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Article(id=1239201873022996896, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.03.08, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1662998400000, receivedDateStr=2022-09-13, revisedDate=null, revisedDateStr=null, acceptedDate=1701187200000, acceptedDateStr=2023-11-29, onlineDate=1773378349785, onlineDateStr=2026-03-13, pubDate=1711296000000, pubDateStr=2024-03-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773378349785, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773378349785, creator=13701087609, updateTime=1773378349785, updator=13701087609, issue=Issue{id=1239201870791627164, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='3', pageStart='161', pageEnd='240', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773378349254, creator=13701087609, updateTime=1773378470498, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239202379392938830, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239202379397133135, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=201, endPage=206, ext={EN=ArticleExt(id=1239201873287238051, articleId=1239201873022996896, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Effect of butylphthalide on oxidative stress indexes and its signaling pathway related factors in patients with acute cerebral infarction, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=
AIM

To study the effect of butylphthalide on oxidative stress indicators and its signaling pathway related factors in patients with acute cerebral infarction.

METHODS

A total of 100 patients with acute cerebral infarction admitted to the hospital from August 2020 to April 2021 were divided into control group and study group by stratified blocked randomization method, with 50 patients in each group. The control group underwent conventional treatment, and the study group was treated with butylphthalide injection （100 mL, iv gtt, bid） for 14 d on the basis of conventional treatment. The two groups were compared in terms of neurological impairment score, oxidative stress indicators, related signaling pathway factors, nerve injury markers, C-reactive protein （CRP） and low-density lipoprotein （LDL） levels, as well as clinical efficacy and safety before and after treatment.

RESULTS

There were 3 cases in the control group and 2 cases in the study group dropped out during treatment. Finally, 47 cases in the control group and 48 cases in the study group were included respectively. After treatment, the level of malondialdehyde in the study group was significantly lower than that in the control group, while superoxide dismutase and glutathione peroxidase were significantly higher than those in the control group （P<0.05）; the Kelch-like ECH-associated protein 1 （Keap1） mRNA in the study group was significantly higher than that in the control group, while nuclear factor E2 related factor （Nrf2） and antioxidant response element （ARE）mRNA were significantly lower than those in the control group （P<0.05）. The levels of CRP and LDL in the study group were significantly lower than those in the control group （P<0.05）. The National Institutes of Health Stroke Scale score and the levels of myelin basic protein, neuron-specific enolase, and S100 calcium binding protein B in the study group were significantly lower than those in the control group （P<0.05）. The total effective rate of treatment in the study group was significantly higher than that in the control group （96% vs. 81%, P<0.05）, with no statistically significant difference in the total incidence of adverse reactions between the two groups （6% vs. 8%, P>0.05）.

CONCLUSION

Butylphthalide is effective in the treatment of patients with acute cerebral infarction, which may inhibit oxidative stress and relieve neurological damage through affecting the Keap1-Nrf2/ARE signaling pathway, and also has the advantage of regulating lipid metabolism abnormalities and reducing inflammation in the body.

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目的

研究丁苯酞对急性脑梗死患者氧化应激指标及其信号通路相关因子水平的影响。

方法

将本院2020年8月至2021年4月收治的100例急性脑梗死患者采用分层区组随机化方法分为对照组和研究组各50例，对照组行常规治疗，研究组在常规治疗上加用丁苯酞注射液（100 mL, iv gtt, bid）治疗14 d。比较2组患者治疗前后神经功能缺损评分和氧化应激指标、相关信号通路因子、神经损伤标志物、C反应蛋白（CRP）、低密度脂蛋白（LDL）水平，以及临床疗效和安全性。

结果

治疗期间对照组脱落3例，研究组脱落2例，最终分别入组47例和48例。治疗后，研究组丙二醛水平显著低于对照组，超氧化物歧化酶、谷胱甘肽过氧化物酶显著高于对照组（P<0.05）；研究组Kelch样ECH相关蛋白1（Keap1）mRNA明显高于对照组，核因子E2相关因子（Nrf2）和抗氧化反应元件（ARE）mRNA明显低于对照组（P<0.05）；研究组CRP、LDL水平明显低于对照组（P<0.05）；研究组美国国立卫生研究院卒中量表评分以及髓鞘碱性蛋白、神经元特异性烯醇化酶、S100钙结合蛋白B均显著低于对照组（P<0.05）。研究组治疗总有效率显著高于对照组（96% vs. 81%，P<0.05），用药期间不良反应发生率与对照组比较无显著差异（6% vs. 8%, P>0.05）。

结论

丁苯酞治疗急性脑梗死患者疗效确切，可能通过影响Keap1-Nrf2/ARE信号通路来抑制机体氧化应激，减轻患者神经功能损伤，且具有调节脂代谢异常、减轻机体炎症的优势。

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丁洁
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王鹏，男，副主任医师，硕士，主要从事脑血管病的研究，E-mail: 。

丁洁，女，副主任技师，硕士，主要从事神经电生理的研究，E-mail:

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王鹏，男，副主任医师，硕士，主要从事脑血管病的研究，E-mail: 。

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Chin J Arterioscler,2019, 27（1）: 65-68., articleTitle=Butylphthalide combined with edaravone improves neurological function in elderly patients with acute cerebral infarction by reducing carotid intima-media thickness, refAbstract=null), Reference(id=1239218222306751108, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, doi=null, pmid=null, pmcid=null, year=2021, volume=41, issue=3, pageStart=477, pageEnd=480, url=null, language=null, rfNumber=[21], rfOrder=28, authorNames=杨东娜, 张涤, 于佳佳, journalName=中国老年学杂志, refType=null, unstructuredReference=杨东娜, 张涤, 于佳佳. 丁苯酞注射液联合依达拉奉对老年急性脑梗死患者细胞因子、血管内皮功能和氧化应激的影响[J]. 中国老年学杂志, 2021, 41（3）: 477-480., articleTitle=丁苯酞注射液联合依达拉奉对老年急性脑梗死患者细胞因子、血管内皮功能和氧化应激的影响, refAbstract=null), Reference(id=1239218222373859974, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, doi=null, pmid=null, pmcid=null, year=2020, volume=36, issue=4, pageStart=615, pageEnd=620, url=null, language=null, rfNumber=[22], rfOrder=29, authorNames=WO X, HAN J, WANG J, journalName=Pak J Med Sci, refType=null, unstructuredReference=WO X, HAN J, WANG J, et al. 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Pak J Med Sci, 2020, 36（4）: 615-620., articleTitle=Sequential butylphthalide therapy combined with dual antiplatelet therapy in the treatment of acute cerebral infarction, refAbstract=null)], funds=[Fund(id=1239218218594791997, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, awardId=2021YJ09, language=CN, fundingSource=2021年度院引进人才科研启动基金项目(2021YJ09), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1239218211196039505, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, xref=null, ext=[AuthorCompanyExt(id=1239218211208622418, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, companyId=1239218211196039505, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Neurology, People’s Hospital of Lishui District, Nanjing JIANGSU 210000, China), AuthorCompanyExt(id=1239218211237982547, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, companyId=1239218211196039505, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=溧水区人民医院　神经内科，江苏　南京　210000)])], figs=[ArticleFig(id=1239218217529438749, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标对照组
（n=47）		研究组
（n=48）		t/χ2值P值
性别/例（男/女）27/2030/180.2530.615
年龄/岁58.19±13.8155.68±14.290.8700.386
发病至入院时间/h12.75±2.8112.94±2.990.3190.750
合并基础疾病/例
高血压10151.2180.270
糖尿病8131.3960.237
高血脂13140.0270.871
临床表现/例
肢体瘫痪10130.4360509
肢体麻木8131.3960.237
发作性头晕580.7310.393
发作性肢体无力8100.2250.635
共济失调650.1280.720
言语障碍780.0560.813
梗死位置/例
额叶16140.2610.609
颞叶12130.0290.864
基底核9100.0420.837
顶叶670.0660.797
枕叶440.0010.975
脑梗死体积/cm36.72±1.286.83±1.430.3950.694
既往用药史/例
阿司匹林690.6400.424
他汀类1080.3290.566
氯吡格雷240.6670.414
治疗前血压/mmHg
收缩压151.26±13.69148.82±13.920.8610.391
舒张压85.91±5.2986.48±5.510.5140.608
MR示血流灌注/例
低灌注32360.5580.455
中灌注1190.3100.578
高灌注430.1780.673
介入治疗/例12160.6950.404
), ArticleFig(id=1239218217617519135, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=CN, label=表1, caption=

2组患者一般资料比较

, figureFileSmall=null, figureFileBig=null, tableContent=
指标对照组
（n=47）		研究组
（n=48）		t/χ2值P值
性别/例（男/女）27/2030/180.2530.615
年龄/岁58.19±13.8155.68±14.290.8700.386
发病至入院时间/h12.75±2.8112.94±2.990.3190.750
合并基础疾病/例
高血压10151.2180.270
糖尿病8131.3960.237
高血脂13140.0270.871
临床表现/例
肢体瘫痪10130.4360509
肢体麻木8131.3960.237
发作性头晕580.7310.393
发作性肢体无力8100.2250.635
共济失调650.1280.720
言语障碍780.0560.813
梗死位置/例
额叶16140.2610.609
颞叶12130.0290.864
基底核9100.0420.837
顶叶670.0660.797
枕叶440.0010.975
脑梗死体积/cm36.72±1.286.83±1.430.3950.694
既往用药史/例
阿司匹林690.6400.424
他汀类1080.3290.566
氯吡格雷240.6670.414
治疗前血压/mmHg
收缩压151.26±13.69148.82±13.920.8610.391
舒张压85.91±5.2986.48±5.510.5140.608
MR示血流灌注/例
低灌注32360.5580.455
中灌注1190.3100.578
高灌注430.1780.673
介入治疗/例12160.6950.404
), ArticleFig(id=1239218217709793827, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别病愈显效有效无效总有效率
对照（n=47）21026938（81）
研究（n=48）61525246（96）b
), ArticleFig(id=1239218217810457126, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=CN, label=表2, caption=

2组患者临床疗效比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别病愈显效有效无效总有效率
对照（n=47）21026938（81）
研究（n=48）61525246（96）b
), ArticleFig(id=1239218217894343208, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别NIHSS/分MBP/ng·mL-1NSE/ng·mL-1S100B/µg·L-1
对照（n=47）治疗前22.86±3.287.34±2.159.88±2.456.47±2.06
治疗后12.23±2.16b4.54±0.79b5.64±1.53b4.28±1.45b
研究（n=48）治疗前21.21±4.127.21±2.389.71±2.286.11±1.86
治疗后8.49±1.65be2.14±0.47be4.11±0.92be2.06±0.86be
), ArticleFig(id=1239218218015978028, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=CN, label=表3, caption=

2组患者美国国立卫生研究院卒中量表（NIHSS）评分和神经损伤标志物比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别NIHSS/分MBP/ng·mL-1NSE/ng·mL-1S100B/µg·L-1
对照（n=47）治疗前22.86±3.287.34±2.159.88±2.456.47±2.06
治疗后12.23±2.16b4.54±0.79b5.64±1.53b4.28±1.45b
研究（n=48）治疗前21.21±4.127.21±2.389.71±2.286.11±1.86
治疗后8.49±1.65be2.14±0.47be4.11±0.92be2.06±0.86be
), ArticleFig(id=1239218218129224239, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别MDA/mmol·L-1SOD/U·mL-1GSH-Px/mmol·L-1CRP/mg·L-1LDL/mmol·L-1
对照（n=47）治疗前13.64±2.713.39±0.6423.97±3.7636.51±5.764.57±0.89
治疗后8.44±1.68b6.47±1.18b31.68±4.68b16.25±3.19b3.51±0.72
研究（n=48）治疗前13.74±2.873.15±0.5223.64±3.4926.84±5.544.23±0.64
治疗后4.67±1.43be8.75±1.22be40.88±4.28be10.64±2.86be2.16±0.52be
), ArticleFig(id=1239218218200527411, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=CN, label=表4, caption=

2组患者治疗前后氧化应激指标比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别MDA/mmol·L-1SOD/U·mL-1GSH-Px/mmol·L-1CRP/mg·L-1LDL/mmol·L-1
对照（n=47）治疗前13.64±2.713.39±0.6423.97±3.7636.51±5.764.57±0.89
治疗后8.44±1.68b6.47±1.18b31.68±4.68b16.25±3.19b3.51±0.72
研究（n=48）治疗前13.74±2.873.15±0.5223.64±3.4926.84±5.544.23±0.64
治疗后4.67±1.43be8.75±1.22be40.88±4.28be10.64±2.86be2.16±0.52be
), ArticleFig(id=1239218218326356535, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别Keap1 mRNANrf2 mRNAARE mRNA
对照（n=47）治疗前0.41±0.112.89±0.582.57±3.76
治疗后0.71±0.15b1.99±0.72b1.76±0.29b
研究（n=48）治疗前0.38±0.092.81±0.512.39±0.64
治疗后0.95±0.25be1.25±0.64be0.84±0.16be
), ArticleFig(id=1239218218410242618, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201873022996896, language=CN, label=表5, caption=

2组患者治疗前后氧化应激相关信号通路指标比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别Keap1 mRNANrf2 mRNAARE mRNA
对照（n=47）治疗前0.41±0.112.89±0.582.57±3.76
治疗后0.71±0.15b1.99±0.72b1.76±0.29b
研究（n=48）治疗前0.38±0.092.81±0.512.39±0.64
治疗后0.95±0.25be1.25±0.64be0.84±0.16be
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丁苯酞对急性脑梗死患者氧化应激指标及其信号通路相关因子水平的影响
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王鹏 , 邹荣成 , 黄健康 , 文洪波 , 丁洁 , 汪捷 , 舒永伟 , 缪家立
中国新药与临床杂志 | 论著 2024,43(3): 201-206
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中国新药与临床杂志 | 论著 2024, 43(3): 201-206
丁苯酞对急性脑梗死患者氧化应激指标及其信号通路相关因子水平的影响
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王鹏 , 邹荣成, 黄健康, 文洪波, 丁洁 , 汪捷, 舒永伟, 缪家立
作者信息
  • 溧水区人民医院　神经内科，江苏　南京　210000

    • 王鹏，男，副主任医师，硕士，主要从事脑血管病的研究，E-mail: 。

    丁洁，女，副主任技师，硕士，主要从事神经电生理的研究，E-mail:

通讯作者:

丁洁
Effect of butylphthalide on oxidative stress indexes and its signaling pathway related factors in patients with acute cerebral infarction
Peng WANG , Rong-cheng ZOU, Jian-kang HUANG, Hong-bo WEN, Jie DING , Jie WANG, Yong-wei SHU, Jia-li MIAO
Affiliations
  • Department of Neurology, People’s Hospital of Lishui District, Nanjing JIANGSU 210000, China
出版时间: 2024-03-25 doi: 10.14109/j.cnki.xyylc.2024.03.08
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摘要
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目的

研究丁苯酞对急性脑梗死患者氧化应激指标及其信号通路相关因子水平的影响。

方法

将本院2020年8月至2021年4月收治的100例急性脑梗死患者采用分层区组随机化方法分为对照组和研究组各50例，对照组行常规治疗，研究组在常规治疗上加用丁苯酞注射液（100 mL, iv gtt, bid）治疗14 d。比较2组患者治疗前后神经功能缺损评分和氧化应激指标、相关信号通路因子、神经损伤标志物、C反应蛋白（CRP）、低密度脂蛋白（LDL）水平，以及临床疗效和安全性。

结果

治疗期间对照组脱落3例，研究组脱落2例，最终分别入组47例和48例。治疗后，研究组丙二醛水平显著低于对照组，超氧化物歧化酶、谷胱甘肽过氧化物酶显著高于对照组（P<0.05）；研究组Kelch样ECH相关蛋白1（Keap1）mRNA明显高于对照组，核因子E2相关因子（Nrf2）和抗氧化反应元件（ARE）mRNA明显低于对照组（P<0.05）；研究组CRP、LDL水平明显低于对照组（P<0.05）；研究组美国国立卫生研究院卒中量表评分以及髓鞘碱性蛋白、神经元特异性烯醇化酶、S100钙结合蛋白B均显著低于对照组（P<0.05）。研究组治疗总有效率显著高于对照组（96% vs. 81%，P<0.05），用药期间不良反应发生率与对照组比较无显著差异（6% vs. 8%, P>0.05）。

结论

丁苯酞治疗急性脑梗死患者疗效确切，可能通过影响Keap1-Nrf2/ARE信号通路来抑制机体氧化应激，减轻患者神经功能损伤，且具有调节脂代谢异常、减轻机体炎症的优势。

丁苯酞  /  脑梗死  /  治疗结果  /  神经功能  /  氧化应激
AIM

To study the effect of butylphthalide on oxidative stress indicators and its signaling pathway related factors in patients with acute cerebral infarction.

METHODS

A total of 100 patients with acute cerebral infarction admitted to the hospital from August 2020 to April 2021 were divided into control group and study group by stratified blocked randomization method, with 50 patients in each group. The control group underwent conventional treatment, and the study group was treated with butylphthalide injection （100 mL, iv gtt, bid） for 14 d on the basis of conventional treatment. The two groups were compared in terms of neurological impairment score, oxidative stress indicators, related signaling pathway factors, nerve injury markers, C-reactive protein （CRP） and low-density lipoprotein （LDL） levels, as well as clinical efficacy and safety before and after treatment.

RESULTS

There were 3 cases in the control group and 2 cases in the study group dropped out during treatment. Finally, 47 cases in the control group and 48 cases in the study group were included respectively. After treatment, the level of malondialdehyde in the study group was significantly lower than that in the control group, while superoxide dismutase and glutathione peroxidase were significantly higher than those in the control group （P<0.05）; the Kelch-like ECH-associated protein 1 （Keap1） mRNA in the study group was significantly higher than that in the control group, while nuclear factor E2 related factor （Nrf2） and antioxidant response element （ARE）mRNA were significantly lower than those in the control group （P<0.05）. The levels of CRP and LDL in the study group were significantly lower than those in the control group （P<0.05）. The National Institutes of Health Stroke Scale score and the levels of myelin basic protein, neuron-specific enolase, and S100 calcium binding protein B in the study group were significantly lower than those in the control group （P<0.05）. The total effective rate of treatment in the study group was significantly higher than that in the control group （96% vs. 81%, P<0.05）, with no statistically significant difference in the total incidence of adverse reactions between the two groups （6% vs. 8%, P>0.05）.

CONCLUSION

Butylphthalide is effective in the treatment of patients with acute cerebral infarction, which may inhibit oxidative stress and relieve neurological damage through affecting the Keap1-Nrf2/ARE signaling pathway, and also has the advantage of regulating lipid metabolism abnormalities and reducing inflammation in the body.

butylphthalide  /  cerebral infarction  /  treatment outcome  /  neurological function  /  oxidative stress
王鹏, 邹荣成, 黄健康, 文洪波, 丁洁, 汪捷, 舒永伟, 缪家立. 丁苯酞对急性脑梗死患者氧化应激指标及其信号通路相关因子水平的影响. 中国新药与临床杂志, 2024 , 43 (3) : 201 -206 . DOI: 10.14109/j.cnki.xyylc.2024.03.08
Peng WANG, Rong-cheng ZOU, Jian-kang HUANG, Hong-bo WEN, Jie DING, Jie WANG, Yong-wei SHU, Jia-li MIAO. Effect of butylphthalide on oxidative stress indexes and its signaling pathway related factors in patients with acute cerebral infarction[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (3) : 201 -206 . DOI: 10.14109/j.cnki.xyylc.2024.03.08
正文
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急性脑梗死为脑组织血液供应突然中断所致脑组织坏死，其主要因血栓、动脉粥样硬化所致管腔狭窄或者闭塞导致，患者发病后会出现半身不遂、头痛以及眩晕等症状，严重影响患者生命健康以及正常生活[1,2]。近期由于我国人口老龄化趋势加剧，急性脑梗死发病率年增长率为8.7%，而40岁以上患者残疾率甚至达到了16.23%，严重增加患者家庭及社会负担[3]。研究显示急性脑梗死患者因大脑供血不足导致脑组织部分位置缺血坏死，进而出现神经功能障碍，致残率较高[4]。临床医师认为，脑梗死患者的重要治疗目标之一是减少缺血对患者神经功能的损伤，进而减少急性脑梗死病情对于患者生活的影响。丁苯酞（butylphthalide）是我国研制生产的用于治疗脑梗死的Ⅰ类化学新药，可以有效改善急性脑梗死患者梗死病灶微循环，改善梗死位置侧支血管血流情况，从而改善患者病情[5,6]。丁苯酞用于治疗急性脑梗死可以减轻患者神经功能损伤，抑制患者体内氧化应激情况，但是其具体作用机制尚不明确。本研究旨在探讨丁苯酞用于急性脑梗死临床治疗时对患者的氧化应激指标及其相关信号通路的影响，以期为临床合理用药提供依据。
资料和方法
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病例选择与分组
以本院2020年8月至2021年4月期间收治的急性脑梗死患者作为研究对象。纳入标准：（1）急性脑梗死患者病情依据《中国急性缺血性脑卒中诊治指南2018》[7]中标准进行诊断；（2）发病至入院时间为2~36 h；（3）影像学检查如MR或者CT证实患者病情；（4）患者精神意识正常，可以配合研究中治疗以及检查；（5）患者及其家属对研究知情同意。排除标准：（1）患者存在肝脏、心脏等器官功能障碍；（2）影像学检查显示患者存在明显脑出血症状；（3）并发肿瘤或者严重感染者；（4）入组前即已采用其他方式进行治疗；（5）对研究中用药过敏者。共入组100例患者，以分层区组随机化方法分为研究组和对照组各50例。研究符合《赫尔辛基宣言》中对应伦理学标准，经溧水区人民医院伦理委员会审核批准。
治疗方法
对照组采用常规方式进行治疗，患者入院后完成基本检查后参照《中国急性缺血性脑卒中诊治指南2018》中标准进行治疗，同时进行营养神经、血压控制、调脂、稳定斑块、纠正水电解质紊乱以及双联抗血小板聚集治疗，对于存在有高血压、高血脂以及糖尿病的患者需要对应予以降压、调脂以及降血糖治疗，发病至入院时间低于6 h且符合介入治疗适应证的患者接受介入治疗。研究组在对照组的治疗基础上静脉滴注丁苯酞氯化钠注射液（石药集团恩必普药业有限公司，批准文号为国药准字H20100041，规格为100 mL：25 mg）100 mL，每日2次，连续用药14 d后评估治疗效果。
观察指标
1　一般资料
采集患者临床资料，包括性别、年龄、发病至入院时间、合并基础疾病、临床表现、梗死位置、脑梗死体积、既往用药史、治疗前血压、MR示血流灌注。患者MR脑部成像扫描，使用西门子3.0T Trio Tim MR仪扫描全脑，先行常规扫描，注射造影剂后再次扫描，将原始图像传送到工作站进行定性分析。低灌注：造影剂可通过血管堵塞部位，但不能充盈远端血管；中灌注：造影剂可通过血管堵塞部位，可以部分充盈远端血管；高灌注：远端血管充盈速度与近端血管充盈速度相同。
2　临床疗效[8]
治疗前（治疗前1 d）和治疗后（治疗结束后1 d）采用美国国立卫生研究院卒中量表（NIHSS）[9]进行评价，对患者意识水平、构音障碍、面瘫、共济失调、忽视症、凝视、上肢运动、感觉、视野、下肢运动、语言等方面神经功能进行评分，总分为42分，评分越高显示患者神经功能障碍越严重。依据NIHSS评分变化[NIHSS评分变化率=（治疗前评分-治疗后评分）/治疗前评分×100%]以及症状改善情况评估患者治疗效果：病愈为患者肢体麻木、头晕等相关症状完全消失，NIHSS评分下降超过90%；显效为患者肢体麻木、头晕等相关症状改善，NIHSS评分下降超过45%；有效为患者肢体麻木、头晕等相关症状改善，NIHSS评分下降超过17%；无效为患者症状未改善甚至出现加重。总有效率=（病愈+显效+有效）/总例数×100%。
3　神经损伤标志物测定
严格按照试剂盒说明书，采用酶联免疫吸附法检测患者空腹静脉血中髓鞘碱性蛋白（myelin basic protein，MBP）、神经元特异性烯醇化酶（neuron specific enolase，NSE）、S100钙结合蛋白B（S100B）水平。MBP试剂盒由武汉伊莱瑞特生物科技股份有限公司提供（批号：E-EL-H0161c），NSE、S100B试剂盒由艾博抗（上海）贸易有限公司提供（批号：ab217778、ab234573）。
4　氧化应激等指标的测定
严格按照试剂盒说明书，采用比色法检测患者血清丙二醛（MDA）、超氧化物歧化酶（SOD）和谷胱甘肽过氧化物酶（GSH-Px）水平，试剂盒由生工生物工程（上海）股份有限公司提供（批号：D799761-0050、D799593-0050、D799617-0050）；采用酶联免疫吸附法测定C反应蛋白（CRP）和低密度脂蛋白（LDL）水平，试剂盒分别由贝克曼库尔特（美国）股份有限公司（批号：2423）和贝克曼库尔特实验系统（苏州）有限公司（批号：AUZ1650）提供。
5　氧化应激相关信号通路指标测定
收集患者晨间空腹静脉血，应用RNAprep Pure血液总RNA抽提试剂盒[天根生化科技（北京）有限公司，货号：DP443]进行总RNA抽提，应用Premix型反转录试剂盒[宝日医生物技术（北京）有限公司，货号：DP443]进行反转录，依据目标基因信使RNA情况进行探针以及引物设计。在美国国家生物技术信息中心（NCBI）网站查找基因核酸序列，在Pick Primers模块中设计引物，并验证引物特异性，在生工生物工程（上海）股份有限公司进行引物合成。参照设计完成引物模板进行扩增反应，扩增反应应用实时荧光定量PCR（RT-qPCR）法，试剂盒由赛默飞世尔科技中国有限公司提供，货号为11732020，在LightCycler480型号PCR仪（瑞士罗氏公司）上检测氧化应激相关信号通路指标Kelch样ECH相关蛋白1（Kelch-like ECH-associated protein 1，Keap1）、核因子E2相关因子（NF-E2-related factor 2，Nrf2）、抗氧化反应元件（antioxidant response element，ARE）。Keap1上游引物（5'-3'）：CAAGGCCATGTTCACCAACG，下游引物（3'-5'）：GCAACTCCACACAGCCAATC；Nrf2上游引物（5'-3'）：AACCAGTGGATCTGCCAACTACTC，下游引物（3'-5'）：CTGCGCCAAAAGCTGCAT；ARE上游引物（5'-3'）：TCGACTAGCTTGGAAATG，下游引物（3'-5'）：GTGACAAAGCAACTTTG。以β-actin为内参，β-actin上游引物（5'-3'）：CCTAAGGCCAACCGTGAA，下游引物（3'-5'）：CTAGCAGCCAGGGCAGTAATC。qRT-PCR反应条件：95 ℃预变性5 min，95 ℃变性20 s，55~60 ℃退火20 s，72 ℃延伸30s，40个循环，依据反应曲线获得Keapl、Nrf2以及ARE mRNA水平。
6　用药安全性
记录治疗期间患者低血压、腹泻、肝肾功能异常、皮疹等相关不良反应发生情况。
统计学分析
采用SPSS 20.0软件进行分析，计量资料以均数±标准差（$\bar{x}\pm s$）表示，组间比较采用t检验；计数资料以例（%）表示，组间比较采用χ2检验。以P<0.05为差异有显著意义。
结果
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一般资料
治疗期间对照组脱落3例，研究组脱落2例，最终分别入组47例和48例。2组患者一般资料比较无显著差异（P>0.05），组间具有可比性，见表1。
临床疗效
研究组患者治疗总有效率高于对照组，组间具有显著差异（96% vs. 81%，P<0.05），见表2。
神经功能缺损评分及神经损伤标志物水平
2组患者治疗后NIHSS评分和MBP、NSE、S100B水平均低于治疗前，差异具有显著意义（P<0.05）；研究组患者上述指标治疗后均显著低于对照组（P<0.05），见表3。
氧化应激指标和CRP、LDL水平
2组患者治疗后MDA、SOD、GSH-Px水平均较治疗前显著改善（P<0.05）；研究组患者治疗后MDA低于对照组，SOD和GSH-Px高于对照组，差异均具有显著意义（P<0.05）。2组患者治疗后CRP、LDL水平显著低于治疗前（P<0.05），研究组患者治疗后CRP、LDL水平显著低于对照组（P<0.05）。见表4。
氧化应激相关信号通路指标
2组患者治疗后Keap1 mRNA高于治疗前，Nrf2 mRNA、ARE mRNA低于治疗前，差异具有显著意义（P<0.05）；研究组患者治疗后Keap1 mRNA显著高于对照组，Nrf2 mRNA、ARE mRNA显著低于对照组（P<0.05），见表5。
安全性
用药期间研究组发生低血压2例、皮疹1例，对照组发生腹泻2例、肝肾功能异常1例、皮疹1例，总不良反应发生率组间比较无显著差异（6% vs. 8%,P>0.05）。
讨论
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当前临床针对脑梗死的治疗仍以及时恢复局部血流灌注、减轻神经功能缺损、改善神经功能、降低病死病残率为目的。丁苯酞在急性脑梗死患者中临床获益相对明确。本研究中研究组患者治疗后总有效率显著高于对照组（96% vs. 81%），表明丁苯酞用药方案治疗效果优于对照组；研究组治疗后MBP、NSE、S100B水平均低于对照组，提示丁苯酞可减少神经损伤因子水平。分析机制，可能因为丁苯酞可抑制梗死位置半暗带神经细胞中Caspase-3表达，减少神经元细胞凋亡，从而减少神经损伤因子释放，发挥神经功能保护作用[10，11]。陈宗胜等[12]的研究也显示急性缺血性卒中患者采用丁苯酞联合丹参川芎嗪治疗可以经由促进微循环重建，保护线粒体功能，改善患者神经功能，与本研究结论相似。但现阶段丁苯酞对急性脑梗死患者的作用机制仍有探究空间。
研究指出，急性脑梗死患者侧支循环开放，诱使损伤脑组织出现缺血再灌注，导致机体自由基大量释放，使脑细胞膜脂质氧化异常，进一步加重脑组织结构损伤以及微循环障碍，因此，减轻急性脑梗死后氧化应激对于改善患者神经功能障碍至关重要[13]。目前关于丁苯酞治疗急性脑梗死对氧化应激反应的影响报道较多，但较少有临床研究进一步从氧化应激信号通路深入分析。LIU等[14]的动物实验证实丁苯酞通过调节Akt/Nrf2或Nrf2/ARE信号通路抑制氧化应激反应。在小鼠脑外伤后1 h腹腔注射丁苯酞，发现丁苯酞不仅可以显著改善神经功能缺损、脑含水量和皮质神经元凋亡，还能使MDA、SOD、GSH-Px活性均恢复正常，认为丁苯酞显著促进Nrf2蛋白从细胞质向细胞核的易位，增加Nrf2/ARE通路相关下游因子表达，阻止SOD、GSH-Px等抗氧化酶活性下降。因此本研究在比较2组氧化应激指标基础上对Nrf2/ARE通路相关下游因子水平进行比较。研究结果显示，研究组患者治疗后MDA水平低于对照组，SOD和GSH-Px高于对照组，说明联合丁苯酞治疗急性脑梗死可有效改善机体氧化应激水平，这与既往报道结论[15,16]相似。同时，研究组治疗后Keap1 mRNA明显高于对照组，Nrf2、ARE mRNA明显低于对照组，或可表明注射丁苯酞后Keap1-Nrf2/ARE信号通路激活，机体激烈氧化应激被抑制。在张立攀等[17]的研究中，急性脑梗死患者采用丁苯酚软胶囊以及脑蛋白水解物治疗，经由Keap1-Nrf2/ARE信号通路抑制了患者体内的氧化应激，与本研究结果相似，均提示丁苯酞可能经由调节Keap1-Nrf2/ARE信号通路，促进氧自由基清除，抑制氧自由基形成，进而保护脑神经功能。
血栓形成或者动脉粥样硬化栓塞是导致急性脑梗死发生的重要原因，而血清CRP与LDL均为评估血栓形成或者动脉粥样硬化栓塞的重要指标[18,19]。国内一项研究显示，丁苯酞可以经由调节机体CRP、LDL水平，改善脑血流速度，上调脑血流量，进而纠正患者神经功能障碍，改善患者预后[20]。本研究中研究组患者治疗后CRP、LDL水平明显低于对照组，显示治疗后患者体内炎症反应减轻，丁苯酞可减轻脑组织炎症、缓解血管内皮损伤、调节脂质代谢异常、改善缺血脑区的微循环和血流量，进而发挥抗炎、调脂、抗脑缺血作用。急性脑梗死患者病情迅速进展，患者缺血脑组织神经元在短时间内出现不可逆损伤，这种损伤不仅会导致患者神经功能障碍，还会导致其后残疾发生，是影响患者生活质量的重要原因。有研究显示丁苯酞可以发挥改善脑循环、减轻炎症反应、促进患者损伤神经功能恢复的作用[21,22]。本试验还显示2组总不良反应发生率比较无显著差异，表明急性脑梗死患者采用丁苯酚治疗并未明显增加不良反应，安全性良好。
综上，丁苯酞对急性脑梗死患者的临床疗效确切，可以显著改善患者神经功能缺损，降低神经损伤因子水平，可能与丁苯酞通过Keap1-Nrf2/ARE信号通路抑制机体氧化应激反应有关；另，丁苯酞注射液在调节脂代谢异常、减轻机体炎症上的优势也更显著。本研究存在不足之处，样本量较小，指标选择代表性不够，研究结果可能存在偏倚，未来将增加样本量、考虑更多的变量、改进数据质量控制来验证结果并进一步深入研究。
基金
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  • 2021年度院引进人才科研启动基金项目(2021YJ09)
文献
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参考文献 引证文献
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2024年第43卷第3期
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文章信息
doi: 10.14109/j.cnki.xyylc.2024.03.08
  • 接收时间：2022-09-13
  • 首发时间：2026-03-13
  • 出版时间：2024-03-25
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  • 收稿日期：2022-09-13
  • 录用日期：2023-11-29
基金
2021年度院引进人才科研启动基金项目(2021YJ09)
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    溧水区人民医院　神经内科，江苏　南京　210000

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丁洁
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https://castjournals.cast.org.cn/joweb/zgxyylczz/CN/10.14109/j.cnki.xyylc.2024.03.08
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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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