耿洪娇;谢雁鸣;庄严;
GENG Hong-jiao;XIE Yan-ming;ZHUANG Yan;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;the PLA Navy General Hospital;

• 1:中国中医科学院中医临床基础医学研究所
• 2:中国人民解放军海军总医院

摘要(Abstract)：

该研究对醒脑静注射液真实世界中治疗脑梗死临床应用实际情况分析,选取全国39家医院住院患者的医院信息系统(hospital information system,HIS)数据库,对11 674例脑梗死患者应用醒脑静注射液的信息进行描述性分析及关联规则分析。结果显示,患者平均年龄69.69岁;中医证候痰瘀滞络证最多(37.56%),其次是风痰阻络证(19.01%);虚证占21.06%。静脉滴注是最主要的给药途径(96.50%);静脉滴注单次用药剂量10～20 mL占52.44%,其他超说明书范围的剂量占比较大(47.56%)。连续用药3 d以内最多(55.45%),15～28 d者占6.96%,>28 d者占0.89%。合并应用的西药前10位主要有降压类、抑酸保胃类、改善脑循环类、脑神经保护类、抗感染类药物。中成药前10位主要是活血化瘀类、清热解表类等。关联规则分析得出三类中西药联用的临床用药模式,主要为第一类:醒脑静注射液+硝苯地平(硝苯啶,硝苯吡啶,利心平)+左氧氟沙星+化瘀通脉剂;第二类:醒脑静注射液+奥美拉唑+依达拉奉+化瘀通脉剂;第三类:醒脑静注射液+神经节苷脂类及神经节苷脂衍生物+依达拉奉+化瘀通脉剂。结果表明,醒脑静注射液在临床用于脑梗死治疗中存在多种不规范用药的现象;同时合并用药以指南推荐用药和常规治疗药物为主,体现中西医结合治疗在临床的应用。
To analyzed the actual clinical application of Xingnaojing Injection in treating cerebral infarction in the real world, selected HIS(hospital information system) database of inpatients in 39 hospitals across the country, and conducted descriptive analysis and association rule analysis on the information of 11 674 patients with cerebral infarction using Xingnaojing Injection. The results showed that the average age of the patients was 69.69 years. TCM syndrome of phlegm stasis and collaterals stagnation was the most(37.56%), followed by wind-phlegm obstruction of collaterals(19.01%). Virtual syndrome accounted for 21.06%. Intravenous drip was the most important route of administration(96.50%). Iv infusion single dose of 10-20 mL(52.44%), other off-label doses accounted for a larger proportion(47.56%). Continuous use of the drug within 3 days(55.45%), 15-28 days accounted for 6.96%, >28 days accounted for 0.89%. The top 10 Western drugs used in combination mainly include antihypertensive drugs, acid-suppressing drugs to protect stomach, drugs to improve brain circulation, drugs to protect brain nerves and drugs to fight infection. The top 10 of Chinese patent medicines are mainly activating blood circulation and removing stasis, clearing heat and clearing the surface, etc. According to the analysis of association rules, three types of clinical drug use modes for the combination of Chinese and Western medicine were obtained, mainly including the first type: Xingnaojing Injection+nifedipine(nifedipine, nifedipyridine, Lixinping)+levoflo-xacin+Huayu Tongmai agent. The second category: Xingnaojing Injection+omeprazole+edaravone+Huayu Tongmai agent; The third category: Xingnaojing Injection+ganglioside and ganglioside derivatives+edaravone+Huayu Tongmai agent. The results show that Xingnaojing Injection is not a standard drug in the treatment of cerebral infarction. At the same time, the combined use of drugs is mainly recommended by the guidelines and conventional treatment drugs, reflecting the clinical application of integrated traditional Chinese and Western medicine.

关键词(KeyWords)： 醒脑静注射液;脑梗死;真实世界;合理用药
Xingnaojing Injection;cerebral infarction;real world;rational drug use

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707410)

作者(Author): 耿洪娇;谢雁鸣;庄严;
GENG Hong-jiao;XIE Yan-ming;ZHUANG Yan;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;the PLA Navy General Hospital;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200221.503

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