Page 85 - 《中国药房》2023年16期

复方脑肽节苷脂注射液治疗缺血性脑卒中的上市后安全性研究

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韩冠英 ，马冰洁 ，王 雨 ，陈 超 ，金蜀蓉 ，苍爱军 （1. 锦州医科大学附属第一医院药学部，辽宁 锦州
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121000；2.辽宁省人民医院药学部，沈阳 110016；3.重庆市人民医院药剂科，重庆 401147）
中图分类号 R969.3；R743 文献标志码 A 文章编号 1001-0408（2023）16-1995-04
DOI 10.6039/j.issn.1001-0408.2023.16.14
摘 要 目的 评价复方脑肽节苷脂注射液用于缺血性脑卒中患者的上市后安全性。方法 采用药源性、前瞻性、非对照的临床研
究设计方法，以全国46家二级甲等及以上医疗机构2020年4月－2021年5月收治的至少接受1次复方脑肽节苷脂注射液治疗的
缺血性脑卒中患者为监测对象，分析其基本情况、用药信息和不良反应发生情况。结果 13 514例缺血性脑卒中患者用药期间的
不良事件发生率为10.01%，其中复方脑肽节苷脂注射液相关不良反应的发生率为0.33%；药物相关不良反应均为轻度或中度，集
中在胃肠系统（18 例）、皮肤及皮下组织（10 例）、神经系统（7 例）等系统/器官，以便秘、腹痛、腹泻、皮疹、瘙痒、头晕等症状为主。
大部分患者（91.03%）用药后痊愈或好转，2例患者死亡；45例发生了不良反应的患者中，84.44%的患者在停药或对症治疗后痊愈
或好转，15.56%的患者无明显变化。三级医院患者的不良反应发生率显著高于二级医院患者，有过敏史患者的不良反应发生率
显著高于没有过敏史的患者（P＜0.05）。有2.76%的患者存在不合理用药情况，其不良反应发生率（2.95%）显著高于不存在不合
理用药的患者（0.26%，P＜0.05）。结论 缺血性脑卒中患者接受复方脑肽节苷脂注射液治疗后的不良反应症状较为常见，其发生
率总体较低，且与患者体质和是否规范用药等因素有关。
关键词 复方脑肽节苷脂注射液；缺血性脑卒中；不良反应；上市后安全性再评价

Study on post-marketing safety of Compound porcine cerebroside and ganglioside injection in the
treatment of ischemic stroke
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HAN Guanying ，MA Bingjie ，WANG Yu ，CHEN Chao ，JIN Shurong ，CANG Aijun（1. Dept. of Pharmacy， the
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First Affiliated Hospital of Jinzhou Medical University， Liaoning Jinzhou 121000， China；2. Dept. of Pharmacy，
the People’s Hospital of Liaoning Province， Shenyang 110016， China；3. Dept. of Pharmacy， Chongqing
General Hospital， Chongqing 401147， China）
ABSTRACT OBJECTIVE To evaluate the post-marketing safety of Compound porcine cerebroside and ganglioside injection in
patients with ischemic stroke. METHODS A drug-induced， prospective， non-controlled clinical study design was conducted. Using
the patients with ischemic stroke who received Compound porcine cerebroside and ganglioside injection at least once in 46
secondary class A and above medical institutions across the country from April 2020 to May 2021 as the monitoring objects， and
their basic data， medication information and the occurrence of adverse drug reactions were analyzed. RESULTS Among 13 514
patients with ischemic stroke， the incidence of adverse events was 10.01%， and the incidence of adverse reactions related to
Compound porcine cerebroside and ganglioside injection was 0.33%. Drug-related adverse drug reactions were mild or moderate，
concentrated in the gastrointestinal system （18 cases）， skin and subcutaneous tissue （10 cases）， nervous system （7 cases） and
other systems/organs， mainly including constipation， abdominal pain， diarrhea， rash， pruritus， dizziness and other symptoms. Most
of the patients （91.03%） recovered or improved after treatment， and 2 patients died. Among the 45 patients with adverse drug
reactions， 84.44% were cured or improved after drug withdrawal or symptomatic treatment， and 15.56% had no significant change.
The incidence of adverse drug reactions in tertiary hospitals was significantly higher than that in secondary hospitals， and the
incidence of adverse drug reactions in patients with allergic history was significantly higher than that in patients without allergic
history （P＜0.05）. Irrational drug use was found in 2.76% of patients， and the incidence of adverse drug reactions（2.95%） was
significantly higher than that in patients without irrational drug use（0.26%，P＜0.05）. CONCLUSIONS The adverse drug reaction
symptoms of ischemic stroke patients treated with Compound porcine cerebroside and ganglioside injection are relatively common，
the incidence rate is generally low， and it is related to the patients’ physique and whether the drug use is standardized.
KEYWORDS Compound porcine cerebroside and ganglio-
＊第一作者 教授，博士。研究方向：临床药学、多糖类药物。电
side injection； ischemic stroke； adverse drug reactions； post-
话：0416-4145198。E-mail：hgy19800223@163.com
# 通信作者 主任药师。研究方向：临床药学、药事管理。电话： marketing safety reevaluation
024-24016113。E-mail：cang1463@126.com

中国药房 2023年第34卷第16期 China Pharmacy 2023 Vol. 34 No. 16 · 1995 ·