评价倍博特对钙离子拮抗剂治疗控制不良的高血压患者的疗效及安全性：一项多中心、前瞻性、观察性研究  

Evaluation on the efficacy and safety of Bebot on the hypertension patients who have poor treatment control by calcium channel blockers：A multicenter, prospective, observational study

作　　者：Muhammad Shahbaz 黄华珊 盛希[1] 季晓平[1] CHINA STATUS Ⅱ工作组 

机构地区：[1]山东大学齐鲁医院心内科,山东济南250012 [2]北京诺华制药有限公司,北京102299

出　　处：《医学检验与临床》2016年第2期12-15,18,共5页Medical Laboratory Science and Clinics

摘　　要：目的：评价单用任意一种钙离子拮抗剂（CCBs）控制不良的中国高血压患者，改用倍博特（缬沙坦氨氯地平片80/5 mg/day）治疗的疗效和安全性。方法：多中心、前瞻性、开放性上市后临床研究。该研究共纳入5413例高血压患者，入组患者单用任意一种CCB治疗不能充分控制血压，改用倍博特治疗，观察8周。主要疗效指标：8周时平均坐位收缩压（MSSBP）和平均坐位舒张压（MSDBP）与患者入组时比较的变化，次要指标：4周时MSSBP和MSDBP与患者入组时比较的变化；8周时，血压的达标率和治疗的有效率。安全性评价指标为不良事件的发生率，用药的依从性和耐受性。结果：倍博特治疗8周后，患者的MSSBP和MSDBP较基线显著下降，降幅分别为27.31±12.15mmHg和14.97±9.56mmHg，P〈0.0001，同时具有良好的安全性和耐受性。结论：对于单用CCBs控制不良的高血压患者改用倍博特治疗可以显著降低MSSBP和MSDBP，并且具有良好的安全性和耐受性。Objective：This prospective observational study was designed to evaluate the efficacy and safety of Bebot（Valsartan/Amlodipine （80/5 mg/day）） in Chinese hypertensive patients who failed to achieve the target blood pressure （〈 140/90 mm Hg） level by monotherapy with any CCB.Methods：This was a prospective, multicenter, open label, post marketing observational study. In this study, 5413 patients were enrolled, who had been treated with calcium channel blockers （CCBs） prior to enrollment. Therapy with Val/Aml （80/5 mg/day） was given for 8 weeks. The primary efficacy variables of our study were changes in mean sitting systolic BP （MSSBP） and mean sitting diastolic BP （MSDBP） from base line to week 8 （end point）, The secondary efficacy variables of this study were changes in mean sitting systolic BP （MSSBP） and mean sitting diastolic BP （MSDBP） from base line to week 4and BP control rate and response rate at week 8. Safety was assessed in terms of adverse events（AEs） and tolerability profile.Results： A marked reduction of 27.3±12.15 mmHg in MSSBP, P 〈0.0001and 14.97±9.56 mmHg in MSDBP, P 〈0.0001from baseline was shown at week 8. It has demonstrated a remarkable safety and tolerability profile as well.Conclusions： Combination therapy Val/Aml has been associated with significantly greater reductions in MSSBP and MSDBP. This combination therapy is highly efficacious and has an excellent safety and tolerability profile.

关 键 词：高血压 倍博特 疗效 安全性 钙离子拮抗剂 

分 类 号：R544.1[医药卫生—心血管疾病]