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实体器官移植后糖尿病患者降糖药物应用专家共识(2024版)

中国研究型医院学会糖尿病学专业委员会, 中华医学会糖尿病学分会, 北京医学会糖尿病学分会, 等. 实体器官移植后糖尿病患者降糖药物应用专家共识(2024版)[J]. 器官移植, 2024, 15(3): 333-351. doi: 10.3969/j.issn.1674-7445.2024111
引用本文: 中国研究型医院学会糖尿病学专业委员会, 中华医学会糖尿病学分会, 北京医学会糖尿病学分会, 等. 实体器官移植后糖尿病患者降糖药物应用专家共识(2024版)[J]. 器官移植, 2024, 15(3): 333-351. doi: 10.3969/j.issn.1674-7445.2024111
Diabetology Committee of Chinese Research Hospital Association, Chinese Diabetes Society, Diabetes Branch of Beijing Medical Association, et al. Expert consensus on the use of hypoglycemic drugs in post transplantation diabetes mellitus (2024 edition)[J]. ORGAN TRANSPLANTATION, 2024, 15(3): 333-351. doi: 10.3969/j.issn.1674-7445.2024111
Citation: Diabetology Committee of Chinese Research Hospital Association, Chinese Diabetes Society, Diabetes Branch of Beijing Medical Association, et al. Expert consensus on the use of hypoglycemic drugs in post transplantation diabetes mellitus (2024 edition)[J]. ORGAN TRANSPLANTATION, 2024, 15(3): 333-351. doi: 10.3969/j.issn.1674-7445.2024111

实体器官移植后糖尿病患者降糖药物应用专家共识(2024版)

doi: 10.3969/j.issn.1674-7445.2024111
详细信息
    通讯作者:

    徐春,Email: xuchh2000-1@163.com

    肖新华,Email: xiaoxh2014@vip.163.com

    窦京涛,Email: jingtaodou@163. com

    郭立新,Email: glx1218@163.com

  • 中图分类号: R617, R587.1

Expert consensus on the use of hypoglycemic drugs in post transplantation diabetes mellitus (2024 edition)

More Information
    Corresponding author: Xu Chun, Department of Endocrinology, the Third Medical Center of People′s Liberation Army General Hospital, Beijing 100039, China, Email: xuchh2000-1@163.comXiao Xinhua, Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Key Laboratory of Endocrinology, National Health Commission, Beijing 100730, China, Email: xiaoxh2014@vip.163.comDou Jingtao, Department of Endocrinology, the First Medical Center of People′s Liberation Army General Hospital, People′s Liberation Army Key Laboratory of Endocrinology and Metabolic Diseases, Beijing 100853, China, Email: jingtaodou@163. comGuo Lixin, Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China, Email: glx1218@163.com
  • 摘要: 近年来有关器官移植后糖尿病(PTDM)诊治的临床证据日益增多,尤其是新型降糖药和血糖监测新技术的不断问世,进一步推动了PTDM的诊治进展。为详细阐述降糖药物在PTDM中的应用,中国研究型医院学会糖尿病学专业委员会、中华医学会糖尿病学分会与北京医学会糖尿病学分会共同组织专家编写了《实体器官移植后糖尿病患者降糖药物应用专家共识(2024版)》,共识主要围绕降糖药物的降糖作用机制、推荐强度、临床应用注意事项及其与免疫抑制剂的相互作用等方面展开,以期进一步提高临床对PTDM患者的管理水平,改善其结局。该共识的发布将有助于规范PTDM的临床诊疗。

     

  • 表  1  英国牛津大学循证医学中心证据分级与推荐标准[1]

    Table  1.   Evidence classification and recommendation criteria of Oxford Center of Evidence-Based Medicine

    推荐强度 证据级别 描述
    A 1a 同质RCT的SR
    1b 单个RCT研究
    1c “全或无”证据(有治疗以前,所有患者都死亡;有治疗之后,有患者能存活。或者在有治疗之前,一些患者死亡;有治疗之后,无患者死亡)
    B 2a 基于队列研究的SR(有同质性)
    2b 单个队列研究(包括低质量RCT,如<80%随访)
    3a 基于病例对照研究的SR(有同质性)
    3b 单个病例对照研究
    C 4 病例报告(低质量队列研究)
    D 5 专家意见或评论
      注:RCT为随机对照试验;SR为系统评价;推荐强度中,A为推荐,B为应当考虑,C为可以考虑,D为不推荐。
    下载: 导出CSV

    表  2  本共识推荐意见汇总一览表

    Table  2.   Summary table of recommended opinions in this consensus

    推荐意见序号 推荐内容 推荐强度 证据级别
    1 PTDM患病率高,危害严重,增加移植物功能丧失及感染风险,严重影响移植受者的长期生存,需要高度关注。应注重筛查,及时诊断,全程随访管理 A 2a
    2 PTDM常合并多重心血管疾病危险因素,包括高血压、血脂紊乱、高尿酸血症、肥胖、慢性肾功能不全等,应对PTDM患者易并发的ASCVD多重危险因素进行筛查、评估及综合管理,以提高其长期生存率及生活质量 A 2a
    3 PTDM的诊断需在免疫抑制剂维持治疗阶段、无应激、移植物功能稳定状态(>术后45 d)下进行,不包括术前已诊断的糖尿病及术后一过性高血糖。诊断标准同WHO糖尿病诊断标准,不建议单独使用HbA1c诊断PTDM,特别是移植术后1年内 B 2a
    4 建议所有成人移植受者在移植前与移植后均进行糖代谢筛查,筛查方式有AGM(糖皮质激素服药后7~8 h)、FPG、HbA1c、OGTT等 A 2b
    5 建议应用SMBG作为器官移植受者糖代谢常规筛查手段。尤其应重视AGM的检测,在移植术后早期(≤术后45 d),AGM用于筛查糖代谢异常的灵敏度优于FPG。HbA1c不适用于血红蛋白异常的移植受者。OGTT是诊断糖代谢异常的金标准,尤其适用于其他筛查方法提示的糖代谢异常患者或者可疑PTDM患者 A 1b
    6 血糖筛查频率:建议在移植术后早期(≤术后45 d)每日至少进行1次SMBG,优先推荐AGM检测,术后3、6、12个月各进行1次SMBG联合HbA1c筛查。此后每年进行至少1次上述筛查,对于高危受者应增加血糖监测频次,必要时进行OGTT筛查 A 2b
    7 移植后稳定期(>术后45 d)血糖控制目标如下,在避免低血糖的情况下,FPG<7.0 mmol/L,2hPG<10.0 mmol/L,HbA1c<7.0%;控制目标应考虑受者年龄、糖尿病合并症/并发症、低血糖发生风险、预期寿命和主观意愿等 B 1c
    8 PTDM 患者均需进行SMBG,监测频次参考成人2 型糖尿病监测原则;根据个体情况,每3~6个月对HbA1c进行检测 B 2b
    9 CGM可应用于血糖波动大、存在无法解释的高血糖、反复发作低血糖或降糖方案/抗排斥方案调整阶段的移植受者 B 1c
    10 生活方式干预是PTDM管理的基础,对单纯生活方式干预后血糖仍不达标者,应当考虑联合降糖药物治疗 A 2b
    11 二甲双胍可用于PTDM的治疗,包括肾移植受者、心脏移植受者和肝移植
    受者
    肾移植B;心脏移植A;肝移植A 肾移植2a;心脏移植2a;肝移植2b
    12 二甲双胍应用于PTDM患者可降低肾移植受者移植物功能丧失风险、全因死亡率和急性排斥反应的发生,可降低心脏移植受者移植心脏血管病变和恶性肿瘤的发生风险,且不增加乳酸酸中毒的风险 A 2a
    13 瑞格列奈可用于PTDM患者的治疗,包括肾移植受者、肝移植受者 B 肾移植1b;肝移植2b
    14 DPP-4i可用于肾移植受者PTDM的治疗,如西格列汀、维格列汀、利格列汀 A 西格列汀1a;维格列汀1b;利格列汀2a
    15 SGLT2i可用于PTDM患者的治疗,包括肾移植受者、心脏移植受者、肝移植受者和肺移植受者 肾移植B;心脏移植B;肝移植B;肺移植C 肾移植1a;心脏移植2a;肝移植2b;肺移植4
    16 GLP-1RA可用于PTDM患者的治疗,包括肾移植受者、心脏移植受者、肝移植受者和肺移植受者 肾移植B;心脏移植B;肝移植B;肺移植C 肾移植2a;心脏移植2a;肝移植2b;肺移植4
    17 存在以下情况时建议起始胰岛素治疗,在生活方式和非胰岛素降糖药治疗的基础上,血糖仍未达标者;合并应激状态,如重症感染、手术等;诊断PTDM时HbA1c≥9.0%或FPG≥11.1 mmol/L,同时伴明显高血糖症状者;PTDM合并消瘦或营养不良者 B 1c
    18 胰岛素的治疗必须高度个体化,包括不同胰岛素治疗方案的选择、起始剂量、剂量调整等 B 1c
      注:ASCVD为动脉粥样硬化性心血管疾病;HbA1c为糖化血红蛋白;AGM为午后血糖监测;FPG为空腹血糖;OGTT为口服葡萄糖耐量试验;SMBG为自我血糖监测;2hPG为餐后2 h血糖;CGM为持续葡萄糖监测;DPP-4i为二肽基肽酶Ⅳ抑制剂;SGLT2i为钠-葡萄糖共转运蛋白2抑制剂;GLP-1RA为胰高糖素样肽-1受体激动剂。
    下载: 导出CSV

    表  3  常用胰岛素及其作用特点[25]

    Table  3.   Common insulin and its characteristics of action

    类别 胰岛素制剂 起效时间 峰值时间 作用持续时间(h)
    餐时胰岛素 短效人胰岛素(RI) 15~60 min 2~4 h 5~8
    超短效胰岛素类似物
     门冬胰岛素 10~15 min 1~2 h 4~6
     赖脯胰岛素 10~15 min 1~1.5 h 4~5
     谷赖胰岛素 10~15 min 1~2 h 4~6
    基础胰岛素 中效人胰岛素(NPH) 2.5~3 h 5~7 h 13~16
    长效胰岛素(PZI) 3~4 h 8~10 h 20
    长效胰岛素类似物
     地特胰岛素 3~4 h 3~14 h 24
     甘精胰岛素U100 2~3 h 无峰 30
    超长效胰岛素类似物
     德谷胰岛素 1 h 无峰 42
     甘精胰岛素U300 6 h 无峰 36
    预混胰岛素 预混人胰岛素(30R,70/30) 0.5 h 2~12 h 14~24
    预混人胰岛素(40R) 0.5 h 2~8 h 24
    预混人胰岛素(50R) 0.5 h 2~3 h 10~24
    预混胰岛素类似物
     门冬胰岛素30 10~ 20 min 1~4 h 14~24
     门冬胰岛素50 15 min 30~70 min 16~24
     赖脯胰岛素25 15 min 30~70 min 16~24
     赖脯胰岛素50 15 min 30~70 min 16~24
    双胰岛素 德谷门冬双胰岛素70/30 10~15 min 1.2 h > 24
      注:甘精胰岛素U100是指胰岛素含量100 U/mL,甘精胰岛素U300指胰岛素含量300 U/mL;预混人胰岛素(30R,70/30)含30%短效胰岛素和70%中效胰岛素;预混人胰岛素(40R)含40%短效胰岛素和60%中效胰岛素;预混人胰岛素(50R)含50%中效胰岛素和50%短效胰岛素;门冬胰岛素30含30%门冬胰岛素和70%精蛋白门冬胰岛素;门冬胰岛素50含50%精蛋白门冬胰岛素和50%门冬胰岛素;赖脯胰岛素25含25%赖脯胰岛素和75%精蛋白锌赖脯胰岛素;赖脯胰岛素50含50%赖脯胰岛素和50%精蛋白锌赖脯胰岛素;德谷门冬双胰岛素70/30含70%德谷胰岛素和30%门冬胰岛素。因受胰岛素剂量、吸收、降解等多种因素的影响,且个体差异大,表中胰岛素作用时间仅供参考。
    下载: 导出CSV

    1  非胰岛素降糖药物在PTDM应用的临床研究及证据等级汇总

    降糖药物种类 研究出处 代表药物 移植器官 患者数 研究设计 证据等级
    双胍类 Vest等[31](2018年) 二甲双胍 肾移植 14 144 回顾性队列研究 2a
    Kwon等[32](2023年) 二甲双胍 肾移植 1 193 回顾性队列研究 2b
    Ram等[33](2019年) 二甲双胍 心脏移植 103 前瞻性队列研究 2a
    Bedanova等[34](2021年) 二甲双胍 心脏移植 497 回顾性队列研究 2b
    Peled等[35](2017年) 二甲双胍 心脏移植 237 前瞻性队列研究 2a
    TZD Kharazmkia等[40](2014年) 吡格列酮 肾移植 62 随机对照试验 1b
    Arashnia等[41](2015年) 吡格列酮 肾移植 58 随机对照试验 1b
    非磺脲类促泌剂 闫赋琴等[42](2016年) 瑞格列奈 肾移植 32 回顾性队列研究 2b
    Niu等[43](2013年) 瑞格列奈 肝移植 86 前瞻性队列研究 2b
    DPP-4i Lane等[46](2011 年) 西格列汀 肾移植 15 回顾性队列研究 3b
    Sanyal等[51](2013 年) 利格列汀 肾移植 21 回顾性队列研究 3b
    Attallah 和Yassine[52](2021年) 利格列汀 肾移植 42 回顾性队列研究 2b
    Boerner等[47](2014年) 西格列汀 肾移植 22 回顾性队列研究 3b
    Haidinger等[50](2014 年) 维格列汀 肾移植 32 随机对照试验 1b
    Strøm Halden等[48](2014年) 西格列汀 肾移植 19 随机对照研究 1b
    Bae等[56](2016年) 维格列汀、西格列汀、利格列汀 肾移植 65 回顾性队列研究 3b
    Soliman等[49](2013 年) 西格列汀 肾移植 45 随机对照研究 1b
    SGLT2i Chewcharat等[57](2020年) 恩格列净、卡格列净、达格列净 肾移植 132 系统评价和荟萃分析 1b
    Oikonomaki等[58](2021年) 卡格列净、恩格列净、达格列净 肾移植 310 系统评价和荟萃分析 1b
    Halden等[59](2019年) 恩格列净 肾移植 44 随机对照试验 1b
    Lim等[60](2022年) SGLT2ia 肾移植 2 083(使用SGLT2i者226例,未用者1 857例) 回顾性队列研究 2b
    Sánchez Fructuoso等[61](2023年) 恩格列净、达格列净、卡格列净 肾移植 339 多中心队列研究 2b
    Hisadome等[62](2021年) SGLT2i 肾移植 89 回顾性队列研究 2b
    Cehic等[63](2019 年) 恩格列净 心脏移植 22 回顾性队列研究 2b
    Sammour等[64](2021年) 恩格列净、卡格列净、达格列净 心脏移植 21 回顾性队列研究 2b
    Cha等[65](2021年) 达格列净 心脏移植 1 病例报告 4
    Sweiss等[66](2023年) SGLT2i 肝、肾、肺、肝-肾联合移植 49 回顾性队列研究 2b
    GLP-1RA Halden等[67](2016年) GLP-1 肾移植 24 随机对照试验 1b
    Singh等[68](2020年) 度拉糖肽、
    利拉鲁肽
    肾、肝、肝-肾联合移植、心脏移植 88 回顾性队列研究 2b
    Kim等[69](2021年) 度拉糖肽 肾移植 36 回顾性队列研究 2b
    Thangavelu等[70](2020年) GLP-1RA 肾、肝、心脏移植 19 回顾性队列研究 2b
    Singh等[71](2019年) 度拉糖肽 肾、肝、肝-肾联合移植、心脏移植 63 回顾性队列研究 2b
    Sweiss等[72](2022年) GLP-1RA 肾、肝、肺移植 118 回顾性队列研究 2b
    Kukla等[73](2020年) 利拉鲁肽、度拉糖肽、艾塞那肽 肾移植 17 回顾性病例系列研究 4
    Yugueros González等[74](2021年) 司美格鲁肽、利拉鲁肽、度拉糖肽 肾移植 15 回顾性病例系列研究 4
    Sato等[75](2023年) GLP-1RA 肾移植 73 回顾性队列研究 2b
    Oikonomaki等[58](2021年) SGLT2i(卡格列净、恩格列净、达格列净)/DPP4/GLP-1RA(利拉鲁肽、艾塞那肽、度拉
    糖肽)
    肾移植 310 系统评价和荟萃分析 1b
      注:PTDM为器官移植后糖尿病;TZD为噻唑烷二酮类;DPP-4i为二肽基肽酶Ⅳ抑制剂;SGLT2i为钠-葡萄糖共转运蛋白2抑制剂;GLP-1RA为胰高糖素样肽-1受体激动剂;GLP-1为胰高糖素样肽-1;DPP4为二肽基肽酶Ⅳ。
    下载: 导出CSV
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  • 收稿日期:  2024-04-02
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