The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Chin J Integr Med. 2020 Jun;26(6):420-427. doi: 10.1007/s11655-020-3094-7. Epub 2020 May 2.
To assess the effect and safety of Hydroxysafflor Yellow A for Injection (HSYAI) in treating patients with acute ischemic stroke (AIS) and blood stasis syndrome (BSS).
A multicenter, randomized, double-blind, multiple-dose, active-controlled phase II trial was conducted at 9 centers in China from July 2013 to September 2015. Patients with moderate or severe AIS and BSS were randomly assigned to low-, medium-, high-dose HSYAI groups (25, 50 and 70 mg/d HSYAI by intravenous infusion, respectively), and a control group (Dengzhan Xixin Injection (, DZXXI) 30 mL/d by intravenous infusion), for 14 consecutive days. The primary outcome was the Modified Rankin Scale (mRS) score ⩽1 at days 90 after treatment. The secondary outcomes included the National Institute of Health Stroke Scale (NIHSS) score ⩽1, Barthel Index (BI) score ⩾95, and BSS score reduced ⩾30% from baseline at days 14, 30, 60, and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment.
Of the 266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases were in the low-, medium-, and high-dose HSYAI and control groups, respectively. The proportions of patients in the medium- and high-dose HSYAI groups with mRS score ⩽1 at days 90 after treatment were significantly larger than the control group (P<0.05). The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium- and high-dose HSYAI groups were all significantly higher than the control group (P<0.05). No significant difference was reported among the 4 groups in any specific adverse events (P>0.05).
HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS. The medium (50 mg/d) or high dose (75 mg/d) might be the optimal dose for a phase III trial. (Registration No. ChiCTR-2000029608).
评估注射用羟基红花黄色素 A（HSYAI）治疗血瘀证急性缺血性脑卒中（AIS）患者的有效性和安全性。
这是一项多中心、随机、双盲、多剂量、阳性药物对照的 II 期临床试验，于 2013 年 7 月至 2015 年 9 月在中国 9 家中心进行。将中重度 AIS 合并血瘀证患者随机分为低、中、高剂量 HSYAI 组（25、50 和 70 mg/d 静脉滴注）和对照组（丹红注射液，30 mL/d 静脉滴注），连续治疗 14 天。主要结局为治疗后 90 天改良 Rankin 量表（mRS）评分 ⩽1。次要结局包括治疗后 14、30、60 和 90 天的美国国立卫生研究院卒中量表（NIHSS）评分 ⩽1、Barthel 指数（BI）评分 ⩾95 分和血瘀证评分降低 ⩾30%。安全性结局为治疗后 90 天内的任何不良事件。
在有效性分析的 266 例患者中，低、中、高剂量 HSYAI 组和对照组分别有 66、67、65 和 68 例患者。治疗后 90 天 mRS 评分 ⩽1 的患者比例中剂量和高剂量 HSYAI 组显著高于对照组（P<0.05）。治疗后 90 天 NIHSS 和 BI 的良好结局发生率以及治疗后 30 天和 60 天血瘀证的显著改善中剂量和高剂量 HSYAI 组均显著高于对照组（P<0.05）。四组患者在任何特定不良事件方面均无显著差异（P>0.05）。
HSYAI 在所有剂量下治疗血瘀证 AIS 患者均安全且耐受良好。中剂量（50 mg/d）或高剂量（75 mg/d）可能是 III 期试验的最佳剂量。（注册号：ChiCTR-2000029608）。
