2023年3月2日，中国医科大学孙英贤教授团队在《柳叶刀》杂志发表论文，比较了非医师社区卫生保健提供者主导的心血管疾病强化血压干预与常规护理的有效性。

非医师社区保健提供者主导的强化血压干预对心血管疾病的有效性尚未确定。该研究旨在在高血压患者中测试这种干预措施与常规护理措施在心血管疾病和全因死亡风险方面的有效性。

在这项开放标签、盲终点、集群随机试验中，研究组招募了年龄至少40岁、未经治疗的收缩压至少为140 mm Hg或舒张压至少为90 mm Hg（对于心血管疾病高危人群或目前正在服用降压药物的人群，≥130 mm Hg和≥80 mm Hg）的个体。随机将326个村庄（1:1）分配给非医师社区卫生保健提供者主导的干预或常规护理，按省、县和乡镇进行分层。

在干预组中，经过培训的非医师社区保健提供者根据简单的阶梯式护理方案开始并分级降压药物，以在初级保健医师的监督下实现收缩压低于130 mm Hg和舒张压低于80 mm Hg的目标。他们还为患者提供打折或免费的抗高血压药物和健康指导。主要有效性结局是研究参与者在36个月随访期间心肌梗死、中风、需要住院治疗的心力衰竭和心血管疾病死亡的综合结局。每6个月评估一次安全性。

2018年5月8日至11月28日，研究组为每组163个村庄进行了登记，其中33个村庄有995名参与者。在36个月内，收缩压降低的组间净差值为-23.1 mm Hg，舒张压降低的净差值为-9.9 mm Hg。干预组中出现主要结局的患者比普通护理组少（每年1.62%对2.40%；危险比[HR]为0.67）。干预组的次要结局也有所降低：心肌梗死（HR 0.77）、卒中（0.66）、心力衰竭（0.58）、心血管疾病死亡（0.70）和全因死亡（0.85）。主要结局的风险降低在年龄、性别、教育程度、抗高血压药物使用和基线心血管疾病风险的亚组中是一致的。干预组的低血压发生率高于正常护理组（1.75%vs 0.89%）。

研究结果表明，由非医师社区保健提供者主导的强化血压干预在减少心血管疾病和死亡方面是有效的。

附：英文原文

Title: Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial

Author: Jiang He, Nanxiang Ouyang, Xiaofan Guo, Guozhe Sun, Zhao Li, Jianjun Mu, Dao Wen Wang, Lixia Qiao, Liying Xing, Guocheng Ren, Chunxia Zhao, Ruihai Yang, Zuyi Yuan, Chang Wang, Chuning Shi, Songyue Liu, Wei Miao, Guangxiao Li, Chung-Shiuan Chen, Yingxian Sun, Xingang Zhang, Jun Wang, Ying Zhou, Ning Ye, Zihan Chen, Pengyu Zhang, Zihao Fan, Nan Ye, Linlin Zhang, Danxi Geng, Shu Zhang, Qiyu Li, Qiying Qin, Canru Liu, Xiaoyu Zheng, Tao Wang, Li Jing, Boqiang Zhang, Qun Sun, Yu Yan, Yueyuan Liao, Qiong Ma, Chao Chu, Yue Sun, Dan Wang, Ling Zhou, Heng Ye, Haoran Wei, Hao Liu, Zhaoqing Sun, Liqiang Zheng, Yanli Chen, Ye Chang, Mohan Jiang, Hongmei Yang, Shasha Yu, Wenna Li, Ning Wang, Chunwei Wu, Lufan Sun, Zhi Du, Yan Li, Nan Gao, Xinchi Liu, Ying Wang, Mingang Huang, Yufang Zhou, Lingrui Meng, Jiawen Zhang, Zhen Huang, Huihui Chen, Yuxian Huang, Lingmin Sun, Xin Zhong, Hanmin Wang, Xinyan Hou, Huan Han, Baohui Jin, Hua He

Issue&Volume: 2023-03-02

Abstract:

Background

Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention on cardiovascular disease has not been established. We aimed to test the effectiveness of such an intervention compared with usual care on risk of cardiovascular disease and all-cause death among individuals with hypertension.

Methods

In this open-label, blinded-endpoint, cluster-randomised trial, we recruited individuals aged at least 40 years with an untreated systolic blood pressure of at least 140 mm Hg or a diastolic blood pressure of at least 90 mm Hg (≥130 mm Hg and ≥80 mm Hg for those at high risk for cardiovascular disease or if currently taking antihypertensive medication). We randomly assigned (1:1) 326 villages to a non-physician community health-care provider-led intervention or usual care, stratified by provinces, counties, and townships. In the intervention group, trained non-physician community health-care providers initiated and titrated antihypertensive medications according to a simple stepped-care protocol to achieve a systolic blood pressure goal of less than 130 mm Hg and diastolic blood pressure goal of less than 80 mm Hg with supervision from primary care physicians. They also delivered discounted or free antihypertensive medications and health coaching for patients. The primary effectiveness outcome was a composite outcome of myocardial infarction, stroke, heart failure requiring hospitalisation, and cardiovascular disease death during the 36-month follow-up in the study participants. Safety was assessed every 6 months. This trial is registered with ClinicalTrials.gov, NCT03527719.

Findings

Between May 8 and Nov 28, 2018, we enrolled 163 villages per group with 33995 participants. Over 36 months, the net group difference in systolic blood pressure reduction was –23·1 mm Hg (95% CI –24·4 to –21·9; p<0·0001) and in diastolic blood pressure reduction, it was –9·9 mm Hg (–10·6 to –9·3; p<0·0001). Fewer patients in the intervention group than the usual care group had a primary outcome (1·62% vs 2·40% per year; hazard ratio [HR] 0·67, 95% CI 0·61–0·73; p<0·0001). Secondary outcomes were also reduced in the intervention group: myocardial infarction (HR 0·77, 95% CI 0·60–0·98; p=0·037), stroke (0·66, 0·60–0·73; p<0·0001), heart failure (0·58, 0·42–0·81; p=0·0016), cardiovascular disease death (0·70, 0·58–0·83; p<0·0001), and all-cause death (0·85, 0·76–0·95; p=0·0037). The risk reduction of the primary outcome was consistent across subgroups of age, sex, education, antihypertensive medication use, and baseline cardiovascular disease risk. Hypotension was higher in the intervention than in the usual care group (1·75% vs 0·89%; p<0·0001).

Interpretation

The non-physician community health-care provider-led intensive blood pressure intervention is effective in reducing cardiovascular disease and death.

DOI: 10.1016/S0140-6736(22)02603-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02603-4/fulltext