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目的评价聚乙二醇洛塞那肽注射液连续给药14周对2型糖尿病患者的安全性、耐受性。方法采用多中心、双盲、随机、平行组对照的设计。将符合条件的63例2型糖尿病患者按照随机原则平均分为3个剂量组。100μg组每周皮下注射100μg剂量,连续给药14周;200μg及300μg组第1、2周皮下注射100μg剂量,第3周起皮下注射200μg或300μg剂量,连续给药12周。结果聚乙二醇洛塞那肽注射液100、200和300μg组的总体不良反应发生率分别为52.38%、61.90%、90.38%,呈明显剂量依赖性,其中300μg组的不良反应发生率显著高于100μg组(P<0.05)。100~300μg剂量下胃肠道的不良反应发生率和严重程度也呈剂量依赖性递增趋势,并可随治疗时间的延长逐步减轻。结论聚乙二醇洛塞那肽注射液连续给药14周的安全性、耐受性良好。
Objective To evaluate the safety and tolerability of injecting loxane peginide injection for 14 weeks in type 2 diabetic patients. Methods A multicenter, double-blind, randomized, parallel-group control design was used. Sixty-three eligible patients with type 2 diabetes were divided equally into three dose groups according to the randomized principle. The 100μg group was subcutaneously injected with 100μg subcutaneously every week for 14 weeks. The 200μg and 300μg subcutaneously injected 100μg subcutaneously in the first and second week and the subcutaneous injection 200μg or 300μg subcutaneously in the third week for 12 weeks. Results The incidence rates of adverse reactions in 100,200 and 300 μg PEGycine injection groups were 52.38%, 61.90% and 90.38%, respectively, in a dose-dependent manner. The incidence of adverse reactions in 300 μg group was significantly higher In the 100 μg group (P <0.05). The incidence and severity of adverse reactions in the gastrointestinal tract at doses of 100-300μg also increased in a dose-dependent manner and gradually decreased with the prolongation of treatment time. Conclusions The injection of lorazanide polyethylene glycol injection continuously for 14 weeks is safe and well tolerated.