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-nbutylphthalide 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 followup, 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-nbutylphthalide for acute ischemic stroke was safe.

Key words: Ischemic stroke; Dl-3-n-butylphthalide; Safety; Efficacy

摘要：

目的 评价丁苯酞氯化钠注射液在真实世界中治疗缺血性卒中的安全性和有效性。 方法 多中心、前瞻性、开放标签Ⅳ期临床试验。研究共纳入2771例发病72 h以内的急性缺血性卒 中患者，给予丁苯酞氯化钠注射液静脉滴注，每日2次，每次25 mg（100 mL），疗程14 d。主要安全性 终点为（90±7）d的全因死亡，主要有效性终点为（90±7）d的mRS评分，次要有效性终点为（7±2）d、 （14±2）d的NIHSS评分。 结果 本研究共纳入2012年3月-2014年12月全国74家中心的2771例患者（全分析集），其中男性 1890例（68.21%），女性881例（31.79%）。2672例受试者（符合方案集）完成90 d随访，脱落率3.39%， 剔除率0.18%。全分析集（2771例）中，安全性终点分析：90 d全因死亡率为1.08%，研究者判定与研究 药物有关及无法判定的不良事件发生率为3.28%。有效性终点分析：治疗前、治疗第90天的mRS评分 0～1分的比例分别为23.29%和63.80%，治疗前后差值均数为（1.36±1.32）分，前后差值具有统计学 意义，P <0.0001。 结论 急性缺血性卒中患者使用丁苯酞氯化钠注射液是安全的。

关键词: 缺血性卒中; 丁苯酞; 安全性; 有效性