【摘要】 目的在口服降糖药（OADs）血糖控制欠佳的中国T2DM患者中,了解起始胰岛素治疗的安全性和疗效。方法 OADs血糖控制欠佳的中国T2DM患者按临床常规起始胰岛素治疗,于基线和治疗16周后分别收集患者的临床数据,主要安全性指标有低血糖事件和药物不良反应的发生情况,主要疗效指标包括HbA1c的变化和达标率、平均FBG和2hBG的变化。结果共观察4847例T2DM患者,女性患者有2327例（48.0%）。完成研究的患者共4364例（90.0%）。基线年龄（59.7±12.2）岁,HbA1c（9.65±2.12）%,糖尿病病程（7.94±6.13）年。起始胰岛素使用比例最高为预混人胰岛素（38.1%）,其次为预混胰岛素类似物（31.3%）。重度低血糖事件的发生率（事件/人年）在基础人胰岛素和类似物组最低（均为0.02）。夜间低血糖发生率在基础-餐时胰岛素类似物组最低（0.27）。治疗后HbA1c降幅为2.3%（P<0.001）,基础-餐时胰岛素类似物组降幅最大（3.02±1.94）%,预混胰岛素类似物组次之（2.61±1.97）%。HbA1c<7.0%的达标率为43.2%。胰岛素治疗后平均FBG和2hBG的降幅分别为3.21 mmol/L和5.21 mmol/L（P<0.001）,均在基础-餐时胰岛素类似物组降幅最大。结论起始胰岛素治疗后T2DM患者整体血糖控制均有显著的改善。基础胰岛素的安全性较好;基础-餐时胰岛素HbA₁c、空腹和餐后血糖的改善情况最佳;预混胰岛素是目前我国T2DM人群最常用的起始治疗胰岛素,其疗效和安全性介于上述两种治疗方案之间,预混胰岛素类似物的无低血糖事件达标率优于其他的常用胰岛素治疗方案。更多还原

【Abstract】 Objective To evaluate the safety and efficacy of initiating insulin therapy in Chinese patients with type 2 diabetes mellitus（T2DM） inadequately controlled with previous oral antidiabetic drugs（OADs）.Methods Insulin therapy was initiated and had been administrated for 16 weeks in Chinese patients with T2DM inadequately controlled with previous OADs.Safety and efficacy data were collected at baseline and at the end of 16 weeks.Results Totally 4847 T2DM patients were enrolled in the study with 2327 females（48.0%）.There were 4364（90.04%） patients who completed both baseline and end-study visits.Enrolled patients had a mean age of 59.7±12.2 years and T2DM duration of 7.94±6.13 years.Prior to the initiation of insulin,mean glycosylated hemoglobin A1c（HbA₁c） was 9.65±2.12%.The proportion of patients using premix human insulin was the highest（38.1%）,followed by premix insulin analogue（31.3%）.The lowest incidence of major hypoglycaemia（0.02 events/person/ year） and nocturnal hypoglycaemia（0.27 events/person year） was observed in patients using basal insulin and basal-bolus insulin analogue respectively.The mean HbA₁c was reduced by 2.3%（P<0.001） after 16 weeks of insulin therapy.The reduction of HbA₁c was the highest in patients with basal-bolus insulin analogue（3.02±1.94%%）,followed by premix insulin analogue（2.61±1.97%%）.The percentage of patients reaching the target HbA₁c<7.0%was 43.2%.The average fasting blood glucose and postprandial blood glucose were reduced by 3.21 mmol/L and 5.21 mmol/L（P<0.001）,respectively, with the highest decrement in patients using basal-bolus insulin analogue.Conclusion The overall glycemic control is significantly improved after 16 weeks of insulin therapy.The patients with basal insulin treatment have the lowest safety concern.The most considerable improvement of HbA₁c,fasting and postprandial blood glucose is observed in patients using basal-bolus insulin.Premix insulin is the most commonly used for initiating insulin therapy in Chinese T2DM patients,and its safety and efficacy are between the above two insulin therapies.The percentages of patients reaching the target HbAiC<7%and≤6.5%without hypoglycaemia in premix insulin analogue treatment group are higher than in other commonly used insulin therapies.更多还原