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Fxm3.4
Fluoxymesteron (Halotestin) – Forschung
Überwiegend Mechanismus / Beobachtung
16 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Fluoxymesteron (Halotestin) sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus mittelwertigen randomisierten Studien, veröffentlicht 1974–2016.
Basierend auf 16 Studien · 11 RCTs
Konfidenz
Mittlere Konfidenz
Nach Outcome
Safety profile
Überwiegend Mechanismus / Beobachtung12 Studien
Androgen replacement (human, legacy)
Überwiegend Mechanismus / Beobachtung7 Studien
Breast-cancer palliation (human)
Überwiegend Mechanismus / Beobachtung6 Studien
Hepatotoxicity
Zu wenige bewertete Studien2 Studien
Ältere Forschungsbasis
Neueste Studie von 2016
197419952016
1RCT1987
Manni A, Santen RJ, Boucher AE, Lipton A, Harvey H, Simmonds M · J Steroid Biochem (1987)
Brubaker LH, Brière J, Laszlo J, Kraut E, Landaw SA, Peterson P · Arch Intern Med (1982)
12Fallstudie1977
Einfach gesagt: Peliosis hepatis was found in 12 patients treated with high-dose oral oxymetholone or fluoxymesterone therapy; in three patients the lesion contributed to fatal hepatic failure, and in one biopsy-confirmed case the lesion regressed after the drug was withdrawn.
Nadell J, Kosek J. · Archives of Pathology & Laboratory Medicine (1977)
Clinicopathologic series of 12 patients who developed peliosis hepatis — blood-filled hepatic cavities — while on high-dose oral 17α-alkylated androgens including fluoxymesterone
In three patients the peliosis contributed to FATAL hepatic failure; in one biopsy-confirmed case the lesion regressed after the drug was stopped, supporting a causal link
A foundational documentation of fluoxymesterone's signature serious hepatotoxicity
13Kohorte2016
Einfach gesagt: Among 103 patients ... the median progression-free survival was 3.9 months (95% CI 3.2-5.3 months) and the clinical benefit rate was 43% ... fluoxymesterone remains a treatment option in heavily pretreated hormone receptor-positive metastatic breast cancer.
Kono M, Fujii T, Lyons GR, Huo L, Bassett R, Gong Y, Karuturi MS, Tripathy D, Ueno NT. · Breast Cancer Research and Treatment (2016)
Retrospective cohort of 103 patients with hormone-receptor-positive metastatic breast cancer treated with fluoxymesterone after failing contemporary hormonal therapy
Median progression-free survival ~3.9 months with a clinical-benefit rate of 43% — a modest palliative signal in a heavily pretreated population
Androgen-receptor positivity was not significantly associated with the survival outcome
Einfach gesagt: The 17 alpha-alkylated steroids (methyltestosterone, oxymetholone, and stanozolol) are directly toxic to hepatocytes ... whereas the nonalkylated steroids were not, supporting the role of 17 alpha-alkylation in anabolic-steroid hepatotoxicity.
Welder AA, Robertson JW, Melchert RB. · Journal of Pharmacological and Toxicological Methods (1995)
In-vitro study exposing primary rat hepatocyte cultures to a panel of anabolic-androgenic steroids (including fluoxymesterone) and measuring LDH release, viability and glutathione depletion
The tested 17α-alkylated steroids (methyltestosterone, oxymetholone, stanozolol) were directly toxic to hepatocytes whereas non-alkylated androgens were not — establishing 17α-alkylation as the mechanism of the class hepatotoxicity fluoxymesterone shares (fluoxymesterone was in the dosed panel but did not itself reach significant toxicity in this assay)
Mechanistic counterpart to the human peliosis-hepatis series: identifies 17α-alkylation as the structural driver of liver injury
Einfach gesagt: In men who did not recover spontaneously, sequential treatments were given; only the androgen produced acceptable results and then only at unusually high doses, suggesting androgen insensitivity in these patients.
Van Thiel DH, Gavaler JS, Sanghvi A. · Gastroenterology (1983)
Prospective follow-up study of 60 abstinent alcoholic men with sexual dysfunction, with sequential treatments including the androgen fluoxymesterone in non-spontaneous recoverers
Only the androgen produced acceptable results, and only at unusually high doses — consistent with an androgen-insensitive state in alcohol-related hypogonadism
Illustrates fluoxymesterone's historical men's-vitality / androgen-replacement use and its limits
Einfach gesagt: Long-term preventive management with the synthetic androgens fluoxymesterone and oxymetholone reduced the frequency and severity of attacks in severely affected patients with hereditary angioedema.
Davis PJ, Davis FB, Charache P. · The Johns Hopkins Medical Journal (1974)
Open-label clinical experience using the synthetic androgens fluoxymesterone and oxymetholone for long-term prophylaxis in severely affected hereditary-angioedema patients
Androgen therapy reduced attack frequency and severity — an early demonstration of the now-classic androgen effect on C1-inhibitor/complement in HAE
Represents one of fluoxymesterone's legitimate (now largely historical) human indications beyond oncology and hypogonadism