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| JIKEI HEART试验：缬沙坦用于日本高血压和心血管疾病患者病死率和重构研究 | ||
| 背景：最近的几项临床研究表明，血管紧张素II受体拮抗剂（ARBs）同时具有心血管和肾脏保护作用。然而这些研究都没有说明亚洲患者包括日本人的情况，日本没有进行过大规模ARB类药物的临床试验。因此，证明这些试验的结果对日本患者有效就很重要。JIKEI心脏研究目的在于研究调查在传统治疗的基础上加用缬沙坦是否能改善日本心血管疾病（高血压、缺血性心脏病、充血性心力衰竭）患者的预后。 方法及结果评价：约3000例高血压、缺血性心脏病和/或充血性心力衰竭患者随机分配接受传统治疗或加用缬沙坦治疗（80mg/d）。随访期3年。主要终点是发生任何心血管事件。二级终点包括任何原因引起的死亡、左室体积和功能的改变、肾功能改变、神经内分沁水平和生活质量评估的改变。亚组研究探索对糖尿病、高脂血症患者的影响和联合用药的疗效。 结论：预后的改善将证明ARB治疗日本心血管疾病患者的疗效。 Cardiovasc Drugs Ther. 2004 Jul;18(4):305-9.  JIKEI HEART Study--a morbi-mortality and remodeling study with valsartan in Japanese patients with hypertension and cardiovascular disease. Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlof B; The JIKEI HEART Study Group. Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan. m_seibu@jikei.ac.jp BACKGROUND: Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. Asian patients including Japanese were under-represented in these trials, however, and no large-scale clinical trials of ARBs have yet been performed in Japan. It is therefore important to verify that the results of these studies are also valid for Japanese patients. The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker, in addition to conventional treatment, will improve the prognosis of Japanese patients with cardiovascular diseases (hypertension, ischemic heart disease, congestive heart failure). METHOD AND EVALUATION OF RESULTS: Around 3,000 patients with hypertension, ischemic heart disease and/or congestive heart failure will be randomized to receive either additional treatment with valsartan (80 mg/day) or conventional therapy. The follow-up period will be three years. The primary endpoint will be the onset of any cardiovascular event. Secondary endpoints will include death from any cause, changes in left ventricular size and function, renal function, changes in neuro-hormonal levels and quality-of-life assessments. Sub-studies will explore the effect in patients with diabetes mellitus, hyperlipidemia and the effects of combination of drugs. CONCLUSION: Improved prognosis would confirm the role of angiotensin II receptor blockers in the treatment of the cardiovascular disease in Japanese patients. |
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