ADA 2013：纪立农认为ORBIT研究示中国T2DM患者胰岛素治疗不及时

    2013年第73届美国糖尿病协会科学年会(ADA2013)于6月21日~25日在美国芝加哥隆重举办，在ADA2013年会上，北京大学第一医院纪立农教授有5篇中国研究入选壁报讨论(2篇 General Poster Sessions)和会议摘要(3篇 Published Only)。其中一篇会议摘要题目为“中国ORBIT研究的设计及9760位患者的基线资料：在真实世界中评价口服药物失效的2型糖尿病患者使用基础胰岛素的安全性和有效性，一项前瞻性观察性注册研究”，ORBIT研究的部分基础资料显示中国2型糖尿病患者推迟使用胰岛素治疗的现象十分普遍。
　　中国ORBIT研究的设计及9760位患者的基线资料：在真实世界中评价口服药物失效的2型糖尿病患者使用基础胰岛素的安全性和有效性，一项前瞻性观察性注册研究。
　　在美国糖尿病学会和中国糖尿病学会的指南中，基础胰岛素治疗是口服降糖药物糖化血红蛋白不能达标的患者的推荐之选。不能及时足量的使用基础胰岛素是血糖控制不佳的重要原因之一。基础胰岛素治疗的观察性注册研究(ORBIT)旨在评价真实世界中开始基础胰岛素治疗的安全性和有效性，以及其影响因素。
　　ORBIT是一个为期6个月的多中心前瞻性观察性注册研究。中国8个地区的200家医院参与研究(100家二级医院和100家三级医院)。大约20000名口服降糖药物血糖控制不良并愿意接受胰岛素治疗的患者进入研究，入组时间12个月。在基线、3个月和6个月各随访一次。
　　截止2012年10月31日，207间医院共纳入9760位患者(二级医院4772位，三级医院4988位)。52.7%为男性，平均年龄为54.6±9.9岁。平均体重指数24.7±3.4  kg/m2。根据基线资料，大多数开始基础胰岛素治疗的患者其糖化血红蛋白和空腹血糖均较高，平均糖化血红蛋白为9.6%，空腹血糖为11.7mmol/L。55.5%的患者糖化血红蛋白大于等于9%,49.2%的患者空腹血糖大于等于11.7mmol/L。在开始基础胰岛素治疗的阶段，71.2%的患者加用口服降糖药物，13.8%的患者加用餐前胰岛素，9.4%的患者为三者合用，5.7%的患者单用胰岛素。初始基础胰岛素的剂量是0.18±0.08U/kg/day。
　　ORBIT研究的部分基础资料显示中国2型糖尿病患者推迟使用胰岛素治疗的现象十分普遍。

【研究摘要】
Design and Baseline Data of 9760 Study Subjects in ORBIT Study: A  Prospective Observational Registry Study on Safety and Effectiveness of  Initializing Basal Insulin in Type 2 Diabetic Patients Uncontrolled by Oral  Antidiabetic Drugs in Real-World Setting in China

Linong Ji MD, Peking University

In both ADA and China Diabetes Society guideline Basal Insulin (BI) therapy  is recommended when the target HbA1c is not achieved with oral hypoglycemia  agents. Using BI untimely or inadequately has been indicated as one of the  causes of ineffective glycemic control. The observational registry for basal  insulin treatment (ORBIT) study is therefore designed to evaluate the safety  effectiveness of intializating BI in real world practice in China and to explore  the impact factors associated with safety and effectiveness of BI treatment.

ORBIT is a 6-month multi-centre observational prospective registry study. Two  hundred hospitals (100 secondary and 100 tertiary) in 8 regions of China will  take part in this study. About 20 000 patients with T2DM who are inadequately  controlled with OADs and willing to accept BI treatment will be consecutively  enrolled during a 12-month period. For each participant interviews will be  conducted at baseline (0 month) 3 month and 6 month.
Up to October 31 2012 207 hospitals have joined the study and recruited 9760  T2DM patients (4772 in secondary and 4988 in tertiary hospitals). 52.7% were  male. The average age was 54.6±9.9 years. The body mass index was 24.7±3.4  kg/m2. According to the baseline data in China most T2DM patients have had high  level of HbA1c and fast plasma glucose (FPG) before they are ready to initiate  basal insulin. The average HbA1c was 9.6% while the average FPG was 11.7mmol/L.  There were 55.5% patients with HbA1c >=9% and 49.2% patients with  FPG>=11mmol/L. At the initial stage of BI treatment 71.2% patients were  prescribed BI+OAD 13.8% BI+prandial insulin 9.4% BI+prandial insulin+OAD 5.7% BI  alone. The initial dose of BI was 0.18±0.08U/kg/day.

The partial baseline data of ORBIT study showed that the delay of insulin  treatment was very common in T2DM patients.