国际脑血管病杂志
國際腦血管病雜誌
국제뇌혈관병잡지
International Journal of Cerebrovascular Diseases
2015年
8期
588-592
,共5页
田月明%佟旭%曹亦宾%刘静华%史楠
田月明%佟旭%曹亦賓%劉靜華%史楠
전월명%동욱%조역빈%류정화%사남
卒中%脑缺血%血栓溶解疗法%组织型纤溶酶原激活物%输注,静脉内%治疗结果%剂量效应关系,药物
卒中%腦缺血%血栓溶解療法%組織型纖溶酶原激活物%輸註,靜脈內%治療結果%劑量效應關繫,藥物
졸중%뇌결혈%혈전용해요법%조직형섬용매원격활물%수주,정맥내%치료결과%제량효응관계,약물
Stroke%Brain Ischemia%Thrombolytic Therapy%Tissue Plasminogen Activator%Infusions,Intravenous%Treatment Outcome%Dose-Response Relationship,Drug
目的：探讨小剂量重组组织型纤溶酶原激活剂( recombinant tissue plasminogen activator, rtPA)静脉溶栓治疗中国急性缺血性卒中患者的安全性和有效性。方法回顾性纳入在发病4．5 h内接受rtPA静脉溶栓的连续急性缺血性卒中患者。根据 rtPA剂量分为小剂量组(0．5~0．8 mg/kg,最大剂量50 mg)和标准剂量组(0．9 mg/kg,最大剂量90 mg)。比较2组有症状颅内出血(symptomatic intracranial hemorrhage, sICH)[分别采用美国国立神经疾病与卒中研究所( National Institute of Neurological Disorders and Stroke, NINDS)、欧洲急性卒中协作研究Ⅱ(European Cooperative Acute Stroke Study Ⅱ, ECASS Ⅱ)以及欧洲卒中溶栓安全监测研究( Safe Implementation of Thrombolysis in Stroke-Monitoring Study, SITS-MOST )的3种定义]、90 d死亡、90 d转归良好[改良Rankin量表(modified Rankin Scale, mRS)评分0~1分]和生活自理(mRS评分0~2分)的发生率。结果共纳入163例患者,小剂量组74例,标准剂量组89例。小剂量组高血压(44．6%对68．5%；χ2=9．490,P=0．002)和糖尿病(5．4%对28．1%；χ2=14．216,P<0．001)的患者构成比显著低于标准剂量组,而吸烟(56．8%对38．2%；χ2=5．590,P=0．018)和小动脉闭塞性卒中(21．6%对10．1%；χ2=4．122,P=0．042)的患者构成比显著高于标准剂量组。在校正年龄、美国国立卫生研究院卒中量表(National Institutes of Health Stroke Scale, NIHSS)评分、高血压、糖尿病、吸烟和缺血性卒中分型后,多变量二分类logistic分析显示,2组之间NINDS定义的sICH[10．8%对9．0%；优势比(odds ratio, OR)1．077,95%可信区间(confidence interval, CI)0．338~3．436]、ECASS Ⅱ定义的sICH(9．5%对9．0%；OR 0．976,95% CI 0．296~3．221)、SITS-MOST 定义的 sICH (8．1%对4．5%；OR 2．269,95% CI 0．522~9．852)、90 d死亡(17．6%对14．6%；OR 1．720,95% CI 0．578~5．119)、90 d转归良好(35．1%对32．6%；OR 0．780,95% CI 0．356~1．709)和生活自理(48．6%对42．7%；OR 0．936,95% CI 0．441~1．987)的发生率差异均无统计学意义(P均>0．05)。结论小剂量rtPA静脉溶栓治疗中国急性缺血性卒中患者的方案是安全和有效的。
目的：探討小劑量重組組織型纖溶酶原激活劑( recombinant tissue plasminogen activator, rtPA)靜脈溶栓治療中國急性缺血性卒中患者的安全性和有效性。方法迴顧性納入在髮病4．5 h內接受rtPA靜脈溶栓的連續急性缺血性卒中患者。根據 rtPA劑量分為小劑量組(0．5~0．8 mg/kg,最大劑量50 mg)和標準劑量組(0．9 mg/kg,最大劑量90 mg)。比較2組有癥狀顱內齣血(symptomatic intracranial hemorrhage, sICH)[分彆採用美國國立神經疾病與卒中研究所( National Institute of Neurological Disorders and Stroke, NINDS)、歐洲急性卒中協作研究Ⅱ(European Cooperative Acute Stroke Study Ⅱ, ECASS Ⅱ)以及歐洲卒中溶栓安全鑑測研究( Safe Implementation of Thrombolysis in Stroke-Monitoring Study, SITS-MOST )的3種定義]、90 d死亡、90 d轉歸良好[改良Rankin量錶(modified Rankin Scale, mRS)評分0~1分]和生活自理(mRS評分0~2分)的髮生率。結果共納入163例患者,小劑量組74例,標準劑量組89例。小劑量組高血壓(44．6%對68．5%；χ2=9．490,P=0．002)和糖尿病(5．4%對28．1%；χ2=14．216,P<0．001)的患者構成比顯著低于標準劑量組,而吸煙(56．8%對38．2%；χ2=5．590,P=0．018)和小動脈閉塞性卒中(21．6%對10．1%；χ2=4．122,P=0．042)的患者構成比顯著高于標準劑量組。在校正年齡、美國國立衛生研究院卒中量錶(National Institutes of Health Stroke Scale, NIHSS)評分、高血壓、糖尿病、吸煙和缺血性卒中分型後,多變量二分類logistic分析顯示,2組之間NINDS定義的sICH[10．8%對9．0%；優勢比(odds ratio, OR)1．077,95%可信區間(confidence interval, CI)0．338~3．436]、ECASS Ⅱ定義的sICH(9．5%對9．0%；OR 0．976,95% CI 0．296~3．221)、SITS-MOST 定義的 sICH (8．1%對4．5%；OR 2．269,95% CI 0．522~9．852)、90 d死亡(17．6%對14．6%；OR 1．720,95% CI 0．578~5．119)、90 d轉歸良好(35．1%對32．6%；OR 0．780,95% CI 0．356~1．709)和生活自理(48．6%對42．7%；OR 0．936,95% CI 0．441~1．987)的髮生率差異均無統計學意義(P均>0．05)。結論小劑量rtPA靜脈溶栓治療中國急性缺血性卒中患者的方案是安全和有效的。
목적：탐토소제량중조조직형섬용매원격활제( recombinant tissue plasminogen activator, rtPA)정맥용전치료중국급성결혈성졸중환자적안전성화유효성。방법회고성납입재발병4．5 h내접수rtPA정맥용전적련속급성결혈성졸중환자。근거 rtPA제량분위소제량조(0．5~0．8 mg/kg,최대제량50 mg)화표준제량조(0．9 mg/kg,최대제량90 mg)。비교2조유증상로내출혈(symptomatic intracranial hemorrhage, sICH)[분별채용미국국립신경질병여졸중연구소( National Institute of Neurological Disorders and Stroke, NINDS)、구주급성졸중협작연구Ⅱ(European Cooperative Acute Stroke Study Ⅱ, ECASS Ⅱ)이급구주졸중용전안전감측연구( Safe Implementation of Thrombolysis in Stroke-Monitoring Study, SITS-MOST )적3충정의]、90 d사망、90 d전귀량호[개량Rankin량표(modified Rankin Scale, mRS)평분0~1분]화생활자리(mRS평분0~2분)적발생솔。결과공납입163례환자,소제량조74례,표준제량조89례。소제량조고혈압(44．6%대68．5%；χ2=9．490,P=0．002)화당뇨병(5．4%대28．1%；χ2=14．216,P<0．001)적환자구성비현저저우표준제량조,이흡연(56．8%대38．2%；χ2=5．590,P=0．018)화소동맥폐새성졸중(21．6%대10．1%；χ2=4．122,P=0．042)적환자구성비현저고우표준제량조。재교정년령、미국국립위생연구원졸중량표(National Institutes of Health Stroke Scale, NIHSS)평분、고혈압、당뇨병、흡연화결혈성졸중분형후,다변량이분류logistic분석현시,2조지간NINDS정의적sICH[10．8%대9．0%；우세비(odds ratio, OR)1．077,95%가신구간(confidence interval, CI)0．338~3．436]、ECASS Ⅱ정의적sICH(9．5%대9．0%；OR 0．976,95% CI 0．296~3．221)、SITS-MOST 정의적 sICH (8．1%대4．5%；OR 2．269,95% CI 0．522~9．852)、90 d사망(17．6%대14．6%；OR 1．720,95% CI 0．578~5．119)、90 d전귀량호(35．1%대32．6%；OR 0．780,95% CI 0．356~1．709)화생활자리(48．6%대42．7%；OR 0．936,95% CI 0．441~1．987)적발생솔차이균무통계학의의(P균>0．05)。결론소제량rtPA정맥용전치료중국급성결혈성졸중환자적방안시안전화유효적。
Objective To investigate the safety and efficacy of low-dose recombinant tissue plasminogen activator (rtPA) in Chinese patients with acute ischemic stroke. Methods Consecutive patients with acute ischemic stroke received rtPA intravenous thrombolysis within 4. 5 h after symptom onset were enrol ed retrospectively. According to the dosage of rtPA, they were divided into either a low-dose group (0. 5-0. 8 mg/kg, the maximum dose 50 mg) or a standard dose group (0. 9 mg/kg, the maximum dose 90 mg). The incidences of symptomatic intracranial hemorrhage ( sICH) ( the National Institute of Neurological Disorders and Stroke [NINDS], and European Cooperative Acute Stroke Study Ⅱ [ECASSⅡ] , European Safe Implementation of Thrombolysis in Stroke-Monitoring Study [ SITS-MOST ] ), 90 d mortality, 90 d good outcome (the modified Rankin Scale [mRS] score 0-1), and life self-care ability (mRS score 0-2) were compared between the two groups. Results A total of 163 patients were enrol ed, including 74 patients in the low-dose group and 89 in the standard dose group. The constituent ratios of hypertension (44. 6% vs. 68. 5%; χ2 =9. 490, P=0. 002) and diabetes (5. 4% vs. 28. 1%; χ2 =14. 216, P<0. 001) in the patients of the low-dose group were significantly lower than those of the standard group, while the constituent ratios of smoking (56. 8% vs. 38. 2%; χ2 =5. 590, P=0. 018 ) and smal artery occlusive stroke (21. 6% vs. 10. 1%; χ2 =4. 122, P=0. 042 ) in patients of the low-dose group were significantly higher than those of the standard group. After adjusting for age, National Institutes of Health Stroke Scale (NIHSS) score, hypertension, diabetes, smoking, and ischemic stroke typing, multivariate binary logistic analysis showed that there were no significant differences in NINDS defined sICH (10. 8% vs. 9. 0%, odds ratio [OR] 1. 077, 95%confidence interval [CI] 0. 338-3. 436), ECASS Ⅱdefined sICH ( 9. 5% vs. 9. 0%; OR 0. 976, 95% CI 0. 296- 3. 221 ), SITS-MOST defined sICH (8. 1% vs. 4. 5%; OR 2. 269, 95% CI 0. 522-9. 852), 90 d mortality (17. 6% vs. 14. 6%; OR 1. 720, 95% CI 0. 578-5. 119), 90 d good outcome (35. 1% vs. 32. 6%;OR 0. 780, 95% CI 0. 356-1. 709), and life self-care ability (48. 6% vs. 42. 7%;OR 0. 936, 95% CI 0. 441-1. 987) between the 2 groups (al P>0. 05). Conclusions The program of intravenous thrombolysis for the treatment of Chinese patients with acute ischemic stroke with low-dose rtPA is safe and effective.
