中国冠心病二级预防研究——老年高血压人群的干预结果分析

目的探讨血脂康对合并高血压的老年患者和无高血压史的老年患者冠心病二级预防结果。方法对一项随机、双盲、安慰剂对照试验中的1 530例合并高血压的老年患者(治疗组772例,对照组758例)和1 020例无高血压史的老年患者(治疗组508例,对照组512例)平均服用血脂康胶囊4年后的冠心病二级预防结果进行统计分析。结果与无高血压史的老年患者比较,合并高血压的老年患者的冠心病事件发生率增加38.1%(P=0.0097),脑卒中事件发生率增加156.3%(P=0.0003),总死亡率增加48.2%(P=0.0035)。在合并高血压的老年患者中,治疗组与对照组比较,冠心病事件减少38.2%(P=0.0009);总死亡事件减少36.3%(P=0.0030);新发肿瘤事件减少49.2%(P=0.0395),其中肿瘤死亡减少67.1%(P=0.0123)。在无高血压史的老年患者中,治疗组与对照组比较,冠心病事件减少47.8%(P=0.0025),其中冠心病死亡减少43.7%(P=0.0369);对经皮冠状动脉介入治疗和(或)冠状动脉旁路移植术的需求减少71.3%(P=0.0018);总死亡事件减少32.0%(P=0.0936)。两类老年患者中均没有发现治疗组临床不良事件或实验室安全指标的增加。结论合并高血压的老年冠心病患者较无高血压史的老年患者处于更高危状态,血脂康胶囊用于老年患者的冠心病二级预防是安全有效的。

China coronary secondary prevention study:conclusion in aged coronary heart disease patients with or without hypertension

Objective To evaluate whether Xuezhikang can reduce the risk of cardiac events and total mortality in aged CHD patients.Methods This study was designed as a randomized,double-blind,placebo controlled clinical trial.1?530 aged CHD patients with hypertension and 1?020 aged CHD patients without hypertension were selected and given capsule Xuezhikang 0.6 g bid or placebo in addition to conventional therapy.The mean follow-up period was four years.The primary end-points were nonfatal myocardial infarction and death from CHD.Results At the end of trial,the results were as follows:In hypertensive patients,the incidence of CHD events was reduced by 38.2% in treatment group(P=0.0009).The incidence of tumor was reduced by(49.2%)(P=0.0395) and the death from tumor was decreased by 67.1%(P=0.0123).The total mortality was lowered by 36.3%(P=0.0030).In patients without hypertension,the incidence of CHD events was reduced by 47.8% in treatment group(P=0.0025) and the incidence of death from CHD was reduced by(43.7%)(P=0.0369).The need of PCI/CABG was decreased by 71.3%(P=0.0018).The total mortality was lowered by 32.0%(P=0.0936).There was no significant difference in side effects and abnormal laboratory indices between two groups.Conclusion Xuezhikang can reduce the risk of cardiac events in aged CHD patients safely and effectively.