡眠障碍的发生率分别为33%(6/18)、28%(5/18)、6%(1/18)、6%(1/18),明显低于对照组的77%(23/30)、37%(11/30)、17%(5/30)、23%(7/30) (χ2=18.90,31.53,12.41,45.19;P<0.05)。

结论

肝移植术后患者应用他克莫司缓释胶囊可以维持稳定的他克莫司血药浓度谷值,具有良好的抗排斥疗效,并可降低不良反应发生率。

Objective

To investigate the application value of Tacrolimus sustained-release capsules in patients after liver transplantation (LT).

Methods

Clinical data of 48 patients after LT treated in the Third Affiliated Hospital of Sun Yat-sen University between January 2011 and December 2013 were retrospectively studied. The informed consents of all patients were obtained and the local ethical committee approval had been received. Among the 48 patients, 43 were males and 5 were females with an average age of (45±12) years old. According to whether Tacrolimus sustained-release capsules were given after LT, the patients were divided into sustained-release group (18 patients) and control group (30 patients). The patients in both groups received combined immunosuppressive therapy of Tacrolimus + Methylprednisolone in the early stage after operation. Patients in sustained-release group were given Tacrolimus sustained-release capsules of equivalent dose 20 d after LT. The changes of plasma valley concentration of Tacrolimus and the incidence of rejection and adverse reactions of the two groups were compared. The comparison of plasma valley concentration of Tacrolimus was conducted using t test, and the comparison of incidence of rejection and adverse reactions was conducted using Chi-square test or Fisher's exact test.

Results

The plasma valley concentration of sustained-release group decreased gradually and stabilized after 30 d, while that of control group fluctuated widely. On 60 d, the plasma valley concentration of sustained-release group was (7±2) μg/L, which was significantly lower than (10±1) μg/L of control group (t=-15.61, P<0.05). The incidence of rejection of sustained-release group was 0 (0/18), which was significantly lower than 7% (2/30) of control group (P<0.05). The incidence of pneumonia, gastrointestinal symptoms, hyperglycemia and sleep disorders of sustained-release group was respectively 33% (6/18), 28% (5/18), 6% (1/18) and 6% (1/18) , which was significantly lower than 77% (23/30), 37% (11/30), 17% (5/30) and 23% (7/30) of control group (χ2=18.90, 31.53, 12.41, 45.19; P<0.05).

Conclusions

The application of Tacrolimus sustained-release capsules in patients after LT can maintain stable plasma valley concentration of Tacrolimus, have good anti-rejection effect and reduce the incidence of adverse reactions.

表1 缓释组和对照组肝移植术后患者一般资料比较
表2 缓释组和对照组肝移植术后患者血ALT比较(U/L,±s
表3 缓释组和对照组肝移植术后患者血AST比较(U/L,±s
表4 缓释组和对照组肝移植术后患者Scr比较(μmol/L,±s
表5 缓释组和对照组肝移植术后患者他克莫司血药浓度谷值的比较(μg/L,±s
表6 缓释组和对照组肝移植术后患者排斥反应及不良反应的比较(例)
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