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依诺肝素。关于其在冠状动脉疾病管理中的临床潜力的综述。

Enoxaparin. A review of its clinical potential in the management of coronary artery disease.

作者信息

Noble S, Spencer C M

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Drugs. 1998 Aug;56(2):259-72. doi: 10.2165/00003495-199856020-00013.

Abstract

UNLABELLED

Enoxaparin (enoxaparin sodium) is a low molecular weight heparin (LMWH) that is widely used in the prevention of deep venous thrombosis and pulmonary embolism in patients undergoing orthopaedic or general surgery. Its efficacy in these indications has led to study of its use in patients with coronary artery disease, particularly those with unstable angina, who have a high risk of myocardial infarction and death. A double-blind multicentre study [ESSENCE (Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q Wave Coronary Events)] showed that subcutaneous enoxaparin was more effective than intravenous unfractionated heparin (UFH) in reducing the incidence of the composite end-point of death, myocardial infarction or recurrent angina after 14 days in 3171 patients with recent-onset resting angina (i.e. unstable angina). There were no statistically significant between-group differences for the secondary end-point of death or myocardial infarction. Preliminary reports of long term follow-up data indicate that the clinical benefit of enoxaparin over UFH is maintained after 1 year. The only significant difference in tolerability between enoxaparin and UFH in ESSENCE was for minor haemorrhage (mostly injection-site ecchymosis), which was more common with the LMWH. Prospective pharmacoeconomic substudies of the ESSENCE trial suggest that total medical costs (including those for subsequent revascularisation procedures) for enoxaparin treatment are lower than those for UFH. The ESSENCE study is the first double-blind trial to show that a LMWH is more effective than UFH in patients with unstable angina. The superiority of enoxaparin was attributable mainly to its effects on recurrent angina. The level of anticoagulation achieved in the UFH group raises a number of issues which might have affected the apparent relative efficacy of enoxaparin and UFH. Preliminary data suggest that enoxaparin is at least as effective as UFH in reducing the incidence of subsequent cardiac events in patients receiving thrombolysis for acute myocardial infarction, and a randomised comparison with no additional treatment (other than aspirin) has demonstrated its efficacy in this indication. Enoxaparin has been ineffective in preventing restenosis after angioplasty

CONCLUSIONS

The ESSENCE study has shown that enoxaparin is more effective than UFH in patients with unstable angina. Although clarification of some methodological issues would be beneficial, the available efficacy data, together with the practical advantages of LMWHs in general, suggest that enoxaparin is an effective and convenient means of treating unstable angina and should provide cost savings compared with UFH.

摘要

未标注

依诺肝素(依诺肝素钠)是一种低分子量肝素(LMWH),广泛用于预防骨科或普外科手术患者的深静脉血栓形成和肺栓塞。其在这些适应症中的疗效促使人们研究其在冠状动脉疾病患者中的应用,尤其是那些患有不稳定型心绞痛、有心肌梗死和死亡高风险的患者。一项双盲多中心研究[ESSENCE(皮下注射依诺肝素在非Q波冠状动脉事件中的疗效和安全性)]表明,在3171例近期发作静息性心绞痛(即不稳定型心绞痛)患者中,皮下注射依诺肝素在降低14天后死亡、心肌梗死或复发性心绞痛复合终点发生率方面比静脉注射普通肝素(UFH)更有效。在死亡或心肌梗死次要终点方面,组间无统计学显著差异。长期随访数据的初步报告表明,依诺肝素相对于UFH的临床益处可维持1年。在ESSENCE研究中,依诺肝素和UFH在耐受性方面唯一的显著差异是轻微出血(主要是注射部位瘀斑),低分子量肝素更常见。ESSENCE试验的前瞻性药物经济学子研究表明,依诺肝素治疗的总医疗费用(包括后续血运重建手术的费用)低于UFH。ESSENCE研究是首个双盲试验,表明低分子量肝素在不稳定型心绞痛患者中比普通肝素更有效。依诺肝素的优越性主要归因于其对复发性心绞痛的作用。UFH组达到的抗凝水平引发了一些可能影响依诺肝素和UFH明显相对疗效的问题。初步数据表明,在接受急性心肌梗死溶栓治疗的患者中,依诺肝素在降低后续心脏事件发生率方面至少与UFH一样有效,并且与无额外治疗(除阿司匹林外)的随机比较已证明其在该适应症中的疗效。依诺肝素在预防血管成形术后再狭窄方面无效。

结论

ESSENCE研究表明,依诺肝素在不稳定型心绞痛患者中比UFH更有效。尽管澄清一些方法学问题会有益处,但现有的疗效数据,以及低分子量肝素总体上的实际优势,表明依诺肝素是治疗不稳定型心绞痛的有效且方便的手段,与UFH相比应能节省成本。

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