Department of Clinical and Experimental Medicine, Federico II University, Naples, Italy.
Diabetes Care. 2013 Sep;36(9):2566-72. doi: 10.2337/dc12-1781. Epub 2013 Jul 17.
To evaluate the feasibility and effectiveness of an intensive, multifactorial cardiovascular risk reduction intervention in a clinic-based setting.
The study was a pragmatic, cluster randomized trial, with the diabetes clinic as the unit of randomization. Clinics were randomly assigned to either continue their usual care (n = 5) or to apply an intensive intervention aimed at the optimal control of cardiovascular disease (CVD) risk factors and hyperglycemia (n = 4). To account for clustering, mixed model regression techniques were used to compare differences in CVD risk factors and HbA1c. Analyses were performed both by intent to treat and as treated per protocol.
Nine clinics completed the study; 1,461 patients with type 2 diabetes and no previous cardiovascular events were enrolled. After 2 years, participants in the interventional group had significantly lower BMI, HbA1c, LDL cholesterol, and triglyceride levels and significantly higher HDL cholesterol level than did the usual care group. The proportion of patients reaching the treatment goals was systematically higher in the interventional clinics (35% vs. 24% for LDL cholesterol, P = 0.1299; 93% vs. 82% for HDL cholesterol, P = 0.0005; 80% vs. 64% for triglycerides, P = 0.0002; 39% vs. 22% for HbA1c, P = 0.0259; 13% vs. 5% for blood pressure, P = 0.1638). The analysis as treated per protocol confirmed these findings, showing larger and always significant differences between the study arms for all targets.
A multifactorial intensive intervention in type 2 diabetes is feasible and effective in clinical practice and it is associated with significant and durable improvement in HbA1c and CVD risk profile.
评估在临床环境中进行强化、多因素心血管风险降低干预的可行性和有效性。
这是一项实用的、集群随机试验，以糖尿病诊所为随机单位。诊所被随机分配继续接受常规护理（n = 5）或应用强化干预，旨在最佳控制心血管疾病（CVD）风险因素和高血糖（n = 4）。为了考虑聚类，使用混合模型回归技术比较 CVD 风险因素和 HbA1c 的差异。分析按意向治疗和按方案治疗进行。
9 家诊所完成了研究；纳入了 1461 名患有 2 型糖尿病且无先前心血管事件的患者。2 年后，干预组的参与者 BMI、HbA1c、LDL 胆固醇和甘油三酯水平明显较低，HDL 胆固醇水平明显较高，而常规护理组则明显较低。达到治疗目标的患者比例在干预诊所中系统地更高（LDL 胆固醇分别为 35%比 24%，P = 0.1299；HDL 胆固醇分别为 93%比 82%，P = 0.0005；甘油三酯分别为 80%比 64%，P = 0.0002；HbA1c 分别为 39%比 22%，P = 0.0259；血压分别为 13%比 5%，P = 0.1638）。按方案治疗的分析证实了这些发现，显示出研究臂之间所有目标的差异更大且始终具有统计学意义。
在 2 型糖尿病中进行多因素强化干预在临床实践中是可行且有效的，与 HbA1c 和 CVD 风险状况的显著和持久改善相关。
