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目的：评价赖脯胰岛素（LP）治疗2型糖尿病（T2DM）的疗效和安全性。方法以“2型糖尿病”、“赖脯胰岛素”和“随机对照试验”为检索词，检索 Medline、Embase、PubMed、Cochrane library、中国知网、维普和万方数据库，对符合纳入标准的文献进行方法学质量评价和 Meta 分析。根据干预措施的不同分为试验组（用 LP 治疗）和对照组[用生物合成人胰岛素（HI）治疗]，2组均可以联合其他口服降糖药或胰岛素。以空腹血糖、餐后2 h 血糖、血糖漂移、糖化血红蛋白、C-肽和胆固醇水平评价疗效，以低血糖事件发生率评价安全性。结果共纳入25篇文献研究，质量为高、中、低者分别为2、9、14篇。患者共2975例。Meta 分析结果显示：LP 降低 T2DM 患者空腹血糖、餐后2 h血糖、糖化血红蛋白及胆固醇的作用优于 HI[均数差（MD）=-0.16，95%置信区间（CI）为-0.27~-0.06，P =0.00；MD =-1.38，95% CI 为-1.46~-1.30，P =0.00；MD =-0.28，95% CI 为-0.33~-0.24，P =0.00；MD =-0.26，95% CI 为-0.35~0.18，P =0.00]。LP 与 HI 对 T2DM 患者血糖漂移、血液中 C 肽含量影响的差异无统计学意义（MD =-0.51，95% CI 为-1.04~0.01，P =0.05；MD=-0.02，95% CI 为-0.26~0.22，P =0.88）；LP 治疗 T2DM 的低血糖发生率低于 HI（OR =0.53，95% CI 为0.38~0.74，P =0.00）。结论 LP 治疗 T2DM 的疗效确切，安全性良好。“,”Objective To evaluate systematically the efficacy and safety of lispro insulin(LP)in patients with type 2 diabetes mellitus(T2DM) Methods “Type 2 diabetes mellitus”,“lispro insulin”, and “randomized controlled trail” were selected as the key words and Medline,Embase,PubMed,Cochrane library,CNKI,and WanFang Data were searched. The evaluation of methodological quality for the literature in accordance with inclusion criteria and Meta-analysis were performed. According to the intervention measures,the subjects were divided into the experimental group(treated with LP)and the control group [treated with biosynthetic human insulin(HI)]. All subjects in the 2 groups could be treated with other oral hypoglycemic drugs or insulin at the same time. The efficacy was evaluated using fasting blood-glucose, 2 h postprandial blood glucose,glycemic excursion,glycosylated hemoglobin,C-peptide,and cholesterol levels;the safety was evaluated using the incidence of hypoglycemia. Results A total of 25 literature were entered in this study and their quality evaluation results were 2 high quality articles,9 medium quality, and 14 low quality. A total of 2 975 patients were entered in the study. The Meta-analysis showed the following results. The efficacy of LP treatment in patients with T2DM to decrease the fasting blood-glucose, 2 h postprandial blood glucose,glycosylated hemoglobin,and cholesterol were better than those of HI treatment(MD = - 0. 16,95% CI:- 0. 27- - 0. 06,P = 0. 00;MD = - 1. 38,95% CI:- 1. 46- - 1. 30, P = 0. 00;MD = - 0. 28,95% CI:- 0. 33- - 0. 24,P < 0. 00;MD = - 0. 26,95% CI:- 0. 35- - 0. 18, P = 0. 00). The differences of glycemic excursion and C-peptide changes in the experimental and the control groups were not significant statistically(MD = - 0. 51,95% CI:- 1. 04-0. 01,P = 0. 05;MD = - 0. 02, 95% CI:- 0. 26- - 0. 22,P = 0. 88);the incidence of hypoglycaemia was lower in the experimental group than that in the control group(OR = 0. 53,95% CI:0. 38-0. 74,P = 0. 00). Conclusion Lispro insulin is effective and safe in treatment in patients with T2DM.