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| 复方脑肽节苷脂注射液治疗611例脊髓损伤患者临床有效性及安全性再评价 |
| Clinical Efficacy and Safety Reevaluation of Compound Porcine Cerebroside and Ganglioside Injection in the Treatment of Patients With Spinal Cord Injury: A Report of 611 Cases |
| 投稿时间：2024-07-02 修订日期：2024-07-02 |
| DOI： |
| 中文关键词: 脊髓损伤 复方脑肽节苷脂注射液 有效性 安全性 |
| 英文关键词: Spinal cord injury Compound porcine cerebroside and ganglioside injection Efficacy Safety |
| 基金项目:辽宁省自然科学基金（201602282） |
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| 中文摘要: |
| 目的：探究复方脑肽节苷脂注射液治疗611例脊髓损伤（SCI）患者临床有效性及安全性。方法：以前瞻性、多中心、非对照方式选择2020年4月~2021年4月全国不同地区46家二级甲等以上医院收治接受复方脑肽节苷脂注射液治疗的SCI患者611例为研究对象。通过监测患者基线特征与用药情况分析患者疾病转归情况及不良事件发生情况。结果：患者治疗有效率为68.25%（417/611），患者治疗后不良事件发生率为5.57%，主要为轻中度（5.57%），转归均较好（4.74%），损伤系统主要涉及全身性损害（1.64%）、胃肠系统损害（1.31%）、其他损害（1.47%）；不同性别、年龄、美国脊柱损伤协会（ASIA）、受损部位、文化程度及既往史等基线特征患者药物不良事件发生率比较无统计学意义（P＞0.05）；是否首次使用复方神经节苷注射液、不同复方神经节苷注射液溶媒种类、不同给药途径患者药物不良事件发生率比较无统计学意义（P＞0.05），合理与不合理用药患者药物不良事件发生率比较有统计学意义（P＜0.05）。结论：SCI患者应用复方脑肽节苷脂注射液治疗不良事件发生率较低，且症状轻微，转归较好。患者不良事发生多与不合理用药有关，在患者用药期间需要重点关注。 |
| 英文摘要: |
| Objective:The purpose of this study was to investigate the clinical efficacy and safety of compound porcine cerebroside and ganglioside injection in the treatment of patients with spinal cord injury (SCI). Methods:From April 2020 to April 2021, A total of 611 patients with SCI were treated with compound porcine cerebroside and ganglioside injection in 46 grade A hospitals of level II or higher level in different regions of China were selected as the research objects in a prospective, multi-center and non-control manner.The prognosis and the incidence of adverse events were analyzed through monitoring the patients’baseline characteristics and medication.Results:The effective rate of treatment in this study was 68.25% (417/611).After treatment,the incidence of adverse events was 5.57%,most of the adverse events were mild to moderate (5.57%), and the outcome was good (4.74%).The damages mainly included systemic damage (1.64%), gastrointestinal system damage (1.31%), and other damage (1.47%).There was no significant difference in the incidence of adverse drug events among patients with different baseline characteristics such as gender, age, American Spinal Injury Association (ASIA) grades, damaged site, education level and previous histories (P>0.05).There was no significant difference in the incidence of adverse drug events between patients with or without the first use of compound porcine cerebroside and ganglioside injection, different solvent types of compound porcine cerebroside and ganglioside injection,and different administration methods( P>0.05 ). The incidence of adverse drug events in patients with rational and irrational drug use was statistically significant (P<0.05).Conclusion:The incidence of adverse events in patients with SCI treated with compound porcine cerebroside and ganglioside injection is low.The patients’symptoms are mild and the prognosis is good.The occurrence of adverse events is mostly related to irrational drug use, which deserves attention during medication. |
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