Wu Monica, Villano Angelo, Russo Giulio, Di Franco Antonino, Stazi Alessandra, Lauria Christian, Sestito Alfonso, Lanza Gaetano A, Crea Filippo
Department of Cardiovascular Sciences, Università Cattolica del Sacro Cuore, Roma, Italy.
Cardiology. 2015;130(4):201-6. doi: 10.1159/000370027. Epub 2015 Mar 12.
To assess the effects of isosorbide-5-mononitrate (ISMN) in patients with microvascular angina (MVA).
We randomized 20 MVA patients, treated with a β-blocker or a calcium antagonist, to 60 mg slow-release ISMN (halved to 30 mg if not tolerated) or placebo once a day for 4 weeks; the patients were then switched to the other treatment for another 4 weeks. Their clinical status was assessed with the Seattle Angina Questionnaire (SAQ) and the EuroQoL score for quality of life. The exercise stress test (EST), coronary blood flow (CBF) response to nitrate and the cold pressor test (CPT), brachial artery flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) were also assessed.
Nine patients (45%) did not complete the ISMN phase due to side effects; 2 patients refused a follow-up. Nine patients completed the study. The SAQ and EuroQoL scores were significantly better with ISMN than with placebo, although the differences were small. No differences were found between the treatments in the EST results, CBF response to nitroglycerin (p = 0.55) and the CPT (p = 0.54), FMD (p = 0.26) and NMD (p = 0.35).
In this study, a high proportion of MVA patients showed an intolerance to ISMN; in those tolerating the drug, significant effects on their angina status were observed, but the benefit appeared to be modest and independent of effects on coronary microvascular function.
评估单硝酸异山梨酯(ISMN)对微血管性心绞痛(MVA)患者的疗效。
我们将20例接受β受体阻滞剂或钙拮抗剂治疗的MVA患者随机分为两组,一组每日服用60mg缓释ISMN(若不耐受则减半至30mg),另一组服用安慰剂,为期4周;之后患者换用另一种治疗方式,再进行4周。采用西雅图心绞痛问卷(SAQ)和欧洲生活质量量表评估患者的临床状况。还评估了运动负荷试验(EST)、硝酸酯类药物对冠状动脉血流(CBF)的反应以及冷加压试验(CPT)、肱动脉血流介导的血管舒张(FMD)和硝酸酯介导的血管舒张(NMD)。
9例患者(45%)因副作用未完成ISMN治疗阶段;2例患者拒绝随访。9例患者完成了研究。ISMN治疗组的SAQ和欧洲生活质量量表得分显著高于安慰剂组,尽管差异较小。两种治疗方式在EST结果、硝酸甘油对CBF的反应(p = 0.55)、CPT(p = 0.54)、FMD(p = 0.26)和NMD(p = 0.35)方面未发现差异。
在本研究中,高比例的MVA患者对ISMN不耐受;在耐受该药物的患者中,观察到其对心绞痛状况有显著影响,但益处似乎不大,且与对冠状动脉微血管功能的影响无关。