预混胰岛素类似物治疗2型糖尿病剂量的系统评价

Dose analysis of premixed insulin analogue from one to triple daily injection in patients with type 2 diabetes: a systematic review

目的系统评价预混胰岛素类似物1～3针治疗2型糖尿病的剂量情况.方法电子检索PubMed数据库,文献检索时间为2009年1月至2014年11月,英文检索关键词包括type 2 diabetes、premixed insulin analogue、aspart30、aspart50、lispro25、lispro50、randomized controlled trial、dose等.纳入预混胰岛素类似物1～3针治疗2型糖尿病的所有随机对照试验,提取符合纳入标准的数据,由于本研究数据不能进行Meta分析,则进行描述性的定性分析.结果最终纳入11项随机对照试验,文献发表时间为2009-2013年,试验组共纳入3555例患者.各研究最终胰岛素用量不尽相同,最小用量0.25U·kg^-1·d^-1,最大用量（1.19±0.44）U·kg^-1·d^-1.最终胰岛素用量不同的原因是多方面的,其中各临床试验设计方面的差异以及患者自身的个体性差异导致的各研究间的异质性可能是导致这种差异的主要原因.结论胰岛素应用的剂量应该体现个体化原则,根据患者的种族、病程、BMI、胰岛素抵抗的程度以及是否与口服药联合治疗等情况而定,不能用一个固定的公式或者模式计算.今后仍有必要进一步开展高质量、大样本、长期随访的预混胰岛素类似物治疗2型糖尿病的随机对照试验.

ObjectiveTo systemically review dose of premixed insulin analogue from one to triple daily injection in patients with type 2 diabetes.Methods Database search of PubMed (from January 2009 to November 2014) was carried out. English key words included type 2 diabetes, premixed insulin analogue, aspart 30, aspart 50, lispro 25, lispro 50, randomized controlled trial, dose. All randomized controlled trials about premixed insulin analogue from one to triple daily injection in patients with type 2 diabetes were included. To extract the eligible data and perform descriptive qualitative analysis rather than Meta-analysis to the data.Results Eventually, 11 randomized controlled trials and 3 555 patients were included, with publishing time from 2009 to 2013. The final insulin dosage of those researches quite different, ranged from 0.25 U2kg-12d-1 to (1.19±0.44)U2kg-12d-1. Several reasons contributed to the difference. The different study design and the heterogeneity among these clinical trials could be the main cause of the discrepancy.ConclusionsThe insulin dose should follow the principle of individuation. The appropriate dose should be chosen according to the patient's race, course, BMI, insulin resistance and oral agents combined with insulin. It is impossible to find a unified dose to normalize the blood glucose.