原研药莫索尼定和仿制药:差异的边缘在哪里?

IF 0.5 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS
V V Skibitskiy, A V Fendrikova, A V Skibitskiy, D V Sirotenko, O V Timofeeva
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引用次数: 0

摘要

目的:比较动脉高血压(AH)控制不佳患者在既往无效的降压治疗基础上加用原研莫索尼定及其仿制药的疗效:这项观察性前瞻性非随机研究纳入了120名之前接受降压治疗但血压控制不佳的患者。所有患者均接受了临床评估,包括人体测量和实验室指标,以及基线和 12 周后的 24 小时血压监测(24-h BPM)。治疗 4 周和 12 周后,记录办公室收缩压和舒张压(SBP 和 DBP)以及心率(HR)。在观察期间,分为 4 组:第 1 组,在治疗过程中添加 Physiotens;第 2 组,使用 Moxonitex;第 3 组,使用 Moxonidine SZ;第 4 组,使用 Moxonidine Canonidine。统计分析使用 StatTech v.4.2.7 软件(© OOO StatTech,俄罗斯)进行:治疗 4 周后,与第 2 组(36.7% 的患者)、第 3 组(16.7% 的患者)和第 4 组(16.7% 的患者)相比,第 1 组(63% 的患者)达到血压目标的频率明显更高(p<0.05)。12周时,所有组的诊室SBP、DBP和心率均显著下降,但第1组的降幅明显更大。与其他组相比,Physiotens组所有研究的24小时BPM参数均有更明显的下降,而且24小时血压曲线正常化的频率也明显更高,66.7%的患者与第2、3和4组的46.7%、33.4%和23.2%的患者相比,均有更高的血压曲线正常化率:在实现降压目标、降低诊室血压和心率以及改善 24 小时血压参数方面,使用原研莫索尼定治疗比使用普通药物更具优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Original Moxonidine and Generics: Where is the Edge of Difference?

Aim: To compare the efficacy of adding original moxonidine and its generics to previous ineffective antihypertensive therapy in patients with poorly controlled arterial hypertension (AH).

Material and methods: This observational prospective non-randomized study included 120 patients with poorly controlled blood pressure on the previous antihypertensive therapy. All patients underwent clinical evaluation, including anthropometric and laboratory indexes, and 24-hour blood pressure monitoring (24-h BPM) at baseline and after 12 weeks of observation. Office systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) were recorded after 4 and 12 weeks of treatment. During the observation period, 4 equal groups were formed: group 1, Physiotens was added to the treatment; group 2, Moxonitex; group 3, Moxonidine SZ; and group 4, Moxonidine Canon. Statistical analysis was performed with the StatTech v.4.2.7 software (© OOO StatTech, Russia).

Results: After 4 weeks of therapy, the BP target was achieved significantly more frequently in group 1 (63% of patients) compared to groups 2 (36.7% of patients), 3 (16.7% of patients), and 4 (16.7% of patients) (p<0.05). At 12 weeks, office SBP, DBP, and HR were significantly decreased in all groups, but the decrease was significantly greater in group 1. The therapy was associated with a more pronounced decrease in all studied 24-h BPM parameters in the Physiotens group than in other groups, as well as with a significantly more frequent normalization of the 24-h BP profile, in 66.7% of patients vs. 46.7%, 33.4%, and 23.2% of patients in groups 2, 3, and 4, respectively.

Conclusion: The treatment with original moxonidine demonstrated advantages over generic drugs in terms of achieving the BP goal, reducing office BP and HR, and improving 24-h BPM parameters.

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来源期刊
Kardiologiya
Kardiologiya 医学-心血管系统
CiteScore
1.70
自引率
20.00%
发文量
94
审稿时长
3-8 weeks
期刊介绍: “Kardiologiya” (Cardiology) is a monthly scientific, peer-reviewed journal committed to both basic cardiovascular medicine and practical aspects of cardiology. As the leader in its field, “Kardiologiya” provides original coverage of recent progress in cardiovascular medicine. We publish state-of-the-art articles integrating clinical and research activities in the fields of basic cardiovascular science and clinical cardiology, with a focus on emerging issues in cardiovascular disease. Our target audience spans a diversity of health care professionals and medical researchers working in cardiovascular medicine and related fields. The principal language of the Journal is Russian, an additional language – English (title, authors’ information, abstract, keywords). “Kardiologiya” is a peer-reviewed scientific journal. All articles are reviewed by scientists, who gained high international prestige in cardiovascular science and clinical cardiology. The Journal is currently cited and indexed in major Abstracting & Indexing databases: Web of Science, Medline and Scopus. The Journal''s primary objectives Contribute to raising the professional level of medical researchers, physicians and academic teachers. Present the results of current research and clinical observations, explore the effectiveness of drug and non-drug treatments of heart disease, inform about new diagnostic techniques; discuss current trends and new advancements in clinical cardiology, contribute to continuing medical education, inform readers about results of Russian and international scientific forums; Further improve the general quality of reviewing and editing of manuscripts submitted for publication; Provide the widest possible dissemination of the published articles, among the global scientific community; Extend distribution and indexing of scientific publications in major Abstracting & Indexing databases.
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