在临床上,2型糖尿病患者在注射胰岛素后,需要等待10~30分钟再进餐。然而,近期发表的一项随机、开放交叉研究提示,对于用人胰岛素进行餐前胰岛素治疗的2型糖尿病患者,胰岛素注射后至进餐的时间间隔(IMI)完全不必要。(DiabetesCare.2013年1月22日在线版)
该研究入组100例2型糖尿病患者,随机分入IMI优先组(即先间隔20min,后取消时间间隔)和IMI最后组(与优先组相反)。研究者发现,忽略IMI仅致糖化血红蛋白(HbA1c)水平轻度升高,由于差异并不具有临床意义,取消IMI的胰岛素治疗方案并不劣于有IMI的方案。在轻微低血糖发生率和血糖参数方面,有无IMI差别不大。取消IMI后,患者对治疗的满意度明显升高,但生活质量总评分并无明显改善。研究者报告,86.5%的受试者更愿意接受无IMI的胰岛素治疗方案。
Randomized Crossover Study to Examine the Necessity of an Injection-to-Meal Interval in Patients With Type 2 Diabetes Mellitus and Human Insulin
Abstract
OBJECTIVEPatients 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 METHODSIn 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.
RESULTSForty-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).
CONCLUSIONSAn IMI for patients with T2DM and preprandial insulin therapy is not necessary.