复方利血平氨苯蝶啶片(降压0号)与吲达帕胺治疗原发性高血压患者的疗效和安全性——一项随机对照临床研究  

Efficacy and safety of reserpine and triamterene compound tablets and indapamide in patients with essential hypertension:a randomized controlled clinical study

作　　者：王鸿懿[1] 孙宁玲[1] 荆珊[2] 陈源源[1] 王鲁雁[1] 

机构地区：[1]北京大学人民医院心脏中心,北京100044 [2]首都医科大学附属北京安贞医院

出　　处：《中华高血压杂志》2016年第9期857-862,共6页Chinese Journal of Hypertension

摘　　要：目的比较复方利血平氨苯蝶啶片(降压0号)与吲达帕胺治疗高危的轻中度原发性高血压患者的疗效和安全性。方法采用多中心、整群随机、活性药对照、前瞻性的临床研究,入选2003年1月至2005年12月,全国10个地区13家医院就诊的高血压患者,随访2年。观察降压0号(1片/d)与吲达帕胺(2.5mg/d)的疗效和安全性。结果入选不同区域高血压患者4062例,降压0号组2324例,吲达帕胺组1738例。治疗2年后,降压0号组和吲达帕胺组收缩压明显降低,但降压幅度比较,差异无统计学意义[(30.2±17.2)比(29.1±19.6)mm Hg,P=0.053];降压0号组的血压达标率(<140/90mm Hg)高于吲达帕胺组(62.6%比56.6%,P<0.05)。随访2年,降压0号组新发低血钾(1.8%比3.5%)、血肌酐增加(49.5%比61.1%)和尿酸增高(50.2%比57.2%)的比例低于吲达帕胺组(均P<0.05);降压0号组药物相关或可能相关不良事件发生率低于吲达帕胺组(2.45%比3.22%,P=0.046)。两组的心脑血管事件发生率分别为0.38%和0.46%。结论降压0号和吲达帕胺治疗高危的轻中度高血压患者安全有效,适宜在基层长期应用,降压0号有更低的低血钾风险。Objective To compare the efficacy and safety of reserpine and triamterene compound tablets （antihyper- tensive No. 0） with indapamide in high-risk patients with mild to moderate essential hypertension. Methods This was a multicenter, cluster randomized, active-controlled and prospective clinical trial. Hypertensive patients were enrolled from 13 hospitals in 10 regions throughout the country between January 2003 and December 2005, and were followed up for 2 years. The efficacy and safety of antihypertensive No. 0 （ 1 tablet per clay） and indapamide （2.5 mg/d） were evaluated. Results A total of 4062 patients with essential hypertension from different regions were enrolled. There were 2324 patients in the antihypertensive No. 0 group and 1738 patients in the indapamide group. After 2-year treatment and followed-up,A decrease in the systolic blood pressure in the both groups, but there was no significant difference in the degree of the decrease between the two groups [（30.2±17.2） vs （29.1± 19.6） mm Hg, P=0. 053-]. The control rates of blood pressure was higher in the antihypertensive No. 0 group than in the indapamide group（62.6 % vs 56.6%, P〈0. 05）. The incidence rates of hypokalemia（ 1.8 %vs 3.5 % ） , increased serum creatinine（49.5% vs 61.1 %）and increased serum uric acid（ 50.2% vs 57.2%） were lower in the an- tihypertensive No. 0 group than in the indapamide group（all P〈0.05）. The incidence rates of drug-related adverse events or possibly related adverse events was lower in the antihypertensive No. 0 group than in the indapamide group （2.45 % vs 3.22 %, P= 0. 046）. The incidence rates of cardiovascular and cerebrovascular events was 0.38 %and 0. 46% in the two groups, respectively. Conclusion Both antihypertensive No. 0 and indapamide were safe and ef- fective in high-risk patients with mild to moderate hypertension, and were suitable for long-term use in primary hos- pitals, while antihypertensive No. 0 had a lower risk of hypokalemia.

关 键 词：复方利血平氨苯蝶啶片 吲达帕胺 原发性高血压 基层医疗 

分 类 号：R544.11[医药卫生—心血管疾病]