诺和锐(R)30治疗2型糖尿病有效性和安全性研究——PRESENT大型临床观察研究中国区结果报道

目的 PRESENT(Physicians' Routine Evaluation of Safety and Efficacv of NovoMixR 30Therapy)为多中心、前瞻性、开放性国际多中心临床观察研究,目的 是评价口服药降糖控制不良的2型糖尿病患者使用预混人胰岛素类似物(诺和锐R 30)的有效性、安全性和治疗满意度.本研究来源于PRESENT中国区研究结果.方法 共4754例以往使用口服降糖药治疗的2型糖尿病患者参与了本研究.参与研究的医生按照产品说明书处方诺和锐R 30特充R,并在基线和治疗后3个月分别收集患者的临床数据.结果 患者基线平均HbA1c(9.09±1.70)%,体重指数(BMI)为(24.30±2.68)kg/m2,年龄(54.63±10.94)岁,糖尿病病程(5.46±4.17)年.治疗开始和3个月后,诺和锐R 30平均日剂量分别为(0.43±0.14)U/kg和(0.48±0.15)U/kg.3个月后,平均HbA1c、空腹血糖(FPG)和餐后血糖(PPG)显著降低分别下降(2.04±1.57)%、(3.51±2.55)mmoL/L、(6.51±4.02)mmol/L,均P<0.01],49.4%的患者达到HbA1c<7%的治疗标准.总体低血糖事件(件/患者年)从基线时10.098下降至3.810,重度低血糖事件从0.787下降至0.126,夜间低血糖事件从2.356下降至0.547.与以往治疗相比,超过99%的医生和患者对使用诺和锐R 30特充R治疗表示"满意"或"非常满意".结论 口服降糖药血糖控制不良的2型糖尿病患者,使用诺和锐R 30特充R可有效改善血糖控制水平,提高治疗达标率,同时降低低血糖发生风险.

Study on efficacy and safety of using NovoMix 30 for type 2 diabetes: result from China cohort in PRESENT study

Objective The PRESENT ( Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy) study is a multinational clinical experience program to report the efficacy, safety and acceptability of NovoMix 30 (BlAsp 30) in patients with type 2 diabetes mellitus inadequately controlled with oral antidiabetic drugs (OADs). Methods A total of 4 754 type 2 diabetes patients inadequately controlled with oral antidiabetic drugs were enrolled in the study. All patients were prescribed BIAsp 30 in accordance with the approved labeling. Data were collected at baseline and at the end of 3 months treatment. Results The mean HbA1c, body mass index (BMI), age, and duration were (9.09±1.70)%, (24.30±2.68)kg/m2, (54.63±10.94)years, and (5.46 ±4.17) years separately. The mean daily dose was (0.43±0.14) U/kg at treatment initiation and (0.48±0.15) U/kg after 3 months treatment. After 3 months, the mean HbA1c, fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) were significantly reduced from baseline levels. The mean HbA1c decreased by (2.04± 1.57)%, FPG by a (3.51±2.55)retool/L, and PPG by a (6.51±4.02) mmol/L (all P<0.01). A significant proportion (49.4%) of the patients achieved target HbA1c of ≤7%. The overall rate of hypoglycaemic episodes (events/patient-yr) decreased from 10. 098 at baseline to 3. 810 at study end. The rate of major hypoglycaemia decreased from 0. 787 to 0.126, and the rate of nocturnal hypoglycaemia decreased from 2.356 to 0.547. Compared with previous treatment, more than 99% of the patients and physicians were "satisfied" or "very satisfied" with BIAsp 30 treatment. Conclusions BIAsp 30 was found to be safe and effective to improve the glycaemia control of type 2 diabetes inadequately controlled with OADs in routine clinical practice.