清心胶囊治疗轻中度高血压病的临床研究

目的 观察中药清心胶囊治疗轻中度高血压病的临床疗效，并进一步探索其降压机理。方法 采用随机对照、双盲双模拟的方法进行临床试验，将98例符合纳入标准的高血压病患者随机分为清心胶囊(A)组34例、卡托普利(B)组32例、清心胶囊加卡托普利(C)组32例，疗程12周。观察治疗前后血压和动态血压的变化，以及临床症状、生活质量、血浆降钙素基因相关肽(CGRP)、血管紧张素Ⅱ(AngⅡ)、内皮素(ET)水平的改变，并记录与药物相关的不良反应。结果 A组、B组、C组降压显效率分别为44．1％、53．1％、75．0％；而改善症状显效率分别为55，9％、46．9％、50．0％；在症状积分下降幅度方面．C组>A组>B组；在改善生活质量方面，A组优于B组(P<0．05)；3组均可显著提高血浆CGRP水平；A组还对血浆AngⅡ、ET有显著的下调作用，治疗前后比较差异有显著性(P<0．05)。结论 清心胶囊对于轻、中度高血压病患者具有良好的降压作用，在改善患者临床症状和提高生活质量方面A组和C组优于B组。清心胶囊取效机制可能与其抑制循环肾素-血管紧张素系统(RAS)活性、纠正ET／CGRP失衡有关，临床使用安全有效。

Clinical Study on Effect of Qingxin Capsule in Treating Patients with Hypertension of Mild or Moderate Degree

OBJECTIVE: To observe the therapeutic effect of qingxin capsule (QXC) in treating patients with hypertension of mild or moderate degree, and to explore its mechanism in lowering blood pressure. METHODS: Adopting randomized double-blind double-simulated positive controlled clinical trial design, 98 patients were randomly divided into three groups, they were treated by QXC (n = 34), captopril (n = 32) and QXC plus captopril (n = 32), respectively for 12 weeks. Changes of blood pressure, clinical symptoms, quality of life (QOF), plasma levels of calcitonin gene-related peptide (CGRP), angiotensin II (Ang II) and endothelin (ET) in patients before and after treatment were observed, and the adverse reactions to the treatment were recorded. RESULTS: The markedly effective rate in lowering blood pressure of QXC, captopril and QXC plus captopril was 44.1%, 53.1% and 75.0% respectively, the markedly effective rate in ameliorating symptoms was 56.0%, 47.0% and 50.0% respectively. In respect of reducing symptomatic scores, QXC > captopril > QXC + captopril, in respect of ameliorating QOF, QXC was superior to captopril (P < 0.05). Single or combined use of QXC and captopril could increase the plasma CGRP level. QXC could also reduce the plasma levels of Ang II and ET, showing statistical significance in comparing the levels before and after treatment (P < 0.05). CONCLUSION: QXC can safely and effectively lower blood pressure of patients with mild or moderate degree of hypertension. QXC alone or combined with captopril could improve clinical symptoms and raise QOF in patients more potently than that of captopril alone. The mechanism of QXC might be related with its inhibition on the activity of circulatory renin-angiotensin system and adjustment on ET/CGRP imbalance.