Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.
The Second School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Chin J Integr Med. 2021 Apr;27(4):252-258. doi: 10.1007/s11655-020-3320-3. Epub 2020 Oct 10.
To evaluate whether the efficacy of Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension.
This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed.
The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05).
GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).
评价葛根通络胶囊（由葛根总黄酮组成）改善恢复期缺血性脑卒中合并原发性高血压患者生活质量和降低血压的疗效是否优于银杏叶提取物（EGB）。
这是一项随机、阳性药物对照、双盲临床试验，于 2015 年 9 月至 2017 年 10 月进行。总共纳入中国 18 家医院的 477 名符合条件的患者，按 2:1:1 的比例随机分配至以下干预组，每天 2 次，持续 12 周：（1）葛根通络胶囊 250 mg 加 EGB 匹配安慰剂 40 mg（237 例，葛根通络胶囊组）；（2）EGB 40 mg 加葛根通络胶囊匹配安慰剂 250 mg（120 例，EGB 组）；或（3）葛根通络胶囊匹配安慰剂 250 mg 加 EGB 匹配安慰剂 40 mg（120 例，安慰剂组）。此外，所有患者均每日口服阿司匹林肠溶片 100 mg，持续 12 周。主要结局指标为巴氏指数（BI）。次要结局指标包括血压控制率和美国国立卫生研究院卒中量表（NIHSS）评分。计算并评估不良事件（AE）的发生率和严重程度。
治疗 12 周后，葛根通络胶囊和 EGB 组的 BI 相对独立率、NIHSS 临床恢复率和 NIHSS 总有效率均明显高于安慰剂组（P<0.05），而葛根通络胶囊组和 EGB 组之间无统计学差异（P>0.05）。治疗后 12、18 和 24 周，葛根通络胶囊组的血压控制率明显高于 EGB 组和安慰剂组（P<0.01）。3 组间 AE、药物不良反应和严重 AE 的发生率无统计学差异（P>0.05）。
葛根通络胶囊在改善患者生活质量和神经功能以及控制高血压方面具有显著疗效。（注册号：ChiCTR1800016667）。
