Safar M, Cournot P, Duchier J
Centre de diagnostic, hôpital Broussais, Paris.
Arch Mal Coeur Vaiss. 1989 Nov;82 Spec No 4:119-24.
In this multicentre controlled single blind trial the effectiveness and safety of cicletanine (100 mg/day) were compared with those of enalapril (20 mg/day) and of the combination of both drugs in the same doses in 72 patients (41 men, 31 women, mean age 64.1 +/- 8.3 years) with permanent moderate essential hypertension without severe cardiovascular complications. In the course of the trial, one patient in each of the three therapeutic groups was excluded either for insufficient effectiveness in monotherapy or for photosensitization under the combined treatment. After two months of treatment, the fall in blood pressure and the number of patients with normalized BP were similar in the groups treated with cicletanine or enalapril alone. In contrast, the cicletanine-enalapril combination produced a significantly greater fall of diastolic arterial pressure than cicletanine alone. In addition, there was a greater reduction of functional symptoms associated with arterial hypertension. Apart from the lone case of photosensitization observed with the combined treatment, only minor side-effects were encountered, including an episode of diarrhoea and a case of extrasystoles with the combination, and a case or nausea with lipothymia under cicletanine alone. There were no significant variations of biochemical values.
在这项多中心对照单盲试验中，对72例（41例男性，31例女性，平均年龄64.1±8.3岁）患有持续性中度原发性高血压且无严重心血管并发症的患者，比较了西氯他宁（100毫克/天）与依那普利（20毫克/天）以及两种药物相同剂量联合使用的有效性和安全性。在试验过程中，三个治疗组中各有一名患者被排除，一名是因为单一疗法效果不佳，另一名是因为联合治疗下出现光敏反应。治疗两个月后，单独使用西氯他宁或依那普利治疗的组中，血压下降情况和血压恢复正常的患者数量相似。相比之下，西氯他宁 - 依那普利联合用药使舒张期动脉压下降幅度明显大于单独使用西氯他宁。此外，与动脉高血压相关的功能性症状有更大程度的减轻。除联合治疗中观察到的一例光敏反应外，仅出现了轻微的副作用，包括联合用药时出现一次腹泻和一例早搏，单独使用西氯他宁时出现一例恶心伴眩晕。生化指标无显著变化。
