Saha S A, Molnar J, Arora R R
Division of Cardiology, Chicago Medical School-North Chicago VA Medical Center, 3001 Green Bay Road, North Chicago, IL 60064, USA.
Diabetes Obes Metab. 2008 Jan;10(1):41-52. doi: 10.1111/j.1463-1326.2006.00688.x.
The aim of this study was to determine the role of tissue angiotensin-converting enzyme (ACE) inhibitors in the prevention of cardiovascular disease in patients with diabetes mellitus without left ventricular systolic dysfunction or clinical evidence of heart failure in randomized placebo-controlled clinical trials using pooled meta-analysis techniques.
Randomized placebo-controlled clinical trials of at least 12 months duration in patients with diabetes mellitus without left ventricular systolic dysfunction or heart failure who had experienced a prior cardiovascular event or were at high cardiovascular risk were selected. A total of 10 328 patients (43 517 patient-years) from four selected trials were used for meta-analysis. Relative risk estimations were made using data pooled from the selected trials and statistical significance was determined using the Chi-squared test (two-sided alpha error <0.05). The number of patients needed to treat was also calculated.
Tissue ACE inhibitors significantly reduced the risk of cardiovascular mortality by 14.9% (p = 0.022), myocardial infarction by 20.8% (p = 0.002) and the need for invasive coronary revascularization by 14% (p = 0.015) when compared to placebo. The risk of all-cause mortality also tended to be lower among patients randomized to tissue ACE inhibitors, whereas the risks of stroke and hospitalization for heart failure were not significantly affected. Treating about 65 patients with tissue ACE inhibitors for about 4.2 years would prevent one myocardial infarction, whereas treating about 85 patients would prevent one cardiovascular death.
Pooled meta-analysis of randomized placebo-controlled trials suggests that tissue ACE inhibitors modestly reduce the risk of myocardial infarction and cardiovascular death and tend to reduce overall mortality in diabetic patients without left ventricular systolic dysfunction or heart failure.
本研究旨在通过汇总荟萃分析技术，在随机安慰剂对照临床试验中确定组织血管紧张素转换酶（ACE）抑制剂在预防无左心室收缩功能障碍或心力衰竭临床证据的糖尿病患者心血管疾病方面的作用。
选择在无左心室收缩功能障碍或心力衰竭且既往有心血管事件或心血管高危的糖尿病患者中进行的至少为期12个月的随机安慰剂对照临床试验。来自四项选定试验的总共10328例患者（43517患者年）用于荟萃分析。使用从选定试验中汇总的数据进行相对风险估计，并使用卡方检验确定统计学显著性（双侧α错误<0.05）。还计算了所需治疗的患者数量。
与安慰剂相比，组织ACE抑制剂可使心血管死亡率显著降低14.9%（p = 0.022），心肌梗死发生率降低20.8%（p = 0.002），侵入性冠状动脉血运重建需求降低14%（p = 0.015）。随机接受组织ACE抑制剂治疗的患者全因死亡率也有降低趋势，而中风和因心力衰竭住院的风险未受到显著影响。用组织ACE抑制剂治疗约65例患者约4.2年可预防1例心肌梗死，而治疗约85例患者可预防1例心血管死亡。
随机安慰剂对照试验的汇总荟萃分析表明，组织ACE抑制剂可适度降低无左心室收缩功能障碍或心力衰竭的糖尿病患者发生心肌梗死和心血管死亡的风险，并倾向于降低总体死亡率。
