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目的:评价天麦消渴片联合门冬胰岛素30治疗口服降糖药物(OAD)失效的Ⅱ型糖尿病(T2DM)的有效性和安全性。方法:将86例OAD失效的T2DM患者停服原用药物并随机分为两组,对照组42例患者给予门冬胰岛素30治疗,治疗组44例患者在对照组基础上联合天麦消渴片治疗。观察治疗前后患者血糖、血脂、C-P、HOMA-IR、HOMA-β的变化及低血糖发生率、胰岛素用量、体重变化。结果:治疗12周后两组患者的FPG、2hPG、HbA1c、TG、TC、LDL-C、FFA、HOMA-IR均显著降低(P<0.05),HDL-C、C-P、HOMA-β显著提高(P<0.01);治疗组TG、TC、LDL-C、HDL-C、FFA、HOMA-IR、C-P、HOMA-β变化幅度更明显,两组间差异显著(P<0.01);治疗组在低血糖发生率、胰岛素用量、体重增加率方面均低于对照组(P<0.01)。结论:天麦消渴片联合门冬胰岛素30治疗OAD失效的Ⅱ型糖尿病在有效地控制血糖、血脂的同时,可减少低血糖的发生率,节约胰岛素的用量,还能改善胰岛β细胞功能。
Objective: To evaluate the efficacy and safety of Tianma Xiaoke Tablet combined with aspart 30 in the treatment of type 2 diabetes mellitus (T2DM) with oral hypoglycemic drugs (OAD) failure. Methods: Eighty-six patients with OAD-refractory T2DM were stopped and randomly divided into two groups. In the control group, 42 patients were treated with insulin aspart 30, and 44 patients in the treatment group were treated with Tianma Diabetes Tablet treatment. The changes of blood glucose, blood lipid, C-P, HOMA-IR, HOMA-β and the incidence of hypoglycemia, insulin dosage and body weight were observed before and after treatment. Results: The levels of FPG, 2hPG, HbA1c, TG, TC, LDL-C, FFA and HOMA-IR of the two groups were significantly decreased (P <0.01). The changes of TG, TC, LDL-C, HDL-C, FFA, HOMA-IR, CP and HOMA-β in the treatment group were more obvious than those in the control group Blood glucose, insulin dosage, weight gain rate were lower than the control group (P <0.01). Conclusion: Tianma Xiaoke tablets combined with insulin aspart 30 in the treatment of type 2 diabetes mellitus with OAD failure can effectively reduce the incidence of hypoglycemia, reduce the dosage of insulin, and improve the function of islet β cells.