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首页|期刊导航|中国伤残医学|国产与进口氯吡格雷治疗缺血性脑卒中有效性及安全性的多中心、前瞻性随机临床II期试验

国产与进口氯吡格雷治疗缺血性脑卒中有效性及安全性的多中心、前瞻性随机临床II期试验

朱淑金 李旭 李瑾 何先霖

中国伤残医学Issue(23):19-21,3.
中国伤残医学Issue(23):19-21,3.DOI:10.13214/j.cnki.cjotadm.2015.23.009

国产与进口氯吡格雷治疗缺血性脑卒中有效性及安全性的多中心、前瞻性随机临床II期试验

A Multiple Center, Randomized, Controlled Trial of Domestic and Imported Clopidogrel in Treatment with Ischemic Stroke

朱淑金 1李旭 2李瑾 3何先霖4

作者信息

  • 1. 中国人民解放军第三二三医院,陕西西安 710054
  • 2. 大安市中医院
  • 3. 敦化市医院
  • 4. 公主岭市人民医院
  • 折叠

摘要

Abstract

Objective:To evaluate the efficacy of clopidogrel and imported clopidogrel ischemic stroke efficacy and safety.Methods:A multicenter, prospective, randomized controlled trials open method , selected 480 cases of ischemic stroke patients ,240 cases were randomly divided into two groups , a control group of 240 cases .Both groups were given blood pressure, lipid , vasodilators , neuropro-tective drugs , domestic observation group while giving clopidogrel loading dose disease onset 300mg,given 140mg /d continuous period of 14 days after hospitalization, two weeks after given 75mg /d, for 12 consecutive months.The control group received imported clopi-dogrel administration methods consistent with the observation group .Recently 1 month follow-up evaluation of patients with acute deaths , the number of cerebrovascular events occurred progress , neurological score .Long-term follow-up of six months, observed neurologi-cal score and the number of recurrent cerebrovascular events.Adverse events observed in patients closely during the same time and then follow-up.Results: The acute phase of the disease continued to progress in the observation group 14 cases, 16 cases in the control group, all-cause deaths were three cases , one case , there was no significant difference ( P>0.05) groups.In addition the use of clo-pidogrel in acute NIHSS score decreased significantly , were 8.32 ±2.71,8 2.4 ±2.18 after treatment 30d.Stability of the whole study group 12 months due to recurrent cerebrovascular events of 10 patients in the control group of 12patients.Follow-up six months later, both groups were significantly decreased Rankin score was 2.0 ±0.2,2.0 ±0.4 does not have a statistically significant difference be-tween the two groups (P>0.05).Both groups during the treatment of bleeding, gastrointestinal adverse reactions, nervous system, blood system does not have a statistically significant incidence (P>0.05).12 months of treatment, occurred midway due to the cost of treat-ment of domestic clopidogrel discontinuation rate was 0.83%, 5.8% in the control group , the two groups have a significant statistical difference.Conclusion:Domestic and imported clopidogrel efficacy and safety of clopidogrel is similar .Lower treatment costs ,lower middle discontinuation rates.

关键词

国产氯吡格雷/进口氯吡格雷/缺血性卒中/有效性

Key words

Domestic clopidogrel/Imported clopidogrel/Ischemic stroke/Effectiveness

分类

医药卫生

引用本文复制引用

朱淑金,李旭,李瑾,何先霖..国产与进口氯吡格雷治疗缺血性脑卒中有效性及安全性的多中心、前瞻性随机临床II期试验[J].中国伤残医学,2015,(23):19-21,3.

中国伤残医学

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