聚乙二醇洛塞那肽注射液联合二甲双胍对2型糖尿病患者的疗效

Curative effect of polyethylene glycol loxenatide injection combined with metformin in patients with type 2 diabetes mellitus

目的观察聚乙二醇洛塞那肽注射液(PEX168)联合二甲双胍对2型糖尿病患者的降糖疗效,并初步评价其安全性。方法纳入2012年11月~2014年1月于陆军总医院干四科就诊的2型糖尿病患者36例,其中男性26例,女性10例,年龄41~65岁,平均年龄(53.6±9.9)岁。采用随机、双盲、平行对照试验设计,将所有患者分为:安慰剂组(11例)、PEX168-100μg组(13例)和PEX168-200μg组(12例)。用药12周,后随访4周。观察治疗前和随访4周后各组患者的糖化血红蛋白(HbA1c)、空腹血糖(FBG)和餐后2h血糖(2h PBG)的变化及药物不良反应的发生情况。结果治疗12周后,PEX168-100μg组和PEX168-200μg组FBG、2hPBG以及HbA1c较治疗前明显下降,差异有统计学意义(P均<0.05)。与安慰剂组治疗后比较,.PEX 168-100μg组和PEX168-200μg组FBG、2h PBG以及HbA1c下降更明显,差异有统计学意义(P均<0.05)。PEX 168-100μg组有1例(7.7%)发生恶心;PEX168-200μg组有2例(16.7%)发生恶心,1例(8.3%)发生头痛,症状均随用药时间的延长而自行改善。所有患者未有低血糖、肝肾功能异常和胰腺炎等不良反应发生。结论聚乙二醇洛塞那肽注射液能有效地降低2型糖尿病患者的血糖,初步观察具有良好的安全性及耐受性,可为今后的临床应用提供参考。但本研究病例数有限,今后需大样本的观察研究。

Objective To observe the curative effect of lowering blood sugar of polyethylene glycol loxenatide injection （PEX168） combined with metformin in patients with type 2 diabetes mellitus （T2DM）, and review the safety. Methods The patients （n=36, male 26, female 10, aged from 41 to 65 and average age=53.6±9.9） were chosen from Chinese PLA Army General Hospital from Nov. 2012 to Jan. 2014. All patients were divided, by applying randomized, double-blind and parallel controlled trial design, into placebo group （n=11）, PEX168-100 μg group （n=13） and PEX168-200 μg group （n=12）. All groups were treated for 12 weeks and followed up for 4 weeks. The changes of glycated hemoglobin （HbAlc）, fasting blood glucose （FBG） and 2-hour postprandial blood glucose （2hPBG）, and adverse drug reactions were observed in all groups before treatment and after followed up for 4 weeks. Results The levels of FBG, 2hPBG and HbA1c decreased significantly in PEX168-100 μg group and PEX168-200 μg group after treatment for 12 weeks （all P〈0.05）. The levels of FBG, 2hPBG and HbA1c decreased more significantly in PEX168-100 μg group and PEX168-200 μg group compared with placebo group after treatment （all P〈0.05）. There was 1 case （7.7%） with nausea in PEX168-100 μg group, 2 （16.7%） with nausea and 1 （8.3%） with headache in PEX168-200 μg group, and the symptoms were relieved as treatment time was prolonged. There were no adverse reactions occurred in all patients including hypoglycemia, dysfunctions of liver and kidney and pancreatitis. Conclusion PEX168 can effectively reduce the level of blood sugar in T2DM patients, and it has higher safety and tolerance after preliminary observation, which can provide a reference for future clinical application. But the cases are limited in this study, larger sample are needed in future observation and study.