论文部分内容阅读
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。
Background According to the new model of medicine, a randomized, double-blind comparison is the gold standard for evaluating drug effects. Many new-generation antihypertensive drugs have few randomized double-blind studies both at home and abroad. In this study, Efficacy, safety, side effects evaluation, provide an important reference for clinicians. METHODS: A randomized, double-blind, parallel study of 511 hypertensive patients was divided into three groups: 172 patients in the nitrendipine group, 20 mg / d to 30 mg / d, and 168 patients in the atencile hydrochloride group, 25 mg / D ~ 50mg / d; Captopril group 171 cases, 50mg / d ~ 75mg / d, observed in June. Results In each group, the blood pressure reached the peak value in March, and the systolic blood pressure rose slightly and the diastolic blood pressure continued to decrease in June. The compliance rate (<140mmHg / 90mmHg) in NI group was 65.2%, and that in ammonia and card group was 50.8% and 48.4% respectively. Drug withdrawal rate card group reached 9.1%, Ni, ammonia group were 5.6%. The cumulative incidence of side effects in each group were similar, card cough up to 36.2%, Nippon flushing 26.1%, ammonia group fatigue 26.3%. Ammonia improved the best quality of life. The card group had a slightly negative effect on cognition, and the nicotine group had a slight negative effect on overall quality of life. Conclusion All the three drugs can be effectively depressurized. The antihypertensive effect of nitrendipine is better than that of Atenolol and Captopril. Ammonia group best quality of life.