Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Ming-zhe HU; Zi-yi ZHOU; Zhong-yu ZHOU; Hui LU; Min GAO; Long-min LIU; Hai-qing SONG; An-ji LIN; Qing-ming WU; Hong-fei ZHOU; Lei LI; Xia WANG; Ye-feng CAI

doi:10.1007/s11655-020-3094-7

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Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Original Article | Updated：2021-08-23

- Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial
- Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial
- Chinese Journal of Integrative Medicine 2020年26卷第6期页码：420-427
- Affiliations：
  
  1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou (510006), China
  2.Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou (510120), China
  3.Department of Acupuncture and Moxibustion, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan (430061), China
  4.Department of Neurology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning (530011), China
  5.Department of Neurology, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou (510095), China
  6.Department of Traditional Chinese Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200062), China
  7.Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing (100053), China
  8.Department of Traditional Chinese Medicine, Xiamen Hospital of Traditional Chinese Medicine, Xiamen (361001), China
  9.Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha (410005), China
  10.Department of Neurology, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang (110032), China
  11.School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan (430030), China
  12.Youcare Pharmaceutical Group Dingcheng Branch, Beijing (100176), China
- Author bio：
  
  Correspondence to: Prof. CAI Ye-feng, E-mail:caiyefeng@126.com
- Funds：
- DOI：10.1007/s11655-020-3094-7
  中图分类号：
- 纸质出版日期：2020-06-01，
  
  网络出版日期：2020-05-02，
  
  录用日期：2020-04-01
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Ming-zhe HU, Zi-yi ZHOU, Zhong-yu ZHOU, 等. Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(6):420-427.

Ming-zhe HU, Zi-yi ZHOU, Zhong-yu ZHOU, et al. Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(6):420-427.
Ming-zhe HU, Zi-yi ZHOU, Zhong-yu ZHOU, 等. Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(6):420-427. DOI： 10.1007/s11655-020-3094-7.

Ming-zhe HU, Zi-yi ZHOU, Zhong-yu ZHOU, et al. Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(6):420-427. DOI： 10.1007/s11655-020-3094-7.

摘要

Abstract

Objective:

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).

Methods:

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 (灯盏细辛注射液

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

and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment.

Results:

Of the 266 patients included in the effectiveness analysis

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 (

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 (

0.05). No significant difference was reported among the 4 groups in any specific adverse events (

0.05).

Conclusions:

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)

关键词

Keywords

hydroxysafflor yellow Aacute ischemic strokerandomized controlled trialblood stasis syndromeChinese medicine

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