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[俄罗斯EKSPERT项目结果:对Ekvator制剂在门诊动脉高血压患者中的疗效及对生活质量的影响进行上市后监测]

[Results of the Russian EKSPERT program: post-marketing supervision over efficacy and influence of the preparation Ekvator on quality of life at out-patients with arterial hypertension].

作者信息

Glezer M G, Vygodin V A, Avakian A A, Prokof'eva E B

出版信息

Kardiologiia. 2014;54(3):15-22. doi: 10.18565/cardio.2014.3.15-22.

Abstract

Results of an open multicenter prospective postmarketing observational program EKSPERT (post-marketing surveillance of the effectiveness and impact of the EKVATOR treatment on quality of life in patients with arterial hypertension in ambulatory practice). Observation of 10 000 patients conducted in 300 medical center in various regions of the Russian Federation in 1005 doctors. Selected for the final analysis 4954 registration cards. It is shown that in patients with initially insufficient effective antihypertensive treatment has a large number of risk factors: men older than 55 years--56.5%, women older than 65 years--27.8%, unfavorable family history of arterial hypertension (AH)--87.9%, diabetes mellitus (DM)--13.4%, smoking--of patients 18.6%, obesity--35%, angina--35.59%, heart failure--41.3% with a history of myocardial infarction--10.9%, stroke--4.5%, renal disease--11.8%, hypercholesterolemia > 5.0 mmol/l--76.7%. Initially drug antihypertensive treatment was performed in 76.6% of patients, while 43.9% were treated regularly. Prior studies angiotensin converting enzyme inhibitors (ACE) afforded 60.56%, sartans--11% of patients, beta-blockers--41.9%, duretics--41.46%, calcium antagonists used in 21.42% of the patients. After the cancellation of previously used other ACE inhibitors, calcium antagonists and sartans patients were switched to therapy with the EKVATOR (amlodipine and lisinopril). Intensity reduction in systolic and diastolic blood pressure (SBP and DBP) did not depend on sex of the patients, the presence of angina, diabetes. Greater reduction in blood pressure in hypertensive duration more than 5 years, in the presence of congestive heart failure due to more frequent initiation of therapy with full-dose combination (amlodipine 10 mg and lisinopril 20 mg). After 1 months of starting therapy changes uorvney target blood pressure (< 140 and 90 mmHg) reached 51.5% of patients. Target SBP reached 59.7% of patients, the target level of DBP--69.4%. It is important that the majority of patients crossed over lowti graduation SBP and DBP and significantly improved their quality of life assessment. Incidence of adverse events was low--1.5% of them are the most common were swelling in the legs, headache, dizziness, and dry cough. Replacing the previous therapy different ACE inhibitors, sartans and calcium antagonists to the fixed combination amlodipine and lisinopril) (drug EKVATOR), leads to a rapid, pronounced, and safe reduction of BP and improve health in the majority of patients with previously uncorrected BP.

摘要

开放多中心前瞻性上市后观察项目EKSPERT(动态血压监测中EKVATOR治疗对高血压患者生活质量的有效性和影响的上市后监测)结果。2005年,俄罗斯联邦各地区300个医疗中心的10000名患者接受观察,由1005名医生负责。最终分析选取了4954份登记卡。结果显示,初始降压治疗效果不佳的患者存在大量危险因素:55岁以上男性占56.5%,65岁以上女性占27.8%,有高血压家族病史的占87.9%,糖尿病患者占13.4%,吸烟者占18.6%,肥胖者占35%,心绞痛患者占35.59%,有心力衰竭病史者占41.3%,有心肌梗死病史者占10.9%,中风患者占4.5%,肾病患者占11.8%,高胆固醇血症(>5.0 mmol/l)患者占76.7%。76.6%的患者接受了初始药物降压治疗,其中43.9%的患者接受了规律治疗。既往研究中,使用血管紧张素转换酶抑制剂(ACE)的患者占60.56%,使用沙坦类药物的占11%,使用β受体阻滞剂的占41.9%,使用利尿剂的占41.46%,使用钙拮抗剂的占21.42%。在停用先前使用的其他ACE抑制剂、钙拮抗剂和沙坦类药物后,患者转而接受EKVATOR(氨氯地平和赖诺普利)治疗。收缩压和舒张压(SBP和DBP)的降幅与患者性别、是否患有心绞痛、糖尿病无关。高血压病程超过5年、伴有充血性心力衰竭的患者血压降幅更大,这是因为更频繁地开始使用全剂量联合治疗(氨氯地平10 mg和赖诺普利20 mg)。开始治疗1个月后,达到目标血压(<140和90 mmHg)的患者比例为51.5%。达到目标SBP的患者比例为59.7%,目标DBP水平的患者比例为69.4%。重要的是,大多数患者的SBP和DBP越过了较低水平,生活质量评估显著改善。不良事件发生率较低——其中1.5%最常见的是腿部肿胀、头痛、头晕和干咳。将先前使用的不同ACE抑制剂、沙坦类药物和钙拮抗剂换成固定复方制剂(氨氯地平和赖诺普利)(EKVATOR药物),可使大多数先前血压未得到控制的患者血压迅速、显著且安全地降低,并改善健康状况。

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