在臨床上,2型糖尿病患者在注射胰島素后,需要等待10~30分鐘再進(jìn)餐。然而,近期發(fā)表的一項(xiàng)隨機(jī)、開放交叉研究提示,對(duì)于用人胰島素進(jìn)行餐前胰島素治療的2型糖尿病患者,胰島素注射后至進(jìn)餐的時(shí)間間隔(IMI)完全不必要。(DiabetesCare.2013年1月22日在線版)
該研究入組100例2型糖尿病患者,隨機(jī)分入IMI優(yōu)先組(即先間隔20min,后取消時(shí)間間隔)和IMI最后組(與優(yōu)先組相反)。研究者發(fā)現(xiàn),忽略IMI僅致糖化血紅蛋白(HbA1c)水平輕度升高,由于差異并不具有臨床意義,取消IMI的胰島素治療方案并不劣于有IMI的方案。在輕微低血糖發(fā)生率和血糖參數(shù)方面,有無(wú)IMI差別不大。取消IMI后,患者對(duì)治療的滿意度明顯升高,但生活質(zhì)量總評(píng)分并無(wú)明顯改善。研究者報(bào)告,86.5%的受試者更愿意接受無(wú)IMI的胰島素治療方案。
Randomized Crossover Study to Examine the Necessity of an Injection-to-Meal Interval in Patients With Type 2 Diabetes Mellitus and Human Insulin
Abstract
OBJECTIVE Patients with diabetes and insulin therapy with human insulin were usually instructed to use an interval of 20–30 min between the injection and meal. We examined the necessity of the injection-to-meal interval (IMI) in patients with type 2 diabetes mellitus (T2DM) and flexible insulin therapy with human insulin.
RESEARCH DESIGN AND METHODS In this randomized, open crossover trial, 100 patients with T2DM (47% men, mean age = 66.7 years) were randomized to the IMI first group (phase 1, IMI 20 min; phase 2, no IMI) or IMI last group (phase 1, no IMI; phase 2, IMI 20 min). The main outcome measures were HbA1c, blood glucose profile, incidence of hypoglycemia, quality of life, treatment satisfaction, and patient preference.
RESULTS Forty-nine patients were randomized to the IMI first group and 51 patients to the IMI last group. Omitting the IMI only slightly increases HbA1c (average intraindividual difference = 0.08% [CI 0.01–0.15]). Since the difference is not clinically relevant, a therapy without IMI is noninferior to its application (P < 0.001). In the secondary outcomes, the incidence of mild hypoglycemia also did not differ between no IMI and IMI significantly (mean of differences = ?0.10, P = 0.493). No difference in the blood glucose profile of both groups was found. Treatment satisfaction increased markedly, by 8.08, if IMI was omitted (P < 0.001). The total score of the quality of life measure did not show differences between applying an IMI or not. Insulin therapy without IMI was preferred by 86.5% of patients (P < 0.001).
CONCLUSIONS An IMI for patients with T2DM and preprandial insulin therapy is not necessary.