Guo Xiao Hui, Ji Li Nong, Lu Ju Ming, Liu Jie, Lou Qing Qing, Liu Jing, Shen Li, Zhang Ming Xia, Lv Xiao Feng, Gu Ming Jun
Peking University First Hospital, Beijing, China.
J Diabetes. 2014 Jul;6(4):290-7. doi: 10.1111/1753-0407.12100. Epub 2013 Nov 26.
The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus (T2DM) patients.
In a 16-week open-label randomized controlled study, 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs (OADs) for >3 months (HbA1c >7.5%) were randomized (1:1) to either an education group (structured diabetes education plus insulin therapy) or a control group (usual care plus insulin therapy). Both groups discontinued previous OADs (except biguanides and α-glucosidase inhibitors) and started twice daily injections of 30% soluble-70% isophane recombinant insulin. The primary endpoint was the change in HbA1c from baseline. Efficacy and safety data were analyzed for within- and between-group differences.
Of the initial 1511 patients, 1289 completed the study (643 in the control group; 646 in the education group). At the end of the study, significant reductions in HbA1c versus baseline were evident in both groups, but the reduction was greater in the education group (2.16% vs. 2.08%; P < 0.05). A higher proportion of patients in the education group achieved target HbA1c levels <7% (43.81% vs. 36.86%; P < 0.05) and ≤6.5% (28.48% vs. 22.71%; P < 0.05). In addition, patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale (P < 0.05). The overall incidence of hypoglycemic events was similar in the two groups.
Structured education can promote the ability of patients to self-manage and their compliance with medications, thereby achieving better outcomes.
本研究旨在评估结构化教育对接受胰岛素治疗的2型糖尿病(T2DM)患者的疗效。
在一项为期16周的开放标签随机对照研究中,1511例对两种或更多种口服降糖药(OADs)治疗反应不佳超过3个月(糖化血红蛋白>7.5%)的T2DM患者被随机(1:1)分为教育组(结构化糖尿病教育加胰岛素治疗)或对照组(常规护理加胰岛素治疗)。两组均停用先前的OADs(双胍类和α-葡萄糖苷酶抑制剂除外),开始每日两次注射30%可溶性-70%低精蛋白重组胰岛素。主要终点是糖化血红蛋白相对于基线的变化。对组内和组间差异进行疗效和安全性数据分析。
最初的1511例患者中,1289例完成了研究(对照组643例;教育组646例)。研究结束时,两组糖化血红蛋白相对于基线均显著降低,但教育组降低幅度更大(2.16%对2.08%;P<0.05)。教育组中达到糖化血红蛋白目标水平<7%(43.81%对36.86%;P<0.05)和≤6.5%(28.48%对22.71%;P<0.05)的患者比例更高。此外,教育组患者在Morisky药物依从性量表上的得分增加更大且改善更明显(P<0.05)。两组低血糖事件的总体发生率相似。
结构化教育可提高患者自我管理能力和用药依从性,从而取得更好的治疗效果。