维格列汀片仿制药品与原研药品治疗2型糖尿病的临床疗效及安全性比较

Comparison of clinical efficacy and safety between generic and original vildagliptin tablets in treatment of type 2 diabetes

目的比较维格列汀片仿制药品(商品名:孚来乐)与原研药品(商品名:佳维乐)对2型糖尿病患者的降糖疗效与安全性,为临床用药提供借鉴参考。方法采用单中心、回顾性真实世界研究,纳入2019年11月13日至2021年11月12日收治的2型糖尿病患者。将入组患者分为集采组(n=112)与原研组(n=103),维格列汀片给药剂量均为50 mg,bid,对比2组患者入组时及治疗3个月后的空腹血糖、餐后血糖、糖化血红蛋白水平及不良反应的发生情况,并行成本-效果分析。结果降糖疗效方面,随访3个月后,2组患者的空腹血糖、餐后血糖均较入组时有所改善,但原研组空腹血糖及餐后血糖均得到了显著降低(P<0.05);2组的糖化血红蛋白水平较入组时均有显著降低(P<0.05)。安全性方面,集采组与原研组不良反应发生率分别为6.25%和6.80%(P>0.05),未发现严重的药物不良反应。成本-效果分析发现,集采组每获得1个单位的疗效需花费5.23元,低于原研组成本17.4元。结论维格列汀片仿制药品治疗2型糖尿病的疗效及安全性不劣于原研药品,且成本-效果比更优。

AIM To compare the hypoglycemic efficacy and safety between generic and original vildagliptin tablets patients with type 2 diabetes,and provide a reference for clinical medication.METHODS A single-center,retrospective real-world study was used to enroll patients with type 2 diabetes who were admitted from November 13,2019 to November 12,2021.The patients were divided into the centralized procurement group and the original research group,and vildagliptin tablets were administered at a dose of 50 mg,bid.The fasting blood glucose,postprandial blood glucose,glycosylated hemoglobin levels,and adverse drug reactions were compared when 2 groups were enrolled and after 3 months of treatment.Cost-effectiveness was analyzed.RESULTS In terms of the effect of hypoglycemic effect,after 3 months of follow-up,the fasting blood glucose and postprandial blood glucose of 2 groups were improved compared with pretreatment,but the fasting blood glucose and postprandial blood glucose of the original research group were significantly reduced(P<0.05).The level of glycosylated hemoglobin in 2 groups was significantly lower than that pre-treatment(P<0.05);in terms of safety,the incidences of adverse drug reactions in the centralized precurement group and the original research group were 6.25%and 6.80%,respective(P>0.05),and no serious adverse drug reactions were found in this study.The cost-effectiveness analysis found that the centralized procurement group costed 5.23 yuan for each unit of curative effect,which was 17.4 yuan lower than the original research group.CONCLUSION The efficacy and safety of generic vildagliptin tablets in the treatment of type 2 diabetes are not inferior to the original vildagliptin tablets,and the cost-effectiveness ratio is better.