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|本期目录/Table of Contents|

复方赖诺普利片治疗轻中度原发性高血压临床观察

《心脏杂志》[ISSN:1009-7236/CN:61-1268/R]

期数:
2009年第5期
页码:
681-682,688
栏目:
临床研究
出版日期:
2009-07-14

文章信息/Info

Title:
xLisinopril hydrochlorothiazide combination in treatment of patients with mild-to-moderate essential hypertension
作者:
黄高忠1; 汤晔华2; 丁茹2; 吴宗贵2
1.上海交通大学附属第六人民医院老年科，上海 200233;2.上海长征医院心内科，上海 200003
Author(s):
HUANG Gao-zhong1;  TANG Ye-hua2;  DING Ru2;  WU Zong-gui2
1.Department of Gerontology, Sixth Peoples Hospital, Shanghai Jiaotong University, Shanghai 200233, China; 2.Department of Cardiology, Changzheng Hospital, Shanghai 200003, China
关键词:
赖诺普利; 复方; 高血压; 原发性; 临床试验
Keywords:
lisinopril;  compound;  hypertension;  essential;  clinical trial
分类号:
R972.4
DOI:
-
文献标识码:
A
摘要:
目的: 评价国产复方赖诺普利片治疗轻、中度原发性高血压(EH)的疗效和安全性。方法: 本研究为随机、双盲、安慰剂对照临床试验，从98例EH患者中筛选出经赖诺普利（10 mg/d）单药治疗4周、血压不能满意控制者(≥140/90 mmHg,1 mmHg=0.133 kPa) 49例，随机分为对照组(n=25)和试验组(n=24)，继续治疗8周，分别服用赖诺普利2片（每片10 mg）或者复方赖诺普利（每片含赖诺普利10 mg、氢氯噻嗪12.5 mg） 1片，每日1次。结果: 复方赖诺普利与赖诺普利(2片/d)的降压效果相似，有效率分别为88%和84%。两组的不良反应均较轻，主要为咳嗽，分别为17%和20%，无统计差异。结论: 国产复方赖诺普利片治疗轻中度EH安全、有效。
Abstract:
AIM: To evaluate the efficacy and safety of compound lisinopril tablets (domestic product) in patients with mild-to-moderate essential hypertension. METHODS: A double-blind, randomized clinical trial was conducted. Patients with essential hypertension (n=98) were treated with placebo for 2 weeks and then lisinopril (10 mg/day) for 4 weeks. Those patients whose blood pressure was still not <140/90 mmHg (n=49) were randomly assigned to receive lisinopril 20 mg, 1/day (control group, n=25) or compound lisinopril tablets (compound group, n=24, lisinopril 10 mg/hydrochlorothiazide 12.5 mg, 1 tablet/day) for 8 weeks. RESULTS: No significant difference was seen in the effective rate between groups (88% and 84%, in compound group and control group, respectively). Adverse reactions were slight and the most common was cough (17% and 20%, in compound group and control group, respectively). CONCLUSION: Compound lisinopril is proven to be safe and effective as an antihypertensive.

参考文献/References

［1］ Mancia G, De Backer G, Dominiczak A ,et al. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology［J］. J Hypertens, 2007, 25(6):1105-1187.

［2］ 陈泽涛,张彬. 高血压病的一级预防和早期药物治疗中常见问题［J］. 心脏杂志， 2006， 18（5）：F002.

［3］ Malacco E, Santonastaso M, Vari NA, et al. Comparison of valsartan 160 mg with lisinopril 20 mg, given as monotherapy or in combination with a diuretic, for the treatment of hypertension: the Blood Pressure Reduction and Tolerability of Valsartan in Comparison with Lisinopril (PREVAIL) study［J］. Clin Ther, 2004, 26(6):855-865.

［4］ 康彩练,高晨燕. 复方抗高血压药物注册临床研究应注意的问题［J］. 中国临床药理学与治疗学, 2006, 11(8):952-954.

［5］ Pathé M. Lisinopril-hydrochlorothiazide combination vs lisinopril for the treatment of hypertension［J］. J Hum Hypertens, 1991， 5(Suppl 2):53-54.

［6］ Murray NH. Review of international safety data for lisinopril-hydrochlorothiazide combination treatment［J］. J Hum Hypertens, 1991，5（Suppl 2）:63-67.

备注/Memo

备注/Memo:
收稿日期：2008-3-4.作者简介：黄高忠，主任医师，博士Email:huanggaozhong@medmail.com.cn
更新日期/Last Update: 2009-07-22