Evidence map›Paper›PMID 40198521›Full record

Observational studyAdvances in therapy2025

Long-Term Efficacy and Safety of Growth Hormone in Children Suffering from Short Stature in China (CGLS): An Open-Label, Multicenter, Prospective and Retrospective, Observational Study.

Wei Wu, Xiaoping Luo

Registry-linked trialAbstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06110910 (Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT06110910 recruitingnot on this map

Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)-an Open-label, Multicenter, Prospective and Retrospective Observational Study

TypeobservationalSponsorXiaoping LuoRan2023 to 2027Enrolled10,000ConditionsChildhood Short StatureArmsPolvethylene glycol recombinant human growth hormone injection (PEG-rhGH) or recombinanthuman growth hormone injection (rhGH)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Observational
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

2 authors.

Wei WuTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xiaoping LuoTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. xpluo@tjh.tjmu.edu.cn.ORCID http://orcid.org/0000-0002-3748-4817

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSeveral primary and secondary disorders disrupting normal growth pattern are responsible for childhood short stature (SS; height less than 2 standard deviation score [SDS] or the third percentile). Pegylated recombinant human growth hormone (PEG-rhGH) is a long-acting growth hormone which has demonstrated efficacy and safety in pediatric growth hormone deficiency. However, limited data is present on its treatment pattern, extensive population use, and long-term follow-up. Therefore, a real-world study is required to evaluate the efficacy and safety of PEG-rhGH and recombinant human growth hormone (rhGH) in treating childhood SS.

methodsThe proposed study will be an open-label, multicenter, prospective and retrospective, observational study that will recruit Chinese children aged ≥ 2 years with SS. The entire study will be categorized into three cohorts: retrospective, retrospective-prospective, and prospective. The study will recruit 10,000 patients including 3000 patients in the retrospective cohort and 7000 in the retrospective-prospective and prospective cohort, respectively. The total duration of this study will be 16 years. The primary objective will be to evaluate the long-term safety (incidence of all adverse events (AEs) and serious adverse events) of PEG-rhGH and rhGH for the treatment of patients with SS having growth hormone disorder (GHD), idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS), Prader-Willi syndrome (PWS), Noonan syndrome (NS), deficiency of the short stature homeobox gene on the X-chromosome (SHOX deficiency), and other causes of SS. The secondary objective will be to evaluate the efficacy of PEG-rhGH and rhGH for the treatment of patients with SS with different etiologies. PLANNED OUTCOMES: The results may provide the evidence of long-term efficacy and safety of PEG-rhGH and rhGH by analyzing the existing patient data and will also provide a vast array of information, which can be used as reference evidence for the Chinese academic community to design national guidelines or consensus for patients with SS.

trial registrationThe study has been registered at ClinicalTrials.gov (NCT06110910). Date of registration October 31, 2023.

Indexed as

DwarfismGrowth DisordersHuman Growth HormoneAdolescentBody HeightChildChild, PreschoolChinaFemaleHumansMaleProspective StudiesRecombinant ProteinsRetrospective StudiesTreatment OutcomeHuman Growth HormoneRecombinant ProteinsGrowth hormonePEG-rhGH/rhGHProspective cohortRetrospectiveShort stature

Identifiers

PMID40198521
PMCPMC12085325

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Registered trials

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.