中国卒中杂志2019，Vol.14Issue(5)：450-455,6.DOI:10.3969/j.issn.1673-5765.2019.05.009
丁苯酞氯化钠注射液治疗急性缺血性卒中安全性及有效性研究——多中心、前瞻性、开放标签Ⅳ期临床试验
Safety and Efficacy of Administration of Dl-3-n-butylphthalide for Acute Ischemic Stroke: A Phase IV, Multicenter, Prospective, Open-lable Trial
LI Shu-Ya 1WANG Yi-Long 1ZHENG Hua-Guang 2ZHAO Xing-Quan 1LIU Li-Ping 1MENG Xia 2WANG Yong-Jun1
作者信息
- 1. Department of Neurology, Beijing Tian Tan Hospital, Capital Medical University
- 2. China National Clinical Research Center for Neurological Diseases (NCRC-ND)
- 折叠
摘要
Abstract
Objective To evaluate the safety and efficacy of administration of dl-3-n-butylphthalide for acute ischemic stroke in the real world. Methods This was a phase IV, multicenter, prospective, open-lable trial. Patients with acute ischemic stroke within 72 hours of onset were enrolled. All patients were given dl-3-n-butylphthalide injection (25 mg /100mL) twice daily for 14 days. The primary safety endpoint was all-cause death at (90±7) days, and the primary efficacy endpoint was mRS score at (90±7) days, the secondary efficacy endpoints were NIHSS scores at (7±2) and (14±2) days. Results From March 2012 to December 2014, a total of 2771 patients from 74 centers were enrolled, including 1890 males (68.21%) and 881 females (31.79%). 2672 patients completed 90-day follow-up, with a drop out rate of 3.39% and a rejection rate of 0.18%. The outcome analysis for all patients (n=2771), the safety endpoint: the 90-day all-cause mortality was 1.11%, and the adverse events was 3.28%; the efficacy endpoint: the proportion of 0-1 points of mRS score before treatment and at 90 days after treatment was 23.29% and 63.80%, respectively, and the mean score difference before and after treatment was 1.36±1.32, and the difference was statistically significant (P<0.0001). Conclusions Data from the post-marketing study showed that administration of dl-3-n-butylphthalide for acute ischemic stroke was safe.关键词
缺血性卒中/丁苯酞/安全性/有效性Key words
Ischemic stroke/Dl-3-n-butylphthalide/Safety/Efficacy引用本文复制引用
LI Shu-Ya,WANG Yi-Long,ZHENG Hua-Guang,ZHAO Xing-Quan,LIU Li-Ping,MENG Xia,WANG Yong-Jun..丁苯酞氯化钠注射液治疗急性缺血性卒中安全性及有效性研究——多中心、前瞻性、开放标签Ⅳ期临床试验[J].中国卒中杂志,2019,14(5):450-455,6.
