Chamontin B, Boccalon H
Service de Médecine Interne et Hypertension Artérielle, CHU Purpan, Toulouse, France.
Therapie. 1995 Mar-Apr;50(2):89-93.
Patients with chronic occlusive arterial disease of lower limbs have an excess mortality due to associated cardiovascular diseases or cancer. They also have an important morbidity with a high prevalence of coronary artery diseases and strokes. In this context, the only benefit of peripheral vasodilators devoid of any effect on morbidity and mortality, could be only on quality of life. Haemodynamic effects of these drugs have been evaluated by several reproducible techniques in order to measure the peripheral blood flow (plethysmography, 133Xe clearance, transcutaneous oxygen-pressure, electromagnetic debimetry). An increase in blood flow has been demonstrated in patients receiving pentoxifylline, naftidrofuryl, or blufomedil in phase II clinical trials using these different methods. No general haemodynamic effect has been observed with these drugs which were better denominated vaso-active drugs. However the most relevant criteria remained to confirm a clinical benefit, particularly on intermittent claudication. Number of positive clinical trials in patients with intermittent claudication have been published, but from a methodological point of view few of them were suitable and demonstrated a statistically significant benefit. Criticisms were mainly related to the type of trial (cross-over is not recommended because of the drug-period effect), the lack of 'intention to treat' analysis, the inhomogeneity of the compared groups (for example different percentages of diabetics and excess of drop-outs). In spite of an established haemodynamic effect and of a demonstrated benefit in claudicants, peripheral vasodilators appear to have a slight interest in the global care of patients with occlusive arterial disease of lower limbs mainly on functional symptoms.
下肢慢性闭塞性动脉疾病患者由于合并心血管疾病或癌症而死亡率过高。他们还存在严重的发病情况，冠状动脉疾病和中风的患病率很高。在这种情况下，外周血管扩张剂唯一的益处（且对发病率和死亡率无任何影响）可能仅体现在生活质量方面。这些药物的血流动力学效应已通过多种可重复的技术进行评估，以测量外周血流量（体积描记法、¹³³Xe清除率、经皮氧分压、电磁血流量测定）。在使用这些不同方法的II期临床试验中，已证实在接受己酮可可碱、萘呋胺酯或丁咯地尔治疗的患者中血流量有所增加。使用这些更确切地称为血管活性药物的药物未观察到一般的血流动力学效应。然而，最相关的标准仍有待确认其临床益处，尤其是对间歇性跛行的益处。已发表了一些针对间歇性跛行患者的阳性临床试验，但从方法学角度来看，其中很少有合适的且显示出统计学上的显著益处。批评主要涉及试验类型（由于药物周期效应不建议采用交叉试验）、缺乏“意向性治疗”分析、比较组的不均匀性（例如糖尿病患者的不同百分比和过多的失访）。尽管外周血管扩张剂已确立了血流动力学效应且在跛行患者中显示出益处，但在下肢闭塞性动脉疾病患者的整体治疗中，外周血管扩张剂似乎对主要的功能症状仅有轻微作用。
