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| 复方脑肽节苷脂注射液治疗625例创伤性周围神经损伤患者的上市后临床安全性再评价 |
| Post-Marketing Clinical Safety Re-Evaluation of Compound Porcine Cerebroside and Ganglioside Injection in the Treatment of 625 Patients With Traumatic Peripheral Nerve Injury |
| 投稿时间：2023-12-25 修订日期：2023-12-25 |
| DOI： |
| 中文关键词: 复方脑肽节苷脂注射液 创伤性周围神经损伤 安全性评价 上市后再研究 |
| 英文关键词: Compound porcine cerebroside and ganglioside injection Traumatic peripheral nerve injury Safety evaluation Post-marketing research |
| 基金项目:辽宁省自然基金指导计划项目（编号：2019-ZD-0615） |
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| 中文摘要: |
| 目的 探究复方脑肽节苷脂注射液治疗625例创伤性周围神经损伤患者的上市后临床安全性。方法 采用前瞻性、多中心、非对照的临床研究设计方法，于2020年4月-2021年4月对46家使用过复方脑肽节苷脂注射液临床单位的625例创伤性周围神经损伤患者的基线资料、药物使用情况、疾病转归和安全性等进行统计和分析。结果 625例创伤性周围神经损伤患者中，痊愈46例，好转529例，无患者死亡。研究期间共收集到与药物相关的不良反应5例，包括轻度不良反应3例，中度不良反应2例；收集到不良事件19例，包括轻度不良事件12例，中度不良事件7例；不良事件以皮肤及其附件损害最常见。其他安全性指标中，用药后患者血红蛋白（Hb）、白细胞计数（WBC）正常的人数较用药前增加（P＜0.05）；用药前后，患者红细胞计数（RBC）、血小板计数（PLT）、谷丙转氨酶（ALT）、谷草转氨酶（AST）、总胆红素（TBIL）和肌酐（Cr）比较差异无统计学意义（P＞0.05）。结论 复方脑肽节苷脂注射液可促进创伤性周围神经损伤患者转归，研究期间偶见不良事件和与药物相关的不良反应，临床应用相对安全。 |
| 英文摘要: |
| Objective To investigate the post-marketing clinical safety of compound porcine cerebroside and ganglioside injection in the treatment of 625 patients with traumatic peripheral nerve injury.Methods A prospective, multi-center, non-controlled clinical study was conducted.The baseline data, drug use,disease outcomes, and safety of 625 patients with traumatic peripheral nerve injury who had been treated with compound porcine cerebroside and ganglioside injection in 46 clinical units from April 2020 to April 2021 were statistically analyzed. Results In this study, 46 patients were cured and 529 patients were improved,and without death. There were 5 cases of adverse drug reactions,including 3 cases of mild adverse reactions and 2 cases of moderate adverse reactions;There were 19 adverse events observed,including 12 mild adverse events and 7 moderate adverse events.Lesions of skin and its appendages were the most common adverse reactions. Among other safety indexes,the number of patients with normal hemoglobin (Hb) and white blood cell count (WBC) after medication increased compared with that before medication(P<0.05).There was no significant difference in red blood cell count (RBC), platelet count (PLT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL) and creatinine (Cr) before and after treatment (P>0.05). Conclusion Compound porcine cerebroside and ganglioside injection can promote the outcome of patients with traumatic peripheral nerve injury.Adverse events and drug-related adverse reactions were occasionally observed during the study, and the clinical application is relatively safe. |
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