Jia Shanshan, Zhang Xin, Yang Xiangyu, Ye Runyu, Yao Yuanyuan, Liu Lu, Zuo Xianghao, Li Yanan, Yan Yu, Liu Kai, Wang Si, Meng Qingtao, Chen Xiaoping
Department of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Department of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, China
BMJ Open. 2025 Feb 7;15(2):e092109. doi: 10.1136/bmjopen-2024-092109.
Hypertension constitutes the primary health burden of cardiovascular diseases, and the global control of blood pressure (BP) remains insufficient. Single pill combinations (SPCs) are employed as a means to streamline the management of poor BP control due to non-adherence and treatment inertia. The compound reserpine and triamterene tablets constitute a quadruple SPC, comprising reserpine 0.1 mg, dihydralazine 12.5 mg, hydrochlorothiazide 12.5 mg and triamterene 12.5 mg. It is widely employed in primary medical institutions and has favourable efficacy, tolerability and cost-effectiveness.
The COSPQ-BP trial is a 12-week prospective randomised controlled trial to enrol 1332 patients with primary mild-to-moderate hypertension. Participants who meet the inclusion criteria will be randomly assigned to a 1:1 ratio to an intervention group (compound reserpine and triamterene tablets) or a control group (valsartan/hydrochlorothiazide). The primary outcome will be mean changes from baseline in 24-hour ambulatory systolic BP after intervention for 12 weeks. The secondary outcomes have been predetermined and will primarily encompass the following: (1) changes in other BP measures, as well as changes in blood lipids, blood glucose and uric acid at 12 weeks and (2) evaluation of the impact of starting antihypertensive therapy with compound reserpine and triamterene tablets or valsartan/hydrochlorothiazide on the depressive and anxiety statess of patients.
The study protocol (version number: V5.0, version date: 17 January 2023) has been approved by the ethics committee (Biomedical Ethics Committee of West China Hospital of Sichuan University, approval number: Review (51) in 2023). Written informed consent will be obtained from each participant by researchers. The findings of this study will be disseminated through conference presentations and peer-reviewed publications.
This study was registered at the Chinese Clinical Trials Registry (ChiCTR2300067920). The COSPQ-BP trial is currently enrolling. The study period will be from 1 January 2024 to 31 December 2025.
高血压是心血管疾病的主要健康负担，全球血压控制情况仍不理想。单片复方制剂（SPCs）被用作一种手段，以简化因不依从和治疗惰性导致血压控制不佳的管理。复方利血平氨苯蝶啶片是一种四联单片复方制剂，每片含利血平0.1毫克、双肼屈嗪12.5毫克、氢氯噻嗪12.5毫克和氨苯蝶啶12.5毫克。它在基层医疗机构中广泛使用，具有良好的疗效、耐受性和成本效益。
COSPQ-BP试验是一项为期12周的前瞻性随机对照试验，将纳入1332例原发性轻至中度高血压患者。符合纳入标准的参与者将按1:1的比例随机分配至干预组（复方利血平氨苯蝶啶片）或对照组（缬沙坦/氢氯噻嗪）。主要结局指标为干预12周后24小时动态收缩压较基线的平均变化。次要结局指标已预先确定，主要包括：（1）其他血压指标的变化，以及12周时血脂、血糖和尿酸的变化；（2）评估起始使用复方利血平氨苯蝶啶片或缬沙坦/氢氯噻嗪进行降压治疗对患者抑郁和焦虑状态的影响。
本研究方案（版本号：V5.0，版本日期：2023年1月17日）已获得伦理委员会（四川大学华西医院生物医学伦理委员会，批准号：2023年审查（51）号）批准。研究人员将从每位参与者处获得书面知情同意书。本研究结果将通过会议报告和同行评审出版物进行传播。
本研究已在中国临床试验注册中心注册（注册号：ChiCTR2300067920）。COSPQ-BP试验目前正在招募患者。研究周期为2024年1月1日至2025年12月31日。
