Salvadeo A, Villa G, Segagni S, Piazza W, Criscuolo D
Int J Clin Pharmacol Ther Toxicol. 1981 Aug;19(8):372-6.
Thirty-one patients with moderate and severe essential hypertension completed a comparative study of oxdralazine and dihydralazine. Treatments were administered for a 6-month period. The therapeutic regimen also included diuretic and a beta-blocking agent given at a constant daily dose. After a 4-week run-in period on diuretic plus beta blocker, which caused a mean blood pressure reduction of 17/7 mmHg, the administration of the vasodilators produced a further, more marked decrease of pressure values. After 1-month treatment mean blood pressure reductions were 26/18 mmHg on oxdralazine and 16/11 mmHg on dihydralazine. After 6 months, 10/15 patients on oxdralazine and 7/16 patients on dihydralazine had achieved a stabile diastolic pressure below 95 mmHg. These results were confirmed by an additional phase of the study, in which 21 patients had the vasodilator cross-over and were observed for a second 6-mont period. Oxdralazine and dihydralazine therapy were well tolerated: only a few patients complained of side effects that were of mild intensity and never required any change in treatment. At the first visit after the cross-over, those patients changing from oxdralazine to dihydralazine complained of side effects with a higher frequency than the patients changing from dihydralazine to oxdralazine. In one patient from the former group it was necessary to stop dihydralazine treatment.
31例中重度原发性高血压患者完成了奥昔肼屈嗪和双肼屈嗪的对比研究。治疗为期6个月。治疗方案还包括使用利尿剂和每日剂量恒定的β受体阻滞剂。在利尿剂加β受体阻滞剂的4周导入期后,平均血压下降了17/7 mmHg,使用血管扩张剂后血压值进一步显著下降。治疗1个月后,奥昔肼屈嗪组平均血压下降26/18 mmHg,双肼屈嗪组平均血压下降16/11 mmHg。6个月后,奥昔肼屈嗪组10/15例患者和双肼屈嗪组7/16例患者舒张压稳定在95 mmHg以下。该研究的另一阶段证实了这些结果,其中21例患者进行了血管扩张剂交叉治疗,并在第二个6个月期间进行了观察。奥昔肼屈嗪和双肼屈嗪治疗耐受性良好:只有少数患者抱怨有轻度副作用,且从未需要改变治疗方案。在交叉治疗后的首次就诊时,从奥昔肼屈嗪换用双肼屈嗪的患者抱怨副作用的频率高于从双肼屈嗪换用奥昔肼屈嗪的患者。前一组中有1例患者必须停止双肼屈嗪治疗。