CAJ | 학술논문

目的：观察尼群洛尔治疗高血压伴心血管危险因素患者的临床效果和安全性，并同时观察其对动态血压的影响。方法本研究是一项多中心随机对照临床试验。18～79岁伴心血管病危险因素的高血压患者在知情同意后进入研究。导入期2周，停用正在使用的降压药物。2周后门诊随访血压为收缩压（SBP）140～179 mmHg和（或）舒张压（DBP）90～109 mmHg者被随机分为尼群洛尔组（A组）或氨氯地平组（B组）。目标血压值为＜140/90 mmHg。随访中根据血压目标增加药物剂量或加其他降压药，治疗随访期6个月。基线、治疗4周和6个月时，各进行1次24小时（h）动态血压监测（ABPM）。研究过程中随时观察不良事件的发生情况。结果全国7个协作中心共随机入选207例高血压患者。治疗1个月后，两组的SBP和DBP就有显著下降，与治疗前相比差异非常显著（P＜0.01），这种趋势一直持续至研究结束。治疗6个月时，尼群洛尔组和氨氯地平组血压分别显著下降18.9/9.2 mmHg和18.2/9.9 mmHg。治疗4周和6个月后，A、B组动态血压监测24 h，白昼和夜间血压均显著下降。治疗1个月时，二组血压达标率已近似50%，治疗6个月时均达到77%。研究过程中无严重不良事件报告。结论尼群洛尔可快速有效降低高危高血压患者血压水平，研究过程中未发现其对糖脂代谢的影响。
목적：관찰니군락이치료고혈압반심혈관위험인소환자적림상효과화안전성，병동시관찰기대동태혈압적영향。방법본연구시일항다중심수궤대조림상시험。18～79세반심혈관병위험인소적고혈압환자재지정동의후진입연구。도입기2주，정용정재사용적강압약물。2주후문진수방혈압위수축압（SBP）140～179 mmHg화（혹）서장압（DBP）90～109 mmHg자피수궤분위니군락이조（A조）혹안록지평조（B조）。목표혈압치위＜140/90 mmHg。수방중근거혈압목표증가약물제량혹가기타강압약，치료수방기6개월。기선、치료4주화6개월시，각진행1차24소시（h）동태혈압감측（ABPM）。연구과정중수시관찰불량사건적발생정황。결과전국7개협작중심공수궤입선207례고혈압환자。치료1개월후，량조적SBP화DBP취유현저하강，여치료전상비차이비상현저（P＜0.01），저충추세일직지속지연구결속。치료6개월시，니군락이조화안록지평조혈압분별현저하강18.9/9.2 mmHg화18.2/9.9 mmHg。치료4주화6개월후，A、B조동태혈압감측24 h，백주화야간혈압균현저하강。치료1개월시，이조혈압체표솔이근사50%，치료6개월시균체도77%。연구과정중무엄중불량사건보고。결론니군락이가쾌속유효강저고위고혈압환자혈압수평，연구과정중미발현기대당지대사적영향。
Objective To observe the curative effect and safety of nitrendipine/atenolol in hypertensive patients with cardiovascular risk factors, and observe the influence of nitrendipine/atenolol on ambulatory blood pressure (BP). Methods The study was a multicenter randomized controlled clinical trial. The hypertensive patients with cardiovascular risk factors aged from 18 to 79 were chosen into the trial after informed consent. In 2-w run-in period, all patients stopped their anti-hypertension durgs. After 2 w, the patients with SBP from 140 mmHg to 179 mmHg and/or DBP from 90 mmHg to 109 mmHg were randomly divided into nitrendipine/atenolol group (group A) and amlodipine besylate group (group B). The target BP was<140/90 mmHg, and during follow-up period (6 months), the drug dose would be increased or other anti-hypertensive agents would be applied according to BP target. The patients were given a 24-h ambulatory blood pressure monitoring (ABPM) respectively at baseline and after treatment for 4 w and 6 months. The incidence of adverse events was observed at any time. Results There were totally 207 hypertensive patients included from 7 national cooperation centers. After treatment for 1 month, SBP and DBP decreased significantly in 2 groups and the difference was significant compared with before treatment (P<0.01), and this trend was continued to the end of the trial. After treatment for 6 months, BP decreased by 18.9/9.2 mmHg in group A and by 18.2/9.9 mmHg in group B. after tratmetn for 4 w and 6 months, 24-h ABPM showed that daytime and nighttime BP decreased significantly in 2 groups. BP control rate reached to 50%after treatment for 1 month and reached to 77%after treatment for 6 months. There were no adverse events reported during the trial. Conclusion Nitrendipine/atenolol can rapidly and effectively reduce BP level in patients with high-risk hypertension, and it has no impact on glucolipid metabolism.