阿齐沙坦氨氯地平与阿利沙坦酯氨氯地平治疗原发性高血压的8周随机对照研究：4周中期疗效分析
A Randomized Controlled Study of Azilsartan Amlodipine Tablets vs. Alisartan Isoproxil Amlodipine Tablets in the Treatment of Essential Hypertension for 8 Weeks:A 4-Week Efficacy Analysis
摘要
背景 阿齐沙坦氨氯地平是最新一代ARB/CCB单片复方制剂产品，具备强效的降压潜力；然而目前尚未在临床大规模使用，临床获益证据仍不充分。为此，我们开展了这项8周随机对照研究，旨在比较阿齐沙坦氨氯地平与阿利沙坦酯氨氯地平治疗原发性高血压的有效性及安全性。本研究原定随访周期为8周，本文首次报道4周中期阶段性研究数据，旨在初步评估药物早期疗效，为后续完整终点分析提供依据。
方法 入组120例原发性高血压患者，随机分为两组，分别给予阿齐沙坦氨氯地平片和阿利沙坦酯氨氯地平片治疗。在治疗4周和8周时对患者进行随访，比较两组诊室坐位SBP和DBP较基线的降幅、治疗达标率、治疗应答率及不良事件结果。本研究暂披露中期（4周）诊室坐位SBP、DBP较基线的降幅以及治疗达标率。
结果 治疗4周后，阿齐沙坦氨氯地平组诊室坐位SBP和DBP降幅平均分别为18.3±14.2 mmHg、8.8±9.4 mmHg，高于阿利沙坦酯氨氯地平组（降幅分别为16.2±11.5 mmHg、7.0±7.4 mmHg）。4周后阿齐沙坦氨氯地平组治疗达标率高于阿利沙坦酯氨氯地平组（分别为64.41%和52.54%）。
结论 本研究4周中期数据初步表明，阿齐沙坦氨氯地平可早期改善患者血压水平，相比于阿利沙坦酯氨氯地平表现出更优的降压效果，可作为原发性高血压患者的优选药物。但是，本研究结果为第4周中期结果，药物疗效与安全性的确证仍需8周完整随访数据予以进一步验证。
Abstract
Background Azilsartan amlodipine is a latest-generation ARB/CCB single-pill combination (SPC) product with potent antihypertensive potential.However,it has not been widely used in clinical practice,and evidence of clinical benefit remains insufficient.Therefore,we conducted this 8-week randomized controlled study to compare the efficacy and safety of azilsartan amlodipine tablets and alisartan isoproxil amlodipine tablets in the treatment of essential hypertension. The intended follow-up period of this study was 8 weeks,and this paper reports the 4-week interim data for the first time,aiming to preliminarily evaluate the early efficacy and safety of the drugs and provide a basis for the subsequent complete endpoint analysis.
Method A total of 120 patients with essential hypertension were enrolled and randomly assigned into two groups, receiving Azilsartan Amlodipine Tablets and Allisartan Isoproxil Amlodipine Tablets respectively.Follow-up visits were scheduled at Weeks 4 and 8 of treatment.The reductions in clinic seated SBP and DBP from baseline,blood pressure control rate,treatment response rate and adverse events were compared between the two groups.Only the interim(Week 4) outcomes including baseline-adjusted declines in clinic seated SBP/DBP and blood pressure control rate were presented in the current analysis.
Result After 4 weeks of treatment,the mean reductions in office sitting SBP and DBP were 18.3±14.2 mmHg and 8.8±9.4 mmHg in the azilsartan amlodipine group, respectively,which were higher than those in the alisartan isoproxil amlodipine group (16.2±11.5 mmHg and 7.0±7.4 mmHg,respectively).The treatment target achievement rate at 4 weeks was 64.41% in the azilsartan amlodipine group and 52.54% in the alisartan isoproxil amlodipine group.
Conclusion The 4-week interim data of this study preliminarily indicate that azilsartan amlodipine can improve blood pressure in patients at an early stage.It shows superior antihypertensive efficacy compared with alisartan isoproxil amlodipine and can be a preferred drug for patients with poorly controlled essential hypertension.This is a week 4 interim analysis and full 8-week follow-up data are required to confirm it’s efficacy and safety.关键词
阿齐沙坦氨氯地平、诊室坐位收缩压、诊室坐位舒张压、血压达标率Key words
Azilsartan Amlodipine、seated clinic systolic blood pressure、seated clinic diastolic blood pressure、BP control rate引用本文复制引用
李威威,王保功.阿齐沙坦氨氯地平与阿利沙坦酯氨氯地平治疗原发性高血压的8周随机对照研究：4周中期疗效分析[EB/OL].(2026-06-02)[2026-06-10].https://www.biomedrxiv.org.cn/article/doi/10.12201/bmr.202606.00006.学科分类
临床医学/药学
