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基于FEARS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究

董博清, 王婧雯, 毕焕京, 等. 基于FEARS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究[J]. 器官移植. doi: 10.3969/j.issn.1674-7445.2024031
引用本文: 董博清, 王婧雯, 毕焕京, 等. 基于FEARS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究[J]. 器官移植. doi: 10.3969/j.issn.1674-7445.2024031
Dong Boqing, Wang Jingwen, Bi Huanjing, et al. Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FEARS database[J]. ORGAN TRANSPLANTATION. doi: 10.3969/j.issn.1674-7445.2024031
Citation: Dong Boqing, Wang Jingwen, Bi Huanjing, et al. Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FEARS database[J]. ORGAN TRANSPLANTATION. doi: 10.3969/j.issn.1674-7445.2024031

基于FEARS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究

doi: 10.3969/j.issn.1674-7445.2024031
基金项目: 国家自然科学基金(82370802);创新药物上市后临床研究科研专项(WKZX2023CX190002);西安交通大学医学“基础一临床”融合创新项目(YXJLRH2022049)
详细信息
    作者简介:
    通讯作者:

    丁小明(ORCID 0000-0002-9082-9191),博士,主任医师,研究方向为肾移植,Email: xmding@xjtu.edu.cn

  • 中图分类号: R617, R392.4

Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FEARS database

More Information
  • 摘要:   目的   探讨他克莫司(Tac)在儿童实体器官移植受者中的不良药物事件(ADE)特征。  方法  研究数据来源于美国食品与药品监督管理局不良事件报告系统数据库,时间覆盖2004年第1季度至2023年第2季度,提取了以Tac为首要怀疑药物的儿童器官移植受者的ADE数据,运用比例失衡法对Tac与ADE之间的关联进行定量分析。分析Tac相关ADE的基本特征及信号强度。探究不同年龄儿童及不同移植器官类型的Tac相关的ADE。  结果  共筛选出1 443份涉及Tac的儿童ADE报告,其中心脏移植188例(13.0%)、肝移植668例(46.3%)、肾移植531例(36.8%)、肺移植56例(3.9%),儿童的中位年龄为10岁,ADE上报国家的前3位分别是美国、法国及英国,中国上报为26例,占比为1.8%。感染及侵染类疾病在Tac相关ADE报告中占比最高(21.0%),包括EB病毒及巨细胞病毒感染等。不同年龄段儿童的Tac相关ADE中感染及侵染类疾病均占据最大比例,但病原体种类存在差异。排斥反应、免疫抑制水平不稳定以及肾功能损伤也是各年龄段儿童常见的Tac相关ADE。心脏移植受者中以神经系统疾病的ADE为主,而肝移植和肾移植受者中感染及侵染类疾病更为常见,肺移植受者中的ADE以排斥反应最为常见。  结论  Tac相关ADE在不同器官移植类型中呈现出不同的分布特点,需重视在儿童器官移植中进行个性化药物监测和风险评估,以优化Tac治疗并降低ADE风险。

     

  • 图  1  2004年至2023年他克莫司相关不良药物事件

    Figure  1.  Adverse drug events related to tacrolimus from 2004 to 2023

    图  2  他克莫司相关药物不良事件的系统器官分类

    Figure  2.  Systemic organ class of adverse drug events related to tacrolimus

    图  3  不同年龄段儿童他克莫司相关不良药物事件的系统器官分类

    注:A图为低年龄段组;B图为中年龄段组;C图为高年龄段组。

    Figure  3.  Systemic organ class of adverse drug events related to tacrolimus in children of different age

    图  4  不同移植器官类型他克莫司相关不良药物事件的系统器官分类

    注:A图为心脏移植;B图为肝移植;C图为肾移植;D图为肺移植。

    Figure  4.  Systemic organ class of adverse drug events related to tacrolimus in different types of transplant organ

    表  1  信号强度前10的他克莫司相关药物不良事件

    Table  1.   Top 10 adverse drug events related to tacrolimus in terms of signal intensity

    ADE 信号强度 SOC ROR(95%CI
    与移植有关的食物过敏 18 免疫系统疾病 2 166.56(1 288.90~3 641.86)
    远达性视网膜病变 5 眼器官疾病 739.95(296.31~1 847.83)
    膈疝 18 胃肠系统疾病 294.27(183.78~471.19)
    门静脉闭塞 4 肝胆系统疾病 280.89(103.66~761.08)
    平滑肌细胞肿瘤 8 良性、恶性及性质不明的肿瘤(包括囊状和息肉状) 277.54(137.15~561.65)
    肝移植排斥反应 47 免疫系统疾病 269.55(201.38~360.80)
    癫痫性脑病 4 各类神经系统疾病 240.18(88.85~649.24)
    免疫抑制水平降低 28 各类检查 236.71(162.45~344.92)
    嗜酸细胞性结肠炎 7 胃肠系统疾病 220.65(104.12~467.60)
    EB病毒血症 19 感染及侵染类疾病 215.31(136.45~339.75)
    下载: 导出CSV

    表  2  信号频数前10的他克莫司相关药物不良事件

    Table  2.   Top 10 adverse drug events related to tacrolimus in terms of signal frequency

    ADE 信号频数 SOC ROR(95%CI
    EB病毒感染 79 感染及侵染类疾病 135.74(108.53~169.77)
    发热 70 全身性疾病及给药部位各种反应 2.02(1.60~2.56)
    排斥反应 63 免疫系统疾病 81.92(63.83~105.12)
    免疫抑制水平升高 62 各类检查 209.21(162.40~269.51)
    移植后淋巴组织增生性疾病 60 良性、恶性及性质不明的肿瘤(包括囊状和息肉状) 140.15(108.45~181.11)
    PRES 60 各类神经系统疾病 62.27(48.24~80.37)
    药物相互作用 56 全身性疾病及给药部位各种反应 3.50(2.69~4.55)
    巨细胞病毒感染 48 感染及侵染类疾病 29.77(22.40~39.57)
    肝移植排斥反应 47 免疫系统疾病 269.55(201.38~360.80)
    惊厥发作 46 各类神经系统疾病 2.65(1.98~3.55)
    下载: 导出CSV

    表  3  不同年龄段儿童他克莫司相关感染及侵染类疾病的分布情况

    Table  3.   Distribution of infections and infectious diseases related to tacrolimus in children of different ages

    低年龄段组 中年龄段组 高年龄段组
    ADE信号 信号频数 ROR(95%CI 信号频数 ROR(95%CI 信号频数 ROR(95%CI
    EB病毒血症 17 569.31(351.31~922.61) 20 99.05(63.71~153.99)
    EB病毒感染 48 244.14(183.12~325.49) 11 57.99(32.04~104.96)
    腺病毒感染 10 113.20(60.73~211.00)
    多瘤病毒相关性肾病 6 90.18(40.41~201.26) 12 180.24(101.98~318.55) 13 209.38(121.10~362.04)
    BK病毒感染 7 74.71(35.53~157.09) 9 95.54(49.58~184.12) 10 113.80(61.05~212.14)
    克雷伯菌感染 4 24.99(9.37~66.68)
    巨细胞病毒感染 12 21.84(12.38~38.53) 19 34.46(21.93~54.15) 17 32.99(20.46~53.20)
    假单胞菌感染 5 18.58(7.72~44.71) 4 14.75(5.53~39.35) 5 19.76(8.21~47.54)
    感染性休克 9 6.41(3.33~12.35) 4 2.82(1.06~7.53) 8 6.06(3.03~12.14)
    假丝酵母菌感染 4 5.80(2.18~15.48) 9 13.92(7.23~26.80)
    呼吸道感染 4 4.90(1.84~13.06)
    脓毒症 17 4.48(2.78~7.22) 17 4.45(2.76~7.17) 10 2.79(1.50~5.20)
    葡萄球菌感染 4 3.42(1.28~9.12) 8 6.80(3.40~13.62) 7 6.37(3.03~13.38)
    上呼吸道感染 5 3.27(1.36~7.86) 5 3.24(1.35~7.80)
    装置相关感染 7 11.71(5.57~24.59)
    病毒感染 5 4.66(1.94~11.22) 4 3.99(1.50~10.65)
    尿脓毒症 5 15.95(6.63~38.38) 4 13.66(5.12~36.44)
    多瘤病毒血症 5 230.95(95.63~557.76)
    水痘 4 48.79(18.27~130.24)
    人多瘤病毒感染 4 257.66(96.11~690.73)
    曲霉感染 4 15.80(5.92~42.16)
    真菌感染 4 3.54(1.33~9.45)
    新型冠状病毒肺炎 4 10.50(3.94~28.02)
    尿路感染 15 2.84(1.71~4.72)
    播散型组织胞浆菌病 9 225.62(116.88~435.50)
    流行性感冒 8 2.46(1.23~4.93)
    肠球菌感染 7 47.03(22.38~98.86)
    感染性动脉瘤 7 416.24(197.01~879.44)
    肾盂肾炎 5 18.46(7.67~44.42)
    支气管肺曲霉病 4 16.98(6.36~45.3)
    埃希菌感染 4 16.18(6.06~43.15)
    巨细胞病毒病毒血症 4 33.76(12.65~90.10)
    变形杆菌感染 4 171.08(63.94~457.77)
    下载: 导出CSV

    表  4  不同年龄段儿童他克莫司相关非感染及侵染类疾病的信号频数

    Table  4.   Signal frequency of non infectious and infectious diseases related to tacrolimus in children of different age

    低年龄段组 中年龄段组 高年龄段组
    ADE信号 SOC 信号频数 ROR(95%CI 信号频数 ROR(95%CI 信号频数 ROR(95%CI
    移植后淋巴组织增生性疾病 良性、恶性及性质不明的肿瘤(包括囊状和息肉状) 38 262.34(190.01~362.2) 11 73.85(40.80~
    133.68)
    11 79.1(43.69~143.20)
    发热 全身性疾病及给药部位各种反应 27 2.3(1.57~3.36) 25 2.11(1.42~
    3.13)
    18 1.62(1.02~
    2.58)
    免疫抑制水平升高 各类检查 22 215.49(141.32~328.6) 18 174.42(109.49~277.84) 22 229.22(150.3~349.59)
    与移植有关的食物过敏 免疫系统疾病 18 6 424.36
    (3 817.34~10 811.82)
    免疫介导性不良
    反应
    免疫系统疾病 16 491.43(299.04~807.61)
    多器官功能不全综合征 全身性疾病及给药部位各种反应 16 10.56(6.46~
    17.27)
    15 9.82(5.91~
    16.33)
    4 2.79(1.05~
    7.44)
    血管性水肿 皮肤及皮下组织类疾病 16 10.13(6.20~
    16.58)
    5 3.13(1.30~
    7.52)
    4 2.68(1.00~
    7.14)
    药物相互作用 全身性疾病及给药部位各种反应 15 2.76(1.66~
    4.58)
    16 2.92(1.79~
    4.78)
    25 4.91(3.31~
    7.29)
    免疫抑制药水平
    降低
    各类检查 14 344.79(203.09~585.34) 11 286.79(158.05~520.41)
    PRES 各类神经系统疾病 14 42.46(25.09~
    71.85)
    29 88.12(61.04~
    127.21)
    17 54.94(34.06~
    88.60)
    惊厥发作 各类神经系统疾病 13 2.21(1.28~
    3.81)
    21 3.55(2.31~
    5.46)
    12 2.17(1.23~
    3.82)
    腹痛 胃肠系统疾病 18 2.28(1.44~
    3.63)
    局灶性节段性肾小球硬化症 肾脏及泌尿系统疾病 16 290.33(177.02~476.18)
    排斥反应 免疫系统疾病 14 53.07(31.36~
    89.82)
    16 60.29(36.84~
    98.66)
    33 134.75(95.43~
    190.26)
    肾功能损伤 肾脏及泌尿系统疾病 16 5.78(3.53~
    9.45)
    14 5.41(3.2~9.15)
    血清肌酐升高 各类检查 6 2.62(1.18~
    5.84)
    12 5.22(2.96~
    9.20)
    15 7(4.21~11.63)
    急性肾损伤 肾脏及泌尿系统疾病 13 1.94(1.13~
    3.35)
    13 1.93(1.12~
    3.33)
    15 2.39(1.44~
    3.97)
    治疗不依从 全身性疾病及给药部位各种反应 13 8.23(4.77~
    14.20)
    呼吸衰竭 呼吸系统、胸及纵隔疾病 13 5.17(3.00~
    8.92)
    9 3.55(1.84~
    6.83)
    12 5.07(2.88~
    8.95)
      注:黑体标注表示该信号在该年龄段组中的频数前十位。
    下载: 导出CSV
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  • 收稿日期:  2024-01-23
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