摘要
目的分析稳定性冠心病国际性、前瞻性、观察性、纵向注册研究（CLARIFY）中国亚组患者数据，揭示中国稳定性冠心病患者心率控制情况及相关影响因素。方法CLARIFY研究是一项前瞻性、国际性、观察性、长期注册研究，2009年11月至2010年7月入选稳定性冠心病的门诊患者，并收集人口统计学信息、临床指标、冠心病用药和血运重建治疗情况。根据基线时的心率将患者分为3组，即心率≤60次／min组（397例）、61—69次／min组（782例）及≥70次／min组（1443例）；根据患者是否使用β受体阻滞剂，将患者分为2组，即用药（1997例）和未用药组（625例）。通过logistic多因素回归分析心率控制不良（≥70次／min）和接受β受体阻滞剂治疗的独立危险因素。结果中国56家中心入选了2622例稳定性冠心病的患者，平均年龄为（63．6±10．3）岁，75．6％（1983例）为男性，55．0％（1443例）患者心率≥70次／min。心电图检测心率为（69．4±10．2）次／min。50．9％（1334例）患者有心肌梗死史，21．9％（575例）的患者有心绞痛症状，88．8％（2327例）的患者曾行冠状动脉造影。减慢心率药物治疗情况：76．2％（1997例）患者服用β受体阻滞剂，其他包括地高辛占2．7％（70例）、维拉帕米或地尔硫[艹卓]占3．9％（103例）、胺碘酮或决奈达隆占1．8％（47例）、伊伐布雷定占0．1％（2例）。不同心率控制组的患者β受体阻滞剂使用比例差异无统计学意义（P〉0．05）。心率控制不佳（〉170次／min）的独立危险因素包括：糖尿病（OR=1．31）、正在吸烟（OR=1．57）、慢性心力衰竭NYHAⅢ级（OR=2．13）和舒张压每升高10mmHg（1mmHg=0．133kPa）（OR=1．30）（P均〈0．05），而平时体力活动量大（OR=0．61，95％CI 0．42-0．89，P=0．049）、戒烟（OR=0．76，95％CI0．64～0．91，P〈0．001）和经皮冠状动脉介入治疗（PCI）史（OR=0．80，95％CI0．66～0．96，P=0．018）与心率控制不良呈负相关。冠心病患者未给予β受体阻滞剂治疗的相关因素包括：高龄（OR=1．11，95％CI1．01～1．47，P=0．005）、舒张压较低（OR=1．47，95％CI1．32～1．68，P=0．012）、无心肌梗死（OR=1．86，95％CI1．43～2．44，P〈0．001）或PCI史（OR=1．94，95％CI1．55—3．73，P〈0．001）、伴有哮喘／慢性阻塞性肺疾病（OR=1．32，95％CI1．15～1．99，P〈0．001）。结论尽管多数稳定性冠心病患者在服用β受体阻滞剂，但心率控制不理想，半数患者静息心率≥70次／min，是否与减慢心率药物的种类和剂量有关还不清楚。其中合并糖尿病、慢性心力衰竭和未行PCI的患者心率控制较差。临床试验注册国际标准随机对照试验注册库，注册号为ISRCTN43070564。
Objective To observe the current status of β-blocker （BB） use and heart rate control in Chinese patients with stable coronary artery disease （SCAD） based on subgroup data of the prospective observational longitudinal registry of patients with stable coronary artery disease （CLARIFY）. Methods The CLARIFY study is an international prospective observational registry of outpatients with SCAD. From November 2009 to July 2010, patients with SCAD were enrolled, and demographic information, chnical indicators, medication and blood flow reconstruction were collected. Patients were divided in three mutually exclusive categories by baseline pulse palpation heart rate （HR） ≤ 60 beats per minute （bpm） （n = 397 ）, 61 -69 bpm（n =782） , and ≥70 bpm（n = 1 443）. The patients were also divided into taking BB or not taking BB groups. The aim of present study is to describe and analyze the current status and factors related to the HR control and BB use in the Chinese subgroup of CLARIFY. Results A total of 2 622 patients were enrolled from 56 centers across China. The mean age was （63.6 ± 10. 3） years old with 75.6% （ 1 983） male patients, 55.0% （1 443） patients had HR≥70 bpm. Mean HR measure by electrocardiogram（ECG） was （69.4±10. 2）bpm, 50. 9% （1 334 cases） patients had myocardial infarction（MI） history. A total of 21.9% （575 cases） patients had anginal symptoms; coronary angiography was performed in 88.8% （2 327 cases） of the patients. 76. 2% （ 1 997 cases） patients were treated with BB （any molecule and any dose）, 2. 7% （70 cases） with digoxin or derivatives, 3.9% （103 cases） with verapamil or diltiazem, and 1.8% （47 cases） with amiodarone or dronedarone and 0. 1% （2 cases） received ivabradine. BB use was similar among 3 HR groups （ P 〉 0.05 ）. The independent risk factors associated with HR ≥ 70 bpm were diabetes （ OR = 1.31 ）, current smoker（ OR = 1.57）, chronic heart failure（CHF） with NYHA m （ OR = 2. 13） and increased diastolic blood pressure （ OR = 1.30）. Conversely, high physical activity （ OR = 0. 61 ）, former smoker （ OR = 0. 76 ） and history of percutaneous coronary intervention （ PCI, OR = 0. 80 ） were associated with lower risk of HR/〉 70 bpm （ all P 〈 0. 05 ）. The independent risk factors associated with non-BB use were older age （ OR = 1.11,95% CI 1.01 - 1.47, P =0. 005） , lower diastolic blood pressure （ OR = 1.47, 95% CI 1.32 - 1.68, P = 0. 012） , no history of MI （ OR = 1.86,95% CI 1.43 - 2. 44, P 〈 0. 001 ） or PCI （ OR = 1.94, 95% CI 1.55 - 3.73, P 〈 0. 001 ） , asthma/chronic obstructive pulmonary disease （ OR = 1.32, 95% CI 1.15 - 1.99, P 〈 0. 001 ）. Conclusions A total of 76.2% Chinese SCAD patients received BB medication hut more than half of them did not reach the optimal HR. Clinical characteristics including diabetes, current smoker, CHF, increased diastolic blood pressure and no PCI were associated with poorly controlled HR（ ≥70 bpm）. More efforts including adjusting the type and dose of heart rate lowering drugs are needed to achieve optimal HR control in Chinese SCAD patients. Clinical Trail Registry International Standard Randomized Controlled Trial, ISRCTN43070564.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2016年第1期19-26,共8页
Chinese Journal of Cardiology
