几种降压药物综合疗效随机双盲研究-511例报告

Comparison the Efficacy of Captopril,Nitrendipine,and Atenolol in the Treatment of Hypertension

背景有据医学的新模式提出随机双盲对照是评价药物效果的金标准，许多新一代降压药物国内外均少随机双盲研究，本研究采用随机双盲法对常用三类药物的降压效果，安全性，副作用进行评价，为临床医师提供重要参考资料。方法采用随机双盲并行研究，经二周安慰剂洗脱后，５１１例高血压患者分入三组：尼群地平组１７２例，２０ｍｇ／ｄ～３０ｍｇ／ｄ；氨酰心安组１６８例，２５ｍｇ／ｄ～５０ｍｇ／ｄ；卡托普利组１７１例，５０ｍｇ／ｄ～７５ｍｇ／ｄ，观察６月。结果各组３月时降压达峰值，六月时收缩压均有轻微回升，而舒张压持续降低。尼组降压达标率（＜１４０ｍｍＨｇ／９０ｍｍＨｇ）为６５．２％，氨及卡组为５０．８％，４８．４％。撤药率卡组达９．１％，尼、氨组均为５．６％。各组副作用累计发生率相似，卡组咳嗽高达３６．２％，尼组面红２６．１％，氨组乏力２６．３％。氨组生活质量改善最佳。卡组对认知有轻度负面影响，尼组对生活质量总体有轻微负面影响。结论三种药物均可有效降压，尼群地平的综合降压效果优于氨酰心安、卡托普利。氨组生活质量最佳。

Aim \ To compare the efficacy and safety of Captopril,nitrendipine and atenolol in treatment of hypertension.\ Methods \ A randomized,doubleblind,parallel study was conducted on 511 patients with blood pressure 140 mmHg/90 mmHg.After a 2week runin period. The eligible patients were assigned to one of the three drugs.Stratified by age (60 or <60 yrs): (1)nitrendipine (NG, n=172, 20 mg30 mg/d); (2)atenolol (AG, n=168, 25 mg/d50mg/d); (3)captopril (CG,n=171,50 mg/d75 mg/d),and followedup twice a month, over a period of 6 months, The blood pressure, heart rate, side effects, compliance,and quality of life (QOL) were investigated.\ Results \ After six months,the blood pressure (mmHg, s) were reduced by 307167/141129 in NG ,273163/13851 in AG,and 268121/13092 in CG ,respectively.The response rate(BP<140 mmHg/90 mmHg) was achieved by 652% in NG,508% in AG,and 484% in CG,respectively. Nitrendipine was ranked as the top 1 by the efficacy of antihypertesion .The quality of life in patients improved in both of AG,CG,but not in NG. No serious side effects has been found. Nevertheless, there were 362% cough occurred in CG 263% fatigues in AG, and 261% flushing in NG.\ Conclusion \ All of the three drugs are safe, effective in lowering blood pressure. QL were improved in AG and CG. The side effects were mild. The response of NG was relatively better than CG and AG.