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Long monotherapy Sildenafil Citrate at various forms of erectile dysfunction

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Purpose. studying of efficiency of long therapy sildenafil Citrate at sick of erectile dysfunction at which its use 50-60 minutes prior to sexual contact has appeared not completely effective.

Material and methods. Sildenafil Citrate applied two times a week a current of 1 year at 86 patients at the age from 32 till 72 years with erectile dysfunction which were dissatisfied reception of this preparation before sexual contact. At 24 from them there was a functional erectile dysfunction Cialis, at 62 — organic.

Results. at 60 (83 %) from 86 patients are reached by the functional and subcompensated and compensated organic erectile dysfunction positive takes according to questionnaire ICEF-5. At ultrasonic dopplerografii have taped authentic intensifying penile a blood flow. The expressed by-effects did not observe at one patient.

Conclusion. monotherapy sildenafil Citrate within 1 year promotes improvement of results of treatment of the functional and subcompensated and compensated stages of organic erectile dysfunction.

ONE OF the PRIMARY GOALS of modern medicine - improvement of quality of life of the patients which integral part are harmonious sex relations. Erectile dysfunction leads to appreciable deterioration of life as men, and women [1]. Prevalence of erectile dysfunction in Usa makes at the age from 20 till 29 years — 7,2 %, from 30 till 39 years - 18,9 %, from 40 till 49 years - 37,3 %, from 50 till 59 years-53,8 %. Thus easy degree of disturbance of an erection met in 16,2 % of cases, average — in 22,5 %, serious - in 8,7 % [2] that corresponds to the results received in 1998 in known Massachusetts research on studying of ageing of men [3].

Allocate the functional, organic and admixed forms of erectile dysfunction. Organic erectile dysfunction part at a stage that corresponds to representation about a continuity of the clinical and morphological changes occurring in a cavernous tissue and tunica to a cover of cavernous bodies of a penis: I (compensated), II (Subcompensated) and III (decompensated).Such division coincides with classification of the erectile dysfunction offered H.Feldman and co-workers.(1994): minimum - it is usually capable, moderated —It is sometimes capable, full - it is never capable.

Now at I and II stages of erectile dysfunction widely apply inhibitors phosphodiesterase 5 types, including sildenafil citrate (Viagra) 50-60 minutes prior to sexual contact. At some kinds of organic erectile dysfunction, in particular the vascular and admixed forms with prevalence of a functional component, the good effect is observed even at the initial stage of III stage. However at application sildenafil Citrate by the standard technique (i.e. directly ahead of sexual contact) at an appreciable part of patients observed by us with erectile dysfunction II and III Stages in 12-18 months appeared noneffective even the maximum doses of a preparation [1].

We have established that at erection stimulation sildenafil citrate partial pressure of oxygen (P02) in a cavernous blood which during an erection is admixed is arterial-venous, reaches 78-79,5 mm hg Though this indicator slightly more low, than at erection stimulation intracavernosal introduction of vasoactive preparations (85 mm hg), but nevertheless, it testifies to good oxygenation of a cavernous blood [1]. Last has great value for synthesis Endothelial factors, such as N0 and Prostaglandinum E1 which participate in occurrence of an erection [4,5]. Besides, at high value PO2, synthesis endotelina-1 is inhibited that also promotes intensifying of an erection [4]. On the basis of this data we have stated a hypothesis that regular reception of an inhibitor phosphodiesterase 5 types will allow to improve oxygenation of a cavernous tissue and to raise efficiency of medicamental therapy of erectile dysfunction.

Studying of efficiency of long therapy sildenafil citrate at sick of erectile dysfunction at which its use 50-60 minutes prior to sexual contact has appeared not completely effective was the Research objective.

Material and methods

In 1999-2004 86 patients with erectile dysfunction, including 24 patients at the age from 32 till 57 years with functional erectile dysfunction and 62 patients at the age from 51 years till 72 years with organic erectile dysfunction have been surveyed. At 14 from 24 patients with functional erectile dysfunction diagnosed a sexual neurosis on type "failure expectations", at 4 — an asthenic syndrome, at 6 - the depressive syndrome bound to psychological and-or sexual problems. The reasons of organic erectile dysfunction were a diabetes (at 9), a hypogonadism (at 7), a sclerosis of a cavernous tissue of a penis (at 11), pathological venous dump of a blood (at 21), proctologic and urological operations (at 8), illness of Pejroni (at 6).

14 patients had I stage of erectile dysfunction (functional - at 4, organic — at 10) (tab. 1). At 60 patients with II stage of erectile dysfunction (functional — at 15, organic — at 45) initially viagra-test was positive. After reception sildenafil Citrate in the picked up dose these patients could enter sexual contact, however in the subsequent, despite augmentation of a dose of a preparation to maximum, sexual contacts were unsatisfactory. At 12 patients with III stage of erectile dysfunction (functional - at 5, organic — at 7) initial viagra-test was negative (a dose sildenafil Citrate - 100 mg).

TABLE 1. Distribution of patients with erectile dysfunction at a stage depending on results viagra-test
Results viagra-test Stages of erectile dysfunction
Functional dysfunction (n=24)
+ 25 mg + 50 mg at 4 patients I stage - 4 patients
+ 100 mg at 15 patients II stage - 15 patients
- 100 mg at 5 patients III stage - 5 patients
Organic dysfunction (n=62)
+ 50 MG at 10 patients I stage - 10 patients
+ 100 mg at 45 patients II stage - 45 patients
- 100 mg at 7 patients III stage - 7 patients

the Note: (+) - positive assay, (-) - negative

Monotherapy sildenafil Citrate continued within 1 year. Patients accepted a preparation regularly 2 once a week without dependence from sexual contacts. If after regular reception sildenafil Citrate the erection renewed, treatment continued; if necessary patients in addition accepted a preparation 50-60 minutes prior to sexual contact.

Before treatment conducted following researches:
  • Obshcheklinichesky survey.
  • Questioning on ICEF-5.
  • Questionnaire for an estimation the patient of results of monotherapy sildenafil Citrate: "excellent" — satisfactory sexual contacts 2 times a week, "good" — once a week, "satisfactory" — at occurrence of an erection without sexual contact, "unsatisfactory" - in the absence of an erection.
  • Ultrasonic doppler sonography research of vessels of a penis on apparatus "UltraMark-9" with frequency of the gauge of 7,5 MHz and "Vivid-4" with frequency of the gauge 10 MHz, Estimated basal and stimulated a blood flow. Stimulation was spent by the LOD-DEVICE by the technique developed by us (the patent of the Russian Federation for the invention №2141799 from 11/27/1999). Investigated the cavernous Arteries in phases of erection Er3-Er4 (on a scale of Junema).
    Results of researches analyzed by means of statistical package SPSS-14.
Results

Treatment sildenafil Citrate have finished 20 of 24 patients with functional erectile dysfunction and 52 of 62 patients with organic erectile dysfunction. In the course of treatment at patients arose spontaneous or an erection. If at sex stimulation after additional reception of a preparation or without it there was a sufficient erection, they entered sexual contact.

The Analysis of results of questioning under questionnaire ICEF-5 before treatment sildenafil is presented by Citrate (Viagra) to tab. 2. At functional erectile dysfunction the quantity of patients with satisfactory and normal indicators of the questionnaire has authentically increased after end of treatment with 10 (41,7 %) to 14 (70,0 %). At organic erectile dysfunction the quantity of patients with satisfactory and normal indicators also was authentically enlarged with 18 (29,0 %) to 35 (67,4 %). This data testifies to clinical efficiency long monotherapy sildenafil Citrate at functional and organic erectile dysfunction. After end of a year course of monotherapy those patients at whom results of treatment have appeared good, stopped regular reception Sildenafil Citrate and used it only before sexual contact in a combination to sex stimulation.

TABLE 2. Results of questioning in points on ICEF-5 before treatment
Kind ED n Full or
Sharp disturbance (0-5)
Expressed
Disturbance
(5-10)
Moderated
Disturbance
(10-15)
the Lung
Disturbance
(16-20)
Before treatment          
functional 24 - 4 (16,6 %) 10 (41,7 %) 6 (25 %)
organic 62 10 (16,1 %) 13 (21 %) 21 (33,9 %) 18 (29 %)
After treatment          
functional 20 - - 4 (20 %) 10 (50 %)
organic 52 2 (3,8 %) 6 (11,5) 9 (17,3 %) 19 (36,6 %)

Note: p 0,001 between groups. Have left group with functional erectile dysfunction 4 patients, with organic - 10

The Analysis of parametres basal penile a blood flow has shown (tab. 3) that after end of course of treatment at functional and organic erectile dysfunction the maximum rate of a blood flow in a systole (Vsis) was authentically enlarged on the average by 10 % in comparison with an initial indicator. The resistance index (IR) was authentically enlarged at functional and to a lesser degree at organic erectile dysfunction. The index pulsation (Pi) also was authentically enlarged by 20 % at functional and to a lesser degree at organic erectile dysfunction.

TABLE 3. Parametres of a basal blood flow in cavernous arteries of a penis before treatment at different kinds of erectile dysfunction
Kind erectile
Dysfunctions
n Vsis (sm/c) IR Pi
30-35 35-40 50-70 >1,0 0,9-0,8 <0,6 1,0-1,5 1,5-1,8 2,0-2,5
Before treatment                    
functional 24 6 (25 %) 13 (54 %) 5 (21 %) 8 (34 %) 14 (58 %) 2 (8 %) 9 (38 %) 12 (50 %) 3 (12 %)
organic 62 12 (19 %) 29 (47 %) 21 (34 %) 10 (16 %) 31 (50 %) 19 (34 %) 12 (19 %) 30 (48 %) 20 (33 %)
After treatment                    
functional 20 3 (15 %) 11 (55 %) 6 (30 %) 2 (10 %) 14 (70 %) 4 (20 %) 1 (5 %) 14 (70 %) 5 (25 %)
organic 52 8 (15 %) 25 (48 %) 19 (37 %) 8 (15 %) 24 (46 %) 20 (39 %) 4 (8 %) 27 (52 %) 21 (40 %)

Note: p 0,001 between groups. Have left group with functional erectile dysfunction 4 patients, with organic - 10. Vsis - the maximum rate of a blood flow in a systole; IR - a resistance index; Pi - an index pulsation

At comparison of parametres stimulated a blood flow before monotherapy sildenafil Citrate (tab. 4) taps blood flow augmentation in cavernous arteries of a penis on 17 % at patients with functional and on 13 % at patients with organic erectile dysfunction. Y513 in group of patients with functional erectile dysfunction it was enlarged by 19 %, and in group of patients with organic erectile dysfunction - On 12 %. KK it was enlarged by 25 % and 17 %, accordingly, and KP - on 24 % and 14 %. At the majority of patients the venous hemodynamic of a penis has improved also.

TABLE 4. Parametres stimulated a blood flow in cavernous arteries of a penis before treatment at different kinds of erectile dysfunction
Kind of erectile dysfunction n % of augmentation of a blood flow Vsis   (TRIMS.) - Vsis (bases.)
(Sm/c)
KR KP
<50 ≥50 15 20 25 0,9-1,0 0,8-0,7 ≤0,6 1,0 0,5-0,6 ≤0,6
Before treatment
functional 24 16 (67 %) 8 (33 %) 7 (29 %) 10 (42 %) 7 (29 %) 6 (25 %) 16 (67 %) 2 (8 %) 7 (29 %) 15 (63 %) 2 (8 %)
organic 62 40 (65 %) 22 (35 %) 17 (27 %) 33 (53 %) 12 (20 %) 18 (29 %) 30 (48 %) 14 (23 %) 16 (26 %) 32 (52 %) 14 (22 %)
After treatment
functional 20 10 (50 %) 10 (50 %) 2 (10 %) 11 (55 %) 7 (35 %) - 10 (50 %) 10 (50 %) 1 (5 %) 9 (45 %)   10 (50 %)
organic 52 28 (54 %) 24 (46 %) 8 (15 %) 24 (46 %) 20 (39 %) 6 (12 %) 22 (42 %) 24 (46 %) 6 (12 %) 20 (38 %) 26 (50 %)

Note: p 0,001 between groups. Have left group with functional erectile dysfunction 4 patients, with organic - 10. KR = IR (TRIMS.) / IR (bases.). KP = Pi (TRIMS.) / Pi. (Bases.)

Thus, along with substantial improvement of clinical results at long monotherapy sildenafil citrate had been reached authentic augmentation basal and stimulated a blood flow in penis arteries. For studying of opinion of patients it was offered to them to answer questions of the additional questionnaire on results of the spent treatment (tab. 5) which consisted of following questions:

  • "As you estimate results of treatment? (Unsatisfactorily, well, well, perfectly)"
  • "you can note What positive moments of this course of treatment?"
  • "you can note What negative moments of this course of treatment?"
  • "you Intend to continue course of treatment by a preparation Viagra?".

Were happy with treatment 18 (90 %) from 20 patients with functional and 30 (57,7 %) from 52 patients with organic erectile dysfunction. From advantages of a preparation speed of offensive of an erection, reliability of results and absence of complications have been noted. From the negative moments high cost of a preparation is allocated. Have agreed to continue treatment 20 (100 %) patients with functional and 35 (67,3 %) patients with organic erectile dysfunction.

The researches conducted by us have shown that at monotherapy sildenafil within 1 year good results have been reached by Citrate at 60 (83 %) from 86 patients with functional go the compensated and subcompensated stages of organic erectile dysfunction. Unsatisfactory results took place at 12 (17 %) patients. At 2 from them with an astheno-depressive syndrome, at 10 - organic erectile dysfunction, including an endocrine genesis functional erectile dysfunction has been diagnosed for 5 patients, vascular - at 4 and neurogenic — at 1. To these patients further it is spent combined a course of medicamental therapy which included application within 6 months sildenafil Citrate and Testosteron-Depotum preparations at a hypogonadism or a preparation thioctic the acids, an endoneural blood flow promoting improvement, at a diabetes.

Any complications demanding the termination of long reception sildenafil citrate, we did not observe. In single instances easily expressed undesirable reactions - a headache, dyspeptic disorders and a nausea became perceptible. Face reddening, a neck and scleras, the rhinitis phenomena is slightly more often became perceptible. The specified symptoms quickly passed without the termination of reception of a preparation and their any treatment.

Discussion

The Reached clinical improvement testifies that at a reception inefficiency sildenafil Citrate before sexual contact at patients with erectile dysfunction long monotherapy by a preparation promotes occurrence and erection deduction more effectively. Obviously, similar results are possible and at daily reception of other inhibitors phosphodiesterase 5th type [6]. When efficiency of treatment also was reached by blood flow activization in penile arteries [7].

We believe that efficiency of long reception Sildenafil Citrate is caused by authentic activization of a blood flow in penile the arteries, established by us at ultrasonic doppler.

On IX Congress of the European society of sex medicine (EOCM) which passed in December 2006 in Vienna, the question on expediency of regular reception of preparations of inhibitors phosphodiesterase 5 types for treatment of erectile dysfunction was considered. In particular, professors F.Montorzi (Italy) and G.Jackson (Great Britain) defended the point of view that regular application of inhibitors phosphodiesterase 5 types at erectile dysfunction should become the standard practice as these preparations improve function of an endothelium of a cavernous tissue and vessels, and also myocardium function. Besides, the data that regular use of these preparations can raise their efficiency at reception "on demand" has been presented. Opponents of such approach DzhDin (Great Britain) and J.Vardi (Israel) specified in necessity of additional researches on this point in question, and also have noted augmentation of cost of treatment [8].

Conclusion

Thus, monotherapy sildenafil citrate within 1 year promotes improvement of results of treatment of the functional and subcompensated and compensated stages of organic erectile dysfunction. Constant application sildenafil Citrate leads to authentic augmentation penile a blood flow at these forms of erectile dysfunction that, apparently, underlies improvement of results of treatment. The augmentation reason penile a blood flow is improvement of function of an endothelium against regular reception sildenafil that confirms its medical effect noted in works of foreign authors [10]. Good shipping of long reception sildenafil Citrate at patients with erectile dysfunction is established.

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