Evidence map›Paper›PMID 35616850›Full record

Trial reportHepatology international2022

Safety and efficacy of Thymosin α1 in the treatment of hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial.

Jun-Feng Chen, Shu-Ru Chen, Zi-Ying Lei, Hui-Juan Cao, Shao-Quan Zhang, Wei-Zhen Weng, Jing Xiong, Deng-Na Lin, Jing Zhang, Yu-Bao Zheng and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03082885 (A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% of its field
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.

NCT03082885 nacompletednot on this map

A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure

TypeinterventionalSponsorSun Yat-sen UniversityRan2017 to 2019Enrolled120ConditionsLiver FailureArmsThymosin-α1
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. [Guidelines for the diagnosis and treatment of acute-on-chronic liver failure (2025 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Guideline
  2. [Guidelines for diagnosis and treatment of liver failure (2024 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Guideline
  3. Review
  4. Recognition on pharmacodynamic ingredients of natural products.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Review
  5. Article
  6. Review
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

12 authors at 1 institution in 1 country.

Jun-Feng Chen *Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Shu-Ru Chen *Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Zi-Ying LeiDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Hui-Juan CaoDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Shao-Quan ZhangDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Wei-Zhen WengDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Jing XiongDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Deng-Na LinDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Jing ZhangDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Yu-Bao ZhengDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Zhi-Liang GaoDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China.
Bing-Liang LinDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510630, China. linbingl@mail.sysu.edu.cn.ORCID http://orcid.org/0000-0003-4069-6287
Sun Yat-sen University · CN

Funding

Guangzhou Research Collaborative Innovation Projects 1561000157National Major Science and Technology Projects of China 2017ZX10203201003National Major Science and Technology Projects of China 2018ZX10302204National Natural Science Foundation of China 81901940National Natural Science Foundation of China 82070612Natural Science Foundation of Guangdong Province 2021A1515010306
6 · The paper itself

Abstract

background/purpose of the studyMortality from hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is high. Severe infection is the most important complication that affects the outcomes of ACLF patients. Thymosin α1 (Tα1) can improve immune imbalance and this study aimed to investigate the safety and efficacy of Tα1 treatment for HBV-related ACLF.

methodsFrom 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885). The control group (N = 58) was treated with standard medical therapy (SMT) only. The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.

resultsThe 90-day cumulated liver transplantation free survival rate of the Tα1 group was 75.0% (95% confidence interval 63.2-86.8%) versus 53.4% (95% confidence interval 39.7-67.1%) for the SMT group (p = 0.030). No significant difference was found in the survival using competitive risk analysis. The incidences of new infection and hepatic encephalopathy in the Tα1 group were much lower than those in the SMT group (32.1% vs 58.6%, p = 0.005; 8.9% vs 24.1%, p = 0.029, respectively). Mortality from severe infection in the SMT group was higher than in the Tα1 group (24.1% vs 8.9%, p = 0.029).

conclusionTα1 is safe for patients with HBV-related ACLF and significantly improves the 90-day liver transplantation-free survival rate. There may be a subgroup which may benefit from Tα1 therapy by the mechanism of preventing infection.

Indexed as

Acute-On-Chronic Liver FailureHepatic EncephalopathyHepatitis BThymalfasinHepatitis B virusHumansPrognosisSurvival RateThymalfasinAcute-on-chronic liver failureCLIF-C ACLF scoresCLIF-C OF scoreCLIF-SOFA scoreHepatic encephalopathyHepatitis B virusInfectionMELD scoreOutcomeThymosin α1

Identifiers

PMID35616850
OpenAlexW4281556402

What OpenQuestion holds

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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.