TANG Li 1 , LI Lüli 2 , LIU Kaixiang 3 , FU Tiejuan 4 , ZHU Yuhong 5 , CHEN Jun 6 , SUN Hongbin 7 , DONG WanLi 8 , MENG Zhihong 9 , ZHANG Shuqiong 10 , LIU Chunfeng 11 , HE Li 1
  • 1. Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
  • 2. Department of Neurology, People’s Hospital of Guangxi Zhuang Antonomous Region, Guilin, Guangxi 530021, P. R. China;
  • 3. Department of Neurology, Affiliated Hospital of Guilin Medical University, Guilin, Guangxi 541000, P. R. China;
  • 4. Department of Neurology, Jilin Provincial People’s Hospital, Changchun, Jilin 130021, P. R. China;
  • 5. Department of Neurology, the Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650032, P. R. China;
  • 6. Department of Neurology, the First Hospital of Lanzhou University, Gansu, Lanzhou 730000, P. R. China;
  • 7. Department of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, Chengdu, Sichuan 610072, P. R. China;
  • 8. Department of Neurology, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P. R. China;
  • 9. Department of Neurology, the First Affiliated Hospital of Tianjin University of TCM, Tianjin 300000, P. R. China;
  • 10. Department of Neurology, Chongqing Three Gorges Central Hospital, Chongqing 404000, P. R. China;
  • 11. Department of Neurology, the Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215004, P. R. China;
HE Li, Email: heli2003new@126.com
Acute cerebral infarction; Oxiracetam; Randomized controlled trial
10.7507/1002-0179.201601060
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Objective  To evaluate the clinical efficacy and safety of imported and domestic oxiracetam injection in the treatment of acute cerebral infarction. Methods  Between March 2013 and July 2014, a multicenter randomized blind controlled clinical study was conducted to learn the clinical efficacy and safety of imported oxiracetam injection (produced by Korea Pharmaceutical Corporation) and domestic oxiracetam injection (named as Oulantong, produced by Harbin Medisan Pharmaceutical Co., Ltd) in the treatment of acute cerebral infarction. West China Hospital of Sichuan University was in charge of the study, and the participants included the People’s Hospital of Guangxi Zhuang Autonomous Region, Affiliated Hospital of Guilin Medical University, Department of Neurology of Jilin Provincial People’s Hospital, the Second Affiliated Hospital of Kunming Medical University, the First Hospital of Lanzhou University, Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Tianjin University of TCM, Chongqing Three Gorges Central Hospital, and the Second Affiliated Hospital of Soochow University. A total of 240 patients with acute cerebral infarction were randomly divided into trial group (basic treatment plus imported oxiracetam injection) and control group (basic treatment plus domestic oxiracetam) with 120 patients in each. Follow-up was conducted 1 week, 2 weeks and 12 weeks after treatment. Finally, 200 patients consistent with the study criteria were included, including 101 in the trial group and 99 in the control group. National Institute of Health Stroke Scale (NHISS), Modified Rankin Scale (mRS) and Barthel Index (BI) were used to evaluate patients’ neurologic impairment, disability degree, life quality and treatment effective rate. Safety indexes included adverse events and life vital signs. Results  NHISS scores of the trial group and the control group were respectively (7.46±1.99) and (7.20±2.47) points before the treatment, (5.81±2.30) and (5.54±2.58) points one week after the treatment, (3.93±2.40) and (3.79±2.39) points two weeks after the treatment, (1.85±1.63) and (2.08±2.01) points 12 weeks after the treatment. There was no significant difference between the two groups at all time points (P>0.05). BI and mRS grading were not significantly different between the two groups at all time points after the treatment (P>0.05). NHISS score, mRS grading and BI at each time point after the treatment were significantly different from those before the treatment (P<0.05). No significant differences were found between the two groups in the treatment effective rate at each time point (P>0.05). Fifty patients (41.66%) in the trial group had 111 adverse events (92.50%), and 61 (50.83%) in the control group had 145 adverse events (120.83%). There was no significant difference between the two groups (P>0.05). Moreover, most of the adverse reactions were at a mild degree. Life vital signs two weeks after the treatment were not significantly different between the two groups, either (P>0.05). Conclusion  Imported oxiracetam injection is of similar efficacy and safety with domestic Oulantong injection in the treatment of acute cerebral infarction.

Citation： TANG Li, LI Lüli, LIU Kaixiang, FU Tiejuan, ZHU Yuhong, CHEN Jun, SUN Hongbin, DONG WanLi, MENG Zhihong, ZHANG Shuqiong, LIU Chunfeng, HE Li. Oxiracetam injection in the treatment of acute cerebral infarction: a multicenter and randomized controlled trial. West China Medical Journal, 2017, 32(4): 509-514. doi: 10.7507/1002-0179.201601060 Copy

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