中国胎盘多肽注射液上市后安全性再评价：一项大规模多中心真实世界研究。
Post-marketing safety re-evaluation of placental peptide injection in China: a large-scale multicenter real-world study.
作者信息
Duan Liguang, An Feiyue, Tian Chen, Yan Wen, Chen Jie, Zhang Hongyin, Liu Xiaoguang, Wang Lingjiao, Zhang Zhuo, Tong Binliang, Zhou Chunhua
机构信息
Pharmacy Department, The First Hospital of Hebei Medical University, Shijiazhuang, China.
Pharmaceutical Department, Kunming Third People's Hospital, Kunming, China.
出版信息
Front Pharmacol. 2025 Mar 4;16:1541005. doi: 10.3389/fphar.2025.1541005. eCollection 2025.
PURPOSE
This study conducted a post-marketing safety re-evaluation of placental polypeptide injections in China to support updates to drug guidelines, pharmacovigilance efforts, and rational clinical use, facilitating its inclusion in essential drug lists and medical insurance coverage.
METHODS
A hospital-based centralized monitoring system tracked 3,000 patients receiving placental polypeptide injections across three medical institutions. Adverse drug reactions (ADRs) and adverse drug events (AEs) were systematically collected and analyzed.
RESULTS
The mean patient age was 49.65 years, with 96.47% being over 18 years of age. A single dose exceeding 4 mL was administered in 98.34% of the cases, with a median treatment duration of 7 days. Concomitant medication use was high (injectable, 98.43%; non-injectable, 75.43%). One case of vertigo was reported as an ADR in a patient aged >60 years who had melanoma.
CONCLUSION
The ADR rate was 0.03%, confirming the favorable safety profile of placental polypeptide injection. These findings support its safe clinical use and can inform future regulatory and policy decisions.
目的
本研究在中国对胎盘多肽注射液进行了上市后安全性再评价，以支持更新药品指南、开展药物警戒工作及促进合理临床使用，推动其被纳入基本药物目录和医保覆盖范围。
方法
基于医院的集中监测系统对三家医疗机构中3000例接受胎盘多肽注射液治疗的患者进行跟踪。系统收集并分析药物不良反应（ADR）和药物不良事件（AE）。
结果
患者平均年龄为49.65岁，96.47%为18岁以上。98.34%的病例单次给药剂量超过4 mL，中位治疗时长为7天。合并用药情况普遍（注射用药，98.43%；非注射用药，75.43%）。1例60岁以上患黑色素瘤的患者报告出现眩晕这一药物不良反应。
结论
药物不良反应发生率为0.03%，证实胎盘多肽注射液安全性良好。这些研究结果支持其临床安全使用，并可为未来的监管和政策决策提供参考。
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