松龄血脉康胶囊联合氨氯地平对河南省农村地区高血压控制的前瞻性队列研究

Songling Xuemaikang capsule combined with amlodipine for blood pressure control in rural areas of Henan Province: a prospective cohort study

摘要

目的 在河南省农村地区评估松龄血脉康胶囊（SXC）联合氨氯地平应用于高血压患者的效果和安全性。方法 这项前瞻性队列研究招募了来自河南省博爱县3个乡镇的1 000例1～2级高血压患者。参与者均服用氨氯地平，分为单独氨氯地平治疗（对照组）或叠加使用SXC治疗（SXC组）。主要终点是1年时血压＜130/80 mmHg的比例。次要终点包括血压＜140/90 mmHg的比例、血压数值、广泛焦虑量表（GAD）、患者健康问卷（PHQ）、血清同型半胱氨酸（Hcy）、尿微量白蛋白（umALB）和复合心脑血管事件。使用倾向得分和逆处理概率加权法来控制混淆。结果 SXC组最终纳入高血压患者582例，对照组纳入高血压患者396例。在1年时，SXC组血压＜130/80 mmHg控制率显著高于对照组（30.2%比8.7%；校正OR=6.13，95%CI：4.32～8.71，P＜0.001）。与对照组相比，SXC组血压＜140/90 mmHg控制率更高（86.1%比45.4%，校正OR=6.93，95%CI：5.03～9.54，P＜0.001），SXC组的平均收缩压降低幅度更大（−22.44 mmHg比−14.56 mmHg；调整后差异为−8.96 mmHg，95%CI：−10.24～−7.68，P＜0.001）。SXC组舒张压改善更明显（−8.65 mmHg比−7.17 mmHg；调整后差异为−1.32 mmHg，95%CI：−2.43～−0.22，P=0.006）。此外，SCX组的PHQ、GAD评分和Hcy水平的改善优于对照组（均P＜0.05），两组之间复合心脑血管事件的发生率相似（P＞0.05）。结论 SXC联合氨氯地平可能改善河南省农村地区居民的血压控制，且未发现不良反应增加。然而，需要进一步的随机对照试验来证实这些结果。

Abstract

Objective To evaluate the efficacy and safety of Songling Xuemaikang capsule (SXC) combined with amlodipine among the patients with hypertension in rural areas of Henan Province. Methods This prospective cohort study recruited 1 000 patients with grade 1 to 2 hypertension from three townships in Bo'ai County, Henan Province. The subjects were divided into the control group (treated with amlodipine alone) or the SXC group (treated with SXC in combination with amlodipine) based on the degree of treatment exposure. The primary endpoint was the proportion of patients with blood pressure ＜ 130/80 mmHg at 1 year. Secondary endpoints included the proportion of patients with blood pressure ＜ 140/90 mmHg, blood pressure values, the Generalized Anxiety Disorder Scale (GAD), the Patient Health Questionnaire (PHQ), serum homocysteine (Hcy), urine microalbumin (umALB), and composite cardiovascular and cerebrovascular events. We used propensity score and inverse probability weighting methods to control confounding. Results A total of 582 patients were finally included in the SXC group, and 396 patients in the control group. At 1 year, the control rate of blood pressure ＜ 130/80 mmHg in the SXC group was significantly higher than that in the control group (30.2% vs. 8.7%; adjusted OR = 6.13, 95%CI: 4.32 to 8.71, P ＜ 0.001). Compared with the control group, the control rate of blood pressure ＜ 140/90 mmHg in the SXC group was higher (86.1% vs. 45.4%, OR= 6.93, 95%CI: 5.03 to 9.54, P ＜ 0.001). Mean Systolic blood pressure reduction was greater in the SXC group (−22.44 mmHg vs. −14.56 mmHg; adjusted difference −8.96 mmHg, 95%CI: −10.24 to −7.68, P ＜ 0.001). The reduction in diastolic blood pressure was significantly greater in the SXC group (−8.65 mmHg vs. −7.17 mmHg; adjusted difference −1.32 mmHg, 95%CI: −2.4 to −0.22, P = 0.006). In addition, the improvements in PHQ, GAD scores, and Hcy levels in the SXC group were better than those in the control group (P ＜ 0.05), and the incidence of composite cardiovascular and cerebrovascular events was similar between the two groups (P ＞ 0.05). Conclusion SXC combined with amlodipine can improve blood pressure control among residents in rural areas of Henan Province, and no increase in adverse reactions was observed. However, further randomized controlled trials are needed to confirm these findings.

关键词

松龄血脉康胶囊 / 氨氯地平 / 原发性高血压 / 村医 / 农村

Key words

Songling Xuemaikang capsule / amlodipine / essential hypertension / community doctor / village

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基金资助

国家科技重大专项(2024ZD0522000)

国家科技重大专项(2024ZD0522001)

国家中医临床研究基地科研专项课题(2019JDZX2009)

中华中医药学会青年人才托举工程项目(2025-QNRC2-B01)

国家自然科学基金项目(82505477)

河南省科技攻关项目(252102311270)