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目的:评价甘精胰岛素与控释格列吡嗪(瑞易宁)联合应用治疗2型糖尿病患者的有效性和安全性。方法:采用随机、开放、低精蛋白锌胰岛素注射液(诺和灵N)平行对照和多中心临床研究方法,对471例服用口服降糖药(OHA)至少3个月而血糖控制不佳(FBG≥7.0mmol_L)的2型糖尿病患者随机进行试验药-甘精胰岛素或对照药-诺和灵N治疗,随访5次共12周。结果:治疗12周时,甘精胰岛素组与诺和灵N组的胰岛素平均每天用量分别为19.21单位和18.68单位,平均空腹血糖分别从入选时10.63mmol_L和10.88mmol_L降至6.96mmol_L和7.20mmol_L,HbA1c分别下降了0.96%和1.25%。甘精胰岛素组和诺和灵N组分别有21.25%(75_353)和28.81%(34_118)的受试者发生低血糖(P=0.0919),其中发生夜间低血糖的受试者分别占9.07%(32_353)和16.10%(19_118)(P=0.0334)。以低血糖的发生例次作为观察指标时,甘精胰岛素组和诺和灵N组分别有174例次和75例次,其中夜间低血糖分别有54例次和44例次,两组均没有严重低血糖事件。结论:12周的临床观察显示,睡前注射一次甘精胰岛素和清晨口服5mg瑞易宁联合应用的治疗方法可使单纯使用口服降糖药而代谢控制不佳的2型糖尿病患者得到良好的血糖控制;以HbA1c和空腹血糖水平作为判断指标,甘精胰岛素和诺和灵N分别与瑞易宁联合应用两种治疗方法对2型糖尿病患者治疗效果相当,但前者夜间低血糖事件发生率低;同时,甘精胰岛素(睡前1次)与瑞易宁联合应用的治疗方法具有良好的耐受性。
Objective: To evaluate the efficacy and safety of insulin glargine combined with controlled release glipizide in the treatment of type 2 diabetes. METHODS: Randomized, open, and hypophosphatemic insulin injection (noradrenaline N) was used in parallel and multicenter clinical trials to control blood glucose levels in 471 patients taking oral hypoglycemic agents (OHA) for at least 3 months FBG≥7.0mmol_L) type 2 diabetic patients randomized to test drugs - insulin glargine or control drug - Novolin N treatment, followed up 5 times for 12 weeks. Results: At 12 weeks of treatment, the mean daily insulin doses of insulin glargine and noradrenol were 19.21 units and 18.68 units, respectively. The average fasting blood glucose decreased from 10.63 mmol_L and 10.88 mmol_L to 6.96 mmol L and 7.20 mmol L, HbA1c decreased by 0.96% and 1.25% respectively. Hypoglycemia (P = 0.0919) occurred in 21.25% (75_353) and 28.81% (34_118) subjects in the insulin glargine and norepinephrine groups, respectively, with nocturnal hypoglycemia subjects accounting for 9.07% 32_353) and 16.10% (19_118) (P = 0.0334). In the hypoglycemic episode as the observation index, there were 174 cases and 75 cases respectively in the insulin glargine group and noradrenon N group, of which 54 cases were nighttime hypoglycemia and 44 cases were nighttime, Severe hypoglycemia. Conclusions: A 12-week clinical observation showed that good blood glucose was obtained in patients with type 2 diabetes mellitus who were only receiving oral hypoglycemic agents and those with poor metabolic control, when a bedtime injection of insulin glargine combined with oral administration of 5 mg of rifampicin early in the morning Control; HbA1c and fasting blood glucose levels as a judge index, glargine and norepinephrine were used in combination with riui Ning two kinds of treatment for type 2 diabetes treatment, but the former low incidence of nocturnal hypoglycemia; At the same time, insulin glargine (bedtime 1) and Rui Yi Ning combination of the treatment method has good tolerance.