The current status of treatment-related severe hypoglycemia in Japanese patients with diabetes mellitus: A report from the committee on a survey of severe hypoglycemia in the Japan Diabetes Society.

The current status of treatment-related severe hypoglycemia in Japanese patients with diabetes mellitus: A report from the committee on a survey of severe hypoglycemia in the Japan Diabetes Society.
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DOI:
10.1111/jdi.12790
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发表时间:
2018-03-02
影响因子:
3.2
通讯作者:
Japan Diabetes Society (JDS) Committee for Surveys on Severe Hypoglycemia
Japan Diabetes Society (JDS) Committee for Surveys on Severe Hypoglycemia
中科院分区:
医学3区
文献类型:
--
作者:
Namba M;Iwakura T;Nishimura R;Akazawa K;Matsuhisa M;Atsumi Y;Satoh J;Yamauchi T;Japan Diabetes Society (JDS) Committee for Surveys on Severe Hypoglycemia

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尽管糖尿病药物治疗取得了巨大进步,但随着年龄的增长,接受药物治疗的糖尿病患者发生低血糖的风险越来越受到关注。这促使日本糖尿病学会(JDS)发起了一项关于临床环境中严重低血糖症现状的调查。2015年7月,经JDS科学调查/研究伦理委员会批准,JDS邀请代表JDS认可的631家医疗机构的执行教育工作者参加拟议的调查。其中,向那些表示愿意参与调查的人发送了一份申请表,要求他们在这些医疗机构获得伦理批准,然后在获得批准后,要求他们在基于网络的注册中心以无链接、匿名的方式输入相关临床数据。目前的调查完全由JDS科学调查/研究委员会资助。从所有参与机构收集机构特定信息(医疗机构数据库)并获得所有参与患者的知情同意后,启动病例登记(临床病例数据库)。重度低血糖定义为"存在低血糖症状,需要他人帮助治疗,最好在疾病发作/诊断时或就诊时静脉血糖水平明显低于60 mg/dL(毛细血管全血葡萄糖,低于50 mg/dL)”,目前的调查是在2014年4月1日至2015年3月31日之间进行的,在此期间,共从193家机构收集了机构特定信息,共从113家机构收集了798份病例报告。在193家受访机构中,有149家机构也设有急诊科,每年需要紧急运输服务到达这些机构的患者中位数为4,962人,其中严重低血糖患者占0.34%(17)。答复机构每年共收治2,237名严重低血糖患者,因此每个中心收治的患者人数为6.5人。共有1,171例患者因重度低血糖入院,每个研究中心因此入院的患者数量为4.0例,占每年因重度低血糖就诊的所有患者的52.3%。对调查期间收集的798例病例报告的回顾显示,分别有240例、480例和78例患者患有1型糖尿病、2型糖尿病和其他类型的糖尿病; 2型糖尿病患者的年龄要大得多(中位数[四分位距],77.0 [68.0 - 83.0])(54.0 [41.0 - 67.0])(P <0.001);而2型糖尿病患者的体重指数明显更高(22.0 [19.5 - 24.8] kg/m2)高于1型糖尿病患者(21.3 [18.9 - 24.0] kg/m2)(P = 0.003)。2型糖尿病患者的肾小球滤过率(eGFR)中位数(50.6 mL [31.8 - 71.1]/min/1.73 m2)显著低于1型糖尿病患者(73.3 [53.5 - 91.1] mL/min/1.73 m2)(P <0.001)。同样,重度低血糖发作时的中位HbA1c值为7.0(6.3 - 8.1)%,占所有检查患者的7.5(6.9 - 8.6)%的1型糖尿病患者和6.8(6.1 - 7.6)%的2型糖尿病患者,2型糖尿病患者发生低血糖时的HbA1c值明显低于对照组(P <0.001)。在所有患者中,分别有35.5%、35.6%和28.9%的患者存在、不存在和未知重度低血糖的前驱症状,1型糖尿病患者(41.0%)的症状性低血糖发生率显著低于2型糖尿病患者(56.9%)。2型糖尿病患者使用的降糖药物为胰岛素制剂(292例患者,包括29例合并磺脲类药物[SU])(60. 8%)、SU(159例胰岛素初治患者)(33. 1%)和非胰岛素制剂或SU(29例患者)(6. 0%)。在接受调查的798名患者中,296名患者(37.2%)之前曾因严重低血糖需要紧急运输服务。因此,该调查首次揭示了日本治疗相关重度低血糖的现状,并明确强调迫切需要实施低血糖预防措施,不仅通过低血糖教育,还通过优化重度低血糖高风险患者或有重度低血糖病史患者的降糖治疗。
Despite great strides in pharmacotherapy for diabetes, there is increasing concern over the risk of hypoglycemia in patients with diabetes receiving pharmacotherapy as they become increasingly older. This has prompted the Japan Diabetes Society (JDS) to initiate a survey on the current status of severe hypoglycemia in clinical settings. In July 2015, following approval from the JDS Scientific Survey/Research Ethics Committee, the JDS extended an invitation to executive educators, who represented a total of 631 healthcare facilities accredited by the JDS for diabetes education, to participate in the proposed survey. Of these, those who expressed their willingness to participate in the survey were sent an application form required for obtaining ethical approval at these healthcare facilities and were then asked, following approval, to enter relevant clinical data on an unlinked, anonymous basis in a web‐based registry. The current survey was fully funded by the JDS Scientific Survey/Research Committee. A case registry (clinical case database) was launched after facility‐specific information (healthcare facility database) was collected from all participating facilities and after informed consent was obtained from all participating patients. With severe hypoglycemia defined as the “presence of hypoglycemic symptoms requiring assistance from another person to treat and preferably venous plasma glucose levels at onset/diagnosis of disease or at presentation clearly less than 60 mg/dL (capillary whole blood glucose, less than 50 mg/dL)”, the current survey was conducted between April 1, 2014 and March 31, 2015, during which facility‐specific information was collected from a total of 193 facilities with a total of 798 case reports collected from 113 facilities. Of the 193 respondent facilities, 149 reported having an emergency department as well, with the median number of patients who required emergency transportation services to reach these facilities totaling 4,962 annually, of which those with severe hypoglycemia accounted for 0.34% (17). The respondent facilities accommodated a total of 2,237 patients with severe hypoglycemia annually, with the number of patients thus accommodated being 6.5 patients per site. A total of 1,171 patients were admitted for severe hypoglycemia, with the number of patients thus admitted being 4.0 per site, who accounted for 52.3% of all patients visiting annually for severe hypoglycemia. A review of the 798 case reports collected during the survey revealed that 240, 480 and 78 patients had type 1 diabetes, type 2 diabetes, and other types of diabetes, respectively; those with type 2 diabetes were shown to be significantly older (median [interquartile range], 77.0 [68.0–83.0]) than those with type 1 diabetes (54.0 [41.0–67.0]) (P < 0.001); and the BMI was shown to be significantly higher for those with type 2 diabetes (22.0 [19.5–24.8] kg/m2) than for those with type 1 diabetes (21.3 [18.9–24.0] kg/m2) (P = 0.003). It was also found that the median estimated glomerular filtration rate (eGFR) was significantly lower among those with type 2 diabetes (50.6 mL [31.8–71.1]/min/1.73 m2) than among those with type 1 diabetes (73.3 [53.5–91.1] mL/min/1.73 m2) (P < 0.001). Again, the median HbA1c value at onset of severe hypoglycemia was shown to be 7.0 (6.3–8.1)% among all patients examined, 7.5 (6.9–8.6)% among those with type 1 diabetes, and 6.8 (6.1–7.6)% among those with type 2 diabetes, with the HbA1c value at onset of hypoglycemia being significantly lower among those with type 2 diabetes (P < 0.001). Antecedent symptoms of severe hypoglycemia were shown to be present, absent and unknown in 35.5, 35.6, and 28.9% of all patients, respectively, with the incidence of symptomatic hypoglycemia being significantly lower among those with type 1 diabetes (41.0%) than among those with type 2 diabetes (56.9%). The antidiabetic agents used in those with type 2 diabetes were insulin preparations (292 patients including 29 receiving concomitant sulfonylureas [SUs]) (60.8%), SUs (159 insulin‐naïve patients) (33.1%), and no insulin preparations or SUs (29 patients) (6.0%). Of the 798 patients surveyed, 296 patients (37.2%) were shown to have required emergency transportation services for severe hypoglycemia before. Thus, the survey revealed, for the first time, the current status of treatment‐related severe hypoglycemia in Japan and clearly highlights the acute need for implementing preventive measures against hypoglycemia not only through education on hypoglycemia but through optimization of antidiabetic therapy for those at high risk of severe hypoglycemia or those with a history of severe hypoglycemia.
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