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卡托普利(开博通)治疗印度原发性高血压患者的临床试验。

Clinical trial of captopril (Aceten) in Indian patients with essential hypertension.

作者信息

Shah B P, Patel K, Oke V G, Raghu C N

出版信息

Int J Clin Pharmacol Ther Toxicol. 1986 Aug;24(8):415-20.

PMID:3531033
Abstract

ACE inhibitors are not available in India. Response to captopril in comparison with M-dopa was therefore seen in Indian hypertensive patients. A double blind randomized non-crossover study was carried out on 39 adult patients of either sex suffering from essential hypertension. Twenty-five patients included were resistant to earlier drug therapy. The remaining 14 were freshly detected hypertensive patients. Patients received either 150 mg/day captopril (Aceten) or 750 mg/day M-dopa in 3 equally divided doses every day for 30 days. The mean systolic and diastolic blood pressure in captopril (Aceten) group before starting drug therapy was 171 +/- 4.11 (mean +/- SE) and 111 +/- 0.22, respectively. At the end of therapy the systolic blood pressure was 132 +/- 1.86 and diastolic blood pressure was 84 +/- 1.36 mm of mercury. This fall in the blood pressure within the group was statistically highly significant (p less than 0.001). Similarly patients on M-dopa produced statistically highly significant fall in blood pressure (p less than 0.001) at the end of 4 weeks therapy. Initial systolic and diastolic blood pressure in both groups were comparable and, at the end of 2 and 4 weeks therapy, patients on captopril (Aceten) showed greater fall in both systolic (p less than 0.001) and diastolic (p less than 0.005) blood pressure than patients on M-dopa. None of the patients in the trial demonstrated clinically significant changes in the biochemical parameters. Six of nineteen patients on methyl dopa had side effects which are well known to this drug. None in the captopril showed any side effect.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在印度无法获取血管紧张素转换酶(ACE)抑制剂。因此,在印度高血压患者中观察了卡托普利与甲基多巴相比的疗效。对39名患有原发性高血压的成年患者(男女不限)进行了一项双盲随机非交叉研究。其中25名患者对先前的药物治疗耐药。其余14名是新确诊的高血压患者。患者每天接受150毫克/天的卡托普利(开博通)或750毫克/天的甲基多巴,分3等份剂量,持续30天。开始药物治疗前,卡托普利(开博通)组的平均收缩压和舒张压分别为171±4.11(平均值±标准误)和111±0.22。治疗结束时,收缩压为132±1.86,舒张压为84±1.36毫米汞柱。该组内血压下降在统计学上具有高度显著性(p<0.001)。同样,服用甲基多巴的患者在4周治疗结束时血压下降在统计学上也具有高度显著性(p<0.001)。两组的初始收缩压和舒张压具有可比性,在治疗2周和4周结束时,服用卡托普利(开博通)的患者收缩压(p<0.001)和舒张压(p<0.005)的下降幅度均大于服用甲基多巴的患者。试验中没有患者的生化参数出现具有临床意义的变化。19名服用甲基多巴的患者中有6人出现了该药物常见的副作用。服用卡托普利的患者中无人出现任何副作用。(摘要截选至250字)

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