Hort J F, Wilkins H M
Cusi (U.K.) Ltd., Haslemere, England.
Curr Med Res Opin. 1991;12(7):430-40. doi: 10.1185/03007999109111514.
A controlled study was carried out in patients with mild to moderate hypertension to compare the efficacy and tolerability of chlorthalidone alone and chlorthalidone combined with the potassium-sparing diuretic triamterene. After a 4-week period on placebo, 129 patients were allocated at random to receive 1 tablet daily of either 25 mg chlorthalidone (67 patients) or 25 mg chlorthalidone plus 50 mg triamterene (62 patients) for 10 weeks. Ninety-one patients (48 who had received chlorthalidone alone and 43 the combination) entered the third part of the study. During this 6-week period there was a partial crossover, approximately half continuing with their existing medication and the other half with the alternative treatment. All patients were then treated for a final 2 weeks with placebo. The placebo periods were single-blind, the active treatment periods were double-blind. Patients were seen at regular intervals throughout the trial. At each visit, measurements were taken of blood pressure and pulse rate and routine haematological and biochemical tests made. The results showed that both treatments produced similar, clinically significant reductions in blood pressure within the first 4 weeks of active medication and by the end of the 10-week period 51% of those on chlorthalidone alone and 57% on the combination showed a decrease of at least 10 mmHg or to less than 90 mmHg in standing diastolic pressure. Serum potassium decreased with both therapies but was less with the combination than with chlorthalidone alone, and the incidence of a serum potassium less than 3.5 mmol/l was significantly less with the combination. After crossover, blood pressure control was maintained but serum potassium decreased in patients changed from the combination to chlorthalidone alone and increased in those changed from chlorthalidone alone to the combination. Few adverse effects were reported and were generally mild and similar in frequency with the two therapies.
一项针对轻至中度高血压患者的对照研究开展，以比较单独使用氯噻酮以及氯噻酮与保钾利尿剂氨苯蝶啶联合使用的疗效和耐受性。在服用安慰剂4周后，129名患者被随机分配，每天服用1片25毫克氯噻酮（67名患者）或25毫克氯噻酮加50毫克氨苯蝶啶（62名患者），为期10周。91名患者（48名单独接受氯噻酮治疗，43名接受联合治疗）进入研究的第三阶段。在这6周期间，有部分交叉，大约一半患者继续使用现有药物治疗，另一半则改用另一种治疗方法。然后所有患者用安慰剂进行为期2周的最终治疗。安慰剂期为单盲，活性治疗期为双盲。在整个试验过程中定期对患者进行检查。每次就诊时，测量血压和脉搏率，并进行常规血液学和生化检查。结果显示，两种治疗方法在活性药物治疗的前4周内均使血压产生了相似的、具有临床意义的降低，到10周结束时，单独使用氯噻酮的患者中有51%，联合用药的患者中有57%的站立舒张压下降至少10 mmHg或降至低于90 mmHg。两种治疗方法均可使血清钾降低，但联合用药组比单独使用氯噻酮组降低得少，血清钾低于3.5 mmol/l的发生率联合用药组明显更低。交叉治疗后，血压控制得以维持，但从联合用药改为单独使用氯噻酮的患者血清钾降低，而从单独使用氯噻酮改为联合用药的患者血清钾升高。报告的不良反应很少，一般较轻，两种治疗方法的不良反应发生频率相似。
