无针注射器和胰岛素笔注射胰岛素降糖疗效和安全性的Meta分析

Meta-Analysis of the Efficacy and Safety of Needle-free Syringes and Insulin Pens for Insulin Injection to Treat Diabetes Mellitus

目的:系统评估应用无针注射器与胰岛素笔注射胰岛素降糖的疗效和安全性。方法:按照纳入和排除标准,计算机检索无针注射器与胰岛素笔的前瞻性队列研究文献。对所纳入文献进行质量评价及提取资料后,采用Rev Man 5. 3软件进行Meta分析。结果:根据纳入排除标准共纳入8篇符合标准的文献,包括466例患者,8项研究NOS评分均大于8分。Meta分析的结果表明,在降低HbA1c水平方面无针注射器组优于胰岛素笔组[MD=-1.05,95%CI(-1.88,-0.22),P=0.01];在降低FBG、早餐后2 h BG和2 h PG方面,无针注射器组显著优于胰岛素笔组[MD=-1.37,95%CI(-1.82,-0.92),P <0.00001;MD=-1.14,95%CI(-1.49,-0.78),P <0.00001;MD=-2.26,95%CI(-3.04,-1.48),P <0.000 01]。在安全性方面,低血糖发生率、注射后疼痛和出血/瘀斑发生率,无针注射器组和胰岛素笔组比较差异无统计学意义[RR=0.30,95%CI(0.08,1.06),P=0.06;RR=0.33,95%CI(0.07,1.58),P=0.17;RR=0.39,95%CI(0.01,19.86),P=0.64],但注射后发生红肿硬结的发生率,无针注射器组少于胰岛素笔组[RR=0.26,95%CI(0.08,0.82),P=0.02]。结论:用无针注射器注射胰岛素可以提高疗效,减少红肿硬结的发生。

Objective: To systematically evaluate the efficacy and safety of needle-free syringes and insulin pens for insulin injection to treat diabetes mellitus. Methods: According to inclusion and exclusion criteria, prospective cohort studies of needle-free syringes and insulin pens were retrieved by computer. After the quality of the included literature was evaluated and extracted, meta-analysis was carried out by using Rev Man 5.3. Results: A total of 8 eligible articles were included according to the inclusion and exclusion criteria, covering 466 patients and 8 studies with NOS scores greater than 8 points. The results of the meta-analysis showed that the needle-free syringe group was superior to the insulin pen group in reducing HbA1 c levels [MD =-1.05, 95% CI(-1.88,-0.22), P = 0.01]. The needle-free syringe group was superior to the insulin pen group in reducing the FBG, 2 h BG after breakfast and2 h PG [MD =-1.37, 95% CI(-1.82,-0.92), P <0.00001;MD =-1.14, 95% CI(-1.49,-0.78), P < 0.00001;MD =-2.26, 95% CI(-3.04,-1.48), P <0.00001]. In terms of safety, there was no significant difference in the incidence of hypoglycemia, post-injection pain, and bleeding/ecchymosis between the needle-free syringe group and the insulin pen group [RR = 0.30, 95% CI(0.08, 1.06), P = 0.06;RR = 0.33, 95% CI(0.07, 1.58), P = 0.17;RR = 0.39, 95% CI(0.01, 19.86), P = 0.64], but the incidence of redness and induration after injection of the needle-free syringe group was less than that of the insulin pen group [RR = 0.26, 95% CI(0.08, 0.82), P = 0.02].Conclusion: Injection of insulin with a needle-free syringe can improve the efficacy and reduce the incidence of redness and induration.