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

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

作者机构：The Second Clinical College of Guangzhou University of Chinese MedicineGuangzhou(510006)China Department of NeurologyThe Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou(510120)China Department of Acupuncture and MoxibustionHubei Provincial Hospital of Traditional Chinese MedicineWuhan(430061)China Department of NeurologyRuikang Hospital Affiliated to Guangxi University of Chinese MedicineNanning(530011)China Department of NeurologyGuangdong Second Traditional Chinese Medicine HospitalGuangzhou(510095)China Department of Traditional Chinese MedicinePutuo HospitalShanghai University of Traditional Chinese MedicineShanghai(200062)China Department of NeurologyXuanwu HospitalCapital Medical UniversityBeijing(100053)China Department of Traditional Chinese MedicineXiamen Hospital of Traditional Chinese MedicineXiamen(361001)China Departm ent of Acupuncture and MoxibustionThe Second Affiliated Hospital of Hunan University of Traditional Chinese MedicineChangsha(410005)China Departm ent of NeurologyThe Affiliated Hospital of Liaoning University of Traditional Chinese MedicineShenyang(110032)China School of Public HealthTongji Medical CollegeHuazhong University of Science and TechnologyW uhan(430030)China Youcare Pharm aceutical Group Dingcheng BranchBeijing(100176)China 

出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志（英文版）)

年 卷 期：2020年第26卷第6期

页      面：420-427页

核心收录：

学科分类：1006[医学-中西医结合] 1002[医学-临床医学] 10[医学] 100602[医学-中西医结合临床] 

基　　金：Guangzhou Youcare Biopharmaceutical Co. Ltd 

主　　题：hydroxysafflor yellow A acute ischemic stroke randomized controlled trial blood stasis syndrome Chinese medicine 

摘      要：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 phaseⅡtrial 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 14,30,60,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,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(P0.05).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 phaseⅢtrial.