Evidence and results obtained with a new trans-epidermal barrier (T.E.B.) drug in the medical treatment of vascular impotence
Curri, S.B.; Menchini Fabris, F.
Bollettino Chimico Farmaceutico 135(5): 316-334
1996
ISSN/ISBN: 0006-6648 PMID: 8942060 Document Number: 469234
After having reviewed the methods and significance of a new topical administration route for vasoactive drugs, the "Trans-Epidermal Barrier" (T.E.B.), based on the physiological capacity of phosphoric ester molecules (Phosphatidylcholine) to penetrate actively through the epidermal barrier, this paper reports the results obtained in the medical treatment of (micro) vasculogenic impotence with a preparation in the form of a 5% Lipogel, containing, as active principle, a Troxerutine/Phosphatidylcholine Complex. A total of 154 patients were subjected to "short term" treatment in order to quantitatively assess (computer assisted laser-Doppler: LDF) the response of the small arteries and arterioles in the dorsal penile region to pharmacological stimulation (microvasculokinesis test). This test enables separation of the patients into two groups: "responders" and "non-responders", according to which it is possible to instrumentally assess the severity of the anatomo-functional alteration of the small arteries and arterioles in penile microangiopathies originating from diabetes, arteriolosclerosis, hypertension and stasis. Microvascular damage was assessed objectively with the Optic Probe Video-Capillaroscopy, taking into consideration the number of microaneurysms and extension of the subischemic or ischemic areas. 75 "responder" patients undertook long term treatment for a minimum period of three months with the same preparation used for the microvasculokinesis test, at the dose of 2-3 topical administrations per day. The clinical parameters for the evaluation of efficacy were): a) number of spontaneous daily erections; b) duration of the erections; and c) penile rigidity; in addition to subjective elements such as recovery of satisfactory sexual activity consistent with the anatomo-functional damage. The response to the treatment was positive in 54 patients (72% of the cases). The clinical improvement was confirmed by the instrumental LDF results, that show a statistically significant increase (P < 0.0001) in the sphygmicity ("pumping function": inotropic potency of the arterio-arteriolar systole) of the small penile arteries, i.e.:92.63 +/- 26.1 at baseline to 177.6 +/- 74.5 after treatment. Follow-up continued in 15 patients for 6 months and in 11 patients for 12 months. Maintenance of the results was achieved by continuing treatment involving gradual reduction of the number of applications. The new route of application proposed by the authors and the investigation methods adopted for objective instrumental assessment of penile microcirculatory damage in (micro) vasculogenic impotence provides new perspectives from the diagnostic as well as the prognostic and therapeutical viewpoints.