摘要
目的探讨聚乙二醇洛塞那肽(PEX-168)注射液治疗2型糖尿病的有效性及安全性。方法选取2018年8月—2019年8月于新疆医科大学第一附属医院诊断为2型糖尿病的患者60例为研究对象,依据随机数字表法分为L组和C组,每组各30例。C组口服二甲双胍片0.5 g/次,2次/d;阿卡波糖25 mg/次,2~3次/d。L组在C组基础上于治疗期内每周于上臂皮下注射(PEX-168)0.5 mL/支,1次/周,持续12周。治疗期结束后4周,检测患者空腹血糖、餐后2 h血糖和糖化血红蛋白(HbA1c)及体重指数(BMI)。记录试验全程两组低血糖、恶心、呕吐、腹部不适、头痛等不良反应发生情况。结果L组治疗后空腹血糖、餐后2 h血糖、HbA1c及BMI显著低于治疗前,差异有统计学意义(P<0.05)。L组治疗后空腹血糖、餐后2 h血糖、HbA1c及BMI显著低于C组,差异有统计学意义(P<0.05)。L组治疗后HbA1c<7.0%人数多于C组,差异有统计学意义(P<0.05)。两组低血糖、头痛、呕吐、腹部不适发生率比较,差异无统计学意义(P>0.05)。结论PEX-168注射液在治疗2型糖尿病方面具有较高的有效性和安全性,但在使用过程中应当注意观察患者胃肠道反应。
Objective To investigate the efficacy and safety of Polyethylene Glycol Loxenatide Injection(PEX-168)injection in the treatment of type 2 diabetes.Methods A total of 60 patients with type 2 diabetes mellitus in our hospital from August 2018 to August 2019 were randomly divided into two groups,they were divided into the L group and C group according to the random number table,with 30 cases in each group.Group C was given Metformin tablet 0.5 g/time,twice a day;Acarbose 25 mg/time,2-3 times/day.Patients in group L were subcutaneously injected with PEX-1680.5 ml/dose in the upper arm once a week for 12 weeks on the basis of group C during the treatment period.Four weeks after the end of the treatment period,fasting blood glucose,2 h postprandial blood glucose and hemoglobin ALC(HbA1c)and bady mass index(BMI)were measured.The occurrence of adverse reactions such as hypoglycemia,nausea,vomiting,abdominal discomfort and headache in the two groups were recorded.Results The fasting blood glucose,2 h postprandial blood glucose,HbA1c and BMI of the L group were significantly lower after treatment than before,with statistically significant differences(P<0.05).Fasting blood glucose,2 h postprandial glucose,HbA1c and BMI in the L group were significantly lower than those in the C group after treatment,with statistically significant differences(P<0.05).After treatment,the number of patients in group L with HbA1c<7.0%was significantly more than that in group C,with a statistically significant difference(P<0.05).There was no significant difference in the incidence of hypoglycemia,headache,vomiting and abdominal discomfort between the two groups(P>0.05).Conclusion PEX-168 Injections has high efficacy and safety in the treatment of type 2 diabetes,but the gastrointestinal reactions of patients should be observed.
作者
李蕾
王飞
李敏
蒋升
LI Lei;WANG Fei;LI Min;JIANG Sheng(Department of Endocrinology,First Affiliated Hospital of Xinjiang Medical University,Xinjiang Uygur Autonomous Region,Urumqi 830054,China;Department of Endocrinology,Ingisha People’s Hospital,Xinjiang Uygur Autonomous Region,Ingisha 844500,China)
出处
《中国医药导报》
CAS
2021年第18期68-71,共4页
China Medical Herald
基金
新疆维吾尔自治区自然科学基金资助项目(2020D01A128)。
关键词
聚乙二醇洛塞那肽
2型糖尿病
随机对照试验
Polyethylene Glycol Loxenatide Injection
Type 2 diabetes mellitus
Randomized controlled trial
