Messerli F H
Department of Internal Medicine, Ochsner Clinic and Alton Ochsner Medical Foundation, New Orleans, Louisiana 70121, USA.
Am J Hypertens. 1996 Dec;9(12 Pt 2):177S-181S. doi: 10.1016/s0895-7061(96)00387-1.
Recent publications purporting to show that calcium antagonists, when used for the treatment of hypertension or in the post myocardial infarction patient, would paradoxically increase the rate of heart attack and mortality have cast doubts on the safety and efficacy of this drug class. All three studies are retrospective, and have various drawbacks. Specifically, the metaanalysis of Furberg et al is fraught with mistakes, of borderline significance, and based on old data pertaining to short-acting nifedipine only (which should not be given in patients who have suffered an acute heart attack). The case control study of Psaty et al suggested that hypertensive patients who were treated with short-acting verapamil, diltiazem, and nifedipine had an excessive rate of myocardial infarction when compared with patients who were treated with diuretics. Two out of the three calcium antagonists that were used in this study were not approved for the treatment of hypertension by the US Food and Drug Administration. Some patients were taking these drugs only once a day whereas, because of their short duration of action, at least a three or four times daily regimen would be required to achieve an acceptable blood pressure control throughout a 24-h period. The cohort study of Pahor et al suggested distinct differences among various calcium antagonists with regard to survival. Blood pressure was controlled in < 40% of all patients, and in some patients blood pressure was never even measured. Recent studies, such as the Prospective Randomized Amlodipine Survival Evaluation (PRAISE), the third Vasodilator-Heart Failure Trial (VHeFT-III), the second Doppler Flow and Echocardiography in Functional Cardiac Insufficiency Assessment of Nisoldipine Therapy (DEFIANT II), the Angina Prognosis Study in Stockholm (APSIS), and the Shanghai Trial of Nifedipine in the Elderly (STONE), attest to the safety and efficacy of the newer long-acting calcium antagonists in patients with a wide spectrum of heart disease. Several ongoing trials including the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) with amlodipine, the International Nifedipine-GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT) with nifedipine, the Hypertension Optimal Treatment study (HOT) with felodipine, the Systolic Hypertension in the Elderly in Europe Trial (SYST-EUR) with nicardipine, the Second Swedish Trial in Old Patients with Hypertension (STOP II) with felodipine, and Nordic Diltiazem Study (NORDIL) with diltiazem, will give us morbidity and mortality data in patients with high blood pressure within the next few years. Until these results are available, we can be confident that the lowering of blood pressure and providing relief of patients with symptomatic angina can be achieved safely and efficiently with the presently available long-acting calcium antagonists.
最近有一些出版物声称,钙拮抗剂在用于治疗高血压或心肌梗死后患者时,反而会增加心脏病发作率和死亡率,这引发了人们对这一类药物安全性和有效性的质疑。这三项研究均为回顾性研究,且都存在各种缺陷。具体而言,弗伯格等人的荟萃分析错误百出,意义不大,且仅基于有关短效硝苯地平的旧数据(急性心脏病发作患者不应使用该药)。普萨特等人的病例对照研究表明,与接受利尿剂治疗的患者相比,接受短效维拉帕米、地尔硫䓬和硝苯地平治疗的高血压患者心肌梗死发生率过高。该研究中使用的三种钙拮抗剂中有两种未获美国食品药品监督管理局批准用于治疗高血压。一些患者每天仅服用一次这些药物,然而,由于其作用持续时间短,要在24小时内实现可接受的血压控制,至少需要每日服用三到四次。帕霍尔等人的队列研究表明,不同钙拮抗剂在生存方面存在明显差异。所有患者中血压得到控制的不到40%,部分患者甚至从未测量过血压。近期的一些研究,如前瞻性随机氨氯地平生存评估(PRAISE)、第三次血管扩张剂-心力衰竭试验(VHeFT-III)、第二次尼索地平治疗对功能性心力衰竭的多普勒血流和超声心动图评估(DEFIANT II)、斯德哥尔摩心绞痛预后研究(APSIS)以及上海老年硝苯地平试验(STONE),都证明了新型长效钙拮抗剂在患有多种心脏病的患者中具有安全性和有效性。包括使用氨氯地平的抗高血压和降脂治疗预防心脏病发作试验(ALLHAT)、使用硝苯地平的国际硝苯地平控释片研究:高血压治疗目标干预(INSIGHT)、使用非洛地平的高血压最佳治疗研究(HOT)、使用尼卡地平的欧洲老年收缩期高血压试验(SYST-EUR)、使用非洛地平的第二次瑞典老年高血压患者试验(STOP II)以及使用地尔硫䓬的北欧地尔硫䓬研究(NORDIL)在内的几项正在进行的试验,将在未来几年为我们提供高血压患者的发病率和死亡率数据。在获得这些结果之前,我们可以确信,使用目前可用的长效钙拮抗剂能够安全有效地降低血压,并缓解有症状心绞痛患者的症状。