贝那鲁肽注射液对2型糖尿病患者骨转换影响的随机、开放对照研究

Effect of Benalutide Injection on Bone Turnover in Patients with Type 2 Diabetes Mellitus: A Randomized,Open-control Study

目的探讨贝那鲁肽注射液对2型糖尿病患者骨转换的影响。方法选取2018年9月-2020年9月就诊的60例2型糖尿病患者作为研究对象,依据随机分配法将其分为研究组(n=30)和对照组(n=30),在生活方式和二甲双胍治疗基础上,对照组患者接受门冬胰岛素30注射液治疗,研究组患者使用贝那鲁肽注射液治疗。比较两组患者不良反应发生情况、心血管事件发生率及治疗前后骨代谢相关指标变化。结果治疗前两组血清羧化骨钙素水平、骨密度比较差异(P>0.05),治疗24周后,较对照组研究组骨密度水平明显上升(P<0.05)。研究组低血糖发生率6.67%低于对照组26.67%(P<0.05),研究组胃肠道不良反应发生率30.00%略高于对照组10.00%(P>0.05)。治疗后,两组血清羧化骨钙素及心血管不良事件发生率比较(P>0.05)。对照组Ⅰ型胶原交联氨基末端肽、Ⅰ型胶原交联羧基末端肽高于研究组,而血清骨特异性碱性磷酸酶、血清骨钙素较研究组而言更低(P<0.05)。结论与门冬胰岛素30注射液治疗相比,给予2型糖尿病患者贝那鲁肽治疗能够调节患者骨转换,改善血清骨代谢指标,有利于减少患者骨质疏松发生情况,不良反应较少,临床应用效果较好。

Objective To investigate the effect of Benalutide injection on bone turnover in patients with type 2 diabetes mellitus. Methods A total of 60 patients with type 2 diabetes who received treatment in our hospital from September 2018 to September 2020 were selected as the research subjects. They were divided into study group(n=30) and control group(n=30) according to random allocation method. On the basis of lifestyle and metformin treatment, the control group received insulin aspartic 30 injection. Patients in the study group were treated with Benalutide injection. The incidence of adverse reactions, incidence of cardiovascular events and changes of bone metabolism before and after treatment were compared between 2 groups. Results Before treatment, there were significant differences in serum carboxylated osteocalcin level and BMD between the two groups(P>0.05). After 24 weeks of treatment, BMD level was significantly higher than that of the control group(P<0.05). The incidence of hypoglycemia in the study group was 6.67% lower than that in the control group 26.67%(P<0.05), and the incidence of gastrointestinal adverse reactions in the study group was 30.00% higher than that in the control group 10.00%(P>0.05). After treatment, the incidence of serum carboxylated osteocalcin and cardiovascular adverse events in 2 groups were compared(P>0.05). The crosslinked amino terminal peptide and crosslinked carboxyl terminal peptide of type ⅰ collagen in the control group were higher than those in the study group, while the serum bone specific alkaline phosphatase and serum osteocalcin in the control group were lower than those in the study group(P<0.05). Conclusions Compared with insulin aspartate 30 injection, benalutide treatment for type 2 diabetes patients can regulate bone conversion and improve serum bone metabolism index, which is beneficial to reduce the occurrence of osteoporosis in patients with less adverse reactions and better clinical application effect.