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Ta15.0
Thymosin Alpha-1 – Forschung
Überwiegend Mechanismus / Beobachtung
23 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Thymosin Alpha-1 sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 1999–2026 mit einer typischen Studiengröße von 361 Teilnehmenden.
Basierend auf 23 Studien · 10 Meta-Analysen · 10 RCTs · 4,682 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Immune supportErhöht die CD4+-T-Zellen sowie das CD4+/CD8+-Verhältnis und reduziert in Metaanalysen die Kurzzeitmortalität und Infektionen bei Sepsis und schwerer akuter Pankreatitis (belegt keine allgemeine Immunstärkung bei gesunden Menschen) · Tage bis Wochen bei akuten Krankheitsbildern
Überwiegend Mechanismus / Beobachtung10 Studien
Hepatitis & liver
Überwiegend Mechanismus / Beobachtung8 Studien
Respiratory & lung
Überwiegend Mechanismus / Beobachtung4 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung4 Studien
Aktives Forschungsgebiet
12 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2025
199920122026
1Meta-Analyse2025
Tian Y, Yao J, Ma Y, Zhang P, Zhou X, Xie W · Front Immunol (2025)
Cao A, Feng F, Zhou X. · Journal of the College of Physicians and Surgeons--Pakistan : JCPSP (2024)
Thymosin alpha 1 could significantly boost the immune function, and improve pulmonary function and arterial blood gas of AECOPD patients than routine treatment only.
More high-quality randomised controlled trials are needed to further confirm Thymosin alpha 1 efficacy.
Einfach gesagt: Further research is needed to validate its long-term efficacy and safety in geriatrics.
Simonova MA, Ivanov I, Shoshina NS, Komyakova AM, Makarov DA, Baranovskii DS, Klabukov ID, Telepenina KP, Atiakshin DA, Shegay PV, Kaprin AD, Stepanenko VN. · International journal of molecular sciences (2025)
Preclinical and clinical studies show that Tα1 can improve vaccine response in the elderly and mitigate immunosenescence.
The hybrid drug Refnot (a fusion of tumor necrosis factor alpha (TNFα) and Tα1) combines Tα1's immunomodulation with TNF's antitumor activity but has reduced toxicity.
It represents a promising therapeutic approach to counteract age-related immune dysfunction and inflammation, potentially by slowing the aging process.
Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). · Gut and liver (2024)
Among them, 271 (54.0%) had hyperglycemia, 371 (73.9%) had hypertriglyceridemia and 229 (45.6%) had both.
Tα1 therapy was associated with reduced incidence of IPN among patients with hyperglycemia (18.8% vs 29.7%: hazard ratio, 0.80; 95% confidence interval, 0.37 to 0.97; p=0.03), but not in the other subgroups.
Additional multivariate regression models using three propensity-score methods yielded similar results.
Einfach gesagt: This article explores the experiences of researchers testing the effect of a thymic peptide hormone, thymosin alpha-1, in preclinical and clinical settings and discuss how its therapeutic utility in the precision medicine era can be accommodated within the PDD framework.
Garaci E, Paci M, Matteucci C, Costantini C, Puccetti P, Romani L. · Frontiers in medicine (2024)
Ultimately, disease definitions are mostly symptom-based rather than mechanism-based, and the therapeutics should be likewise.
In recent years, there has been a renewed interest in PDD due to its potential to address the complexity of human diseases, including the holistic picture of multiple metabolites engaging with multiple targets constituting the central hub of the metabolic host-microbe interactions.
Although PDD presents challenges such as hit validation and target deconvolution, significant achievements have been reached in the era of big data.
Einfach gesagt: For thymosin α(1), there was a trend for a reduced risk of dying and of improved DFS.
Wolf E, Milazzo S, Boehm K, Zwahlen M, Horneber M. · Cochrane Database Syst Rev (2011)
Cochrane systematic review/meta-analysis of thymic peptides as an adjunct to chemo-/radiotherapy in cancer: 26 trials, 2736 patients (6 trials used thymosin α1 or thymopentin)
For thymosin α1 specifically the pooled overall-survival RR was 1.21 (95% CI 0.94-1.56, P = 0.14) and disease-free-survival RR 3.37 (0.66-17.30, P = 0.15) — only non-significant trends, not proof of benefit
Purified thymus extracts reduced severe infectious complications during cancer therapy (RR 0.54, 0.38-0.78) but did not improve survival or tumour response
Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. · BMC medicine (2026)
Results Thirty patients were enrolled and all underwent curative-intent minimally invasive gastrectomy. pCR was achieved in 30.0% (9/30), and MPR in 56.7% (17/30). ypN0 status was observed in 63.3% (19/30), with N-stage downstaging in 80.0% (24/30).
Any-grade adverse events (AEs) occurred in 93.3% of patients, grade ≥ 3 AEs in 26.7%, and immune-related AEs in 23.3%.
Conclusions Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma.
Einfach gesagt: Tα1 has the potential to decrease 28-day mortality rates in patients with sepsis; however, it is crucial to recognize that its efficacy differs among various subgroups.
Gu B, Zhou Y, Nie Y, Wang L, Liang L, Liao Z, Wen J, Guan X, Chen M, Wu J, Pei F. · Front Cell Infect Microbiol (2025)
Overall 28-day mortality was reduced (OR 0.73, 95% CI 0.59-0.90) — but the benefit DISAPPEARED in the high-quality subgroup (OR 0.82, 0.65-1.03) and the multicenter subgroup (OR 0.86, 0.68-1.08)
Trial sequential analysis indicated the pooled sample size is still inadequate to confirm benefit; subgroup signals (cancer, diabetes, coronary disease) were low-to-moderate credibility
Einfach gesagt: The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.
Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. · Crit Care (2013)
ETASS: the pivotal multicenter RCT — 361 severe-sepsis patients across six Chinese teaching hospitals randomized 1:1 to Tα1 or control
28-day all-cause mortality 26.0% (Tα1) vs 35.0% (control); relative risk 0.74 (95% CI 0.54-1.02) — a borderline result (nonstratified P = 0.062; log-rank P = 0.049)
Tα1 produced greater recovery of monocyte HLA-DR (an immune-restoration marker) on days 3 and 7, consistent with its immunomodulatory mechanism
Einfach gesagt: Thymosin α1 alone was associated with significantly lower 28-day mortality... but there was no significant difference in the 90-day mortality.
Feng Z, Shi Q, Fan Y, Wang Q, Yin W. · J Trauma Acute Care Surg (2016)
12 studies in severe sepsis comparing ulinastatin and/or Tα1 immunomodulatory therapy
Tα1 alone reduced 28-day mortality (RR 0.72, 95% CI 0.55-0.93) but NOT 90-day mortality (RR 0.84, 95% CI 0.54-1.31) — GRADE rating low/very low for Tα1 alone
Combination (ulinastatin + Tα1) reduced both 28- and 90-day mortality (moderate GRADE)
Einfach gesagt: ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone.
Peng D, Xing HY, Li C, Wang XF, Hou M, Li B, Chen JH. · BMC Gastroenterol (2020)
Seven RCTs, 1144 subjects with HBV-related cirrhosis
Entecavir + Tα1 gave higher complete response (RR 1.18) and higher HBV-DNA-undetectable and HBeAg-loss rates at 24 weeks versus entecavir alone
Differences were not significant at 48-52 weeks, and HBsAg loss was unchanged — benefit attenuates over time
Einfach gesagt: There was a trend towards HBeAg loss when using combination therapy... This could clinically indicate a potential important difference that would need confirmation in subsequent trials.
Lim SG, Wai CT, Lee YM, Dan YY, Sutedja DS, Wee A, Suresh S, Wu YJ, Machin D, et al. · Antivir Ther (2006)
Double-blind RCT, 98 HBeAg-positive chronic hepatitis B patients; Tα1 + interferon versus interferon + placebo for 24 weeks
HBeAg loss at 72 weeks 45.8% (combination) vs 28.0% (monotherapy) — a 17.8% difference that did NOT reach significance (95% CI -1.2% to 35.3%, P = 0.067)
No significant differences in HBeAg seroconversion, histology, ALT normalization or HBV-DNA loss
19Meta-Analyse2023
Einfach gesagt: Our study suggests that treatment with thymosin alpha-1 may reduce mortality rate in moderate to critical COVID-19 patients. Randomized clinical trials (RCTs) are still required to verify the findings.