聚乙二醇洛塞那肽注射液用于2型糖尿病患者的随机对照试验

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Abstract 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-168 0.5 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.

Key words： Polyethylene Glycol Loxenatide Injection

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	LI Lei1 WANG Fei1 LI Min2 JIANG Sheng1▲

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LI Lei1 WANG Fei1 LI Min2 JIANG Sheng1▲. A randomized controlled trial Polyethylene Glycol Loxenatide Injection for patients with type 2 diabetes mellitus[J]. 中国医药导报, 2021, 18(18): 68-71.

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https://www.yiyaodaobao.com.cn/EN/ OR https://www.yiyaodaobao.com.cn/EN/Y2021/V18/I18/68

[1] Ma RCW. Epidemiology of diabetes and diabetic complications in China [J]. Diabetologia，2018，61（6）：1249-1260. DOI：10.1007/s00125-018-4557-7.
[2] Lyseng-Williamson KA. Glucagon-Like Peptide-1 Receptor Analogues in Type 2 Diabetes：Their Use and Differential Features [J]. Clin Drug Investig，2019，39（8）：805-819. DOI：10.1007/s40261-019-00826-0.
[3] 慕杨娜，赵磊，王庆伟，等.PEX168注射液治疗2型糖尿病的随机对照临床研究[J].中南药学，2015（2）：195-199. DOI：10.7539/j.issn.1672-2981.2015.02.024.
[4] 中华医学会糖尿病学分会.中国2型糖尿病防治指南（2017年版）[J].中国实用内科杂志，2018，38（4）：292-344.
[5] 姚璐，武云涛，田国祥，等.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[J].中国循证心血管医学杂志，2017，9（5）：577-579. DOI：10.3969/j.issn.1674-4055.2017.05.17.
[6] Gentilella R，Pechtner V，Corcos A，et al. Glucagon-like peptide-1 receptor agonists in type 2 diabetes treatment：are they all the same? [J]. Diabetes Metab Res Rev，2019， 35（1）：e3070. DOI：10.1002/dmrr.3070.
[7] Cheang JY，Moyle PM. Glucagon-Like Peptide-1 （GLP-1）-Based Therapeutics：Current Status and Future Opportunities beyond Type 2 Diabetes [J]. Chem Med Chem，2018，13（7）：662-671. DOI：10.1002/cmdc.201700781.
[8] Drucker DJ. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1 [J]. Cell Metab，2018，27（4）：740-756. DOI：10.1016/j.cmet.2018.03.001.
[9] Knop FK，Br?覬nden A，Vilsb?覬ll T. Exenatide：pharmacokinetics，clinical use，and future directions [J]. Expert Opin Pharmacother，2017，18（6）：555-571. DOI：10.1080/14656566. 2017.1282463.
[10] McCarty D，Olenik A，McCarty BP. Efficacy and Safety of Basal Insulin/GLP-1 Receptor Agonist Used in Combination for Type 2 Diabetes Management [J]. J Pharm Pract，2019，32（6）：671-678. DOI：10.1177/0897190018 764984.
[11] Drucker DJ，Habener JF，Holst JJ. Discovery，characterization，and clinical development of the glucagon-like peptides [J]. J Clin Invest，2017，127（12）：4217-4227. DOI：10.1172/JCI97233.
[12] Wang J，Huang J，Li W，et al. Polyethylene glycol loxenatide （PEX168） in subjects with renal impairment：A pharmacokinetic study [J]. Br J Clin Pharmacol，2019，85（12）：2714-2720. DOI：10.1111/bcp.14091.
[13] 都宵晓，靳京，商倩，等.已上市胰高血糖素样肽-1受体激动剂的研究进展[J].药物评价研究，2020，43（3）：559-564. DOI：10.7501/j.issn.1674-6376.2020.03.037.
[14] Luo Y，Li L，Xu X，et al. Decreased circulating BMP-9 levels in patients with Type 2 diabetes is a signature of insulin resistance [J]. Clin Sci （Lond），2017，131（3）：239-246. DOI：10.1042/CS20160543.
[15] 张蓓宁.聚乙二醇洛塞那肽对2型糖尿病患者血糖控制的效果观察[J].世界最新医学信息文摘，2020，20（17）：119-121. DOI：10.19613/j.cnki.1671-3141.2020.17. 073
[16] DeFronzo RA. Combination Therapy With GLP-1 Receptor Agonist and SGLT2 Inhibitor [J]. Diabetes Obes Metab，2017，19（10）：1353-1362. DOI：10.1111/dom.12982.
[17] 中华医学会内分泌学分会，中华医学会糖尿病学分会.胰高糖素样肽-1（GLP-1）受体激动剂用于治疗2型糖尿病的临床专家共识[J].中华内科杂志，2020，59（11）：836-846. DOI：10.3760/cma.j.cn112138-20200704-00646.
[18] 李楠，雍小兰，王蓝天，等.聚乙二醇洛塞那肽注射液对2型糖尿病患者安全性和耐受性评价[J].解放军药学学报，2016，32（5）：440-443. DOI：10.3969/j.issn.1008-9926.2016.05.019.
[19] Brown E，Cuthbertson DJ，Wilding JP. Newer GLP-1 receptor agonists and obesity-diabetes [J]. Peptides，2018，100：61-67. DOI：10.1016/j.peptides.2017.12.009.
[20] Jensterle M，Janez A，Fliers E，et al. The role of glucagon-like peptide-1 in reproduction：from physiology to therapeutic perspective [J]. Hum Reprod Update，2019，25（4）：504-517. DOI：10.1093/humupd/dmz019.
[21] Dhir G，Cusi K. Glucagon like peptide-1 receptor agonists for the management of obesity and non-alcoholic fatty liver disease：a novel therapeutic option [J]. J Investig Med，2018，66（1）：7-10. DOI：10.1136/jim-2017-000554.
[22] Drab SR. Glucagon-Like Peptide-1 Receptor Agonists for Type 2 Diabetes：A Clinical Update of Safety and Efficacy [J]. Curr Diabetes Rev，2016，12（4）：403-413. DOI：10.2174/1573399812666151223093841.
[23] Bahne E，Sun EWL，Young RL，et al. Metformin-induced glucagon-like peptide-1 secretion contributes to the actions of metformin in type 2 diabetes [J]. JCI Insight，2018，3（23）：e93936. DOI：10.1172/jci.insight.93936.
[24] Yang GR，Zhao XL，Jin F，et al. Pharmacokinetics and pharmacodynamics of a polyethylene glycol （PEG）-conjugated GLP-receptor agonist once weekly in Chinese patients with type 2 diabetes [J]. J Clin Pharmacol，2015，55（2）：152-158. DOI：10.1002/jcph.386.
[25] Chen X，Lv X，Yang G，et al. Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients [J]. J Diabetes，2017，9（2）：158-167. DOI：10.1111/1753-0407.12397.