Li Feng-Fei, Xu Xiao-Hua, Fu Li-Yuan, Su Xiao-Fei, Wu Jin-Dan, Lu Chun-Feng, Ye Lei, Ma Jian-Hua
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210012, China.
Nanjing University of Chinese Medicine, Nanjing 210023, China.
Int J Endocrinol. 2015;2015:903524. doi: 10.1155/2015/903524. Epub 2015 Nov 11.
Background and Aims. To evaluate the effect of adding acarbose on glycemic excursions measured by continuous glucose monitoring system (CGMS) in patients with type 2 diabetes mellitus (T2DM) already on insulin therapy. Materials and Methods. This was an opened and unblended study. 134 patients with T2DM were recruited. After initial rapidly corrected hyperglycaemia by continuous subcutaneous insulin infusion (CSII) for 7 d, a 4-6-day premixed insulin titration period subsequently followed. Patients were then randomized 1 : 1 to acarbose plus insulin group or insulin therapy group for 2 weeks. CGMS was used to measure glucose fluctuations for at least 3 days after therapy cessation. Results. Patients in acarbose plus insulin group achieved a significant improvement of MAGE compared to that of insulin therapy only group (5.56 ± 2.16 versus 7.50 ± 3.28 mmol/L, P = 0.044), accompanied by a significant decrease in the incremental AUC of plasma glucose concentration above 10.0 mmol/L (0.5 [0.03, 0.9] versus 0.85 [0.23,1.4] mmol/L per day, P = 0.037). Conclusions. Add-on acarbose to insulin therapy further improves glucose fluctuation in patients with T2DM. This study was registered with ClinicalTrials.gov registration number ChiCTR-TRC-11001218.
背景与目的。评估在已接受胰岛素治疗的2型糖尿病（T2DM）患者中，加用阿卡波糖对通过连续血糖监测系统（CGMS）测量的血糖波动的影响。材料与方法。这是一项开放、非盲法研究。招募了134例T2DM患者。最初通过持续皮下胰岛素输注（CSII）快速纠正高血糖7天，随后是4 - 6天的预混胰岛素滴定期。然后患者按1∶1随机分为阿卡波糖加胰岛素组或胰岛素治疗组，为期2周。在治疗停止后，使用CGMS测量至少3天的血糖波动。结果。与仅接受胰岛素治疗组相比，阿卡波糖加胰岛素组患者的平均血糖波动幅度（MAGE）有显著改善（5.56±2.16对7.50±3.28 mmol/L，P = 0.044），同时血浆葡萄糖浓度高于10.0 mmol/L的增量曲线下面积（AUC）显著降低（0.5 [0.03, 0.9]对0.85 [0.23, 1.4] mmol/L/天，P = 0.037）。结论。胰岛素治疗中加用阿卡波糖可进一步改善T2DM患者的血糖波动。本研究已在ClinicalTrials.gov注册，注册号为ChiCTR - TRC - 11001218。
