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目的:评价利拉鲁肽和甘精胰岛素治疗2型糖尿病(T2DM)的临床疗效,并进行药物经济学分析,为治疗T2DM提供经济、合理的治疗方案。方法:将80例T2DM患者按照随机数字表法分为利拉鲁肽组和甘精胰岛素组,各40例。两组患者在停用原治疗方案的其他口服降糖药后,给予盐酸二甲双胍缓释片口服,0.5~2.0 g/d,并给予糖尿病膳食和运动训练指导。在此基础上,利拉鲁肽组患者给予利拉鲁肽注射液皮下注射,每次0.6~1.2 mg,qd;甘精胰岛素组患者于每晚22:00给予甘精胰岛素皮下注射,起始剂量为0.2 IU/(kg·d),两组患者均根据餐后血糖、空腹及夜间血糖水平调整用量,直至患者的空腹血糖(FBG)≤7 mmo1/L、餐后2 h血糖(2 h PG)≤10 mmol/L。两组疗程均为12周。观察两组患者治疗前后FBG、2 h PG、糖化血红蛋白(HbA1c)和体质量指数(BMI)的变化。采用最小成本分析法对两种药物治疗方案进行比较评价。结果:治疗后两组患者的FBG、2 h PG、HbA1c水平均较治疗前明显下降,差异均有统计学意义(P<0.05),但组间比较差异无统计学意义(P>0.05)。治疗后利拉鲁肽组患者的BMI较治疗前及甘精胰岛素组明显降低,差异均有统计学意义(P<0.05);甘精胰岛素组患者的BMI治疗前后比较差异无统计学意义(P>0.05)。最小成本分析结果显示,甘精胰岛素组方案在降低FBG、2 h PG和HbAlc方面所需成本均小于利拉鲁肽组,但在降低BMI方面所需成本则大于利拉鲁肽组。敏感度分析结果验证了最小成本分析结果的稳定性和可靠性。结论:利拉鲁肽和甘精胰岛素具有基本相当的临床疗效,但甘精胰岛素在控制血糖水平方面具有较佳的成本优势,而利拉鲁肽是控制体质量较佳的治疗方案。
OBJECTIVE: To evaluate the clinical efficacy of liraglutide and insulin glargine in the treatment of type 2 diabetes mellitus (T2DM) and conduct pharmacoeconomic analysis, and to provide economical and reasonable T2DM treatment plan. METHODS: 80 T2DM patients were randomized into liraglutide group and insulin glargine group, with 40 cases in each group. Both groups were given Metformin hydrochloride sustained-release tablet orally 0.5-2.0 g/d, and diabetes mellitus diet and sport training guide after oral antidiabetic drug withdrawal of previous treatment plan. Liraglutide group was given Liraglutide injection hypodermically, 0.6-1.2 mg, qd; insulin glargine group was given insulin glargine hypodermically at 22 o’clock, initial dose of 0.2 IU/(kg·d), adjusted according to the levels of PG, FBG, nocturnal blood glucose level till FBG≤7 mmo1/L and 2 h PG ≤10 mmol/L in both group. Treatment course of 2 groups lasted for 12 weeks. The changes of FBG, 2 h PG, HbA1c and BMI were observed in 2 groups before and after treatment. 2 therapy plans were evaluated and compared by cost-minimization analysis. RESULTS: After treatment, the levels of FBG, 2 h PG and HbA1c decreased significantly in 2 groups, compared to before treatment, with statistical significance (P<0.05), but there was no statistical significant difference between 2 groups (P>0.05). After treatment, BMI of liraglutide group decreased significantly compared with before treatment and insulin glargine group, with statistical significance (P<0.05). There was no statistical significant difference in BMI of insulin glargine group before and after treatment (P>0.05). Cost-minimization analysis showed that the cost of insulin glargine group in reducing FBG, 2 h PG and HbA1c were less than liraglutide group, but were more than liraglutide group in reducing BMI. ?Sensitivity analysis demonstrated the stability and reliability of cost-minimization analysis. CONCLUSIONS: Liraglutide and insulin glargine have the same clinical efficacy, but insulin glargine need lower cost in blood glucose control, and liraglutide is better therapy plan for body weight control.
2型糖尿病利拉鲁肽甘精胰岛素最小成本分析血糖体质量
Type 2 diabetes mellitusliraglutideInsulin glargineCost-minimization analysisBlood glucoseBody weight
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