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标准化鸡冠花茶和油橄榄提取物(NW 洛神花)的降压疗效和安全性:一项 II 期、随机、双盲、卡托普利对照临床试验。

Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts (NW Roselle): A phase-II, randomized, double-blind, captopril-controlled clinical trial.

机构信息

Internal Medicine and Diabetology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.

Internal Medicine Department, Medical Division, National Research Centre, Giza, Egypt.

出版信息

Phytother Res. 2020 Dec;34(12):3379-3387. doi: 10.1002/ptr.6792. Epub 2020 Jul 29.

Abstract

Hypertension is a public health concern that needs immediate attention upon diagnosis. The demand for natural alternatives is on the rise; Hibiscus sabdariffa and Olea europaea are traditionally used for hypertension management in Egypt. In this study, we aimed to investigate the antihypertensive efficacy and safety of two doses of an herbal product of Hibiscus sabdariffa calyxes and Olea europaea leaves (NW Roselle) in Egyptian patients with grade 1 essential hypertension. We equally randomized 134 patients to receive captopril 25 mg, low-dose NW Roselle, or high-dose NW Roselle BID for 8 weeks. No significant decrease was found in systolic blood pressure or diastolic blood pressure when we compared low-dose NW Roselle and high-dose NW Roselle to captopril (p > .05). In all groups, mean reduction in BP at 8 weeks was significant; 16.4/9.9 mmHg (p < .0001), 15.4/9.6 mmHg (p < .0001), and 14.9/9.4 mmHg (p < .0001) with captopril, low-dose NW Roselle, and high-dose NW Roselle respectively. In addition, low-dose NW Roselle induced a significant reduction in the mean level of triglycerides (17.56 mg/dL; p = .038). In conclusion, NW Roselle had comparable antihypertensive efficacy and safety to captopril in Egyptian patients with grade 1 essential hypertension.

摘要

高血压是一个需要立即关注的公共卫生问题。对天然替代品的需求正在上升;在埃及,芙蓉葵和油橄榄叶传统上被用于高血压管理。在这项研究中,我们旨在研究两种剂量的芙蓉葵花萼和油橄榄叶(NW 洛神花)草药产品对埃及 1 级原发性高血压患者的降压效果和安全性。我们将 134 名患者随机均分为三组,分别接受卡托普利 25mg、低剂量 NW 洛神花或高剂量 NW 洛神花 bid 治疗 8 周。与卡托普利相比,低剂量 NW 洛神花和高剂量 NW 洛神花对收缩压或舒张压均无显著降低(p >.05)。在所有组中,8 周时 BP 的平均降低均有显著意义;分别为 16.4/9.9mmHg(p < .0001)、15.4/9.6mmHg(p < .0001)和 14.9/9.4mmHg(p < .0001),与卡托普利、低剂量 NW 洛神花和高剂量 NW 洛神花分别相关。此外,低剂量 NW 洛神花可显著降低甘油三酯的平均水平(17.56mg/dL;p = .038)。总之,NW 洛神花在埃及 1 级原发性高血压患者中的降压效果和安全性与卡托普利相当。

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