治疗流程
请注意药品名称和品牌、药品处方或地区之间的配方/用药途径和剂量可能有所不同。治疗建议针对患者特定群体提出: 查看免责声明
儿童和非妊娠成人
基础-餐时胰岛素
无论患者是成人还是儿童,从诊断开始都为其提供每日注射多次的基础-餐时胰岛素方案。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 [34]National Institute for Health and Care Excellence. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng18 对于新诊断出 1 型糖尿病的成人患者,请勿提供每日两次混合胰岛素、仅含基础胰岛素或仅含餐时胰岛素的治疗方案。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17
联合使用长效胰岛素(地特胰岛素、德谷胰岛素或甘精胰岛素)进行基础给药,使用速效胰岛素(赖脯胰岛素、门冬胰岛素或谷赖胰岛素)进行餐时给药,可以根据医生偏好和患者意愿设计每日注射多次(multiple daily injections, MDI)方案,并根据血糖监测数据进行调整。
在英国,英国国家卫生与临床优化研究所(National Institute for Health and Care Excellence, NICE)建议将每日两次地特胰岛素作为成人的基础胰岛素治疗。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 NICE 建议考虑以下方案之一作为每日两次地特胰岛素的替代方案:患者依据商定治疗目标确定且能达到该目标的一种胰岛素方案;每日一次甘精胰岛素,如果患者不能耐受地特胰岛素,或者强烈希望每日一次基础注射,;每日一次德谷胰岛素,如果特别担心夜间低血糖;每日一次超长效胰岛素(如德谷胰岛素),如果患者需要照护者或医疗卫生专业人士的帮助进行注射。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 如果患者使用上述方案未能达到治疗目标,NICE 建议考虑其他基础胰岛素治疗方案,同时需考虑到患者意愿和合并症、低血糖和糖尿病酮症酸中毒风险,以及所有依从性相关问题。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17
NICE 建议将速效胰岛素类似物作为餐时给药的一线选择。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17
对于在血糖控制或减少并发症方面,胰岛素类似物是否优于传统胰岛素,目前尚无共识。[62]Laranjeira FO, de Andrade KR, Figueiredo AC, et al. Long-acting insulin analogues for type 1 diabetes: an overview of systematic reviews and meta-analysis of randomized controlled trials. PLoS One. 2018 Apr 12;13(4):e0194801. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0194801 http://www.ncbi.nlm.nih.gov/pubmed/29649221?tool=bestpractice.com [63]Fullerton B, Siebenhofer A, Jeitler K, et al. Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database Syst Rev. 2016 Jun 30;(6):CD012161. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012161/full http://www.ncbi.nlm.nih.gov/pubmed/27362975?tool=bestpractice.com [ ] How do short-acting insulin analogs compare with regular human insulin in adults with type 1 diabetes mellitus?/cca.html?targetUrl=https://cochranelibrary.com/cca/doi/10.1002/cca.1466/full展示答案
成人的胰岛素初始每日总剂量为 0.2–0.4 U/kg。儿童的起始剂量为每日 0.5–1.0 U/kg,在青春期,剂量需求可加至每日 1.5 U/kg。1 型糖尿病患者刚开始使用胰岛素治疗时,经常会经历一个“蜜月期”,在此期间,他们每天需要的单位数可能会较少。通常情况下,总剂量的一半作为基础胰岛素给予,另一半作为餐时剂量给予。[45]American Diabetes Association. Standards of medical care in diabetes - 2021. Diabetes Care. 2021;44(suppl 1):S1-S232. https://care.diabetesjournals.org/content/44/Supplement_1 餐时剂量分次给予,分别在各餐前给予。基础剂量给药时机根据个体患者需求和所用胰岛素类型而有所不同(例如,地特胰岛素通常根据患者需要每日给药一次或两次,甘精胰岛素和德谷胰岛素通常在一天中的任何时间每天给药一次,但最好在每天的同一时间给药)。给药时间可能会有所不同;查看您当地的指南,以获取更多信息。患者需要自我监测其血糖水平。在成人中,可每 2–3 天调整一次胰岛素剂量,以维持目标血糖值。鼓励每天注射多次胰岛素的儿童和青少年在每次血糖测量后酌情调整胰岛素剂量。[34]National Institute for Health and Care Excellence. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng18
为了将 HbA1c 目标维持在 ≤48 mmol/mol(6.5%),建议成人 1 型糖尿病患者参考如下目标:睡醒时:空腹血糖水平 5–7 mmol/L(90–126 mg/dL);餐前(在一天中的其他时间):血糖水平 4–7 mmol/L(72–126 mg/dL);餐后:至少餐后 90 分钟,血糖水平 5–9 mmol/L(90–162 mg/dL);睡前:个体化血糖水平(考虑到最后一餐的时间及其相关胰岛素剂量,与建议的睡醒时空腹血糖水平一致)。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17
18 岁以下儿童和青少年应参考以下目标:睡醒时:空腹血糖水平 4–7 mmol/L(72–126 mg/dL);餐前(在一天中的其他时间):血糖水平 4–7 mmol/L(72–126 mg/dL);餐后:血糖水平 5–9 mmol/L(90–162 mg/dL)。[34]National Institute for Health and Care Excellence. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng18
如果患者需要驾驶,确保其了解当地关于血糖水平的建议。在英国,驾驶员和车辆许可发放机构(Driver and Vehicle Licensing Agency, DVLA)建议驾驶前达到至少 5 mmol/L(90 mg/dL)的目标水平。[48]Driver and Vehicle Licensing Agency. Guidance: Information for drivers with diabetes. March 2020 [internet publication]. https://www.gov.uk/government/publications/information-for-drivers-with-diabetes
最简单的计算餐时胰岛素需求量的方法是按照食物份量提供一系列对应剂量:比如小份食物用 4 个单位,中等份食物 6 个单位,大份食物 8 个单位等。若食物中碳水化合物成分高,餐前胰岛素可以按照进食的碳水化合物计算或者该患者的个人胰岛素-碳水化合物比例来计算。
对于成人,保守的起始方法是每 15 g 膳食碳水化合物使用 1 U餐时胰岛素(不过,应谨记,胰岛素与碳水化合物的比例可能因当地规程而异)。患者可使用食品包装上列出的每份食物的碳水化合物含量来评估其预期膳食中的克数,但最好是在营养师的帮助下或通过结构化的糖尿病教育计划来计算碳水化合物克数。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 根据饮食日记以及餐后 2 小时血糖测量结果,可以调整胰岛素-碳水化合物之比。
方案应个体化,以获得最佳血糖控制。
因根据餐前血糖情况,在餐前大剂量基础上加用校正剂量。
对于一些不适合每日注射多次方案或每日注射多次方案不成功的患者,可以考虑使用胰岛素泵(持续皮下胰岛素输注 [CSII])。
在英国,NICE 建议,对于 MDI 治疗不切实际或不合适的 12 岁以下儿童,可选择使用胰岛素泵;预期这些患者将在 12-18 岁之间的某个时间点尝试使用 MDI 治疗。[64]National Institute for Health and Care Excellence. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. Jul 2008 [internet publication]. https://www.nice.org.uk/guidance/ta151
NICE 还建议将胰岛素泵作为试图使用 MDI 方案达到目标 HbA1c 水平,结果导致失能性低血糖,对生活质量产生重大影响的 ≥12 岁患者的治疗选择;只有在胰岛素泵使 HbA1c 水平持续下降和/或低血糖发作频率降低的情况下,这些患者才应继续使用此治疗方法。[64]National Institute for Health and Care Excellence. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. Jul 2008 [internet publication]. https://www.nice.org.uk/guidance/ta151
胰岛素泵有一个皮下胰岛素输注端口,每 3 天更换一次。胰岛素泵使用短效胰岛素或速效胰岛素,提供基础速率输注和餐时胰岛素输注。然而,患者(或者父母或其照护者)仍需频繁测量血糖(在实践中,每天 4–7 次),以调整胰岛素泵,使其输送合适的剂量。胰岛素泵可以减少低血糖的发生,尤其是与动态血糖监测系统(continuous glucose monitoring, CGM)和阈值暂停功能结合使用时,还能改善 HbA1c 水平,同时提供更大的灵活性。[53]Ly TT, Nicholas JA, Retterath A, et al. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial. JAMA. 2013 Sep 25;310(12):1240-7. http://jamanetwork.com/journals/jama/fullarticle/1741822 http://www.ncbi.nlm.nih.gov/pubmed/24065010?tool=bestpractice.com [65]Benkhadra K, Alahdab F, Tamhane SU, et al. Continuous subcutaneous insulin infusion versus multiple daily injections in individuals with type 1 diabetes: a systematic review and meta-analysis. Endocrine. 2016 Aug 1;55(1):77-84. http://www.ncbi.nlm.nih.gov/pubmed/27477293?tool=bestpractice.com [66]Monami M, Lamanna C, Marchionni N, et al. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in type 1 diabetes: a meta-analysis. Acta Diabetol. 2010 Dec;47(suppl 1):77-81. http://www.ncbi.nlm.nih.gov/pubmed/19504039?tool=bestpractice.com [67]Li XL. Multiple daily injections versus insulin pump therapy in patients with type 1 diabetes mellitus: a meta analysis. J Clin Rehabil Tissue Eng Res. 2010;14:8722-5.[68]Cummins E, Royle P, Snaith A, et al. Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation. Health Technol Assess. 2010 Feb;14(11):iii-iv;xi-xvi;1-181. http://www.journalslibrary.nihr.ac.uk/hta/volume-14/issue-11 http://www.ncbi.nlm.nih.gov/pubmed/20223123?tool=bestpractice.com 由于需要进行监测和调整剂量,使用胰岛素泵需要熟练掌握糖尿病自我管理技能的积极主动患者,并且能联系接受过胰岛素泵治疗培训的执业医师。[69]Kordonouri O, Hartmann R, Danne T. Treatment of type 1 diabetes in children and adolescents using modern insulin pumps. Diabetes Res Clin Pract. 2011 Aug;93(suppl 1):S118-24. http://www.ncbi.nlm.nih.gov/pubmed/21864743?tool=bestpractice.com [70]REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017 Mar 30;356:j1285. https://www.bmj.com/content/356/bmj.j1285.long http://www.ncbi.nlm.nih.gov/pubmed/28360027?tool=bestpractice.com 如果患者为儿童,他们将需要强有力的家庭支持。[69]Kordonouri O, Hartmann R, Danne T. Treatment of type 1 diabetes in children and adolescents using modern insulin pumps. Diabetes Res Clin Pract. 2011 Aug;93(suppl 1):S118-24. http://www.ncbi.nlm.nih.gov/pubmed/21864743?tool=bestpractice.com
带有葡萄糖传感器并被整合成一个装置的胰岛素泵被称为传感器增强型胰岛素泵。已将传感器和胰岛素泵的功能整合到一个可用装置中:“闭环式”系统。可根据感测的葡萄糖浓度自动判定基础胰岛素给药。整合装置使用计算机控制算法建立混合闭环式胰岛素给药系统,起到人工胰腺的作用。[39]Chiang JL, Maahs DM, Garvey KC, et al. Type 1 diabetes in children and adolescents: a position statement by the American Diabetes Association. Diabetes Care. 2018 Aug 9;41(9):2026-44. http://care.diabetesjournals.org/content/41/9/2026.long http://www.ncbi.nlm.nih.gov/pubmed/30093549?tool=bestpractice.com [71]Weisman A, Bai JW, Cardinez M, et al. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017 May 19;5(7):501-12. http://www.ncbi.nlm.nih.gov/pubmed/28533136?tool=bestpractice.com [72]Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016 Sep;59(9):1795-805. https://link.springer.com/article/10.1007%2Fs00125-016-4022-4 http://www.ncbi.nlm.nih.gov/pubmed/27364997?tool=bestpractice.com 在临床试验中,已经证明此系统能降低夜间低血糖发生风险并改善血糖控制情况,包括儿童。[73]Phillip M, Battelino T, Atlas E, et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. https://www.nejm.org/doi/full/10.1056/NEJMoa1206881 http://www.ncbi.nlm.nih.gov/pubmed/23445093?tool=bestpractice.com [74]Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. http://www.nejm.org/doi/full/10.1056/NEJMoa1002853#t=article http://www.ncbi.nlm.nih.gov/pubmed/20587585?tool=bestpractice.com [75]Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-17. https://www.doi.org/10.1056/NEJMoa1907863 http://www.ncbi.nlm.nih.gov/pubmed/31618560?tool=bestpractice.com 有些型号配有智能手机应用程序,可用于监测血糖水平和胰岛素给药剂量。传感器和传感器增强型泵的使用越来越多。
提醒患者在同一身体区域内轮换注射部位。英国药品和医疗产品监管署(Medicines and Healthcare products Regulatory Agency, MHRA)建议,这样做是为了防止或减少注射部位发生皮肤淀粉样变性(胰岛素脂肪营养不良)的风险,皮肤淀粉样变性可能会导致糖尿病控制不佳,因为淀粉样物质可导致胰岛素吸收不足。[76]Medicines and Healthcare products Regulatory Agency. Insulins (all types): risk of cutaneous amyloidosis at injection site. Sep 2020 [internet publication]. https://www.gov.uk/drug-safety-update/insulins-all-types-risk-of-cutaneous-amyloidosis-at-injection-site
不应从胰岛素笔装置或卡式瓶中取出胰岛素。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 英格兰 NHS 发出警示称,胰岛素笔装置中胰岛素的强度可能会以 100 单位/mL 的倍数变化,而胰岛素注射器的刻度仅适用于计算标准 100 单位/mL 的剂量。如果从胰岛素笔装置或卡式瓶中提取的胰岛素强度高于预期,而在确定所需量时未考虑到这一点,则可能导致严重且可能致死的过量使用。[77]NHS England. Patent safety alert: Risk of severe harm and death due to withdrawing insulin from pen devices. Dec 2019 [internet publication]. https://www.england.nhs.uk/publication/patent-safety-alert-risk-severe-harm-and-death-withdrawing-insulin-pen-devices
按品牌名称开具胰岛素处方,以确保将胰岛素用药错误风险降至最低。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 有许多“听起来很像”的胰岛素药品,在某些情况下,每种类型的胰岛素有多种不同规格和剂型。[78]Inpatient Diabetes Training and Support (ITS). Insulin and insulin safety.[internet publication]. https://www.inpatientdiabetes.org.uk/insulin-and-insulin-safety
另外,遵循当地关于最大限度降低在高强度、固定组合或胰岛素生物仿制药产品方面出现用药错误风险的指导。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 MHRA: High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error Opens in new window
第一选择
地特胰岛素
或
甘精胰岛素
或
德谷胰岛素
-- 和 --
赖脯胰岛素
或
门冬胰岛素
或
赖谷胰岛素
餐前胰岛素校正剂量
针对特定患者群中部分患者治疗的附加建议
根据餐前血糖水平,可将校正(或调整)剂量胰岛素联合餐时胰岛素使用。在实践中,对于成人而言,计算校正剂量的保守方法是假设 1 U 的胰岛素可使患者的血糖降低 4 mmol/L(72 mg/dL)。如果进餐量固定,还可以用患者的胰岛素每日总剂量(total daily dose, TDD)来计算校正剂量。可将校正剂量添加到患者的餐时胰岛素需求量(基于一般食物份量或碳水化合物含量计算)中,作为总餐时剂量给予。
二甲双胍
针对特定患者群中部分患者治疗的附加建议
如果患者为成人,体重指数(body mass index, BMI)为 25 kg/m² 或更高(南亚人及相关少数民族:23 kg/m² 或更高),并且希望在尽量减少有效胰岛素剂量的同时改善血糖控制,那么可考虑在胰岛素治疗的基础上加用二甲双胍。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17 然而,这种方法的益处一直是争论的话题。[84]What role for metformin in type 1 diabetes? Drug Ther Bull. 2018 Jul;56(7):78-80. https://www.doi.org/10.1136/dtb.2018.7.0645 http://www.ncbi.nlm.nih.gov/pubmed/30008442?tool=bestpractice.com [85]Petrie JR, Chaturvedi N, Ford I, et al; REMOVAL Study Group. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):597-609. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641446 http://www.ncbi.nlm.nih.gov/pubmed/28615149?tool=bestpractice.com
在英国,这是一种超说明书用药。
第一选择
二甲双胍: 成人:500 mg,口服(速释型),每日一次,持续至少 1 周,然后 500 mg,每日两次,持续至少一周,再然后 500 mg,每日 3 次,每日最高剂量 2000 mg
更多 二甲双胍现已有该药的控释制剂。
固定剂量胰岛素(仅限成人)
对于使用固定剂量胰岛素方案已获得良好效果、无法管理每日注射多次方案或无法混合胰岛素的成人患者,使用固定剂量胰岛素治疗。有多种固定剂量胰岛素制剂可供选择;请参考当地药物处方集,以获取相关信息。
妊娠
基础-餐时胰岛素
英国国家卫生与临床优化研究所(National Institute for Health and Care Excellence, NICE)指南建议患有 1 型糖尿病的孕妇达到以下血糖目标(只要能在不引起问题性低血糖的情况下,实现这些目标):空腹 < 5.3 mmol/L(< 95.4 mg/dL);并且餐后 1 小时 < 7.8 mmol/L(< 140.4 mg/dL);或者餐后 2 小时 < 6.4 mmol/L(< 115.2 mg/dL)。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3
建议使用胰岛素的糖尿病孕妇将其毛细血管血糖水平维持在 4 mmol/L(72 mg/dL)以上。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3
在预约就诊时测量所有患有糖尿病孕妇的 HbA1c 水平,以确定妊娠风险水平。考虑在妊娠中期和晚期测量患有糖尿病孕妇的 HbA1c 水平,以评估妊娠风险水平。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 HbA1c 高于 48 mmol/mol(6.5%)时,患有糖尿病孕妇的妊娠风险水平上升。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3
孕妇应每天检测其空腹、餐前、餐后 1 小时及睡前血糖水平。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 在妊娠早期每隔数周监测一次患者情况,以便对营养成分和摄入时间、运动情况和胰岛素剂量进行调整,从而达到最佳血糖控制。胰岛素需求量通常在妊娠早期增加;然后在妊娠约 8 周至 16 周减少,之后再次增加,直到妊娠结束。
使用每日注射多次(multiple daily injection, MDI)方案或胰岛素泵进行强化胰岛素治疗很重要。妊娠期间常用的胰岛素包括等向胰岛素(NPH)、地特胰岛素、中性胰岛素、赖脯胰岛素和门冬胰岛素。[93]Mathiesen ER, Hod M, Ivanisevic M, et al; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. http://care.diabetesjournals.org/content/35/10/2012.long http://www.ncbi.nlm.nih.gov/pubmed/22851598?tool=bestpractice.com 关于 1 型糖尿病孕妇的持续血糖监测的试验(Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial, CONCEPTT)表明,对于 1 型糖尿病女性,在妊娠期间,与仅使用自我血糖监测(self-monitoring of blood glucose, SMBG)相比,使用实时(real-time, RT)CGM 与血糖控制和新生儿结局改善有关。[94]Feig DS, Donovan LE, Corcoy R, et al; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-59. [Erratum in: Lancet. 2017 Nov 25;390(10110):2346.] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32400-5/fulltext http://www.ncbi.nlm.nih.gov/pubmed/28923465?tool=bestpractice.com 在英国,NICE 建议向所有患有 1 型糖尿病的孕妇提供 CGM。对于所有明确表达希望使用瞬感血糖监测和/或不能使用 CGM 的女性,可提供瞬感血糖监测。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 [95]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period [A] Continuous glucose monitoring NICE guideline NG3 Methods, evidence and recommendations. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3/evidence/a-evidence-reviews-for-continuous-glucose-monitoring-pdf-8955770797 英国临床糖尿病专家协会(Association of British Clinical Diabetologists)发布了妊娠期糖尿病技术应用指南。[91]Association of British Clinical Diabetologists. Using diabetes technology in pregnancy. Mar 2020 [internet publication]. https://abcd.care/dtn/best-practice-guides
NICE 建议所有病因糖尿病患者在妊娠期间首选等向胰岛素作为长效胰岛素。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 在实践中,对于已经稳固采用基础-餐时胰岛素给药常规且已经在妊娠前使用长效胰岛素类似物(如地特胰岛素或甘精胰岛素)实现良好血糖控制的 1 型糖尿病女性患者,在妊娠期间继续使用此方案可能更合适。尚无大型随机对照研究支持妊娠糖尿病患者使用甘精胰岛素的安全性。[96]Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet. 2015 Oct;292(4):749-56. https://link.springer.com/article/10.1007%2Fs00404-015-3692-3 http://www.ncbi.nlm.nih.gov/pubmed/25855052?tool=bestpractice.com 不过,甘精胰岛素已在妊娠期被安全地用于许多患者。有限的证据表明,与常规人胰岛素相比,速效胰岛素类似物(门冬胰岛素或赖脯胰岛素)可能与低血糖风险降低和血糖控制改善相关。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 在糖尿病孕妇中比较胰岛素泵治疗(持续皮下胰岛素输注 [CSII])与每日注射多次胰岛素结局的数据很少。[97]Farrar D, Tuffnell DJ, West J, et al. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes. Cochrane Database Syst Rev. 2016;(6):CD005542. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005542.pub3/full http://www.ncbi.nlm.nih.gov/pubmed/27272351?tool=bestpractice.com
第一选择
人低精蛋白锌胰岛素 (insulin isophane human, NPH)
或
地特胰岛素
-- 和 --
中性胰岛素
或
赖脯胰岛素
或
门冬胰岛素
第二选择
甘精胰岛素
-- 和 --
中性胰岛素
或
赖脯胰岛素
或
门冬胰岛素
二甲双胍
针对特定患者群中部分患者治疗的附加建议
在妊娠期间(和孕前阶段),当改善血糖控制带来的可能益处大于潜在危害时,可考虑在胰岛素治疗的基础上加用二甲双胍。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 在除胰岛素缺乏外还存在胰岛素抵抗的女性中,最可能出现这种情况,如果女性体重指数(body mass index, BMI)为 25 kg/m² 或更高(南亚人及相关少数民族:23 kg/m² 或更高),并且希望在尽量减少有效胰岛素剂量的同时改善血糖控制,那么建议考虑采用这种方案。[36]National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. Jul 2021 [internet publication]. https://www.nice.org.uk/guidance/ng17
在英国,这是一种超说明书用药。
第一选择
二甲双胍: 500 mg,口服(速释),每天一次,持续至少 1 周,然后 500 mg,每天两次,持续至少一周,然后 500 mg,每天 3 次,最大剂量 2000 mg/天
更多 二甲双胍现已有该药的控释制剂。
低剂量阿司匹林
针对特定患者群中所有患者的治疗建议
建议患有 1 型糖尿病的孕妇从 12 周开始服用阿司匹林,直至婴儿出生。[90]National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. Dec 2020 [internet publication]. https://www.nice.org.uk/guidance/ng3 [99]National Institute for Health and Care Excellence. Hypertension in pregnancy: diagnosis and management. June 2019 [internet publication]. https://www.nice.org.uk/guidance/ng133 这些女性存在子痫前期高风险。[99]National Institute for Health and Care Excellence. Hypertension in pregnancy: diagnosis and management. June 2019 [internet publication]. https://www.nice.org.uk/guidance/ng133
第一选择
阿司匹林: 75- 150 mg,口服,每日一次
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