珍菊降压片联合长效降压药物治疗高血压的临床研究  

Clinical Trials on Zhenjujiangya Tablets Combined with Long-acting Antihypertensive Drugs in the Treatment of Hypertension

作　　者：朱国琴 王文健 何燕[3] 王肖龙[4] 符德玉[5] 李月华[6] 薛艳清 李松林 

机构地区：[1]上海雷允上药业有限公司,上海201401 [2]上海市中西医结合学会 [3]上海中医药大学附属龙华医院 [4]上海中医药大学附属曙光医院 [5]上海中医药大学附属岳阳中西医结合医院 [6]上海交通大学医学院附属新华医院

出　　处：《中国药师》2015年第8期1349-1352,共4页China Pharmacist

基　　金：上海市科委中药现代化专项资助(编号:09DZ1977300)

摘　　要：目的:评价珍菊降压片联合长效降压药物治疗高血压的疗效和安全性。方法:220例高血压患者随机分为观察组和对照组各110例。两组患者均维持原服用的长效降压药物,qd。观察组口服珍菊降压片(0.25 g,bid),对照组口服珍菊降压片模拟片(每次1片,bid),共治疗4周。以治疗后的血压降低幅度、高血压临床症状积分、动态血压监测指标等评价临床疗效。通过症状、体征、实验室检查等评价药物安全性。结果:治疗4周后,两组收缩压、舒张压均较治疗前显著下降(P<0.01),且观察组下降值明显高于对照组(P<0.01);两组高血压临床症状总评分均较治疗前明显下降(P<0.01),且观察组症状评分下降值明显高于对照组(P<0.01),观察组高血压临床症状疗效整体优于对照组(P<0.01);两组24 h、白昼、夜间的平均收缩压、舒张压以及血压非正常值的次数等指标比较,差异无统计学意义(P>0.05),但观察组24 h平均收缩压、白昼平均收缩压与治疗前相比有统计学意义(P<0.05),对照组组内治疗前后相比无统计学意义(P>0.05),观察组24h及白昼血压非正常次数有下降趋势。两组药品不良反应发生率差异无统计学意义(P>0.05)。结论:在长效降压药物基础上加用珍菊降压片能进一步提高降压疗效,无明显不良反应,适合临床应用。To determine the efficacy and safety of Zhenjujiangya tablets combined with long-acting antihypertensive drugs in the patients with hypertension. Methods：A controlled study was carried out among 220 patients meeting the inclusion / ex-clusion criteria. All the patients were randomly divided into the experimental group and the control group. Both groups were treated with long-acting antihypertensive drugs as usual. The 110 patients in the experimental group were orally treated with Zhenjujiangya tab-lets （ bid） , while the other 110 patients in the control group were orally treated with Zhenjujiangya simulated tablets （ bid） , and the treatment course was 4 weeks. The efficacy was assessed using the reduction range of blood pressure, the clinical symptom score of hy-pertension and the indicators of ambulatory blood pressure monitoring as the indices, and the safety was assessed by the symptoms, signs and laboratory tests. Results：After the four-week treatment, the systolic blood pressure, diastolic blood pressure and hyperten-sion clinical symptom score were significantly decreased in the two groups, and the changes in the experimental group were more signifi-cant than those in the control group （P〈0. 01）. The effect on the clinical symptom of the experimental group was better than that of the control group （P〈0. 01）. There was no significant difference in systolic blood pressure, diastolic blood pressure and the number of abnormal blood pressure in 24h, daytime and nighttime （P〉0. 05）. After the treatment, the changes in average systolic blood pres-sure in 24h and daytime in the experimental group showed statistically significant difference （P〈0.05）,while those in the control group were without statistically significant difference （P〉0. 05）, and the number of abnormal blood pressure in 24h and daytime in the experimental group exhibited reduction trend. There were no significant difference in the incidence of adverse events between the two groups （P〉0. 05）. Conclusi

关 键 词：高血压 珍菊降压片 长效降压药物 双盲法 随机对照试验 疗效 安全性 

分 类 号：R286[医药卫生—中药学]