Evidence mapPaperPMID 41367530Full record

ReviewTranslational pediatrics2025

Expert consensus on the off-label use of drugs for pediatric rare diseases in China (2025 edition).

Xiaolan Mo, Houliang Deng, Jinlian Yang, Jiale Li, Shan Ouyang, Feng Chen, Yanqin Cui, Xia Gao, Hua Jiang, Xiaojing Li and 40 more

Abstract readReview
In one paragraph

Review in Translational pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

50 authors.

Xiaolan Mo *Department of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Houliang Deng *Department of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jinlian YangDepartment of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jiale LiDepartment of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Shan OuyangDepartment of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Feng ChenDepartment of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Yanqin CuiHeart Center, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Xia GaoDepartment of Nephrology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Hua JiangDepartment of Hematology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Xiaojing LiDepartment of Neurology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Li LiuDepartment of Genetics and Endocrinology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jie LiuState Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Lin QiuDepartment of Hematology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Xiaoming RongDepartment of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Zhe WenDepartment of Pediatric Surgery, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jiayi WangDepartment of Hematology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Ping ZengDepartment of Immunology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Wen ZhangDepartment of Genetics and Endocrinology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Xiaopeng ZhaoDepartment of Neonatology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Juan ZhouDepartment of Immunology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jie ChenDepartment of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Pan ChenDepartment of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Wenying ChenDepartment of Pharmacy, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
Zebin ChenDepartment of Pharmacy, Shenzhen Children's Hospital, Shenzhen, China.
Rui FangDepartment of Pharmacy, Guangdong Women's and Children's Hospital, Guangzhou, China.
Xiaomei FanDepartment of Pharmacy, Shenzhen Bao'an Women's and Children's Hospital, Shenzhen, China.
Yuntao JiaDepartment of Pharmacy, Children's Hospital of Chongqing Medical University, Chongqing, China.
Zhiling LiDepartment of Pharmacy, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Xuejuan LiDepartment of Pharmacy, Shenzhen Children's Hospital, Shenzhen, China.
Xiaoyan LiDepartment of Pharmacy, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Yunzhu LinDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Maochang LiuDepartment of Pharmacy, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Haiyan MaiDepartment of Pharmacy, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Jing MiaoDepartment of Pharmacy, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Xiaoling Wang
Yong Wang
Jinghao WangDepartment of Pharmacy, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Li WeiDepartment of Pharmacy, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Junyan WuDepartment of Pharmacy, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Shanshan YuDepartment of Pharmacy, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
Linan ZengDepartment of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Bo ZhangDepartment of Pharmacy, Peking Union Medical College Hospital, Beijing, China.
Hongliang ZhangDepartment of Pharmacy, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Zhihua Zheng
Xiao ChenDepartment of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Sujian XiaDepartment of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, China.
Wenhao ZhouDepartment of Neonatology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Jing SunDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yilei LiDepartment of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Rare Disease Expert Committee of Guangdong Pharmaceutical Association

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The package insert is a key reference and legal basis for clinical medication. However, in the field of rare diseases, advances in diagnosis and treatment often outpace updates to drug labels, resulting in widespread off-label drug use-a practice that is particularly common and often unavoidable in pediatric populations. Inappropriate off-label use, however, carries significant clinical and safety risks. Methods: Under the guidance of the Rare Disease Expert Committee of the Guangdong Pharmaceutical Association, a multidisciplinary panel of experts from clinical medicine, pharmacy, and related specialties developed the "Expert consensus on the off-label use of drugs for pediatric rare diseases in China (2025 edition)". The consensus integrates available evidence, clinical experience, evidence quality, and medication safety profiles, and was finalized after several rounds of rigorous iterative review. Results: The consensus presents 73 recommendations on off-label drug use across 21 rare diseases, organized in a tabular format for clarity and ease of reference. Conclusions: This consensus aims to standardize the management of off-label drug use in pediatric rare diseases. It supports medical institutions in developing off-label drug formularies, promotes rational drug use, and helps address the diagnostic and therapeutic needs of pediatric rare disease patients. Furthermore, it contributes to the establishment of a structured evaluation and management framework for off-label drug use in this clinical context.

Indexed as

Expert consensusoff-label usepediatricrare diseases

Identifiers

PMID41367530
PMCPMC12683492

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.