谷赖胰岛素或赖脯胰岛素联合甘精胰岛素对糖尿病的有效性及安全性

目的 比较谷赖胰岛素和赖脯胰岛素联合甘精胰岛素对糖尿病的有效性、安全性.方法 本研究为多中心、随机、对照研究,包括4周的导人期和12周的治疗期.2007年2月至2008年6月共人选糖尿病患者484例（1型34例,2型450例）,患者糖化血红蛋白（HbA1c）为6.5％～11.0％,之前已接受连续3个月的胰岛素治疗.按3：1随机给予谷赖胰岛素（363例）或赖脯胰岛素（121例）每日3次联合甘精胰岛素每日1次治疗,比较两组治疗12周后HbA1c、血糖变化及低血糖发生情况和治疗满意度.组间数据比较采用ANOVA方法.结果 治疗12周后,谷赖胰岛素和赖脯胰岛素组HbA1c分别由8.7％±1.2％降至7.9％±1.0％及由8.8％±1.2％降至7.9％±1.0％（组内治疗前后比较,t=- 12.55、-8.88,均P＜0.05）.两组空腹血糖（FPG）分别由（8.6±2.8）mmol/L降至（7.7±2.5）mmol/L及由（8.6±2.5） mmol/L降至（7.8±2.2）mmol/L（组内治疗前后比较,t=-6.55、-2.98,均P＜0.05）.谷赖胰岛素组标准餐后2h血糖（2 h PPG）由（10.6±3.8） mmol/L降至（ 10.2±3.7） mmol/L（t=-2.07,P＜0.05）；赖脯胰岛素组2 h PPG治疗前后差异无统计学意义[由（ 10.9±4.0）mmol/L降至（10.4±3.5） mmol/L,t=-1.37,P＞0.05].治疗12周期间,谷赖胰岛素组和赖脯胰岛素组低血糖事件发生率分别为33.9％ （123/363）和34.7％ （42/121）.治疗前后谷赖胰岛素组和赖脯胰岛素组治疗满意度总评分分别由29±5升至31±5及由29±5升至31±4（组内治疗前后比较,t =6.81、4.21,均P＜0.05）.结论 谷赖胰岛素和赖脯胰岛素联合甘精胰岛素治疗糖尿病的临床疗效、安全性及治疗满意度相似.

Comparison of the efficacy and safety of insulin glulisine and insulin lispro combined with insulin glargine in patients with diabetes

Objective To compare the efficacy and safety of insulin glulisine and insulin lispro combined with insulin glargine in patients with diabetes mellitus. Methods This was a multi-centre randomly controlled study.Thirty four patients with type 1 and 450 patients with type 2 diabetes mellitus with a HbAlc level of 6.5％ to 11.0％ and more than 3 months of continuous insulin treatment immediately prior to study entry were enrolled from February 2007 to June 2008.After 4-week run-in period with insulin lispro (three times a day,0-15 min before the meals) combined with insulin glargine treatment (once daily before breakfast),all the subjects were randomized (3:1 ) to receive a 12-week treatment with insulin glulisine or insulin lispro in combination with insulin glargine.The data collected at the visit after the 4-weeks run-in period was defined as the baseline data.The change in HbAlc,blood glucose,treatment satisfaction and incidence of hypoglycemia after the treatment was recorded and compared.The data of the two groups were compared by using an ANOVA model.Results After 12-week of treatment,HbA1 c reduced from 8.7％ ±1.2％ to7.9％ ±1.0％ in insulin glulisine group,and from 8.8％ ±1.2％ to 7.9％ ±1.0％ in insulin lispro group (compared with baseline,t =- 12.55 and - 8.88,both P ＜0.05).Fasting plasma glucose (FPG) decreased significantly compared with baseline in both groups: for insulin glulisine group,from (8.6 ±2.8) mmoL/L to (7.7 ±2.5) mmoL/L,and for insulin lispro group,from (8.6 ±2.5) mmol/L to (7.8 ± 2.2) mmol/L ( compared with baseline,t =- 6.55 and - 2.98,both P ＜ 0.05 ).The 2 h postprandial glucose (2 h PPG) decreased significantly in insulin glulisine group (from ( 10.6 ± 3.8)mmol/L to ( 10.2 ±3.7) mmol/L,t =- 2.07,P =0.04),but it was no difference in insulin lispro group ( from ( 10.9 ± 4.0) mmol/L to ( 10.4 ± 3.5 ) mmol/L,t =- 1.37,P ＞ 0.05 ).The incidence of all categories of symptomatic hypoglycemia was comparable between the two groups (33.9％ vs 34.7％ ) during treatment period.An increase of satisfaction scores after treatment was found both in the insulin glulisine group (from 29 ±5 to 31 ±5,t =6.81 P ＜0.05) and insulin lispro group (from 29 ±5 to 31 ±4,t =4.21,P ＜0.05).Conclusions It showed that when used in combination with insulin glargine,insulin glulisine is clinical equivalent to insulin lispro in decreasing HbA1c and plasma glucose in Chinese patients with diabetes mellitus.Both regimens are well tolerated and safe.