Evidence map›Paper›PMID 40542826›Full record

Observational studyEuropean journal of pediatrics2025

Five-year safety and growth response of long-acting PEGylated recombinant human growth hormone in children with growth hormone deficiency-data from CGLS database.

Wei Wu, Haiyan Wei, Hongwei Du, Liyang Liang, Chunxiu Gong, Yan Zhong, Liyan Ma, Feihong Luo, Ruimin Chen, Xiaoyan Huang and 26 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
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

36 authors.

Wei WuDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Haiyan WeiDepartment of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhenzhou, 450000, China.
Hongwei DuDepartment of Pediatrics, First Hospital of Jilin University, Changchun, 130021, China.
Liyang LiangDepartment of Pediatrics, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, China.
Chunxiu GongDepartment of Endocrine and Genetics and Metabolism, Beijing Children's Hospital, Capital Medical University, National Centre for Children's Health, Beijing, 100045, China.
Yan ZhongDepartment of Child Health Care, Hunan Children's Hospital, Changsha, 410007, China.
Liyan MaDepartment of Pediatrics, The General Hospital of Ningxia Medical University, Ningxia, 750004, China.
Feihong LuoDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, 201102, China.
Ruimin ChenDepartment of Pediatric Endocrinology, Genetics and Metabolism, Fuzhou Children's Hospital, Fuzhou First General Hospital Affiliated With Fujian Medical University, Fujian Medical University, Fuzhou, 350005, China.
Xiaoyan HuangDepartment of Genetics, Metabolism and Endocrinology, Hainan Women and Children's Medical Center, Haikou, 570206, China.
Kan YeDepartment of Child Health, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, 215002, China.
Yunpu CuiDepartment of Pediatrics, Peking University Third Hospital, Beijing, 100191, China.
Chunlin WangDepartment of Pediatrics, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China.
Min ZhuDepartment of Endocrinology, Genetics and Metabolism, Children'S Hospital of Chongqing Medical University, Chongqing, 400014, China.
Kundi WangDepartment of Pediatrics, China-Japan Friendship Hospital, Beijing, 100029, China.
Yufang ZhaoDepartment of Pediatrics, Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, 321000, China.
Huiwen ZhangDepartment of Pediatric Endocrinology and Genetic Metabolism, School of Medicine, Xinhua Hospital, Shanghai Institute for Pediatric Research, Shanghai Jiao Tong University, Shanghai, 200092, China.
Xu XuDepartment of Endocrinology, Wuxi Children'S Hospital, Affiliated Children's Hospital of Jiangnan University, Wuxi, 214023, China.
Haiying WuDepatment of Endocrinology, Genetics and Metabolism, Children's Hospital of Soochow University, Suzhou, 215025, China.
Yuan LiDepartment of Pediatrics, The First People's Hospital of Yunnan Province, Kunming, 650032, China.
Jin CaiDepartment of Pediatrics, Affiliated Hospital of Nantong University, Nantong, 226001, China.
Hongxiao ZhangDepartment of Pediatrics, Second Hospital of Lanzhou University, Lanzhou, 730030, China.
Lirong YingDepartment of Pediatrics, Cixi People's Hospital, Cixi, 315300, China.
Zhihong ChenDepartment of Pediatric Endocrinology, Metabolism & Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
Wei GuDepartment of Endocrinology, Genetics and Metabolism, Children's Hospital of Nanjing Medical University, Nanjing, 210008, China.
Zheng LiuDepartment of Pediatrics, Tai'an Maternal and Child Health Care Hospital, Tai'an, 271000, China.
Yuwen LiDepartment of Pediatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Rongxiu ZhengDepartment of Pediatrics, Tianjin Medical University General Hospital, Tianjin, 300052, China.
Naijun WanDepartment of Pediatrics, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.
Guimei LiDepartment of Pediatrics, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, 250021, China.
Jingsi LuoGenetic and Metabolic Center, Maternaland , Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
Yaping MaDepartment of Pediatrics, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Yuqing ChenDepartment of Endocrinology and Metabolism, Anhui Children's Hospital, Hefei, 230022, China.
Nan LiResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, 100191, China.
Tingting WangMedical Affairs Department, GeneScience Pharmaceuticals Co., Ltd, Changchun, 130012, China.
Xiaoping LuoDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. xpluo@tjh.tjmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Growth hormone deficiency (GHD) is an endocrine disorder characterized by insufficient production of growth hormone (GH). PEGylated recombinant human growth hormone (PEG-rhGH; Jintrolong®, GeneScience Pharmaceuticals Co., Ltd.) is the only long-acting GH approved in China for treating paediatric GHD (PGHD). Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China (CGLS) is a large, surveillance registry database of participants with short stature treated with PEG-rhGH or rhGH in a real-world setting. In this study, we evaluated the safety profile and five-year growth response of PEG-rhGH based on the data from the CGLS database in participants with PGHD in China. In this real-world registry-based observational study, a total of 1,207 participants were included in the safety analysis set. Of these, 339 participants who had received PEG-rhGH continuously for five years were also included in the efficacy analysis. Key outcomes assessed comprised adverse events (AEs), serious AEs (SAEs), and height gain. The safety assessment indicated that 563 participants exhibited 1328 AEs with an incidence rate of 46.6%. Furthermore, SAEs occurred in 1.0% of participants (n = 12), with none of them associated with PEG-rhGH treatment. A significant increase in mean change in height-SD score (∆Ht SDS) was observed during the treatment period, with a mean ∆Ht SDS of 2.1 ± 0.9 in five years. Subgroup analysis showed that the younger participants exhibited a more favourable response to therapy.

conclusionCGLS data showed that five-year PEG-rhGH treatment in children with PGHD was associated with a favourable safety profile and sustained height gain. WHAT IS KNOWN: • Several long-acting growth hormones (LAGH) have been approved for use in PGHD. PEGylated recombinant growth hormone (PEG-rhGH) is the only LAGH marketed in China, with its three-year efficacy and safety have been reported. WHAT IS NEW: • Data from the CGLS database confirms that PEG-rhGh has an acceptable safety profile over five years, with significant improvement in height. Importantly, the data indicate that initiating the treatment earlier yields better outcomes.

Indexed as

Growth DisordersHuman Growth HormonePolyethylene GlycolsAdolescentBody HeightChildChild, PreschoolChinaDatabases, FactualFemaleHumansMaleRecombinant ProteinsRegistriesTreatment OutcomeHuman Growth HormonePolyethylene GlycolsRecombinant ProteinsCGLS databaseGrowth hormoneGrowth responsePEG-rhGHSafety

Identifiers

PMID40542826
PMCPMC12182472

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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 OpenQuestion graph.