复方曲肽注射液治疗急性缺血性脑卒中400例:多中心回顾性研究  

Treatment of 400 cases of acute ischemic stroke with compound troxerutin and poreine cerebroside injection: A multi-center retrospective study

作　　者：刘莹[1] 于生元[2] 顾平[3] 田军彪[4] 贾延劼[5] 姜新[6] 胡风云[7] 何志义[8] 杜怡峰[9] 张祥建[1] LIU Ying;YU Shengyuan;GU Ping;TIAN Junbiao;JIA Yanjie;JIANG Xin;HU Fengyun;HE Zhiyi;DU Yifeng;ZHANG Xiangjian(The Second Hospital of Hebei Medical University,Shijiazhuang 050004,Hebei,China;The General Hospital of The Chinese People’s Liberation Army,Beijing 100853,China;The First Hospital of Hebei Medical University,Shijiazhuang 050030,Hebei,China;The Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050013,Hebei,China;The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,Henan,China;Liaoning Provincial People’s Hospital,Shenyang 110016,Liaoning,China;Shanxi Provincial People’s Hospital,Taiyuan 030012,Shanri,China;First Affiliated Hospital of China Medical University,Shenyang 110001,Liaoning,China;Shandong Provincial Hospital,Jinan 250021,Shandong,China)

机构地区：[1]河北医科大学第二医院,河北石家庄050004 [2]中国人民解放军总医院,北京100853 [3]河北医科大学第一医院,河北石家庄050030 [4]河北省中医院,河北石家庄050013 [5]郑州大学第一附属医院,河南郑州450052 [6]辽宁省人民医院,辽宁沈阳110016 [7]山西省人民医院,山西太原030012 [8]中国医科大学附属第一医院,辽宁沈阳110001 [9]山东省立医院,山东济南250021

出　　处：《武汉大学学报（医学版）》2022年第5期781-786,792,共7页Medical Journal of Wuhan University

基　　金：国家自然科学基金资助项目(编号:81974184)。

摘　　要：目的:评价复方曲肽注射液治疗急性缺血性脑卒中(IS)的安全性和有效性。方法:选择2017年11月至2018年11月河北医科大学附属第二医院等9家医院收治的急性IS患者400例为研究对象,在常规治疗的基础上,根据合并用药不同分为试验组203例(复方曲肽注射液+常规治疗),对照组85例(其他神经节苷脂类药物+常规治疗)及空白组112例(常规治疗)。观察治疗前后各组的美国国立卫生研究院脑卒中量表(NIHSS)评分及改良Rankin量表(mRS)评估结果,根据NIHSS评分改变情况评估疗效。将试验涉及的其他药物作为疗效判定的混杂因素,采用倾向性评分法对其进行控制,并对试验结果进一步分析。结果:治疗后,试验组、对照组和空白组的显效率分别为84.24%、48.24%和12.50%,有效率分别为92.61%、57.65%和33.04%,组间差异均有统计学意义(均P<0.05)。各组治疗后NIHSS评分相较基线降低的程度从高到低排序为试验组、对照组和空白组,组间差异有统计学意义(P<0.05)。经倾向指数评分后,试验组和对照组最终各获得53例匹配病例,试验组和空白组最终各获得96例匹配病例。再进行组间两两比较。试验组和对照组总有效率和显效率分别为86.79%vs 52.83%(P<0.05),73.58%vs 44.17%(P<0.05)。试验组NIHSS评分相对于基线下降3(15,1),对照组降低1(12,0),差异有统计学意义(P<0.05)。倾向指数评分后,试验组和空白组总有效率和显效率分别为91.67%vs 31.25%(P<0.05)、83.33%vs 10.42%(P<0.05)。试验组NIHSS评分相对于基线降低5(15,1),空白组降低0(6,0),差异有统计学意义(P<0.05)。与对照组和空白组比,试验组有更多比例的患者Rankin分值分布于完全无症状-轻度残疾区间。三组的不良事件发生率组间差异无统计学意义(P>0.05),未观察到严重不良事件。结论:复方曲肽注射液治疗急性IS安全、有效。Objective: To retrospectively assess the efficacy and safety of compound troxerutin and poreine cerebroside(CTPC)injection on the ischemic stroke. Methods: This retrospective study identified a total of 400 patients presenting with acute ischemic stroke from November 2017 to November 2018from nine general hospitals in China. In addition to routine treatment, all selected patients grouped into 3 groups according to the neuroprotective agents they received as following: a CTPC treatment group, a control group in which the patients received the other ganglioside agents, and a blank control group in which the patients received other neuroprotective agents that do not contain ganglioside ingredients. All patients were evauated with acute National Institute of Health Neurologic Impairment Score(NIHSS) and the modified Rankin scale(mRS) before treatment. The efficacy was evaluated by NIHSS scores at Day 14 and the mRS at Day 28 post-treatment. Adverse events were also analyzed among the three groups. In order to control for confounding factors of concomitant medications and routine treatment agents, the outcomes were further compared among the three groups by using the propensity score matching method. Results: After treatment with CTPC injections or the other ganglioside agents, the NIHSS scores at day 14 showed statistical differences as compared with those in the blank control group(P<0. 05). The improvements of NIHSS scores in the CTPC treatment group and control group were higher than those in the blank control group on Day 14(P<0. 05). To compare the effects of CTPC injections and the other ganglioside agents, the improvements of NIHSS in the CTPC treatment group were higher than in control group(treatment of the other ganglioside agents)(P<0. 05). A statistically significant difference in the 28-day mRS scores was not observed among the three groups(P>0. 05). By using the propensity score matching method, compared with that in the control group and the blank group, Rankin scoring results showed that more cases we

关 键 词：复方曲肽注射液 缺血性脑卒中 倾向性评分 NIHSS 

分 类 号：R743.3[医药卫生—神经病学与精神病学]