Lévy S
Hôpital Nord, CHU, Service de Cardiologie, Marseille.
Ann Cardiol Angeiol (Paris). 1995 Apr;44(4):203-12.
Trimetazidine is a cytoprotective anti-ischaemic agent whose antianginal efficacy has been demonstrated in monotherapy versus placebo and versus reference products, and in combination with beta-blockers and nifedipine. As coprescription with diltiazem has not been previously studied, the objective of this study was to evaluate the benefit of the addition of trimetazidine (60 mg/24 h) to diltiazem (180 mg/24 h) in the stable exertional angina insufficiently improved by calcium channel blocker alone. This multicentre double-blind placebo-controlled study was conducted over a period of 6 months. The inclusion criteria were stable angina with electrically positive stress test, which remained positive despite a 15-day treatment with diltiazem (180 mg/24 h). It was conducted in 67 patients randomized into two groups: diltiazem-placebo (group I: 35 patients) and diltiazem-trimetazidine (group II: 32 patients). The follow-up consisted of clinical assessment and a stress test on inclusion and at 6 months. The two groups were similar on inclusion for all ergometric parameters, excepted for the time to onset of the ischaemic threshold of 1 mm and the total duration of effort, which were significantly longer in the placebo group. Comparison of the stress tests performed at the sixth month and on inclusion between groups I and II showed that the ischaemic threshold of 1 mm was significantly delayed by 2 minutes 41 seconds in the trimetazidine group (p < 0.001) versus 42 seconds in the placebo group (NS). Similarly, the work performed at this threshold was significantly increased by 1446 kpm in the trimetazidine group (p < 0.001) versus 564 kpm in the placebo group (p = 0.012). The difference between the two groups was significant for these two parameters, p = 0.008 and p = 0.018, respectively. At maximum effort, the total duration and the total work also increased significantly in the trimetazidine group, by 50 seconds (p = 0.006) and 570 kpm (p = 0.004), respectively, versus 16 seconds and 221 kpm in the placebo group (NS). The [double product (SBP x HR)/load (in watts)] ratio at the ischaemic threshold of 1 mm reached at M0, decreased significantly in the trimetazidine group by 69.9 (p < 0.001) versus 20.3 in the placebo group (NS). The difference between the two groups was significant (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
曲美他嗪是一种具有细胞保护作用的抗缺血药物，其抗心绞痛疗效已在单药治疗对比安慰剂和对照产品，以及与β受体阻滞剂和硝苯地平联合使用时得到证实。由于此前尚未研究过与地尔硫䓬联合处方的情况，本研究的目的是评估在单独使用钙通道阻滞剂改善不足的稳定劳力性心绞痛患者中，加用曲美他嗪（60毫克/24小时）至地尔硫䓬（180毫克/24小时）的益处。这项多中心双盲安慰剂对照研究进行了6个月。纳入标准为运动试验心电图阳性的稳定型心绞痛，尽管接受了15天地尔硫䓬（180毫克/24小时）治疗，运动试验仍为阳性。研究共纳入67例患者，随机分为两组：地尔硫䓬 - 安慰剂组（I组：35例患者）和地尔硫䓬 - 曲美他嗪组（II组：32例患者）。随访包括纳入时和6个月时的临床评估及运动试验。两组在纳入时所有运动参数方面相似，但安慰剂组的缺血阈值1毫米出现时间和总运动持续时间明显更长。I组和II组在第6个月和纳入时进行的运动试验比较显示，曲美他嗪组缺血阈值1毫米显著延迟2分41秒（p < 0.001），而安慰剂组延迟42秒（无统计学意义）。同样，曲美他嗪组在该阈值时的做功显著增加1446千帕米（p < 0.001），而安慰剂组增加564千帕米（p = 0.012）。这两个参数在两组间差异显著，p值分别为0.008和0.018。在最大运动时，曲美他嗪组的总持续时间和总做功也显著增加，分别增加50秒（p = 0.006）和570千帕米（p = 0.004），而安慰剂组分别增加16秒和221千帕米（无统计学意义）。在M0时达到的缺血阈值1毫米处的[双乘积（收缩压×心率）/负荷（瓦特）]比值，曲美他嗪组显著降低69.9（p < 0.001），而安慰剂组降低20.3（无统计学意义）。两组间差异显著（p < 0.01）。（摘要截断于250字）
