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Article(id=1199335104511308090, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335100786766058, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.2544.2023.0825, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1670256000000, receivedDateStr=2022-12-06, revisedDate=null, revisedDateStr=null, acceptedDate=1679587200000, acceptedDateStr=2023-03-24, onlineDate=1763873371484, onlineDateStr=2025-11-23, pubDate=1709049600000, pubDateStr=2024-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763873371484, onlineIssueDateStr=2025-11-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763873371484, creator=13701087609, updateTime=1763873371484, updator=13701087609, issue=Issue{id=1199335100786766058, tenantId=1146029695717560320, journalId=1189873630562394117, year='2024', volume='49', issue='2', pageStart='123', pageEnd='244', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1763873370596, creator=13701087609, updateTime=1763874072387, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1199338044361896535, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335100786766058, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1199338044361896536, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335100786766058, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=152, endPage=158, ext={EN=ArticleExt(id=1199335105501163845, articleId=1199335104511308090, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Effects of different doses of statins on clinical outcomes in patients with acute ischemic stroke who received intravenous urokinase thrombolysis, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To investigate the effect of different doses of statins on the clinical efficacy and safety outcome of intravenous thrombolytic therapy of urokinase in patients with acute ischemic stroke (AIS). Methods Based on a large prospective, multicenter study, the Chinese Intravenous Thrombolysis Registry for AIS within 4.5 h of onset (INTRECIS) database, clinical data of 898 patients with urokinase intravenous thrombolysis for AIS were retrospectively analyzed. According to the amount of statin used during hospitalization, the patients were divided into 132 patients in no-statin group, 591 patients in conventional statin group and 175 patients in intensive statin group. Clinical outcome measures included 14-day improvement in the National Institutes of Health Stroke Scale (NIHSS) and 90-day excellent prognosis (improved Rankin score ≤1 point). Safety measures included recurrent stroke, bleeding events, and 90-day all-cause mortality. Results After adjusting for differences in baseline characteristics (age, coronary heart disease, diabetes, atrial fibrillation, systolic blood pressure, OTT, DNT, previous anti-plate use, blood glucose, and treatment in Class A hospitals), NIHSS scores improved at 14 days after admission and excellent prognosis at 90 days after admission in convention-dose and intensive statin groups were superior to those in no-statin group (P<0.05); Univariate and multivariate analysis of safety outcome indicators showed no statistically significant differences in stroke recurrence and bleeding events among the three groups (P>0.05); The 90-day all-cause mortality was significantly higher in no-statin group (10.6%) than in convention-dose statin group (2.0%) and intensive dose statin group (2.9%) (P<0.01). Conclusions In patients with AIS who were treated with intravenous urokinase thrombolytic therapy, intensive statin use was associated with improved 14-day NIHSS score and near-term prognosis without increasing the risk of stroke recurrence and bleeding events. Statin use is beneficial to reduce mortality.

, correspAuthors=Hui-Sheng Chen, authorNote=null, correspAuthorsNote=
E-mail:
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目的 探讨不同剂量他汀类药物对急性缺血性卒中(AIS)患者尿激酶静脉溶栓的临床疗效的影响。方法 基于一项前瞻性、多中心的大型研究——中国发病4.5 h内缺血性卒中的静脉溶栓登记研究(INTRECIS)数据库，回顾性分析经尿激酶静脉溶栓的898例AIS患者的临床资料。根据患者住院期间他汀类药物的用量分为不使用他汀组(132例)、常规剂量他汀组(591例)和强化剂量他汀组(175例)。临床疗效评价指标包括14 d美国国立卫生研究院卒中量表(NIHSS)评分改善和90 d预后极好(改良Rankin 评分≤1分)率。安全性评价指标包括卒中复发、出血事件和90 d全因死亡率。结果 在调整基线特征(年龄、冠心病、糖尿病、房颤、收缩压、卒中发作到静脉溶栓时间、入院到静脉溶栓给药时间、既往抗血小板用药史、血糖、三甲医院治疗)的差异后，常规剂量他汀组和强化剂量他汀组入院到14 d的NIHSS评分改善、90 d预后极好率均优于不用他汀组(P<0.05)；安全性结局指标的单因素与多因素分析结果显示，3组的卒中复发和出血事件比较差异均无统计学意义(P>0.05)；3组90 d全因死亡率比较，不用他汀组(10.6%)明显高于常规剂量他汀组(2.0%)和强化剂量他汀组(2.9%)(P<0.01)。结论 对于AIS尿激酶静脉溶栓的患者，强化剂量他汀类药物的使用可促进14 d NIHSS评分和近期预后改善，同时不增加卒中复发和出血事件的风险；他汀类药物使用有利于降低病死率。

, correspAuthors=陈会生, authorNote=null, correspAuthorsNote=
陈会生，E-mail：
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王维姣，药学硕士，主要从事神经系统疾病药物治疗等方面的研究

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王维姣，药学硕士，主要从事神经系统疾病药物治疗等方面的研究

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王维姣，药学硕士，主要从事神经系统疾病药物治疗等方面的研究

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Stroke, 2016, 47(11): 2870-2873., articleTitle=Combination of thrombolysis and statins in acute stroke is safe: results of the STARS randomized trial (Stroke Treatment with Acute Reperfusion and Simvastatin), refAbstract=null), Reference(id=1199335113122214574, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2021, volume=16, issue=9, pageStart=1807, pageEnd=1812, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=Bruning T, Al-Khaled M, journalName=Neural Regen Res, refType=null, unstructuredReference=Bruning T, Al-Khaled M. Do statins reduce the mortality rate in stroke patients treated with systemic thrombolysis in a 5-year single-center study?[J]. 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Neurology, 2013, 80(7): 655-661., articleTitle=The THRombolysis and STatins (THRaST) study, refAbstract=null), Reference(id=1199335114418254518, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2021, volume=268, issue=7, pageStart=2560, pageEnd=2569, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=Yang WY, Li YF, Wang ZR, journalName=J Neurol, refType=null, unstructuredReference=Yang WY, Li YF, Wang ZR, et al. Combined therapy of intensive statin plus intravenous rt-PA in acute ischemic stroke: the INSPIRE randomized clinical trial[J]. J Neurol, 2021, 268(7): 2560-2569., articleTitle=Combined therapy of intensive statin plus intravenous rt-PA in acute ischemic stroke: the INSPIRE randomized clinical trial, refAbstract=null), Reference(id=1199335114523112123, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2014, volume=45, issue=2, pageStart=509, pageEnd=514, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=Scheitz JF, Seiffge DJ, Tütüncü S, journalName=Stroke, refType=null, unstructuredReference=Scheitz JF, Seiffge DJ, Tütüncü S, et al. Dose-related effects of statins on symptomatic intracerebral hemorrhage and outcome after thrombolysis for ischemic stroke[J]. Stroke, 2014, 45(2): 509-514., articleTitle=Dose-related effects of statins on symptomatic intracerebral hemorrhage and outcome after thrombolysis for ischemic stroke, refAbstract=null), Reference(id=1199335114602803903, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2013, volume=127, issue=2, pageStart=251, pageEnd=257, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=Violi F, Calvieri C, Ferro D, journalName=Circulation, refType=null, unstructuredReference=Violi F, Calvieri C, Ferro D, et al. Statins as antithrombotic drugs[J]. Circulation, 2013, 127(2): 251-257., articleTitle=Statins as antithrombotic drugs, refAbstract=null), Reference(id=1199335114737021635, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2019, volume=26, issue=33, pageStart=6174, pageEnd=6185, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=Aznaouridis K, Masoura C, Vlachopoulos C, journalName=Curr Med Chem, refType=null, unstructuredReference=Aznaouridis K, Masoura C, Vlachopoulos C, et al. Statins in Stroke[J]. 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Acta Neurochir Suppl, 2016, 121: 269-275., articleTitle=Early use of statin in patients treated with alteplase for acute ischemic stroke, refAbstract=null), Reference(id=1199335114959319758, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2020, volume=49, issue=5, pageStart=503, pageEnd=508, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=Mowla A, Shah H, Lail NS, journalName=Cerebrovasc Dis, refType=null, unstructuredReference=Mowla A, Shah H, Lail NS, et al. Statins use and outcome of acute ischemic stroke patients after systemic thrombolysis[J]. Cerebrovasc Dis, 2020, 49(5): 503-508., articleTitle=Statins use and outcome of acute ischemic stroke patients after systemic thrombolysis, refAbstract=null), Reference(id=1199335115118703315, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, doi=null, pmid=null, pmcid=null, year=2011, volume=308, issue=1-2, pageStart=128, pageEnd=134, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=Cappellari M, Deluca C, Tinazzi M, journalName=J Neurol Sci, refType=null, unstructuredReference=Cappellari M, Deluca C, Tinazzi M, et al. Does statin in the acute phase of ischemic stroke improve outcome after intravenous thrombolysis? A retrospective study[J]. J Neurol Sci, 2011, 308(1-2): 128-134., articleTitle=Does statin in the acute phase of ischemic stroke improve outcome after intravenous thrombolysis? A retrospective study, refAbstract=null)], funds=[Fund(id=1199335110911816285, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, awardId=2017YFC1308200, language=EN, fundingSource=National Key Research and Development Program of China(2017YFC1308200), fundOrder=null, country=null), Fund(id=1199335111071199842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, awardId=2017YFC1308200, language=CN, fundingSource=国家重点研发计划(2017YFC1308200), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1199335106570711419, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, xref=null, ext=[AuthorCompanyExt(id=1199335106574905724, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, companyId=1199335106570711419, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Neurology, the Northern Theater Command Hospital of Chinese PLA, Shenyang, Liaoning 110016, China), AuthorCompanyExt(id=1199335106583294333, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, companyId=1199335106570711419, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=解放军北部战区总医院神经内科，辽宁沈阳 110016)])], figs=[ArticleFig(id=1199335108432982531, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Fig.1, caption=The flow chart of inclusion and exclusion of patients with acute ischemic stroke, figureFileSmall=6OspNPIvOp7sJDU7S/V3ag==, figureFileBig=hn17PzTL2Lh6QQ0KPJ/8Tw==, tableContent=null), ArticleFig(id=1199335108554617356, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=图1, caption=急性缺血性卒中患者纳入与排除流程

AIS. 急性缺血性卒中；INTRECIS. 中国发病 4.5 h内缺血性卒中的静脉溶栓登记研究

, figureFileSmall=6OspNPIvOp7sJDU7S/V3ag==, figureFileBig=hn17PzTL2Lh6QQ0KPJ/8Tw==, tableContent=null), ArticleFig(id=1199335109720633885, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Fig.2, caption=Modified rankin scale at the 90th day in 3 groups of acute ischemic stroke patients with different doses of statins, figureFileSmall=LPM/mtkoJ1rRr4Ql03Bh0Q==, figureFileBig=AxvOxbJs6HMTE9Ppdp/3xQ==, tableContent=null), ArticleFig(id=1199335109829685796, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=图2, caption=接受不同剂量他汀治疗的3组急性缺血性卒中患者90 d改良 Rankin 评分分布

AIS. 急性缺血性卒中；INTRECIS. 中国发病 4.5 h内缺血性卒中的静脉溶栓登记研究

, figureFileSmall=LPM/mtkoJ1rRr4Ql03Bh0Q==, figureFileBig=AxvOxbJs6HMTE9Ppdp/3xQ==, tableContent=null), ArticleFig(id=1199335109980680748, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Tab.1, caption=

Statin doses in two groups of patients with acute ischemic stroke

, figureFileSmall=null, figureFileBig=null, tableContent=
他汀类药物

常规剂量他汀组
(n=591)

强化剂量他汀组
(n=175)

剂量(mg)例数剂量(mg)例数
合计591175
阿托伐他汀10~2041040~80118
瑞舒伐他汀5~101552057
普伐他汀105--
匹伐他汀22--
辛伐他汀10~2019--
), ArticleFig(id=1199335110106509876, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=表1, caption=

两组急性缺血性卒中患者他汀类药物使用情况

, figureFileSmall=null, figureFileBig=null, tableContent=
他汀类药物

常规剂量他汀组
(n=591)

强化剂量他汀组
(n=175)

剂量(mg)例数剂量(mg)例数
合计591175
阿托伐他汀10~2041040~80118
瑞舒伐他汀5~101552057
普伐他汀105--
匹伐他汀22--
辛伐他汀10~2019--
), ArticleFig(id=1199335110194590265, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Tab.2, caption=

Comparison of baseline data of 3 groups of acute ischemic stroke patients with different doses of statins

, figureFileSmall=null, figureFileBig=null, tableContent=
变量不用他汀组(n=132)常规剂量他汀组(n=591)强化剂量他汀组(n=175)P
年龄(岁, $\bar{x}±s$)65.8±11.162.9±10.563.2±10.20.021(1)
性别[例(%)]0.777
男88(66.7)410(69.4)118(67.4)
女44(33.3)181(30.6)57(32.6)
BMI [kg/m2, M(Q1, Q3)]23.9(21.5, 25.9)24.0(22.0, 25.7)24.2(22.0, 26.4)0.292
受教育程度[例(%)]0.220
小学及以下50(37.9)185(31.3)52(29.7)
中学68(51.5)360(60.9)112(64.0)
大学及以上14(10.6)46(7.8)11(6.3)
吸烟史[例(%)]22(16.7)257(43.5)82(46.9)0.001(1)
饮酒史[例(%)]16(12.1)161(27.2)49(28.0)0.001(1)
高血压[例(%)]53(40.2)327(55.3)99(56.6)0.004(1)
冠心病[例(%)]11(8.3)83(14.0)40(22.9)0.001(1)
糖尿病[例(%)]19(14.4)103(17.4)43(24.6)0.044(1)
房颤[例(%)]11(8.3)53(9.0)7(4.0)0.100
既往卒中[例(%)]29(22.0)139(23.5)49(28.0)0.389
收缩压[mmHg, M(Q1, Q3)]145(130, 166)152(138, 166)157(140, 172)0.012(1)
舒张压[mmHg, M(Q1, Q3)]82(80, 97)88(80, 97)90(80, 100)0.067
OTT [min, M(Q1, Q3)]162(119, 224)190(146, 230)194(150, 240)0.005(1)
DNT [min, M(Q1, Q3)]50(30, 76)60(39, 95)52(30, 85)0.001(1)
NIHSS评分[分, M(Q1, Q3)]5(3, 8)5(3, 9)4(2, 9)0.126
既往抗血小板用药史[例(%)]7(5.3)75(12.7)23(13.1)0.046(1)
既往他汀用药史[例(%)]5(3.8)43(7.3)8(4.6)0.194
血糖[mmol/L, M(Q1, Q3)]8.5(6.5, 11.5)6.7(5.7, 8.6)6.8(5.7, 8.8)0.001(1)
TC (mmol/L, $\bar{x}±s$)4.46±1.194.61±1.304.74±1.250.447
TG [mmol/L, M(Q1, Q3)]1.22(1.03, 2.13)1.35(1.02,2.16)1.74(1.03, 2.59)0.359
LDL-C (mmol/L, $\bar{x}±s$)2.98±0.712.80±0.972.73±0.920.267
HDL-C [mmol/L, M(Q1, Q3)]0.99(0.95, 1.28)1.08(0.91, 1.35)1.04(0.86, 1.23)0.379
三甲医院治疗[例(%)]126(95.5)541(91.5)151(86.3)0.016(1)
TOAST分型[例(%)]0.001(1)
LAA61(46.2)271(45.9)91(52.0)
CE26(19.7)50(8.5)9(5.1)
SAO35(26.5)223(37.7)58(33.1)
ODC016(2.7)3(1.7)
UND10(7.6)31(5.2)14(8.0)
), ArticleFig(id=1199335110333002299, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=表2, caption=

接受不同剂量他汀治疗的3组急性缺血性卒中患者基线资料比较

, figureFileSmall=null, figureFileBig=null, tableContent=
变量不用他汀组(n=132)常规剂量他汀组(n=591)强化剂量他汀组(n=175)P
年龄(岁, $\bar{x}±s$)65.8±11.162.9±10.563.2±10.20.021(1)
性别[例(%)]0.777
男88(66.7)410(69.4)118(67.4)
女44(33.3)181(30.6)57(32.6)
BMI [kg/m2, M(Q1, Q3)]23.9(21.5, 25.9)24.0(22.0, 25.7)24.2(22.0, 26.4)0.292
受教育程度[例(%)]0.220
小学及以下50(37.9)185(31.3)52(29.7)
中学68(51.5)360(60.9)112(64.0)
大学及以上14(10.6)46(7.8)11(6.3)
吸烟史[例(%)]22(16.7)257(43.5)82(46.9)0.001(1)
饮酒史[例(%)]16(12.1)161(27.2)49(28.0)0.001(1)
高血压[例(%)]53(40.2)327(55.3)99(56.6)0.004(1)
冠心病[例(%)]11(8.3)83(14.0)40(22.9)0.001(1)
糖尿病[例(%)]19(14.4)103(17.4)43(24.6)0.044(1)
房颤[例(%)]11(8.3)53(9.0)7(4.0)0.100
既往卒中[例(%)]29(22.0)139(23.5)49(28.0)0.389
收缩压[mmHg, M(Q1, Q3)]145(130, 166)152(138, 166)157(140, 172)0.012(1)
舒张压[mmHg, M(Q1, Q3)]82(80, 97)88(80, 97)90(80, 100)0.067
OTT [min, M(Q1, Q3)]162(119, 224)190(146, 230)194(150, 240)0.005(1)
DNT [min, M(Q1, Q3)]50(30, 76)60(39, 95)52(30, 85)0.001(1)
NIHSS评分[分, M(Q1, Q3)]5(3, 8)5(3, 9)4(2, 9)0.126
既往抗血小板用药史[例(%)]7(5.3)75(12.7)23(13.1)0.046(1)
既往他汀用药史[例(%)]5(3.8)43(7.3)8(4.6)0.194
血糖[mmol/L, M(Q1, Q3)]8.5(6.5, 11.5)6.7(5.7, 8.6)6.8(5.7, 8.8)0.001(1)
TC (mmol/L, $\bar{x}±s$)4.46±1.194.61±1.304.74±1.250.447
TG [mmol/L, M(Q1, Q3)]1.22(1.03, 2.13)1.35(1.02,2.16)1.74(1.03, 2.59)0.359
LDL-C (mmol/L, $\bar{x}±s$)2.98±0.712.80±0.972.73±0.920.267
HDL-C [mmol/L, M(Q1, Q3)]0.99(0.95, 1.28)1.08(0.91, 1.35)1.04(0.86, 1.23)0.379
三甲医院治疗[例(%)]126(95.5)541(91.5)151(86.3)0.016(1)
TOAST分型[例(%)]0.001(1)
LAA61(46.2)271(45.9)91(52.0)
CE26(19.7)50(8.5)9(5.1)
SAO35(26.5)223(37.7)58(33.1)
ODC016(2.7)3(1.7)
UND10(7.6)31(5.2)14(8.0)
), ArticleFig(id=1199335110442054212, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Tab.3, caption=

Univariate and multivariate analysis of the effectiveness of statins at different doses

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有效性结果不用他汀组(n=132)常规剂量他汀组(n=591)强化剂量他汀组(n=175)P
90 d mRS 0~1分[例(%)]88(66.7)411(69.6)135(77.1)
未调整OR(95%CI)1(参照)1.142(0.764~1.707)1.687(1.018~2.797)0.088
调整OR(95%CI)1(参照)1.599(0.994~2.571)2.734(1.482~5.044)(2)(3)0.005
90 d mRS 0~2分[例(%)]101(76.5)478(80.9)146(83.4)
未调整OR(95%CI)1(参照)1.298(0.826~2.040)1.545(0.877~2.722)0.313
调整OR(95%CI)1(参照)1.530(0.899~2.602)2.206(1.113~4.372)0.076
90 d mRS的分布[例(%)]
021(15.9)235(39.8)77(44.0)
167(50.8)176(29.8)58(33.1)
213(9.8)67(11.3)11(6.3)
38(6.1)61(10.3)10(5.7)
44(3.0)26(4.4)7(4.0)
55(3.8)14(2.4)7(4.0)
612(2.0)12(2.0)5(2.9)
未调整OR(95%CI)0.001
0~14 d NIHSS的变化[分, M(Q1, Q3)]2.0(0.3, 4.0)3.0(1.0, 5.0)3.0(1.0, 5.0)
未调整B值(95%CI)-1.141(-2.271, -0.010)0.487(-0.357, 1.331)(2)0(参照)(1)0.003
调整B值(95%CI)-1.178(-2.503, 0.146)0.579(-0.369, 1.527)(2)0(参照)(1)0.006
), ArticleFig(id=1199335110576271946, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=表3, caption=

不同剂量他汀有效性的单因素与多因素分析结果

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有效性结果不用他汀组(n=132)常规剂量他汀组(n=591)强化剂量他汀组(n=175)P
90 d mRS 0~1分[例(%)]88(66.7)411(69.6)135(77.1)
未调整OR(95%CI)1(参照)1.142(0.764~1.707)1.687(1.018~2.797)0.088
调整OR(95%CI)1(参照)1.599(0.994~2.571)2.734(1.482~5.044)(2)(3)0.005
90 d mRS 0~2分[例(%)]101(76.5)478(80.9)146(83.4)
未调整OR(95%CI)1(参照)1.298(0.826~2.040)1.545(0.877~2.722)0.313
调整OR(95%CI)1(参照)1.530(0.899~2.602)2.206(1.113~4.372)0.076
90 d mRS的分布[例(%)]
021(15.9)235(39.8)77(44.0)
167(50.8)176(29.8)58(33.1)
213(9.8)67(11.3)11(6.3)
38(6.1)61(10.3)10(5.7)
44(3.0)26(4.4)7(4.0)
55(3.8)14(2.4)7(4.0)
612(2.0)12(2.0)5(2.9)
未调整OR(95%CI)0.001
0~14 d NIHSS的变化[分, M(Q1, Q3)]2.0(0.3, 4.0)3.0(1.0, 5.0)3.0(1.0, 5.0)
未调整B值(95%CI)-1.141(-2.271, -0.010)0.487(-0.357, 1.331)(2)0(参照)(1)0.003
调整B值(95%CI)-1.178(-2.503, 0.146)0.579(-0.369, 1.527)(2)0(参照)(1)0.006
), ArticleFig(id=1199335110685323856, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=EN, label=Tab.4, caption=

Univariate and multivariate analysis of statin safety at different doses

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安全性结果不用他汀组(n=132)常规剂量组(n=591)强化剂量组(n=175)
卒中复发[例(%)]2(1.5)14(2.4)5(2.9)
未调整OR(95%CI)1(参照)1.577(0.354~7.024)1.912(0.365~10.011)
调整OR(95%CI)1(参照)1.344(0.261~6.925)0.827(0.136~5.023)
其他出血事件[例(%)]05(0.8)2(1.1)
未调整OR(95%CI)1.355(0.261~7.045)
调整OR(95%CI)1.621(0.270~9.731)
90 d全因死亡[例(%)]14(10.6)12(2.0)5(2.9)
未调整OR(95%CI)1(参照)0.175(0.079~0.387)(1)0.248(0.087~0.707)(1)
调整OR(95%CI)1(参照)0.123(0.046~0.328)(1)0.168(0.046~0.607)(1)
), ArticleFig(id=1199335110765015637, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335104511308090, language=CN, label=表4, caption=

不同剂量他汀安全性的单因素与多因素分析结果

, figureFileSmall=null, figureFileBig=null, tableContent=
安全性结果不用他汀组(n=132)常规剂量组(n=591)强化剂量组(n=175)
卒中复发[例(%)]2(1.5)14(2.4)5(2.9)
未调整OR(95%CI)1(参照)1.577(0.354~7.024)1.912(0.365~10.011)
调整OR(95%CI)1(参照)1.344(0.261~6.925)0.827(0.136~5.023)
其他出血事件[例(%)]05(0.8)2(1.1)
未调整OR(95%CI)1.355(0.261~7.045)
调整OR(95%CI)1.621(0.270~9.731)
90 d全因死亡[例(%)]14(10.6)12(2.0)5(2.9)
未调整OR(95%CI)1(参照)0.175(0.079~0.387)(1)0.248(0.087~0.707)(1)
调整OR(95%CI)1(参照)0.123(0.046~0.328)(1)0.168(0.046~0.607)(1)
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他汀类药物对急性缺血性卒中患者尿激酶静脉溶栓临床疗效的影响
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王维姣 , 陈会生 *
解放军医学杂志 | 临床研究 2024,49(2): 152-158
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解放军医学杂志 | 临床研究 2024, 49(2): 152-158
他汀类药物对急性缺血性卒中患者尿激酶静脉溶栓临床疗效的影响
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王维姣, 陈会生*
作者信息
  • 解放军北部战区总医院神经内科，辽宁沈阳 110016

    • 王维姣，药学硕士，主要从事神经系统疾病药物治疗等方面的研究

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陈会生，E-mail：
Effects of different doses of statins on clinical outcomes in patients with acute ischemic stroke who received intravenous urokinase thrombolysis
Wei-Jiao Wang, Hui-Sheng Chen*
Affiliations
  • Department of Neurology, the Northern Theater Command Hospital of Chinese PLA, Shenyang, Liaoning 110016, China
出版时间: 2024-02-28 doi: 10.11855/j.issn.0577-7402.2544.2023.0825
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摘要
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目的 探讨不同剂量他汀类药物对急性缺血性卒中(AIS)患者尿激酶静脉溶栓的临床疗效的影响。方法 基于一项前瞻性、多中心的大型研究——中国发病4.5 h内缺血性卒中的静脉溶栓登记研究(INTRECIS)数据库，回顾性分析经尿激酶静脉溶栓的898例AIS患者的临床资料。根据患者住院期间他汀类药物的用量分为不使用他汀组(132例)、常规剂量他汀组(591例)和强化剂量他汀组(175例)。临床疗效评价指标包括14 d美国国立卫生研究院卒中量表(NIHSS)评分改善和90 d预后极好(改良Rankin 评分≤1分)率。安全性评价指标包括卒中复发、出血事件和90 d全因死亡率。结果 在调整基线特征(年龄、冠心病、糖尿病、房颤、收缩压、卒中发作到静脉溶栓时间、入院到静脉溶栓给药时间、既往抗血小板用药史、血糖、三甲医院治疗)的差异后，常规剂量他汀组和强化剂量他汀组入院到14 d的NIHSS评分改善、90 d预后极好率均优于不用他汀组(P<0.05)；安全性结局指标的单因素与多因素分析结果显示，3组的卒中复发和出血事件比较差异均无统计学意义(P>0.05)；3组90 d全因死亡率比较，不用他汀组(10.6%)明显高于常规剂量他汀组(2.0%)和强化剂量他汀组(2.9%)(P<0.01)。结论 对于AIS尿激酶静脉溶栓的患者，强化剂量他汀类药物的使用可促进14 d NIHSS评分和近期预后改善，同时不增加卒中复发和出血事件的风险；他汀类药物使用有利于降低病死率。

他汀  /  急性缺血性卒中  /  尿激酶  /  静脉溶栓  /  预后

Objective To investigate the effect of different doses of statins on the clinical efficacy and safety outcome of intravenous thrombolytic therapy of urokinase in patients with acute ischemic stroke (AIS). Methods Based on a large prospective, multicenter study, the Chinese Intravenous Thrombolysis Registry for AIS within 4.5 h of onset (INTRECIS) database, clinical data of 898 patients with urokinase intravenous thrombolysis for AIS were retrospectively analyzed. According to the amount of statin used during hospitalization, the patients were divided into 132 patients in no-statin group, 591 patients in conventional statin group and 175 patients in intensive statin group. Clinical outcome measures included 14-day improvement in the National Institutes of Health Stroke Scale (NIHSS) and 90-day excellent prognosis (improved Rankin score ≤1 point). Safety measures included recurrent stroke, bleeding events, and 90-day all-cause mortality. Results After adjusting for differences in baseline characteristics (age, coronary heart disease, diabetes, atrial fibrillation, systolic blood pressure, OTT, DNT, previous anti-plate use, blood glucose, and treatment in Class A hospitals), NIHSS scores improved at 14 days after admission and excellent prognosis at 90 days after admission in convention-dose and intensive statin groups were superior to those in no-statin group (P<0.05); Univariate and multivariate analysis of safety outcome indicators showed no statistically significant differences in stroke recurrence and bleeding events among the three groups (P>0.05); The 90-day all-cause mortality was significantly higher in no-statin group (10.6%) than in convention-dose statin group (2.0%) and intensive dose statin group (2.9%) (P<0.01). Conclusions In patients with AIS who were treated with intravenous urokinase thrombolytic therapy, intensive statin use was associated with improved 14-day NIHSS score and near-term prognosis without increasing the risk of stroke recurrence and bleeding events. Statin use is beneficial to reduce mortality.

statin  /  acute ischemic stroke  /  urokinase  /  intravenous thrombolysis  /  prognosis
王维姣, 陈会生. 他汀类药物对急性缺血性卒中患者尿激酶静脉溶栓临床疗效的影响. 解放军医学杂志, 2024 , 49 (2) : 152 -158 . DOI: 10.11855/j.issn.0577-7402.2544.2023.0825
Wei-Jiao Wang, Hui-Sheng Chen. Effects of different doses of statins on clinical outcomes in patients with acute ischemic stroke who received intravenous urokinase thrombolysis[J]. Medical Journal of Chinese People’s Liberation Army, 2024 , 49 (2) : 152 -158 . DOI: 10.11855/j.issn.0577-7402.2544.2023.0825
正文
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2019年全球疾病负担报告(global burden of disease，GBD)显示，卒中已成为我国成人致死、致残的首要原因[1]。中国一项流行病学调查显示，缺血性卒中患病率达1700/10万，且整体呈上升趋势[2]。急性缺血性卒中(acute ischemic stroke，AIS)是常见的脑血管病类型[3-4]，其治疗的关键是早期开通责任动脉，恢复缺血部位血流，实现再灌注。对于发病时间<6 h的AIS患者，静脉溶栓是有效的临床治疗方法[5-6]。目前，我国常用的溶栓药物有阿替普酶和尿激酶[7]。一项前瞻性、多中心的大型研究——中国发病4.5 h内缺血性卒中的静脉溶栓登记研究(Intravenous Thrombolysis Registry for Chinese Ischemic Stroke within 4.5 h Onset，INTRECIS)显示，在发病4.5 h内，尿激酶与阿替普酶治疗轻至中度AIS同样安全、有效[8]。有研究显示，他汀类药物的使用可改善AIS的临床结局[9-10]，但高剂量的他汀类药物可能增加AIS的出血风险[11]。AIS行静脉溶栓治疗时，如何合理地联合使用他汀类药物，对于改善患者预后尤为重要。本研究旨在观察不同剂量他汀类药物联合尿激酶静脉溶栓对AIS患者临床结局的影响。
1 资料与方法
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1.1 研究对象
回顾性分析2017年4月1日-2019年7月1日纳入INTRECIS研究的接受尿激酶(100万~150万U)静脉溶栓治疗的898例AIS患者的临床资料，根据患者住院期间治疗情况分为不用他汀组(132例)、常规剂量他汀组(591例)和强化剂量他汀组(175例)，筛选流程见图1。本研究方案严格遵循1975年颁布的《赫尔辛基宣言》中的伦理准则，并通过解放军北部战区总医院伦理委员会审核[伦审K(2016)36]。
1.2 纳入与排除标准
(1)纳入标准：年龄≥18岁；符合中国AIS诊治指南 2014 的诊断标准；首次发病或既往脑梗死病史无明显后遗症 [改良Rankin 评分(modified Rankin scale，mRS)分值≤1]；发病4.5 h内；经尿激酶静脉溶栓治疗；经影像学检查确诊。(2)排除标准：符合中国AIS诊治指南 2014 的排除标准；住院期间他汀类药物使用情况不详；尿激酶剂量不在100万~150万U；临床基线资料不完整。
1.3 临床资料
(1)一般情况：年龄、性别、体重指数(BMI)、受教育程度、吸烟史、饮酒史；(2)临床特征：既往病史(糖尿病、冠心病、高血压、房颤等)、既往用药史(抗血小板、他汀)、美国国立卫生研究院卒中量表评分(National Institute of Health Stroke Scale，NIHSS)、mRS评分、卒中发作到静脉溶栓时间(onset to treatment，OTT)、进入医院到静脉溶栓给药时间(door-to-needle time，DNT)、收缩压、舒张压等；(3)实验室检查指标：血糖、总胆固醇、三酰甘油、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇等。
1.4 治疗方法
1.4.1 基础治疗
3组患者均给予改善循环、营养神经及脱水降颅压等对症支持治疗。使用尿激酶进行静脉溶栓：100万~150万U溶于100 ml氯化钠注射液，30 min完成静脉滴注。
1.4.2 他汀药物治疗
本研究是一项多中心研究，每个中心所用他汀类药物种类、剂量均不相同，根据2022年《中国缺血性卒中和短暂性脑缺血发作二级预防指南》[3]中他汀类药物降脂强度分为常规剂量他汀组和强化剂量他汀组，分组情况见表1。
1.5 观察指标
(1)有效性指标：使用mRS 评分评估治疗90 d后的临床疗效，观察90 d时mRS评分分值分布情况，mRS评分≤1分为预后极好，mRS评分>1分为预后不佳；使用入院0~14 d的NIHSS评分改善情况评估近期临床疗效。(2)安全性指标：90 d卒中复发率、出血事件发生率、90 d全因死亡率。
1.6 统计学处理
采用IBM SPSS 26.0软件进行统计分析。符合正态分布的计量资料以$\bar{x}±s$表示，多组间比较采用单因素方差分析，进一步两两比较采用LSD-t检验；不符合正态分布的计量资料以M(Q1，Q3)表示，组间比较采用Kruskal-Wallis H检验；计数资料以百分率(%)表示，组间比较采用 χ2 检验。因变量为分类变量的进行单因素与多因素logistic回归分析，因变量为连续变量且不符合正态分布的选择广义线性模型，计算调整前后的优势比(odds ratio，OR)和相应的95%置信区间(confidence interval，CI)。将单因素分析中P<0.05的变量纳入多因素logistic回归分析模型。所有检验均为双尾，P<0.05为差异有统计学意义。
2 结果
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2.1 3组AIS患者的基线特征比较
接受尿激酶静脉溶栓治疗的AIS 898例中，住院期间接受了常规剂量他汀类药物治疗591例(65.8%)、强化剂量他汀类药物治疗175例(19.5%)，未接受他汀类药物治疗132例(14.7%)。与住院期间接受常规和强化剂量他汀类药物治疗的患者比较，未接受他汀类药物治疗的患者年龄和血糖值更高，吸烟史、饮酒史者占比更低，患高血压、冠心病、糖尿病和既往抗血小板用药史者占比更低，入院时收缩压更低，卒中发作到静脉溶栓时间、入院到静脉溶栓给药时间更短，在三甲医院治疗者占比更高，差异均有统计学意义(P<0.05)；此外，3组间TOAST分型差异有统计学意义(P=0.001)，其他基线指标差异均无统计学意义(P>0.05，表2)。
2.2 3组AIS患者治疗的有效性比较
单因素与多因素分析结果显示，在未调整基线指标时，3组间静脉溶栓的90 d预后极好(mRS评分≤1分)率比较，强化剂量他汀组明显高于不用他汀组(77.1% vs. 66.7%，P<0.05)，与常规剂量他汀组差异无统计学意义(77.1% vs. 69.6%，P=0.088，表3)。在多因素logistic回归分析中，调整了年龄、吸烟史、饮酒史、高血压、冠心病、糖尿病、收缩压、卒中发作到静脉溶栓时间(OTT)、入院到静脉溶栓给药时间(DNT)、既往抗血小板用药史、血糖、三甲医院治疗和TOAST分型的差异后，3组间静脉溶栓的90 d预后极好率比较差异有统计学意义(P=0.005)，其中，常规剂量他汀组和强化剂量他汀组均优于不用他汀组(P<0.05，图2)。
采用广义线性模型分析3组尿激酶静脉溶栓AIS患者他汀治疗的近期临床疗效，在调整基线差异后，常规剂量他汀组和强化剂量他汀组入院到14 d的NIHSS评分改善均优于不用他汀组(P<0.05)。
2.3 3组AIS患者尿激酶静脉溶栓治疗的安全性结果
单因素与多因素分析结果显示，在调整基线差异后，不用他汀组、常规剂量他汀组和强化剂量他汀组的卒中复发和出血事件差异比较均无统计学意义(P=0.697，P=0.597)。不用他汀组90 d全因死亡率(10.6%)明显高于常规剂量他汀组(2.0%)和强化剂量他汀组(2.9%，P<0.01)，在调整基线差异后仍差异明显(P<0.01，表4)。
3 讨论
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他汀类药物具有降低血脂、控制炎症、改善血管张力、保护神经及降低血小板聚集等多种作用，有利于改善AIS的预后[12-13]。既往研究显示，AIS患者服用他汀类药物可从中获益。一些观察性研究显示，在卒中急性期之前或期间使用他汀类药物与更好的功能结局及病死率降低有关[14-15]。SPARCL(强化降低胆固醇预防卒中)研究是针对非心源性缺血性卒中的随机对照研究，其结果显示，与安慰剂比较，每天服用阿托伐他汀80 mg，可将卒中复发相对风险降低16%[16]。但高剂量的他汀类药物可能增加AIS患者的出血风险。
本研究发现，强化剂量他汀可改善AIS患者尿激酶静脉溶栓后14 d NIHSS评分和90 d mRS评分，且不增加卒中复发和出血事件的风险；另外，在静脉溶栓后早期服用他汀类药物可降低患者病死率。
STARS研究显示了辛伐他汀治疗AIS的疗效及与组织型纤溶酶原激活剂(t-PA)联合应用的安全性[17]。Bruning等[18]研究显示，他汀类药物预处理以及住院期间给予他汀类药物与脑梗死静脉溶栓患者的预后呈正相关。THRaST研究是一项多中心回顾性研究，其结果显示，在静脉溶栓后早期使用他汀类药物与神经功能改善(OR=1.68，95%CI 1.26~2.25，P=0.001)、良好的功能结局(OR=1.63，95%CI 1.18~2.26，P=0.003)及较低的病死率(OR=0.48，95%CI 0.28~0.82，P=0.003)相关[19]。与上述研究结果类似，本研究结果显示，他汀类药物在行尿激酶静脉溶栓的AIS患者中同样安全、有效。INSPIRE是一项前瞻性、随机对照、盲法评估的多中心临床研究[20]，其结果显示，在接受静脉溶栓治疗的AIS患者中，与低剂量他汀治疗相比，强化剂量他汀治疗可能无法改善临床结局(70.3% vs. 66.5%，P=0.464)，但两组安全性相近。在临床疗效方面，本研究结果显示，强化剂量他汀可改善90 d的临床预后，与INSPIRE研究结果不一致；在安全性方面，本研究与INSPIRE研究结果一致。本研究与INSPIRE研究结果在临床疗效方面不一致的可能原因是，本研究纳入了静脉溶栓后不用他汀类药物治疗的患者，且样本量多于INSPIRE研究。
既往多项研究显示，他汀类药物用于接受静脉溶栓治疗的AIS患者时存在颅内出血风险。Scheitz等[21]观察到静脉溶栓后使用高剂量他汀类药物与发生症状性颅内出血(symptomatic intracranial hemorrhage，sICH)风险之间存在正相关。该风险可能是由于他汀类药物在促进溶栓、抗凝和抗血小板作用方面具有多效性[22-23]。另有研究显示，他汀类药物的使用与脑出血(OR=0.525，95%CI 0.184~1.504，P=0.230)或sICH(OR=0.915，95%CI 0.060~13.941，P=0.949)的发生之间没有明显的相关性[24]。Mowla等[25]的研究显示，接受他汀类药物治疗的患者发生sICH的风险与静脉溶栓后不良结局之间的相关性不显著。INSPIRE研究显示，对于静脉溶栓治疗的AIS患者，强化剂量他汀不会增加症状性脑出血的风险[20]。本研究结果与上述结果一致。
本研究与既往相关研究有部分不同之处。首先，使用的溶栓药物不一致。既往研究中他汀类药物联合静脉溶栓治疗AIS患者常使用阿替普酶，本研究在INTRECIS研究[7]结果的基础上，选取尿激酶静脉溶栓治疗的AIS患者。选取尿激酶的原因是尿激酶较阿替普酶价格低，更符合中国国情。其次，他汀类药物使用情况不同。既往多数研究均是在静脉溶栓后72 h内使用他汀类药物，或卒中前已经使用他汀类药物，本研究则是在静脉溶栓后24 h内使用他汀类药物，这是基于既往研究[26]得出的卒中后越早启动他汀治疗预后越好的提示。第三，研究对象不同。既往多数研究的对象为在卒中前后使用他汀类药物，或服用常规剂量，与强化剂量他汀类药物比较，限制因素较多，研究范围较细。本研究的观察对象为静脉溶栓后早期不用他汀与常规剂量他汀及强化剂量他汀的比较，范围较为全面。最后，本研究是基于真实世界研究得出的结果，结果较为可靠。
本研究存在局限性。首先，回顾性分析不可避免地存在选择偏倚；其次，在进行多因素logistic回归分析时，调整了不平衡的基线指标，排除了可能的混杂因素的干扰，但其他未记录的混杂因素亦可能对结果产生影响；第三，未收集出院后他汀类药物使用情况的相关数据，可能会引起偏差。
综上所述，对于尿激酶静脉溶栓的AIS患者，强化剂量他汀类药物的使用可促进14 d NIHSS评分和近期预后的改善，同时不增加卒中复发和出血事件的风险；与不用他汀类药物比较，使用他汀类药物有利于降低病死率。
基金
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  • 国家重点研发计划(2017YFC1308200)
文献
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doi: 10.11855/j.issn.0577-7402.2544.2023.0825
  • 接收时间：2022-12-06
  • 首发时间：2025-11-23
  • 出版时间：2024-02-28
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  • 收稿日期：2022-12-06
  • 录用日期：2023-03-24
基金
National Key Research and Development Program of China(2017YFC1308200)
国家重点研发计划(2017YFC1308200)
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    解放军北部战区总医院神经内科，辽宁沈阳 110016

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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