Liu Lu, Guo Jiayue, Jiao Xitong, You Lili
Chinese Academy of Medical Sciences and Peking Union Medical College, School of Health Policy and Management, Beijing, 100005, China.
Hypertens Res. 2025 Feb;48(2):456-469. doi: 10.1038/s41440-024-01892-4. Epub 2024 Oct 23.
Digital therapeutics (DTx) intervention is an emerging therapy for the treatment and long-term management of hypertension. We aim to systematically evaluate the overall effect of DTx intervention on improving hypertension management. The systematic review and meta-analysis of RCTs was conducted and the PubMed, EMBASE, Web of Science, and Cochrane Library were searched to identify eligible RCTs published between Jan 1, 1982 and Sep 10, 2023. Random-effect models were utilized to pool estimates of net changes in systolic blood pressure (BP), diastolic BP, BP control rate, body mass index, weight, waist circumference, and physical activity between the DTx group and control group. 15 RCTs were included with a total of 3789 participants. Compared with the control group, DTx intervention was associated with significant changes in systolic BP, diastolic BP, and BP control rate of -3.75 mmHg(95% CI -5.74 to 1.77), -1.79 mmHg (95% CI -2.81 to -0.77) and 1.47% (95% CI 1.10 to 1.95), respectively. In addition, DTx intervention was statistically significant for improving other risk factors such as lower BMI (-0.5 kg/m2, 95% CI -0.86 to -0.15), increased physical activity (66.73 min/week, 95%CI 49.64 to 83.81), and reduced waist circumference (-2.91 cm, 95% CI -5.15 to -0.66). No difference between groups was demonstrated in weight (P = 0.30). Subgroup analyses revealed consistent effects of the change in SBP and DBP across study duration, age, sample size, patient baseline status, and intervention scenario settings(P > 0.05). DTx intervention may be useful for lowering BP and long-term management of hypertension. More large-size trials providing evidence on the same product are needed.
数字疗法(DTx)干预是一种用于治疗和长期管理高血压的新兴疗法。我们旨在系统评估DTx干预对改善高血压管理的总体效果。我们进行了随机对照试验(RCT)的系统评价和荟萃分析,并检索了PubMed、EMBASE、Web of Science和Cochrane图书馆,以识别1982年1月1日至2023年9月10日期间发表的符合条件的RCT。采用随机效应模型汇总DTx组和对照组之间收缩压(BP)、舒张压、血压控制率、体重指数、体重、腰围和身体活动净变化的估计值。纳入了15项RCT,共3789名参与者。与对照组相比,DTx干预与收缩压、舒张压和血压控制率的显著变化相关,分别为-3.75 mmHg(95%CI -5.74至1.77)、-1.79 mmHg(95%CI -2.81至-0.77)和1.47%(95%CI 1.10至1.95)。此外,DTx干预在改善其他危险因素方面具有统计学意义,如较低的体重指数(-0.5 kg/m²,95%CI -0.86至-0.15)、增加的身体活动(66.73分钟/周,95%CI 49.64至83.81)和减小的腰围(-2.91 cm,95%CI -5.15至-0.66)。两组在体重方面未显示差异(P = 0.30)。亚组分析显示,在研究持续时间、年龄、样本量、患者基线状态和干预场景设置方面,收缩压和舒张压变化的影响一致(P > 0.05)。DTx干预可能有助于降低血压和高血压的长期管理。需要更多关于同一产品的大型试验来提供证据。