Leiva Alfonso, Aguiló Antonio, Fajó-Pascual Marta, Moreno Lucia, Martín M Carmen, Garcia Elena Marina, Duro Rosa Elena, Serra Francisca, Dagosto Pilar, Iglesias-Iglesias Ana Aurelia, Company Rosa Maria, Yañez Aina, Llobera Joan
Primary Care Research Unit of Mallorca, Baleares Health Services-IbSalut, Mallorca, Spain.
Research Group on Evidence, Lifestyles and Health, Universitat Illes Balears, Palma, Spain.
Patient Prefer Adherence. 2014 Dec 5;8:1683-90. doi: 10.2147/PPA.S66927. eCollection 2014.
Lowering blood pressure (BP) by antihypertensive (AHT) drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events.
To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP.
METHODS/DESIGN: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18-80 years, taking AHT drugs with uncontrolled BP (n=221) were randomized to a control group (usual care) or a multifactorial adherence-based intervention including nurse-led motivational interviews, pill reminders, family support, BP self-recording, and simplification of the dosing regimen by a pharmacist.
The primary outcome was 12-month blinded measure of systolic BP (mean of three measurements). The secondary outcomes were 12-month diastolic BP and proportion of patients with adequately controlled BP.
One hundred and fourteen patients were allocated to the intervention group and 109 to the control group. At 12 months, 212 (89%) participants completed the study. The systolic BP in the intervention group was 151.3 versus 153.7 in the control group (P=0.294). The diastolic BP did not differ between groups (83.4 versus 83.6). Of the patients in the control group, 9.2% achieved BP control versus a 15.8% in the intervention group. The relative risk for achieving BP control was 1.72 (95% confidence interval: 0.83-3.56).
A multifactorial intervention based on improving adherence in patients with uncontrolled hypertension failed to find evidence of effectiveness in lowering systolic BP.
ISRCTN21229328.
使用抗高血压（AHT）药物降低血压可降低心血管事件、中风和全因死亡率的风险。然而，对AHT药物的依从性差会降低其疗效并增加不良事件的风险。
评估在初级保健环境中基于多因素依从性的干预措施降低血压的有效性。
方法/设计：多中心平行随机对照试验。西班牙三个地区28个初级保健中心的32名护士。年龄在18 - 80岁、服用AHT药物但血压未得到控制的患者（n = 221）被随机分为对照组（常规护理）或基于多因素依从性的干预组，该干预包括护士主导的动机性访谈、服药提醒、家庭支持、血压自我记录以及药剂师简化给药方案。
主要结局是12个月时收缩压的盲法测量值（三次测量的平均值）。次要结局是12个月时的舒张压以及血压得到充分控制的患者比例。
114名患者被分配到干预组，109名患者被分配到对照组。12个月时，212名（89%）参与者完成了研究。干预组的收缩压为151.3，而对照组为153.7（P = 0.294）。两组之间的舒张压无差异（83.4对83.6）。对照组中9.2%的患者实现了血压控制，而干预组为15.8%。实现血压控制的相对风险为1.72（95%置信区间：0.83 - 3.56）。
基于改善未控制高血压患者依从性的多因素干预未能找到降低收缩压有效性的证据。
ISRCTN21229328
