天麦消渴片联合门冬胰岛素30治疗口服降糖药失效的Ⅱ型糖尿病疗效及安全性

Efficacy and Safety of Tianmaixiaoke Tablets Plus Insulin Aspart 30 Injection in T2DM Patients with Failure of Glucose Control by Oral Anti-diabetic Drugs

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 tianmaixiaoke tablets plus insulin aspart 30 injection in treating T2DM patients with failure of glucose control by oral anti-diabetic drugs （OAD）. Methods：86 cases of T2DM patients with failure of glucose control by OAD were randomized into two groups , All patients were treated with insulin aspart 30 injection, 44s in the trial group received treatment of tianmaixiaoke tablets at the same time. The blood glucose, blood lipids, C-P, HOMA-IR, HOMA-β, weight, incidence of hypoglycemia, and insulin dose were observed for comparison with before and after treatment. Results：After 12 weeks of treatment, the levels of FPG, 2hPG, HbA1c, HOMA-IR, TG, TC, LDL-C, FFA were decreased significantly （ all P〈 0.05） ,while the HDL-C,C-P, HOMA-β was increased （P〈0.01）. the difference of the levels of TG,TC,LDL-C, HDL-C,FFA,CP, HOMA-IR and HOMA-βbetween the two groups was significant in statistics （P〈0.01） ;however , the insulin dose , the incidence of hypoglycemia, and weight increase were all less in the trial group than in the control group （P〈0.01）. Conclusion：The treatment with tianmaixiaoke tablets plus insulin aspart 30 injection is effective and safe for T2DM patients. It is superior in low incidence of hypoglycemia, save insulin and being able to improve islet/3cell function.