TY - JOUR AU - Frias, Juan AU - Virdi, Naunihal AU - Raja, Praveen AU - Kim, Yoona AU - Savage, George AU - Osterberg, Lars PY - 2017 DA - 2017/07/11 TI -数字药物在改善无法控制的高血压和2型糖尿病患者临床结果方面的有效性:前瞻性、开放标签、簇随机临床试验JO - J Med Internet Res SP - e246 VL - 19 IS - 7kw -数字医学KW -高血压KW - 2型糖尿病KW -患者参与、药物依从性KW -治疗惯性AB -背景:高血压和2型糖尿病是心、脑血管和肾脏疾病的主要可改变危险因素。疾病控制不佳的原因包括不坚持、患者缺乏参与和治疗惰性。目的:本研究的目的是评估使用数字药物(DMO)对临床测量血压(BP)和糖化血红蛋白(HbA1c)的影响，该数字药物(DMO)使用数字药物(使用可摄取传感器服药)、可穿戴传感器贴片和移动设备应用程序测量药物摄入依从性、身体活动和休息。收缩压升高(SBP≥140mmhg)和糖化血红蛋白(≥7%)抗高血压(≥2种药物)和口服糖尿病治疗失败的参与者被纳入这项三组、12周、整群随机研究。参与者使用DMO(包括数字药物、可穿戴传感器贴片和移动设备应用程序)4或12周，或接受基于现场随机化的常规护理。DMO部门的提供者可以通过Web门户审查DMO数据。在所有三个组中，提供者都被指示在每次就诊时根据所有可用的临床信息做出医疗决策(药物滴定、依从性咨询、教育和生活方式指导)。主要结局是第4周收缩压的改变。其他结果包括第12周时收缩压和糖化血红蛋白的变化，第4周和第12周时低密度脂蛋白胆固醇(LDL-C)和舒张压(DBP)的变化，以及第4周和第12周时血压目标(<140/90 mm Hg)的患者比例，医疗决策和药物依从性模式。 Results: Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions: For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration: Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) SN - 1438-8871 UR - //www.mybigtv.com/2017/7/e246/ UR - https://doi.org/10.2196/jmir.7833 UR - http://www.ncbi.nlm.nih.gov/pubmed/28698169 DO - 10.2196/jmir.7833 ID - info:doi/10.2196/jmir.7833 ER -