Mohanty P K, Gonasun L M, Goodman R P, Kirkendal W M, Kontos H A, Samuel P, Wright J T
Medical College of Virginia, Richmond.
Am J Hypertens. 1988 Jul;1(3 Pt 3):241S-244S. doi: 10.1093/ajh/1.3.241s.
The effects of 10 weeks of treatment with isradipine (ISRP), a new dihydropyridine Ca antagonist, was evaluated in a prospective, randomized, double-blind, parallel group, hydrochlorothiazide (HCTZ) controlled study in patients with mild to moderate hypertension. Of 98 patients enrolled, 73 completed the study and were deemed valid for efficacy analyses; 36 in the ISRP group and 37 in the HCTZ group. Monotherapy with ISRP significantly (P less than 0.001) decreased (mean +/- SD) sitting systolic blood pressure (BP) from 146 +/- 11 mm Hg to 128 +/- 11 mm Hg and diastolic BP from 100 +/- 4 mm Hg to 83 +/- 5 mm Hg. Heart rate during the plateau period was not significantly different (76 +/- 11 vs 78 +/- 11 bpm) between the ISRP and HCTZ groups. These reductions in BP were comparable to monotherapy with HCTZ. The mean reduction in diastolic BP with ISRP (17 +/- 6 mm Hg) was significantly (P less than 0.05) greater than that with HCTZ (14 +/- 5 mm Hg). The mean doses for ISRP and HCTZ were 12 mg/day and 60 mg/day, respectively. There was no significant difference in frequency of common side effects (headache, nausea, fatigue, dizziness, palpitations) between the two groups. However, transient or intermittent peripheral edema occurred more frequently in ISRP group. Four patients in ISRP group (two due to edema and two due to palpitations) and two patients in HCTZ group (due to poor BP control) were discontinued from the study. Our results indicate that ISRP in doses of 5 to 10 mg bid is as effective as HCTZ as monotherapy in the treatment of mild to moderate hypertension.
在一项前瞻性、随机、双盲、平行组、以氢氯噻嗪（HCTZ）为对照的研究中，评估了新型二氢吡啶类钙拮抗剂伊拉地平（ISRP）治疗10周对轻至中度高血压患者的疗效。98名入组患者中，73名完成了研究并被认为可进行疗效分析；ISRP组36名，HCTZ组37名。ISRP单药治疗使坐位收缩压（BP）（均值±标准差）从146±11 mmHg显著降低（P<0.001）至128±11 mmHg，舒张压从100±4 mmHg降至83±5 mmHg。ISRP组和HCTZ组在平台期的心率无显著差异（76±11对78±11次/分钟）。这些血压降低幅度与HCTZ单药治疗相当。ISRP使舒张压的平均降低幅度（17±6 mmHg）显著大于HCTZ（14±5 mmHg）（P<0.05）。ISRP和HCTZ的平均剂量分别为12 mg/天和60 mg/天。两组常见副作用（头痛、恶心、疲劳、头晕、心悸）的发生率无显著差异。然而，ISRP组短暂或间歇性外周水肿出现得更频繁。ISRP组有4名患者（2名因水肿，2名因心悸）和HCTZ组有2名患者（因血压控制不佳）退出研究。我们的结果表明，每日两次服用5至10 mg的ISRP作为单药治疗轻至中度高血压与HCTZ同样有效。
