Juul Anne Benedicte, Wetterslev Jørn, Kofoed-Enevoldsen Allan, Callesen Torben, Jensen Gorm, Gluud Christian
Copenhagen Trial Unit, Center for Clinical Intervention Research, H:S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Am Heart J. 2004 Apr;147(4):677-83. doi: 10.1016/j.ahj.2003.10.030.
Recent trials suggest that perioperative beta-blockade reduces the risk of cardiac events in patients with a risk of myocardial ischemia who are undergoing noncardiac surgery. Patients with diabetes mellitus are at a high-risk for postoperative cardiac morbidity and mortality. They may, therefore, benefit from perioperative beta-blockade.
The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial is an investigator-initiated and -controlled, centrally randomized, double-blind, placebo-controlled, multicenter trial. We compared the effect of metoprolol with placebo on mortality and cardiovascular morbidity rates in patients with diabetes mellitus who were beta-blocker naive, >or=40 years old, and undergoing noncardiac surgery. The study drug was given during hospitalization for a maximum of 7 days beginning the evening before surgery. The primary outcome measure is the composite of all-cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure leading to hospitalization or discovered or aggravated during hospitalization. Follow-up involves re-examination of patients at 6 months and collection of mortality and morbidity data via linkage to public databases. The study was powered on the basis of an estimated 30% 1-year event rate in the placebo arm and a 33% relative risk reduction in the metoprolol arm. The median follow-up period was 18 months.
Enrollment started in July 2000 and ended in June 2002. A total of 921 patients were randomized, and 54% of these patients had known cardiac disease, hypertension, or both.
The results of this study may have implications for reduction of perioperative and postoperative risk in patients with diabetes mellitus who are undergoing major noncardiac surgery.
近期试验表明，围手术期使用β受体阻滞剂可降低接受非心脏手术且有心肌缺血风险患者发生心脏事件的风险。糖尿病患者术后发生心脏并发症及死亡的风险较高。因此，他们可能从围手术期使用β受体阻滞剂中获益。
糖尿病术后死亡率和发病率（DIPOM）试验是一项由研究者发起并控制、中心随机、双盲、安慰剂对照的多中心试验。我们比较了美托洛尔与安慰剂对未使用过β受体阻滞剂、年龄≥40岁且接受非心脏手术的糖尿病患者死亡率及心血管疾病发病率的影响。研究药物在术前晚开始住院期间给予，最多使用7天。主要结局指标为全因死亡率、急性心肌梗死、不稳定型心绞痛或导致住院或在住院期间发现或加重的充血性心力衰竭的综合指标。随访包括在6个月时对患者进行复查，并通过与公共数据库链接收集死亡率和发病率数据。该研究的效能基于安慰剂组估计的1年事件发生率为30%以及美托洛尔组相对风险降低33%。中位随访期为18个月。
入组于2000年7月开始，2002年6月结束。共有921例患者被随机分组，其中54%的患者患有已知的心脏病、高血压或两者皆有。
本研究结果可能对降低接受大型非心脏手术的糖尿病患者围手术期及术后风险具有意义。
