Nyberg G, Carlens P, Lindström E, Lundman T, Nordlander R, Rehnqvist N, Ulvenstam G, Aberg A, Aström H
Eur Heart J. 1986 Oct;7(10):835-42. doi: 10.1093/oxfordjournals.eurheartj.a061969.
Twenty-four patients with stable exercise-induced angina pectoris entered a double-blind cross-over study. Isosorbide-5-mononitrate (5-ISMN) 60 mg in a controlled release formulation (Durules) given once daily was compared with identical placebo. The exercise tolerance was determined by bicycle ergometry before and 3 h after a single dose of 5-ISMN and following one week's treatment with 5-ISMN and placebo. Nineteen patients completed the study. Exercise tolerance until the onset of chest pain and until 1 mm ST segment depression increased significantly 3 h after dose. The same increase was seen both after a single dose and the same dose under steady-state conditions. No increase was seen with placebo. The heart rate and systolic blood pressure reactions in the standing position were less pronounced 3 h after dose in steady-state than after a single dose of 5-ISMN. Headache was the only bothersome side-effect reported. The study demonstrates that 60 mg 5-ISMN in a Durules formulation given once daily has a significant anti-anginal effect and that tolerance does not develop.
24例稳定型运动诱发心绞痛患者进入一项双盲交叉研究。将每日一次给予的控释制剂（Durules）中的60毫克单硝酸异山梨酯（5-ISMN）与相同的安慰剂进行比较。在单次服用5-ISMN前、服用后3小时以及用5-ISMN和安慰剂治疗一周后，通过自行车测力计测定运动耐量。19例患者完成了研究。服药后3小时，直至胸痛发作和直至ST段压低1毫米时的运动耐量显著增加。单剂量给药后以及稳态条件下相同剂量给药后均出现相同程度的增加。安慰剂组未见增加。稳态下服药后3小时，站立位时的心率和收缩压反应比单次服用5-ISMN后更不明显。头痛是报告的唯一令人困扰的副作用。该研究表明，每日一次给予Durules制剂中的60毫克5-ISMN具有显著的抗心绞痛作用，且不会产生耐受性。
