摘要
目的:系统评估聚乙二醇洛塞那肽(PEX168)在中国2型糖尿病(T2DM)患者中的疗效和安全性,为临床用药提供循证学依据。方法:计算机检索从建库至2021年3月31日的Cochrane Library、ClinicalTrails、Embase、Medline、PubMed、CNKI、万方、维普等数据库,检索聚PEX168治疗2型糖尿病的随机对照试验,对符合纳入标准的研究进行资料提取和质量评价,采用R软件的META程序包进行统计分析。结果:共纳入3项RCT共1012名患者,背景治疗药物均为二甲双胍,Meta分析结果提示PEX168100μg与200μg组降低糖化血红蛋白MD分别为(-0.83,95%CI:-0.87~0.79,P<0.01)和(-1.08,95%CI:-1.41~-0.75,P<0.01),显著优于安慰剂组;不良反应中恶心、呕吐发生率高于对照组,差异有统计学意义(P<0.01,P=0.0003)。结论:每周一次皮下注射PEX168100μg或200μg与二甲双胍联用可显著改善血糖相关变量,而不会增加低血糖的风险,且具有良好的耐受性和安全性。
OBJECTIVE To explore the efficacy and safety of polyethylene glycol loxenatide(PEX168)systematically in Chinese patients with type 2 diabetes mellitus(T2 DM)so as to provide evidence-based rationales for clinical medication.METHODS The randomized controlled trials(RCTs)of PEX168 for T2 DM were retrieved from the English and Chinese databases of Cochrane Library,ClinicalTrials,Embase,MEDLINE,PubMed,CNKI,WanFang and Weipu from database inception to March 31,2021.Data extraction and quality evaluation of studies fulfilling the inclusion criteria were conducted and statistical analysis was performed using the META package of R software.RESULTS A total of 1012 patients in 3 RCTs were enrolled with a background treatment of metformin.Meta-analysis revealed that mean deviation(MD)of HbA1 c in PEX168 groups of 100/200μg declined by(-0.83,95%CI:-0.87-0.79,P<0.01)and(-1.08,95%CI:-1.41-0.75,P<0.01).Both were significantly better than placebo group.The incidence of nausea and vomiting was higher than that of control group.And the results were significantly different(P<0.01,P=0.0003).CONCLUSION Weekly subcutaneous injection of 100/200μg PEX168 plus metformin may significantly improve glycemic variables without a higher risk of hypoglycemia.The regimen is generally well-tolerated and safe.
作者
史琛
王聪
刁长冬
解吉奕
张琪琳
郭维
张玉
SHI Chen;WANG Cong;DIAO Chang-dong;XIE Ji-yi;ZHANG Qi-lin;GUO Wei;ZHANG Yu(Department of Pharmacy,Affiliated Union Hospital,Huazhong University of Science&Technology,Hubei Wuhan 430022,China;Hubei Provincial Clinical Research Center of Precision Medicine for Major Diseases,Hubei Wuhan 430022,China)
出处
《中国医院药学杂志》
CAS
北大核心
2021年第17期1703-1709,共7页
Chinese Journal of Hospital Pharmacy
基金
湖北省重点研发计划项目(编号:2020BCA060)。
关键词
聚乙二醇洛塞那肽
安全性
有效性
2型糖尿病
系统评价
polyethylene glycol loxenatide(PEX168)
efficacy
safety
type 2 diabetes mellitus(T2DM)
systematic evaluation
作者简介
史琛,女,博士,副主任药师,研究方向:临床药学;王聪,女,硕士,主管药师,研究方向:内分泌药理;通讯作者:张玉,男,博士,主任药师,教授,博士生导师,研究方向:临床药学。
