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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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| 篇名： | 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 |
| TITLE： | Study on post-marketing safety of Compound porcine cerebroside and ganglioside injection in the treatment of ischemic stroke |
| 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13514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。 |
| 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. |
| 期刊： | 2023年第34卷第16期 |
| 作者： | 韩冠英；马冰洁；王雨；陈超；金蜀蓉；苍爱军 |
| AUTHORS： | HAN Guanying，MA Bingjie，WANG Yu，CHEN Chao，JIN Shurong，CANG Aijun |
| 关键字： | 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 |
| KEYWORDS： | Compound porcine cerebroside and ganglio- |
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