Aoki Yohei, Asayama Kei, Ohkubo Takayoshi, Nishimura Takuya, Kikuya Masahiro, Metoki Hirohito, Hozawa Atsushi, Hashimoto Junichiro, Michimata Mari, Matsubara Mitsunobu, Araki Tsutomu, Imai Yutaka
Department of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Science and Medicine, Sendai, Japan.
Clin Exp Hypertens. 2004 Feb;26(2):119-27. doi: 10.1081/ceh-120028548.
Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure Study (HOMED BP Study) is the first large-scale intervention trial in Japan using a Prospective Randomized Open Blinded Endpoint (PROBE) design to determine an optimal target blood pressure (BP) level on the basis of self-measured BP at home, and an optimal initial course of antihypertensive medication. The registered patients are randomized to either a more intensive BP-lowering group (home systolic BP < 125 mmHg and diastolic < 80 mmHg) or a less intensive group (home systolic/diastolic BP within the range 134-125/84-80 mmHg) by host computer via the Internet. The differential effect of three classes of initial antihypertensive regimens on the prognosis, i.e., calcium antagonist (Ca-A), angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor antagonist (ARB), which are used most frequently in Japan, are examined. Three regimens are also randomly assigned to the host computer via the Internet. A pilot study was started in May 2001. In March 2002, the number of participating doctors was 461. At the end of March 2002, 546 patients were recruited. Of these, 412 (202 men and 210 women, aged 58.4 +/- 10.2 y) were randomized. Patients will be recruited until February, 2006 and followed for 7 years.
高血压基于电子设备测量血压的目标治疗研究（HOMED BP研究）是日本首个采用前瞻性随机开放盲法终点（PROBE）设计的大规模干预试验，旨在根据在家自测血压确定最佳目标血压水平以及最佳初始降压药物疗程。登记的患者通过主机计算机经由互联网随机分为强化降压组（家庭收缩压<125 mmHg且舒张压<80 mmHg）或非强化降压组（家庭收缩压/舒张压在134 - 125/84 - 80 mmHg范围内）。研究考察了日本最常用的三类初始降压方案，即钙拮抗剂（Ca - A）、血管紧张素转换酶抑制剂（ACE - I）或血管紧张素II受体拮抗剂（ARB）对预后的不同影响。这三种方案也通过互联网随机分配给主机计算机。一项试点研究于2001年5月启动。2至02年3月，参与的医生有461名。至2002年3月底，招募了546名患者。其中，412名（202名男性和210名女性，年龄58.4±10.2岁）被随机分组。患者将招募至2006年2月，并随访7年。
