| 曾 钰,姚 寅,唐勇胜,孙 玲,文 君.复方脑肽节苷脂注射液用于4239例出血性脑卒中患者的临床安全性再评价[J].现代生物医学进展英文版,2024,(1):96-100. |
| 复方脑肽节苷脂注射液用于4239例出血性脑卒中患者的临床安全性再评价 |
| Re-evaluation of the Clinical Safety of Compound Porcine Cerebroside and Ganglioside Injection in 4239 Patients with Hemorrhagic Stroke |
| Received:June 02, 2023 Revised:June 26, 2023 |
| DOI：10.13241/j.cnki.pmb.2024.01.018 |
| 中文关键词: 复方脑肽节苷脂注射液 出血性脑卒中 安全性 评价 |
| 英文关键词: Compound porcine cerebroside and ganglioside injection Hemorrhagic stroke Safety Evaluation |
| 基金项目:重庆市卫健委中医药科技项目（ZY201802124） |
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| 中文摘要: |
| 摘要 目的：评价复方脑肽节苷脂注射液上市后用于4239例出血性脑卒中患者的临床安全性，从而为临床合理用药提供参考。方法：采用多中心、前瞻性、非对照的临床研究设计方法，对2020年3月至2021年3月全国46家医疗机构中使用复方脑肽节苷脂注射液的4239例出血性脑卒中患者的基本情况、用药信息、药物不良反应及疾病转归情况进行统计分析。结果：4239例出血性脑卒中患者平均用药时间（13.62±2.22）d。用药期间仅13例经研究判断为药物不良反应，不良反应发生率为0.307%，药物不良反应主要是集中在胃肠系统疾病、全身性疾病。4239例出血性脑卒中患者应用复方脑肽节苷脂注射液后有190例痊愈，3109例好转，912例无明显变化，27例病情加重，1例死亡。13例药物不良反应患者中10例患者治疗后出现好转，3例患者治疗后无明显变化。4239例出血性脑卒中患者不同用药情况中，49.99%患者药物使用剂量≤6 mL，50.0%患者药物使用剂量≧8 mL，不同药物使用剂量患者药物不良反应发生率比较无统计学差异（P>0.05）；溶媒种类以0.9%生理盐水为主，其次为5%葡萄糖，不同溶媒种类药物不良反应发生率比较无统计学差异（P>0.05）；药物注射后81.17%患者未冲管，17.65%患者冲管，1.18%患者更换输液器，不同措施药物药物不良反应发生率比较无统计学差异（P>0.05）；92.19%患者未出现不合理用药，7.81%患者存在不合理用药，二者之间药物不良反应发生率比较有统计学差异（P<0.05）。结论：复方脑肽节苷脂注射液上市后在4239例出血性脑卒中患者的治疗中不良反应发生率较低且风险可控，同时其不良反应症状均为前期已知或注射剂常见的不良反应。 |
| 英文摘要: |
| ABSTRACT Objective: To evaluate the clinical safety of compound porcine cerebroside and ganglioside injection in 4239 patients with hemorrhagic stroke after the market, so as to provide reference for clinical rational drug use. Methods: From March 2020 to March 2021, a multi-center, prospective and non-controlled clinical study design method was used to analyze the basic situation, medication information, adverse drug reactions and disease outcome of 4239 patients with hemorrhagic stroke who used compound porcine cerebroside and ganglioside injection in 46 medical institutions in China. Results: The average medication time of 4239 hemorrhagic stroke patients was (13.62±2.22) days. Only 13 cases were judged to be adverse drug reactions during medication, and the incidence of adverse reactions was 0.307%. The adverse drug reactions were mainly concentrated in gastrointestinal diseases and systemic diseases. Among the 4239 patients with hemorrhagic stroke, 190 were cured, 3109 improved, 912 had no significant change, and 27 exacerbation, and 1 patient died. Among the 13 patients with adverse drug reactions, 10 patients improved after treatment, and 3 patients showed no significant change after treatment. Among the 4239 patients with hemorrhagic stroke with different medication conditions, 49.99% of the patients used a dose of ≤6 mL, and 50.0% of the patients used a dose of ≥8 mL, and there was no significant difference in the incidence of adverse drug reactions between patients with different drug doses(P>0.05). 0.9% saline was the main vehicle type, followed by 5% glucose, and there was no statistical difference in the incidence of adverse drug reactions between different vehicle types(P>0.05). 81.17% of the patients did not flush the tube, 17.65% of the patients flushed the tube, and 1.18% of the patients changed the infusion set, and there was no significant difference in the incidence of adverse drug reactions between different measures(P>0.05). 92.19% of the patients had no irrational drug use, there were irrational drug use in the 7.81% patients, and there was a statistically significant difference in the incidence of adverse drug reactions between the two(P<0.05). Conclusion: The incidence of adverse reactions of compound porcine cerebroside and ganglioside injection in 4239 patients with hemorrhagic stroke after the market was low and the risk was controllable. At the same time, the adverse reaction symptoms were known or common adverse reactions. |
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