指南与共识
ENGLISH ABSTRACT
中国胰岛素泵治疗指南(2021年版)
中华医学会内分泌学分会
中华医学会糖尿病学分会
中国医师协会内分泌代谢科医师分会
作者及单位信息
·
DOI: 10.3760/cma.j.cn311282-20210428-00265
China Insulin Pump Clinical Guideline(2021)
Chinese Society of Endocrinology
Chinese Diabetes Society
Chinese Endocrinologist Association
Mu Yiming
Zhu Dalong
Ji Linong
Authors Info & Affiliations
Chinese Society of Endocrinology
Chinese Diabetes Society
Chinese Endocrinologist Association
Mu Yiming
Zhu Dalong
Ji Linong
·
DOI: 10.3760/cma.j.cn311282-20210428-00265
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摘要

胰岛素泵治疗是胰岛素强化治疗的重要手段之一,它可以最大程度地模拟人体胰岛素的生理性分泌模式,更好地实现糖尿病患者的血糖管理。此版中国胰岛素泵治疗指南是在2009、2010、2014年版指南的基础上进行的第4次重大更新。新版指南不仅突出了新型和经典胰岛素泵治疗的操作技术,还较为全面地涵盖了与胰岛素泵治疗密切相关的问题,包括胰岛素泵治疗期间的饮食与运动管理、血糖监测、血糖控制质量评估、低血糖对策、胰岛素泵的安装、院内外管理和维护等。

糖尿病;持续皮下胰岛素输注;指南
ABSTRACT

Insulin pump therapy (continuous subcutaneous insulin infusion, CSII) is one of the important methods of intensive insulin therapy. It can simulate physiological insulin secretion to the maximum extent and improve glucose control in patients with diabetes. The newly-revised edition of Chinese Insulin Pump Clinical Guideline(2021) is the fourth-updated edition based on the 2009, 2010, and 2014 editions. The new version of the guideline not only highlights the technology of new and classic insulin pump therapy, but also comprehensively covers the issues closely-related to insulin pump therapy, including diet and exercise management, blood glucose monitoring, quality assessment on glycemic control, countermeasures for hypoglycemia, insulin pump installation, in-hospital and out-hospital management and maintenance, etc.

Diabetes mellitus;Continuous subcutaneous insulin infusion (CSII);Guideline
Mu Yiming, Email: nc.defmoabc.latipsoh103gnimiyum
Zhu Dalong, Email: nc.defudabe.ujngnoladuhz
Ji Linong, Email: nc.defudabe.umjbnlij
引用本文

中华医学会内分泌学分会,中华医学会糖尿病学分会,中国医师协会内分泌代谢科医师分会. 中国胰岛素泵治疗指南(2021年版)[J]. 中华内分泌代谢杂志,2021,37(08):679-701.

DOI:10.3760/cma.j.cn311282-20210428-00265

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目录
第一章 指南更新说明 681
  一、前言 681
  二、文献检索与评价 681
第二章 胰岛素泵治疗的定义和工作原理 681
  一、胰岛素泵治疗的定义 681
  二、胰岛素泵的工作原理 681
第三章 胰岛素泵治疗技术的发展和临床使用现状 682
  一、胰岛素泵治疗技术的发展 682
  二、胰岛素泵的临床使用现状 682
第四章 胰岛素泵治疗的优势和临床获益 682
  一、有效、安全控糖 682
  二、降低糖尿病并发症的发生风险 683
  三、提高生活质量 683
  四、经济成本效益 683
第五章 中国市场主要胰岛素泵的特点 683
  一、经典胰岛素泵 683
  二、传感器增强型胰岛素泵 683
  三、无导管胰岛素泵 683
第六章 胰岛素泵疗效的临床证据 684
  一、短期胰岛素泵强化治疗 684
  二、长期胰岛素泵治疗 684
第七章 胰岛素泵治疗的适应证和禁忌证 684
  一、短期胰岛素泵治疗的适应证 684
  二、长期胰岛素泵治疗的适应证 684
  三、不适合胰岛素泵治疗的人群及禁忌证 685
第八章 血糖控制目标、胰岛素剂量设定与调整 685
  一、血糖控制目标 685
  二、胰岛素的选择 686
  三、胰岛素泵初始剂量设定 686
  四、住院短期强化治疗胰岛素泵的应用 687
  五、院外长期血糖优化管理 689
第九章 胰岛素泵治疗期间的血糖监测 690
  一、不同血糖监测方法的价值 690
  二、血糖控制质量评估新指标 691
第十章 胰岛素泵治疗期间的饮食与运动管理 691
  一、胰岛素泵治疗期间的饮食原则 691
  二、胰岛素泵治疗期间的运动原则 691
第十一章 胰岛素泵的安装与维护 692
  一、植入和输注部位的选择 692
  二、胰岛素泵的安装 692
  三、胰岛素泵常见问题与处理 692
  四、胰岛素泵治疗期间的护理与管理 693
第十二章 胰岛素泵治疗技术展望 694
附录1  中国市场主要胰岛素泵的产品特点 695
附录2  补充大剂量计算 696
附录3  校正大剂量 696
附录4  胰岛素泵的其他功能 696
附录5  结合传感器葡萄糖水平及葡萄糖变化趋势的干预措施调整原则 697
附录6  趋势箭头对应的餐时胰岛素剂量调整 697
附录7  胰岛素泵个人用户出现故障应急处理原则 697
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附录
附录1
中国市场主要胰岛素泵的产品特点
附录2
补充大剂量计算

定义:正餐外临时加餐前所追加的一次大剂量胰岛素输注,主要根据食物中碳水化合物含量和碳水化合物系数进行计算。碳水化合物系数值是指每1单位胰岛素所能平衡的碳水化合物克数。该系数可通过500/450原则计算(注:速效胰岛素用500,短效胰岛素用450),或者参考 表11

碳水化合物系数(g/U胰岛素)=(500或450 g)/TDD

食物中碳水化合物含量通过中国食物成分表查阅,查得碳水化合物总量之后,按照下式计算补充大剂量:

补充大剂量(U)=食物的碳水化合物总量/碳水化合物系数

注意事项:碳水化合物系数多在T1DM患者中研究获得,不同的研究中碳水化合物系数多在250~500/TDD之间 [ 121 , 122 , 123 , 124 ] ,个体存在较大差异。T2DM因存在胰岛素抵抗,理论上碳水化合物系数应当更低。因此,在计算出补充大剂量并输注后,应当观察处理后血糖是否落在目标血糖范围。如血糖较预计更高/更低,应当按照10%~20%的步进减少/增加碳水化合物系数。

附录3
校正大剂量

定义:校正大剂量用于纠正当前高于目标值的血糖时所需补充的胰岛素量。校正大剂量通过实测与目标血糖之差以及胰岛素敏感系数计算:

校正大剂量=(实测血糖-目标血糖)/胰岛素敏感系数。

胰岛素敏感系数的含义为每1单位胰岛素能降低的血糖(mmol/L)值,按照下式计算:

胰岛素敏感系数(mmol·L -1·U -1)=(1 800或1 500)/(TDD×18)。其中,式中速效胰岛素用1 800,短效胰岛素用1 500。

与碳水化合物系数一样,胰岛素敏感系数相关研究多在T1DM患者中总结,不同临床研究中碳水化合物系数多在1 500~2 000/(TDD×18)之间,不同的个体存在一定的差异。T2DM因存在胰岛素抵抗,根据公式所计算得的胰岛素剂量可能偏低。因此,实施校正大剂量后,应当观察处理后血糖是否落在目标血糖范围。如血糖较预计更高/更低,应当按照10%~20%的步进减少/增加胰岛素敏感系数。

另外,实施临时输注的校正/补充大剂量时,应当考虑扣除体内剩余活性胰岛素的情况(即上次大剂量输注后残余的胰岛素降糖活性)。有大剂量向导功能的胰岛素泵,可自动跟踪并减去活性胰岛素量。

附录4
胰岛素泵的其他功能

在院外血糖管理过程中,应用好临时基础率、方波和双波大剂量以及大剂量向导功能,有助于患者在某些特殊情况实现个体化和精准化血糖管理,减少患者的血糖波动。

(1)临时基础率 为在一段时间内,临时设定的基础率,用于短时异常活动或情况时控制血糖水平,如生病、计划外运动等。在进行临时基础率期间,其他所有基础率都被临时取代,以应对生活中的突发事件,在设定胰岛素泵剂量初期,也可以使用临时基础率应对应用泵治疗前的药物洗脱期。

(2)方波餐前大剂量 方波餐前大剂量指的是将所设定的大剂量在一定时长内(30 min~8 h)内均匀输注一个餐前大剂量。主要用于长时间较匀速的进餐、胃轻瘫等情况,以适应营养物质持续缓慢吸收产生的血糖变化。

(3)双波餐前大剂量 双波餐前大剂量指将所设的餐前大剂量分割成一个常规餐前大剂量和随后的一个方波餐前大剂量。这一输注模式,主要是为了适应摄入同时含有容易消化部分和需要长时间才能吸收的混合食物时,也可用于前快后慢的长时间进餐。

(4)大剂量向导 部分胰岛素泵具有大剂量向导功能,可以预设碳水化合物系数和胰岛素敏感系数,根据当前血糖值、目标血糖范围及摄入的碳水化合物量,自动扣除活性胰岛素并计算出患者所需的大剂量胰岛素,为高血糖的胰岛素校正和加餐时的胰岛素补充提供了便利。

附录5
结合传感器葡萄糖水平及葡萄糖变化趋势的干预措施调整原则
葡萄糖变化趋势 传感器葡萄糖水平
低于目标范围 在目标范围内 高于目标范围
下降 进食;减少或暂停胰岛素基础率;15 min后复查 可考虑进食(如有症状);可考虑减少胰岛素基础率;30~60 min后复查 可考虑给予校正大剂量;1~2 h后复查
稳定 进食;15~30 min后复查 无需处理 给予校正大剂量;1~2 h后复查
上升 可考虑进食(如有症状);15~30 min后复查 30~60 min后复查 给予校正大剂量;1~2 h后复查;排除酮症
附录6
趋势箭头对应的餐时胰岛素剂量调整
趋势箭头 校正因子(CF)
<1.4 1.4~<2.8 2.8~<4.1 ≥4.1
+3.5 U +2.5 U +1.5 U +1.0 U
+2.5 U +1.5 U +1.0 U +0.5 U
不调整      
-2.5 U -1.5 U -1.0 U -0.5 U
-3.5 U -2.5 U -1.5 U -1.0 U
附录7
胰岛素泵个人用户出现故障应急处理原则

(1)当胰岛素泵出现故障,个人用户建议带有随时补充的胰岛素注射替代疗法保持血糖的正常水平。

(2)如果泵确实发生故障,可以通过泵的背面找到制造商的电话,个人用户可以通过电话与制造商进行有效沟通,帮助排除故障,并获得一个备用泵,以代替故障泵。

(3)个人泵用户定期用血糖仪监测他们的血糖水平。如果血糖水平保持在16.7 mmol/L以上,或患者感到不适,建议前往医院急诊,以防止糖尿病酮症酸中毒。

(4)针对泵故障预防处理原则,重点掌握相关制造商胰岛素泵的报警处理原则、胰岛素泵的马达位移测试、胰岛素泵的高压敏感实验,以提前预防泵故障不良事件发生。

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备注信息
A
母义明,Email: nc.defmoabc.latipsoh103gnimiyum,解放军总医院第一医学中心内分泌科,北京 100853
B
朱大龙,Email: nc.defudabe.ujngnoladuhz,南京大学医学院附属鼓楼医院内分泌科,南京 210008
C
纪立农,Email: nc.defudabe.umjbnlij,北京大学人民医院内分泌科,北京 100044
D
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