Delonca J, Giraud T, Beaufils P, Dupuis B, Haïat R, Théry C
Département Cardiovasculaire, Laboratoires Hoechst, Paris, France.
Eur Heart J. 1997 Aug;18(8):1300-6. doi: 10.1093/oxfordjournals.eurheartj.a015442.
Although linsidomine shares common properties with nitrovasodilators, it releases nitric oxide directly without catalytic involvement by thiols. We conducted a prospective, randomized, multicentre, parallel group, single-blind study to compare the efficacy of intravenous administration of linsidomine with that of isosorbide dinitrate in unstable angina.
Between November 1990 and July 1992, 568 patients with suspected unstable angina (class IIIB of the Braunwald classification) received a continuous infusion of either linsidomine (1 mg.h-1 on average) or isosorbide dinitrate (2.5 mg.h-1 on average) for 72 h. All patients received concomitant aspirin and intravenous heparin, 81% beta-blockers and 38% calcium antagonists. Holter monitoring was performed in all patients and analysed blindly. Only 25% of the patients had at least one episode of chest pain during the study (24.6% vs 25.8% in the linsidomine and isosorbide dinitrate groups, P = 0.74), of which 12% were associated with ECG changes. Holter criteria yielded similar results in both groups: 33% of patients presented episodes of myocardial ischaemia (32.6% vs 33.9% in the linsidomine and isosorbide dinitrate groups, P = 0.74), while 45% showed episodes of ventricular arrhythmia (43.5% vs 46.5% in the linsidomine and isosorbide dinitrate groups, P = 0.48). The incidence of serious clinical events at 72 h (death, myocardial infarction or myocardial revascularization) was 6.5% (5% vs 8% in the linsidomine and isosorbide dinitrate groups, P = 0.17).
Intravenous linsidomine is at least as efficacious as isosorbide dinitrate in the stabilization of patients with severe unstable angina.
尽管林西多明与硝基血管扩张剂具有共同特性，但它可直接释放一氧化氮，无需硫醇的催化作用。我们进行了一项前瞻性、随机、多中心、平行组、单盲研究，以比较静脉注射林西多明与硝酸异山梨酯治疗不稳定型心绞痛的疗效。
1990年11月至1992年7月期间，568例疑似不稳定型心绞痛（Braunwald分类中的IIIB级）患者接受了林西多明（平均1mg·h⁻¹）或硝酸异山梨酯（平均2.5mg·h⁻¹）持续输注72小时。所有患者均同时服用阿司匹林和静脉注射肝素，81%的患者服用β受体阻滞剂，38%的患者服用钙拮抗剂。对所有患者进行动态心电图监测并进行盲法分析。研究期间只有25%的患者至少有一次胸痛发作（林西多明组和硝酸异山梨酯组分别为24.6%和25.8%，P = 0.74），其中12%与心电图改变有关。动态心电图标准在两组中产生了相似的结果：33%的患者出现心肌缺血发作（林西多明组和硝酸异山梨酯组分别为32.6%和33.9%，P = 0.74），而45%的患者出现室性心律失常发作（林西多明组和硝酸异山梨酯组分别为43.5%和46.5%，P = 0.48）。72小时时严重临床事件（死亡、心肌梗死或心肌血运重建）的发生率为6.5%（林西多明组和硝酸异山梨酯组分别为5%和8%，P = 0.17）。
静脉注射林西多明在稳定重度不稳定型心绞痛患者方面至少与硝酸异山梨酯一样有效。
