CAJ | 학술논문

目的：评价国产氯吡格雷与进口氯吡格雷治疗缺血性脑卒中有效性与安全性。方法：采用多中心、前瞻性、随机开放性对照试验方法，入选480例缺血性脑卒中患者，随机分为观察组240例，对照组240例。2组均给予降压、调脂、扩血管药物、神经保护药物治疗，观察组同时给予国产氯吡格雷，疾病发作时给予负荷剂量600mg，后住院期间给予150mg／d连续7天，7天后给予75mg／d，连续12个月。对照组给予进口氯吡格雷，给药方法与观察组一致。近期随访1个月，评价患者急性期死亡、脑血管事件进展发生人数、神经功能评分。远期随访6个月，观察神经功能评分及脑血管事件再发人数。同时再随访期间密切观察患者不良事件。结果：急性期观察组病情持续进展14例，对照组16例，全因死亡病例分别为3例，1例，2组比较无明显统计学差异（P＞0．05）。另外急性期采用氯吡格雷治疗NIHSS评分下降明显，2组治疗30天后分别为8．32±2．71，8．24±2．18。稳定期观察组12个月全因脑血管事件再发为10例，对照组12例。随访6个月后，2组Rankin评分均明显下降为2．0±0．2，2．0±0．4，2组比较不具有统计学差异（P＞0．05）。2组治疗过程中出血、胃肠道不良反应、神经系统、血液系统发生率并不具有统计学差异（ P＞0．05）。12个月治疗过程中，国产氯吡格雷中途因治疗费用停药的发生率为0．83％，对照组为5．8％，2组比较具有显著的统计学差异。结论：国产氯吡格雷与进口氯吡格雷有效性与安全性相似。治疗费用更低，中途停药率更低。
목적：평개국산록필격뢰여진구록필격뢰치료결혈성뇌졸중유효성여안전성。방법：채용다중심、전첨성、수궤개방성대조시험방법，입선480례결혈성뇌졸중환자，수궤분위관찰조240례，대조조240례。2조균급여강압、조지、확혈관약물、신경보호약물치료，관찰조동시급여국산록필격뢰，질병발작시급여부하제량600mg，후주원기간급여150mg／d련속7천，7천후급여75mg／d，련속12개월。대조조급여진구록필격뢰，급약방법여관찰조일치。근기수방1개월，평개환자급성기사망、뇌혈관사건진전발생인수、신경공능평분。원기수방6개월，관찰신경공능평분급뇌혈관사건재발인수。동시재수방기간밀절관찰환자불량사건。결과：급성기관찰조병정지속진전14례，대조조16례，전인사망병례분별위3례，1례，2조비교무명현통계학차이（P＞0．05）。령외급성기채용록필격뢰치료NIHSS평분하강명현，2조치료30천후분별위8．32±2．71，8．24±2．18。은정기관찰조12개월전인뇌혈관사건재발위10례，대조조12례。수방6개월후，2조Rankin평분균명현하강위2．0±0．2，2．0±0．4，2조비교불구유통계학차이（P＞0．05）。2조치료과정중출혈、위장도불량반응、신경계통、혈액계통발생솔병불구유통계학차이（ P＞0．05）。12개월치료과정중，국산록필격뢰중도인치료비용정약적발생솔위0．83％，대조조위5．8％，2조비교구유현저적통계학차이。결론：국산록필격뢰여진구록필격뢰유효성여안전성상사。치료비용경저，중도정약솔경저。
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.