Objective  To evaluate the clinical value of single-pill combination (SPC) of perindopril and amlodipine for the treatment of hypertension and provide reference for the selection and rational use in medical institutions.

Methods  A comprehensive clinical evaluation index system was established based on literature research and expert demonstration. Therefore, the safety, effectiveness, economy, innovation, suitability and accessibility of drugs were analyzed qualitatively and quantitatively.

Results  A total of 12 studies reported the outcome of perindopril and amlodipine SPC, including efficacy and safety. Perindopril amlodipine SPC was safe, and there was no significant difference in the incidence of adverse events during treatment compared with monotherapy, monotherapy combination or other antihypertensive SPC. In terms of effectiveness, perindopril and amlodipine SPC had clear antihypertensive effect, which could significantly reduce systolic blood pressure, diastolic blood pressure, pulse pressure difference and heart rate, and the blood pressure compliance rate of perindopril and amlodipine SPC was better than that of amlodipine or perindopril monotherapy group. Compared with other depressurized SPCs, it showed better or non-inferior effect. Perindopril amlodipine SPC, as a patented drug, has good innovation, high patient compliance, and has been included in China's medical insurance catalog, but the current medical institutions have a low supply rate, and drug prices and affordability are still at a relatively high level.

Conclusion  Perindopril amlodipine SPC has significant advantages in safety, effectiveness, suitability and innovation, but its economy and accessibility still need to be improved.

1.国家心血管病中心. 《中国心血管健康与疾病报告2023》概要[J]. 中国循环杂志, 2024, 39(7): 625-660. [National Center for Cardiovascular Diseases. Report on cardiovascular health and diseases in China 2023: an updated summary[J]. Chinese Circulation Journal, 2024, 39(7): 625-660.] DOI: 10.3969/j.issn.1000-3614. 2024.07.001.

2.Mancia G, Kreutz R, Brunström M, et al. 2023 ESH guidelines for the management of arterial hypertension. the Task Force for the management of arterial hypertension of the European Society of Hypertension[J]. J Hypertens, 2023, 41(12): 1874-2071. DOI: 10.1097/HJH.0000000000003480.

3.国家心血管病中心. 国家基层高血压防治管理指南2020版[J]. 中国循环杂志, 2021, 36(3): 209-220. [National Center for Cardiovascular Diseases. National clinical practice guidelines on the management of hypertension in primary health care in China (2020)[J]. Chinese Circulation Journal, 2021, 36(3): 209-220.] DOI: 10.3969/j.issn.1000-3614.2021.03.001.

4.国家卫生健康委办公厅. 药品临床综合评价管理指南（2021年版试行） [EB/OL]. (2021-07-28) [2024-07-31]. http://www.nhc.gov.cn/yaozs/s2908/202107/532e20800a47415d84adf3797b0f4869.shtml.

5.国家药物和卫生技术综合评估中心. 心血管病药品临床综合评价技术指南（2022年版试行）[EB/OL]. (2022-06-29) [2024-07-28]. http://www.nhei.cn/nhei/znfb/202206/c01d87a290664b01bf42a9dad769d69f.shtml.

6.王璐, 曾露, 郭洁茹, 等. 基于德尔菲法和层次分析法构建钠-葡萄糖协同转运蛋白2抑制剂治疗2型糖尿病的综合评价体系[J]. 临床药物治疗杂志, 2024, 22(3): 68-72. [Wang L, Zeng L, Guo JR, et al. Construction of clinical comprehensive evaluation index system for sodium-glucose cotransporter 2 inhibitor of type 2 diabetes mellitus based on delphi method and analytic hierarchy process[J]. Clinical Medication Journal, 2024, 22(3): 68-72.] DOI: 10.3969/j.issn.1672-3384.2024.03.013.

7.管晓东, 史录文. 基于WHO/HAI标准调查法的我国基本药物可及性评价方法研究[J]. 中国药房, 2013, 24(24): 2212-2215. [Guan XD, Shi LW. Study on evaluation method for the accessibility of essential medicine in China based on WHO/HAI standardized approach[J]. China Pharmacy, 2013, 24(24): 2212-2215.] DOI: 10.6039/j.issn.1001-0408.2013.24.02.

8.魏安华, 曾露, 桂玲, 等. 马昔腾坦治疗肺动脉高压有效性、安全性和经济性的快速卫生技术评估[J]. 中国药师, 2021, 24(12): 2197-2203. [Wei AH, Zeng L, Gui L, et al. Effectiveness, safety and economy of macitentan in the treatment of pulmonary arterial hypertension: a rapid health technology assessment[J]. China Pharmacist, 2021, 24(12): 2197-2203.] DOI: 10.19962/j. cnki.issn1 008-049X.2021.12.011.

9.刘莹, 王晨飞, 安卓玲. 比索洛尔氨氯地平单片复方制剂治疗高血压的药品临床综合评价[J]. 临床药物治疗杂志, 2023, 21(6): 63-71. [Liu Y, Wang CF, An ZL. Clinical application evaluation of single-pill combination of bisoprolol and amlodipine for treatment of hypertension[J]. Clinical Medication Journal, 2023, 21(6): 63-71.] DOI: 10.3969/j.issn.1672-3384.2023.06.010.

10.吕鹏, 张京莉, 万元胜, 等. 特立帕肽治疗骨质疏松的快速卫生技术评估[J]. 药物流行病学杂志, 2024, 33(1): 75-84. [Lyu P, Zhang JL, Wan YS, et al. Teriparatide treatment for osteoporosis: a rapid health technology assessment[J]. Chinese Journal of Pharmacoepidemiology, 2024, 33(1): 75-84.] DOI: 10.12173/j.issn. 1005-0698.202312071.

11.Mostafa S, Shabana H, Khalil F, et al. Evaluation of the safety and efficacy of dual therapy perindopril/amlodipine in the management of hypertension. a systematic review and Meta-analysis[J]. High Blood Press Car, 2022, 29(6): 565-576. DOI: 10.1007/s40292-022-00544-3.

12.黄果, 汪阳, 周颖玉, 等. 培哚普利氨氯地平片治疗高血压的Meta分析[J]. 中国现代医生, 2022, 60(24): 40-48. [Huang G, Wang Y, Zhou YY, et al. Efficacy and safety of perindopril and amlodipine fixed-dose combination for hypertension treatment: a Meta-analysis[J]. China Modern Doctor, 2022, 60(24): 40-48.] DOI: 1673-9701(2022)24-0040-09.

13.Ruilope L, Schaefer A. The fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine: a randomized, double-blind trial in patients with hypertension[J]. Adv Ther, 2013, 30(12): 1086-1099. DOI: 10.1007/s12325-013-0076-6.

14.Mancia G, Asmar R, Amodeo C, et al. Comparison of single-pill strategies first line in hypertension[J]. J Hypertens, 2015, 33(2): 401-411. DOI: 10.1097/HJH.0000000000000409.

15.Redon J, Pichler G, Missed Dose Study Group. Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabetes[J]. J Hypertens, 2016, 34: 359-367. DOI: 10.1097/HJH.0000000000000793.

16.Redon J, Pichler G, Missed Dose Study Group. Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral and central blood pressure parameters after missed dose in Type 2 diabetes[J]. Am J Hypertens, 2016, 29(9): 1055-1062. DOI: 10.1093/ajh/hpw033.

17.Sobngwi E, Mfeukeu-Kuate L, Kouam M, et al. Short-term effects of perindopril-amlodipine vs perindopril-indapamide on blood pressure control in sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension: a double-blinded randomized controlled trial[J]. J Clin Hypertens (Greenwich), 2019, 21(7): 1002-1008. DOI: 10.1111/jch.13557.

18.Poulter NR, Dolan E, Gupta AK, et al. Efficacy and safety of incremental dosing of a new single-pill formulation of perindopril and amlodipine in the management of hypertension[J]. Am J Cardiovasc Drug, 2019, 19(3): 313-323. DOI: 10.1007/s40256-018-00314-4.

19.Ojji DB, Mayosi B, Francis V, et al. Comparison of dual therapies for lowering blood pressure in black Africans[J]. N Engl J Med, 2019, 380: 2429-2439. DOI: 10.1056/NEJMoa1901113.

20.魏品兰. 培哚普利氨氯地平SPC治疗老年高血压病对患者血压达标率的影响[J]. 中国医药指南, 2023, 21(12): 13-16. [Wei PL. Effect of perindopril amlodipine SPC on blood pressure standard rate in elderly patients with hypertension[J]. Guide of China Medicine, 2023, 21(12): 13-16.] DOI: 10.15912 /j.cnki.gocm.2023.12.037.

21.刘超, 蒋建刚, 卢鹏云. 培哚普利氨氯地平片（Ⅲ）复方制剂治疗原发性高血压的临床效果、依从性及经济性分析[J]. 中国医院药学杂志, 2020, 40(24): 2565-2569. [Liu C, Jiang JG, Lu PY. Clinical effect, compliance and economic analysis of perindopril arginine and amlodipine besylate tablets (III) in the treatment of essential hypertension[J]. Chinese Journal of Hospital Pharmacy, 2020, 40(24): 2565-2569.] DOI: 10.13286/j.1001-5213.2020.24.13.

22.Visco V, Finelli R, Pascale AV, et al. Larger blood pressure reduction by fixed-dose compared to free dose combination therapy of ACE inhibitor and calcium antagonist in hypertensive patients[J]. Transl Med, 2017, 16: 17-23. https://pubmed.ncbi.nlm.nih.gov/28775965/.

23.刘蔚. 联合降压治疗选择自由联合还是单片复方制剂?[J] .中华高血压杂志, 2019, 27(11): 1001-1004. [Liu W. Combined antihypertensive treatment should choose free combination or single-pill combination?[J]. Chinese Journal of Hypertension, 2019, 27(11): 1001-1004.] DOI: 10.16439/j.cnki.1673-7245.2019.11.001.

24.Xie M, Tang T, Liang H. Efficacy of single-pill combination in uncontrolled essential hypertension: a systematic review and network Meta-analysis[J]. Clin Cardiol, 2023, 46(8): 886-898. DOI: 10.1002/clc.24082.

25.杜雯雯, 徐伟. 基于药品采购数据库的医疗机构药品配备使用现状研究: 以江苏省为例[J]. 中国现代应用药学, 2022, 39(6): 810-814. [Du WW, Xu W. Research on drug using situation in medical institutions based on drug procurement database in Jiangsu province[J]. Chinese Journal of Modern Applied Pharmacy, 2022, 39(6): 810-814.] DOI: 10.13748/j.cnki.issn1007-7693.2022.06.017.

26.李孟林, 徐伟, 杜雯雯, 等. 我国上市专利药品可获得性实证研究[J]. 卫生经济研究, 2019, 36(12): 59-61. [Li ML, Xu W, Du WW, et al. Empirical study on the availability of patented drugs in China[J]. Health Economics Research, 2019, 36(12): 59-61.] DOI: 10.14055/j.cnki. 33-1056/f. 2019.12.016.