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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1541005
This article is part of the Research Topic Clinical Pharmacist Service Promotes the Improvement of Medical Quality Volume II View all 42 articles
Post-Marketing Safety Re-evaluation of Placental Peptide Injection in China: A Large-Scale Multicenter Real-World Study
Provisionally accepted
Liguang Duan 1*
Feiyue An 1 Chen Tian 1* Wen Yan 1* Jie Chen 2* Hongyin Zhang 3* Xiaoguang Liu 4* Lingjiao Wang 1* Zhuo Zhang 1* Binliang Tong 1* Chunhua Zhou 1*- 1 The First hospital of Hebei Medical University, Shijiazhuang, China
- 2 The Third People’s Hospital of Kunming City, Kunming, Yunnan Province, China
- 3 Yunnan Cancer Hospital, Kunming, Yunnan Province, China
- 4 Beijing Dehuijia Pharmaceutical Technology Co., Ltd., Beijing, China
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.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.
Keywords: Real-world study, placental peptide injection, Post-marketing safety re-evaluation, adverse drug reactions, centralized hospital monitoring method
Received: 06 Dec 2024; Accepted: 10 Feb 2025.
Copyright: © 2025 Duan, An, Tian, Yan, Chen, Zhang, Liu, Wang, Zhang, Tong and Zhou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Liguang Duan, The First hospital of Hebei Medical University, Shijiazhuang, China
Chen Tian, The First hospital of Hebei Medical University, Shijiazhuang, China
Wen Yan, The First hospital of Hebei Medical University, Shijiazhuang, China
Jie Chen, The Third People’s Hospital of Kunming City, Kunming, Yunnan Province, China
Hongyin Zhang, Yunnan Cancer Hospital, Kunming, Yunnan Province, China
Xiaoguang Liu, Beijing Dehuijia Pharmaceutical Technology Co., Ltd., Beijing, China
Lingjiao Wang, The First hospital of Hebei Medical University, Shijiazhuang, China
Zhuo Zhang, The First hospital of Hebei Medical University, Shijiazhuang, China
Binliang Tong, The First hospital of Hebei Medical University, Shijiazhuang, China
Chunhua Zhou, The First hospital of Hebei Medical University, Shijiazhuang, China
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