比索洛尔/氢氯噻嗪复方片治疗原发性高血压的疗效与安全性  

Therapeutic Effect and Safety of Bisprolol/hydrochlorothiazide Compound Tablet on Patients with Essential Hypertension

作　　者：漆泓[1] 杨天伦[1] 吴声滨[1] 荆施展[1] 

机构地区：[1]中南大学湘雅医院心血管内科,长沙410008

出　　处：《医药导报》2006年第11期1158-1160,共3页Herald of Medicine

摘　　要：目的评价比索洛尔／氢氯噻嗪复方片治疗轻中度原发性高血压的临床疗效与安全性。方法采用随机、双盲、平行对照的方法，选择轻中度原发性高血压患者31例，经2周安慰药洗脱后，随机分为试验组16例和对照组15例。试验组给予比索洛尔／氢氯噻嗪复方片（2.5mg／6．25mg）口服，对照组给予比索洛尔片2．5mg口服，均每天1次。治疗4周末若坐位舒张压仍〉／90mmHg（1mmHg=0．133kPa），则剂量分别加至比索洛尔／氢氯噻嗪复方片5mg／6．25mg或比索洛尔片5mg，qd，治疗至8周末。于安慰药洗脱末及治疗2，4，6，8周末测量诊室血压、心率、体征并记录不良反应。试验开始前及结束时进行实验室及心电图检查。结果共29例患者完成试验，其中试验组16例，对照组13例。两组服药后4周末和8周末坐位收缩压、舒张压及心率与服药前比较均明显降低（均P〈0．01）；试验组坐位舒张压下降幅度较对照组大（P〈0．05）；试验组8周末坐位收缩压下降幅度较对照组大（P〈0．05）。服药8周后，试验组总有效率（93．75％）明显高于对照组（53．33％）（P〈0．05）。两组不良反应均较轻而少，组间比较差异无显著性。两组治疗前后实验室检查指标异常率差异无显著性。结论每天一次给予比索洛尔／氢氯噻嗪复方片2．5～5．0mg／6.25mg治疗轻、中度原发性高血压的疗效优于单药比索洛尔，且安全性好。Objective To evaluate the therapeutic effect and safety of bisprolol/ hydrochlorothiazide compound tablet on patients with essential hypertension. Methods In this randomized controlled clinical trial, after 2 weeks single blind placebo was hout, patients with essential hypertension were randomly assigned to receive bisprolol/hydrochlorothiazide compound tablet 2.5 mg/6.25 mg or bisprolol tablet 2.5 mg once daily for 4 weeks. Doses were added to bisprolol/ hydrochlorothiazide compound tablet 5 mg/6.25 mg or bisprolol tablet 5 mg once daily for another 4 weeks in patients having seated DBP ≥90 mmHg at the end of 4 weeks. Blood pressure, heart rates, symptoms and signs as well as adverse effects were examined and inquired at the end of washout and 2, 4, 6, 8 weeks, laboratory examinations and electrocardiogram were performed at baseline and the end of the trial. Results Thirty one essential hypertensive patients were recruited and randomly divided into bisprolol/ hydrochlorothiazide compound tablet group （16 cases） or bisprolol tablet group （15 cases） . Twenty nine eligible essential hypertensive patients completed the trial, 16 patients in bisprolol/hydrochlorothiazide compound tablet group and 13 patients in blsprolol tablet group. At the end of 4 , 8 weeks , systolic blood pressure （SBP） , diastolic blood pressure （DBP） , and heart rate（HR） were significantly lowered compared with those at baseline （P 〈 0.01 ）; there was significant difference in the reduction of seated DBP between the two groups （P 〈 0.05）. At the end of 8 weeks, there was significant difference in the reduction of seated SBP and the response rate between the two groups （ P 〈 0.05 ） , the response rate being 93.75% in bisprolol/hydroehlorothiazide compound tablet group and 53.33 % in bisprolol tablet group. Side effects were mild and few with no significant difference between 2 groups. At the end of 8 weeks, no difference was found in laboratory findings compared with those at baseline in the two groups �

关 键 词：比索洛尔/氢氯噻嗪复方片 高血压 原发性 随机对照临床试验 

分 类 号：R544.1[医药卫生—心血管疾病] R972.4[医药卫生—内科学]