通过个体化试验提高高血压治疗的精准度：一项试点研究。
Increasing the Precision of Hypertension Treatment Through Personalized Trials: a Pilot Study.
机构信息
Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, 622 West 168th Street, PH9-311, New York, NY, 10032, USA.
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, USA.
出版信息
J Gen Intern Med. 2019 Jun;34(6):839-845. doi: 10.1007/s11606-019-04831-z. Epub 2019 Mar 11.
BACKGROUND
There are substantial differences in the effects of blood pressure (BP) medications in individual patients. Yet, the current standard approach to prescribing BP medications is not personalized.
OBJECTIVE
To determine the feasibility of individualizing the selection of BP medications through pragmatic personalized (i.e., N-of-1) trials.
DESIGN
Series of N-of-1 trials.
SETTING
Outpatient.
PATIENTS
Hypertensive adults prescribed none or one BP medication.
INTERVENTION
Participation in a flexible, open-label personalized trial of two to three BP medications (NCT02744456).
MEASUREMENTS
BP was measured twice per day with a validated home BP device. Frequency and severity of side effects were assessed at the end of the day via an electronic questionnaire. Patients' BP medication preference was assessed after reviewing BP lowering and side effect results with a study clinician. Feasibility was assessed by determining the proportion of patients who adhered to self-assessments. Benefit was assessed by asking patients to rate the helpfulness of participation and whether they would recommend personalized trials to other hypertensive patients.
KEY RESULTS
Of ten patients enrolled, two dropped out prior to initiation, one discovered white coat hypertension through ambulatory BP monitoring, and seven (mean age 58 years, 71% of women) completed personalized trials. All seven were compliant with home BP monitoring and side effect tracking. All seven recommended personalized trials of BP medications to others. Thiazides were preferred by three patients, renin-angiotensin system-blocking agents by two patients, a combination of thiazide and beta-blocker by one patient, and any of three classes by one patient.
CONCLUSIONS
Personalized trials of BP medications were feasible and led to improved treatment precision. Heterogeneity of patient preferences and of therapeutic BP response for first-line BP medications can be determined through a personalized trial approach.
背景
在个体患者中，血压（BP）药物的作用存在很大差异。然而，目前的 BP 药物处方标准并非个性化。
目的
通过实用的个性化（即 N-of-1）试验确定个性化选择 BP 药物的可行性。
设计
一系列 N-of-1 试验。
设置
门诊。
患者
服用一种或无 BP 药物的高血压成年人。
干预措施
参加为期两到三种 BP 药物的灵活、开放标签个性化试验（NCT02744456）。
测量
使用经过验证的家庭 BP 设备每天测量两次血压。通过电子问卷在一天结束时评估副作用的频率和严重程度。在与研究临床医生一起查看 BP 降低和副作用结果后，评估患者对 BP 药物的偏好。通过确定遵守自我评估的患者比例来评估可行性。通过询问患者对参与的帮助程度以及他们是否会向其他高血压患者推荐个性化试验来评估获益。
主要结果
在纳入的十名患者中，两名在开始前退出，一名通过动态血压监测发现白大衣高血压，七名（平均年龄 58 岁，71%为女性）完成了个性化试验。所有七名都遵守家庭 BP 监测和副作用跟踪。所有七名都向他人推荐 BP 药物的个性化试验。三名患者首选噻嗪类药物，两名患者首选肾素-血管紧张素系统阻滞剂，一名患者首选噻嗪类和β受体阻滞剂的组合，一名患者首选三类药物中的任何一种。
结论
BP 药物的个性化试验是可行的，并导致治疗精度提高。通过个性化试验方法可以确定患者偏好和一线 BP 药物的治疗 BP 反应的异质性。
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