長(zhǎng)春西汀不同給藥途徑治療破裂顱內(nèi)動(dòng)脈瘤栓塞術(shù)并發(fā)腦血管痙攣的療效及安全性對(duì)比研究

杜延平，李樂軍，時(shí)忠華，梁建廣，吳春富

(南京中醫(yī)藥大學(xué)無錫附屬醫(yī)院 1.神經(jīng)外科， 2.神經(jīng)內(nèi)科，江蘇 無錫 214000;3.無錫市解放軍101醫(yī)院神經(jīng)外科，江蘇 無錫 214008)

長(zhǎng)春西汀不同給藥途徑治療破裂顱內(nèi)動(dòng)脈瘤栓塞術(shù)并發(fā)腦血管痙攣的療效及安全性對(duì)比研究

杜延平1，李樂軍2，時(shí)忠華3，梁建廣1，吳春富1

(南京中醫(yī)藥大學(xué)無錫附屬醫(yī)院 1.神經(jīng)外科， 2.神經(jīng)內(nèi)科，江蘇 無錫 214000;3.無錫市解放軍101醫(yī)院神經(jīng)外科，江蘇 無錫 214008)

目的 探討經(jīng)靜脈滴注與經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療破裂顱內(nèi)動(dòng)脈瘤栓塞術(shù)并發(fā)腦血管痙攣(cerebral vascular spasm，CVS)的效果及安全性。方法 選取行顱內(nèi)動(dòng)脈瘤栓塞術(shù)中發(fā)生CVS的動(dòng)脈瘤性蛛網(wǎng)膜下腔出血(aneurysmal subarachnoid hemorrhage，aSAH)患者共105例為研究對(duì)象，隨機(jī)分為A組、B組和C組，每組35例。C組給予3H治療，B組在C組基礎(chǔ)上聯(lián)合靜脈泵注長(zhǎng)春西汀，A組在C組基礎(chǔ)上聯(lián)合經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀。比較各組大腦中動(dòng)脈(middle cerebral artery，MCA)血流速度、美國(guó)國(guó)立衛(wèi)生院卒中量表(National Institutes of Health stroke scale, NIHSS)評(píng)分、格拉斯哥預(yù)后(Glasgow outcome scale，GOS)分級(jí)、臨床療效、低血壓發(fā)生率及再出血發(fā)生率。結(jié)果 治療后7、14 d，A組和B組MCA血流速度較C組明顯降低(P<0.05)，且A組低于B組。治療后d 28，A組、B組NIHSS評(píng)分較C組明顯降低(P<0.05)，且A組低于B組(P<0.05)。 A組、B組治療有效率明顯高于C組(P<0.05)，且A組高于B組(P<0.05)。治療后28 d，B組低血壓發(fā)生率明顯高于A組和C組(P<0.05)，但C組和A組間比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)；3組再出血率比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)。治療后3個(gè)月，A組、B組GOS分級(jí)明顯優(yōu)于C組(P<0.05)，且A組優(yōu)于B組(P<0.05)。結(jié)論 經(jīng)靜脈泵注和經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀均可有效治療顱內(nèi)動(dòng)脈瘤栓塞術(shù)中CVS，但經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀具有更好的效果和安全性。

長(zhǎng)春西汀；腦血管痙攣；顱內(nèi)動(dòng)脈瘤；動(dòng)脈瘤性蛛網(wǎng)膜下腔出血；經(jīng)導(dǎo)引導(dǎo)管注入；3H療法

顱內(nèi)動(dòng)脈瘤破裂是誘發(fā)動(dòng)脈瘤性蛛網(wǎng)膜下腔出血(aneurysmal subarachnoid hemorrhage，aSAH)的主要原因[1]。血管內(nèi)栓塞術(shù)是治療顱內(nèi)動(dòng)脈瘤的主要方法，具有創(chuàng)傷小、恢復(fù)快、療效確切等優(yōu)點(diǎn)[2]。但值得注意的是，顱內(nèi)動(dòng)脈瘤栓塞術(shù)中易發(fā)生腦血管痙攣(cerebral vascular spasm，CVS)等并發(fā)癥，且以aSAH者發(fā)生率最高，約為70%，其中50%為癥狀性CVS，是顱內(nèi)動(dòng)脈瘤患者致死、致殘的重要原因[3]。如何防治CVS是臨床亟待解決的重點(diǎn)及難點(diǎn)問題[4]。長(zhǎng)春西汀是從夾竹桃科小蔓長(zhǎng)春花中提取的一種天然藥物，具有腦血管擴(kuò)張作用。臨床實(shí)踐表明，長(zhǎng)春西汀可有效防治CVS，但其療效、安全性及用藥途徑選擇仍缺乏循征醫(yī)學(xué)證據(jù)支持。本研究旨在對(duì)比經(jīng)靜脈滴注與經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療顱內(nèi)動(dòng)脈瘤栓塞術(shù)中CVS的療效及安全性，以期為臨床提供依據(jù)。

1 資料與方法

1.1 一般資料 選取2014年4月至2016年4月南京中醫(yī)藥大學(xué)無錫附屬醫(yī)院及無錫市解放軍101醫(yī)院收治105例顱內(nèi)動(dòng)脈瘤栓塞術(shù)(規(guī)范操作)時(shí)發(fā)生CVS的aSAH患者為研究對(duì)象。CVS診斷標(biāo)準(zhǔn)[5]：① aSAH治療后癥狀波動(dòng)或進(jìn)行性加重；② 出現(xiàn)神經(jīng)系統(tǒng)局灶體征；③ 意識(shí)由清醒轉(zhuǎn)為嗜睡或昏迷；④ TCD示大腦中動(dòng)脈(middle cerebral artery，MCA)及大腦前動(dòng)脈(anterior cerebral artery，ACA)≥120 cm·s-1，大腦后動(dòng)脈(posterior cerebral artery，PCA)血流速度≥90 cm·s-1；⑤ 排除再出血、急性腦積水、顱內(nèi)血腫及電解質(zhì)紊亂。納入標(biāo)準(zhǔn)：① CT明確SAH，且為首次發(fā)作；② 符合CVS診斷標(biāo)準(zhǔn)。排除標(biāo)準(zhǔn)：① 合并血液系統(tǒng)疾??；② 血壓<90/60 mmHg；③ 對(duì)受試藥物不耐受者。按隨機(jī)數(shù)字表法將入組患者分為3組，即A組、B組和C組，每組35例。A組男性22例，女性13例；年齡36～72歲，平均(46.1±12.5)歲；Hunt-Hess分級(jí)：Ⅰ級(jí)3例，Ⅱ級(jí)5例，Ⅲ級(jí)12例，Ⅳ級(jí)15例。B組男性19例，女性16例；年齡34～75歲，平均(47.3±13.1)歲；Hunt-Hess分級(jí)：Ⅰ級(jí)2例，Ⅱ級(jí)4例，Ⅲ級(jí)13例，Ⅳ級(jí)16例。C組男性21例，女性14例；年齡32～77歲，平均(47.5±11.8)歲；Hunt-Hess分級(jí)：Ⅰ級(jí)2例，Ⅱ級(jí)5例，Ⅲ級(jí)14例，Ⅳ級(jí)14例。3組性別、年齡、Hunt-Hess分級(jí)比較差異無顯著性(P>0.05)，具有可比性。

1.2 方法 C組給予傳統(tǒng)3H療法，即擴(kuò)充血容量、升高血壓、稀釋血液。B組在C組基礎(chǔ)上加用長(zhǎng)春西汀注射液(河南潤(rùn)弘制藥股份有限公司；批號(hào)：國(guó)藥準(zhǔn)字H200110467；規(guī)格：2 mL ∶10 mg)持續(xù)微泵靜脈注射(30 mg·d-1)。A組在C組基礎(chǔ)上加用經(jīng)導(dǎo)引導(dǎo)管持續(xù)注入長(zhǎng)春西汀，即退出導(dǎo)絲撤除機(jī)械刺激后，經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀(河南潤(rùn)弘制藥股份有限公司；批號(hào)：國(guó)藥準(zhǔn)字H200110467；規(guī)格： 2 mL ∶10 mg)5 mL。

1.3 觀察指標(biāo)

1.3.1 MCA血流速度 分別于治療前及治療后7、14 d，采用TCD監(jiān)測(cè)雙側(cè)MCA血流速度，取樣深度為大腦MCA 50～60 mm。

1.3.2 神經(jīng)功能 分別于治療前及治療后28 d，采用美國(guó)國(guó)立衛(wèi)生院卒中量表(national institutes of health stroke scale, NIHSS)評(píng)價(jià)患者神經(jīng)功能缺損程度，評(píng)分越低則神經(jīng)功能缺損越少。

1.3.3 GOS分級(jí)[6]于治療后3個(gè)月，采用格拉斯哥預(yù)后(Glasgow outcome scale，GOS)分級(jí)評(píng)價(jià)預(yù)后。Ⅰ級(jí)：死亡；Ⅱ級(jí)：植物生存；Ⅲ級(jí)：重度殘疾，需他人照顧；Ⅳ級(jí)：中度殘疾，生活可自理；Ⅴ級(jí)：恢復(fù)良好，可正常工作、生活。

1.3.4 臨床療效[7]顯效：臨床癥狀、體征完全消失，影像學(xué)檢查未見新發(fā)病灶，Hunt-Hess分級(jí)≥Ⅱ級(jí)；有效：臨床癥狀、體征明顯改善，影像學(xué)檢查未見新發(fā)病灶，Hunt-Hess分級(jí)較治療前明顯改善；無效：無改善，甚至惡化者。治療有效率/%=[(顯效+有效)/總例數(shù)]×100%。

1.3.5 并發(fā)癥 統(tǒng)計(jì)患者治療后28 d內(nèi)低血壓及再出血發(fā)生率。

2 結(jié)果

2.1 MCA血流速度 治療前，3組MCA血流速度比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)；治療后，A組、B組MCA血流速度較C組明顯降低(P<0.05)，且A組低于B組(Tab 1)。

2.2 NIHSS評(píng)分 治療前，3組NIHSS評(píng)分比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)；治療后d 28，A組、B組NIHSS評(píng)分較C組明顯降低(P<0.05)，且A組低于B組(P<0.05)，見Tab 2。

Tab 1 The MCA blood flow velocity

GroupBeforetreatmentAftertreatment7d14dC132.6±13.8115.3±6.0100.2±5.8B133.0±17.194.8±5.2*86.2±3.9*A130.5±16.482.6±4.5*#79.6±4.3*#

*P<0.05vsC group；#P<0.05vsB group

GroupBeforetreatmentAftertreatment28dC14.5±4.68.7±1.4B14.4±4.27.9±1.8*A14.9±3.56.2±2.1*#

*P<0.05vsC group；#P<0.05vsB group

2.3 GOS分級(jí) A組、B組GOS分級(jí)明顯優(yōu)于C組(P<0.05)，且A組優(yōu)于B組(P<0.05)，見Tab 3。

Tab 3 The GOS grading of three groups(n=35)

2.4 臨床療效 A組、B組治療有效率明顯高于C組(P<0.05)，且A組高于B組(P<0.05)，見Tab 4。

Tab 4 The clinical efficacy of three groups(n=35)

*P<0.05vsC group；#P<0.05vsB group

2.5 再出血率及低血壓率 B組低血壓發(fā)生率明顯高于A組和C組(P<0.05)，但A組和C組間比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)；3組再出血率比較差異無統(tǒng)計(jì)學(xué)意義(P>0.05)，見Tab 5。

Tab 5 The hypotension rate and rehaemorrhagia rate of three groups(n=35,n/%)

*P<0.05vsC group；#P<0.05vsA group

3 討論

顱內(nèi)動(dòng)脈瘤栓塞術(shù)中CVS的發(fā)生機(jī)制尚未完全明確，目前多認(rèn)為與以下因素有關(guān)：① 術(shù)中引導(dǎo)管、微導(dǎo)管、微導(dǎo)絲等手術(shù)器械及高滲造影劑對(duì)血管壁反復(fù)刺激，造成血管內(nèi)膜損傷，導(dǎo)致血管平滑肌細(xì)胞Ca2+內(nèi)流，達(dá)到平滑肌收縮閥值，繼而引發(fā)血管平滑肌收縮；② aSAH可激活內(nèi)源性凝血系統(tǒng)，誘發(fā)微血栓形成和氧化應(yīng)激，進(jìn)一步加劇血管痙攣。CVS可引起血管閉塞等嚴(yán)重后果，造成腦血流灌注不足，繼而誘發(fā)缺血性神經(jīng)功能障礙，導(dǎo)致預(yù)后不良[8]。因此，防治CVS是提高動(dòng)脈瘤栓塞術(shù)療效、改善臨床預(yù)后的關(guān)鍵環(huán)節(jié)。

長(zhǎng)春西汀是一類吲哚類生物堿，具有較高的脂溶性，易于透過血腦屏障，既往被廣泛應(yīng)用于缺血性腦血管疾病的治療[9]。現(xiàn)代藥理學(xué)研究證實(shí)，長(zhǎng)春西汀具有多種藥理學(xué)活性。首先，長(zhǎng)春西汀可選擇性作用于腦血管系統(tǒng)，抑制腦磷酸二酯酶(phosphodiesterase，PDEs)活性，舒張腦血管平滑肌，增加腦部血流灌注；其次，長(zhǎng)春西汀可改善腦部血流動(dòng)力學(xué)，降低全血黏度，抑制血小板聚集和血栓形成；再者，長(zhǎng)春西汀可直接作用于神經(jīng)元細(xì)胞，阻滯Ca2+離子通路，防止細(xì)胞內(nèi)Ca2+超載所致細(xì)胞損傷；此外，長(zhǎng)春西汀還可刺激神經(jīng)元突觸分泌神經(jīng)遞質(zhì)，減輕神經(jīng)功能損傷，改善認(rèn)知[10-12]。魏忠梅等[13]研究表明，在尼莫地平治療基礎(chǔ)上聯(lián)合長(zhǎng)春西汀靜脈注射可有效緩解aSAH后CVS，其效果優(yōu)于單純尼莫地平治療，提示長(zhǎng)春西汀具有治療CVS的作用。但長(zhǎng)春西汀治療顱內(nèi)動(dòng)脈瘤栓塞術(shù)中CVS的療效及安全性尚缺乏循征醫(yī)學(xué)證據(jù)支持。

MCA流速增高是診斷CVS的重要依據(jù)[14]。本研究結(jié)果顯示，采用靜脈泵注和經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療腦動(dòng)脈瘤栓塞術(shù)中CVS，均可有效降低MCA流速，且有效率均明顯高于傳統(tǒng)3H療法(P<0.05)，但經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療的效果優(yōu)于靜脈泵注(P<0.05)，提示經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀緩解CVS的效果優(yōu)于經(jīng)靜脈泵注。究其原因可能與經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀可使藥物直接作用于痙攣的腦血管部位，提高局部藥物濃度，快速促進(jìn)血管擴(kuò)張，從而緩解血管痙攣有關(guān)。NIHSS評(píng)分可反映患者神經(jīng)功能缺損程度，而GOS分級(jí)則可反映顱腦損傷后預(yù)后情況。通過隨訪發(fā)現(xiàn)，經(jīng)靜脈泵注和經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療者NIHSS評(píng)分及GOS分級(jí)均較3H法治療者明顯改善(P<0.05)，提示長(zhǎng)春西汀2種途徑給藥均可獲得肯定的長(zhǎng)期療效；但經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀治療的長(zhǎng)期療效優(yōu)于靜脈泵注(P<0.05)，分析其原因可能與經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀更快速地緩解血管痙攣、改善腦血流灌注有關(guān)。值得注意的是，短時(shí)大劑量靜脈泵注長(zhǎng)春西汀可引發(fā)低血壓，而經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀并不會(huì)導(dǎo)致低血壓的發(fā)生，其原因可能與該給藥方式作用準(zhǔn)確、用藥量小有關(guān)，提示經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀較靜脈泵注具有較高的安全性。

綜上所述，經(jīng)靜脈滴注和經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀均可有效治療顱內(nèi)動(dòng)脈瘤栓塞術(shù)中CVS，但經(jīng)導(dǎo)引導(dǎo)管注入長(zhǎng)春西汀具有更好的效果和安全性。

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Comparative study on efficacy and safety of different routes for vinpocetine injection by intravenous or trans-angiographic catheter on cerebral vasospasm following embolization of ruptured aneurysm

DU Yan-ping1,LI Le-jun2,SHI Zhong-hua3,LIANG Jian-guang1,WU Chun-fu1

(1.DeptofNerosurgery, 2.DeptofNeurology,theWuxiAffiliatedHospitalofNanjingUniversityofTraditionalChineseMedicine,WuxiJiangsu214000,China; 3.DeptofNeurosurgery,the101stHospitalofPLA,WuxiJiangsu214008,China)

Aim To evaluate the efficacy and safety of different routes for vinpocetine injection by intravenous or trans-angiographic catheter on cerebral vasospasm(CVS).Methods A total of 105 aneurysmal subarachnoid hemorrhage(aSAH)patients with CVS following intracranial aneurysm embolization were chosen and randomly divided into group C, B and A, with 35 cases in each group. Patients in group C were treated with 3H therapeutic regimen, while those in group B and A were with 3H therapeutic regimen plus vinpocetine by intravenous injection or trans-angiographic catheter, respectively. The index including middle cerebral artery(MCA) blood flow velocity, National Institutes of Health stroke scale(NIHSS) score, Glasgow outcome scale(GOS) grading, clinical efficacy, hypotension rate and rehaemorrhagia rate were detected and compared among three groups.Results After the 7 d and 14 d treatment, the MCA blood flow velocity of group A and B was observed to be significantly lower than that of group C(P<0.05), and the MCA blood flow velocity of group A was significantly lower than that of group B(P<0.05). The NIHSS score of group A and B was significantly lower than that of group A(P<0.05), and the score of group A was significantly lower than that of group B(P<0.05) following 28 d treatment. Moreover，the clinical efficacy of group A and B was significantly higher than that of group C(P<0.05), and the clinical efficacy of group A was significantly higher than that of group B(P<0.05). After the 28 d treatment, the hypotension rate of group B was found to be significantly higher than that of group C and A(P<0.05), while there was no statistical difference(P>0.05) observed in the hypotension rate between group A and C. Also, there was no statistical difference(P>0.05)found in the rehaemorrhagia rate among three groups. However, the GOS grading of group A and B was significantly better than that of group C(P<0.05), and the grading of group A was significantly better than that of group B(P<0.05)after 3 months treatment.Conclusions Using vinpocetine by intravascular injection or by trans-angiographic catheter could be the efficient treatment for the CVS after intracranial aneurysm embolization, and vinpocetine injection by trans-angiographic catheter is the better mode of administration with the consideration of efficacy and safety.

vinpocetine; cerebral vasospasm; intracranial aneurysm; aneurysmal subarachnoid hemorrhage; trans-angiographic catheter injection；3H therapy

時(shí)間：2017-5-25 17:44 網(wǎng)絡(luò)出版地址：http://kns.cnki.net/kcms/detail/34.1086.R.20170525.1744.044.html

2017-02-10,

2017-03-13

國(guó)家科技支撐計(jì)劃項(xiàng)目資助(No 2014BAI10B05)

杜延平(1977-)，男，碩士，主治醫(yī)師，研究方向：腦血管病及顱腦創(chuàng)傷，E-mail：duyanping2016d@163.com； 李樂軍(1972-)，男，博士，主任中醫(yī)師,研究方向：中西醫(yī)結(jié)合腦血管病的臨床研究，通訊作者，E-mail：lilejjun999@163.com

10.3969/j.issn.1001-1978.2017.06.022

A

1001-1978(2017)06-0859-04

R452；R743V905；R743.310.5