Treatment of Masked Hypertension with a Chinese Herbal Formula A Randomized, Placebo-Controlled Trial
Treatment of Masked Hypertension with a Chinese Herbal Formula A Randomized, Placebo-Controlled Trial
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用中草药配方治疗隐匿性高血压：一项随机、安慰剂对照试验。
DOI：
10.1161/circulationaha.120.046685
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发表时间：
2020-11-10
期刊：
影响因子：
37.8
通讯作者：
Wang，Ji-Guang
中科院分区：
文献类型：
--
作者：
Zhang，Dong-Yan;Cheng，Yi-Bang;Wang，Ji-Guang
背景：隐匿性高血压与不良心血管结局相关。尽管如此，在治疗隐蔽性高血压方面还没有随机对照试验。本随机、安慰剂对照试验的目的是研究中药天麻钩藤颗粒（GUG）降压治疗隐匿性高血压患者的有效性和安全性。研究方法：门诊血压<140/90 mmHg，白天动态血压收缩压135-150 mmHg和/或舒张压85-95 mmHg的患者以1：1的比例随机接受GUG或安慰剂治疗，每天两次，每次5-10克，持续4周。主要疗效变量为日间动态血压的变化。结果如下：基线时，251名参与者（平均年龄50.4岁，53.4%为男性，平均体重指数24.5 kg/m2，分别有2.8%、1.6%和30.7%的心血管疾病、糖尿病和吸烟）的办公室和日间血压平均值分别为129/82和135/89 mmHg。在意向治疗分析中，GUG组和安慰剂组的日间收缩压/舒张压分别降低了5.44 /3.39和2.91/1.60 mmHg。白天（2.52/1.79 mmHg，P≤0.025）和24小时BP（2.33/1.49 mmHg，P≤0.012）的BP降低的组间差异显著，但门诊和夜间BP的差异不显著（P≥0.162）。在229例患者中进行的符合方案分析产生了类似的结果。仅报告了1起不良事件（白天嗜睡），未发生严重不良事件。结论：中药古格降压治疗隐匿性高血压有效。临床试验注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT 02156024。
Background: Masked hypertension is associated with adverse cardiovascular outcomes. Nonetheless, no randomized controlled trials exist in the treatment of masked hypertension. The aim of this randomized, placebo-controlled trial was to investigate the efficacy and safety of blood pressure (BP) lowering treatment with a Chinese herbal formula, gastrodia-uncaria granules (GUG), in patients with masked hypertension. Methods: Patients with an office BP of <140/90 mmHg and daytime ambulatory BP of 135-150 mmHg systolic and/or 85-95 mmHg diastolic were randomized 1:1 to the treatment of GUG or placebo 5-10 grams twice daily for 4 weeks. The primary efficacy variable was the change in daytime ambulatory BP. Results: At baseline, office and daytime BP of the 251 participants (mean age 50.4 years, 53.4% men, mean body mass index 24.5 kg/m2, and 2.8%, 1.6%, and 30.7% with cardiovascular disease, diabetes mellitus, and smoking, respectively) averaged 129/82 and 135/89 mmHg, respectively. In the intention-to-treat analysis, daytime systolic/diastolic BP was reduced by 5.44 /3.39 and 2.91/1.60 mmHg in the GUG and placebo groups, respectively. The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mmHg, P≤0.025) and 24-h BP (2.33/1.49 mmHg, P≤0.012), but not for the clinic and nighttime BPs (P≥0.162). The per-protocol analysis in 229 patients produced similar results. Only one adverse event (sleepiness during the day) was reported and no serious adverse event occurred. Conclusions: BP lowering treatment with Chinese traditional medicine GUG is efficacious for patients with masked hypertension. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02156024.