Article "The influence of Mexidol on the quality of life and functional status of patients with chronic cerebral ischemia and chronic heart failure with low ejection fraction"

What is the duration of treatment?

In the absence of additional risk factors, tamoxifen is prescribed for 5 years without interruption.

If at least one of the unfavorable prognosis factors is present, tamoxifen may be prescribed for up to 10 years. These factors include locally advanced breast cancer (T3-4), G3, the presence of HER2/neu expression or its amplification according to the results of the FISH reaction, a high level of Ki67, as well as the presence of pronounced lymphovascular invasion according to the results of histological examination.

Ban on tanning

Oncological diseases also have contraindications for tanning. It is worth saying more - any thermal procedures are strictly prohibited, including visiting a sauna, bathhouse, etc. But why? Let's take a closer look. So, cancer is not just a disease, it is a mutation of cells:

• cells appear in the human body with a malfunction in their program;
• because of this failure, they begin to actively and randomly divide;
• with prolonged division, malignant cells begin to appear over time;
• these malignant cells do not attach to the tumor and begin to spread freely throughout the body;
• since the cells are carried with the bloodstream, an increase in volume and speed of movement allows “bad” cells to enter other parts of the human body, growing and increasing.

As you know, on the beach, in a solarium or steam room, the speed of blood flow increases and blood vessels dilate. So if you have cancer, there is a strict taboo on visiting such places.

Is it necessary to turn off ovarian function and what does it depend on?

Tamoxifen has its effect regardless of ovarian function.

Most often, ovarian suppression - ovarian suppression - is used in the following cases:

• age up to 45 years;
• presence of unfavorable prognosis factors.

Contraindications for use

• pregnancy;
• age under 18 years (safety and effectiveness in children not shown);
• thrombophlebitis;
• hypersensitivity to the components of the drug.

Use with caution when:

• ophthalmological pathology (including cataracts);
• liver diseases;
• leukopenia, thrombocytopenia.

What are the most common side effects?

The drug affects all organs and systems. The full range of side effects is always indicated in the official instructions for the drug, which is included in each package.

We will list the most common and/or important ones:

• headache and dizziness;
• visual impairment;
• thrombophlebitis, thromboembolism;
• stomach ache;
• menstrual irregularities, bleeding or discharge from the genital tract;
• feeling of heat, hot flashes;
• endometrial hyperplasia with long-term use;
• isolated cases of endometrial cancer.

On-demand use of tadalafil for erectile dysfunction in special categories of patients

S.I. Gamidov1, 2, T.V. Shatylko3, N.G. Hasanov1, N.A. Naumov1

1 Federal State Budgetary Institution Scientific Center for Obstetrics, Gynecology and Perinatology named after. IN AND. Kulakov" of the Ministry of Health of Russia; Russia, 117997 Moscow, st. Academician Oparina, 4; 2 Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after. THEM. Sechenov Ministry of Health of Russia; Russia, 119991 Moscow, st. Bolshaya Pirogovskaya, 2, building 4; 3 Federal State Budgetary Educational Institution of Higher Education “Saratov State Medical University named after. IN AND. Razumovsky" of the Ministry of Health of Russia; Russia, 410012 Saratov, st. Bolshaya Kazachya, 112 Contacts: Taras Valerievich Shatylko

Introduction

Erectile dysfunction (ED) is one of the most common and widely discussed types of sexual dysfunction in men. Worldwide, 5–20% of men have moderate or severe ED [1]. The prevalence of ED is constantly increasing, and by 2025, according to projections, 322 million men will suffer from this disorder [2]. Despite the fact that ED as such does not affect life expectancy, it significantly worsens the quality of life not only for the patient himself, but also for his partner.

Currently, there are several treatment strategies for ED, which involve non-invasive and invasive methods. According to the recommendations of the European Association of Urology, the 1st line of therapy includes oral administration of phosphodiesterase type 5 inhibitors (PDE-5) [3]. From a chemical point of view, the IPDE-5 molecules are similar in structure to cyclic guanosine monophosphate. Therefore, they can competitively bind to phosphodiesterase and suppress the hydrolysis of guanosine monophosphate, which facilitates the development of erection [4]. Currently, a large number of drugs of the PDE-5 class are proposed, although not all of them have undergone clinical trials and have been approved by the relevant regulatory authorities. Thus, in Russia, drugs are available based on one of 4 active ingredients: sildenafil, tadalafil, vardenafil and udenafil. Their effectiveness and safety are comparable; some unprincipled differences are noted in the structure of adverse events during use [5–7].

Meta-analysis by L. Chen et al. in 2015, showed that sildenafil is characterized by the highest effectiveness and the highest frequency of adverse events, and tadalafil is characterized by average effectiveness and the minimum frequency of adverse events [8]. However, these data require revision, since the meta-analysis included all studies on these drugs. B. Gong et al. conducted a more statistically rigorous meta-analysis, including only those studies that directly compared sildenafil and tadalafil [9]. It turned out that their effectiveness is approximately the same, but patients and their partners prefer tadalafil because of its ease of administration.

An important factor when choosing a drug is its pharmacokinetics. Tadalafil is a selective long-acting PDE-5 inhibitor. Tadalafil should be taken at least 16 minutes before intended sexual intercourse. The half-life of tadalafil in healthy men is 17.5 hours, and it is this pharmacokinetic parameter that makes tadalafil attractive for the symptomatic treatment of ED. Due to its long half-life, it has the longest duration of action of any PDE-5 inhibitor, which can be up to 36 hours. The patient can attempt sexual activity at any time within 36 hours after taking the drug to determine the optimal time for response development. About 52% of patients with severe ED can successfully have sexual intercourse within 30 minutes after taking tadalafil at a standard dose [10]1.

Probably, thanks to these qualities, in the near future, tadalafil will be able to occupy the niche of the main IPDE-5 for the treatment of ED. Drugs based on it entered the market in 2003.

However, it would be wrong to assume that any one drug can be equally suitable for all patients with ED, especially considering the polyetiology and heterogeneity of this syndrome. This article is devoted to the use of tadalafil in special categories of patients with ED.

Tadalafil in patients with metabolic syndrome

There are several different definitions of metabolic syndrome, but they all include 4 features: abdominal obesity, hypertension, dyslipidemia and carbohydrate metabolism disorders. In the absence of therapy and lifestyle correction, impaired glucose tolerance can develop into type II diabetes mellitus. Treatment of ED in patients with diabetes mellitus is not an easy task due to the combination of vasculogenic and neurogenic components of the pathogenesis of ED, as well as the need to take into account the associated cardiovascular risks and the interaction of prescribed drugs with hypoglycemic agents. Despite this, on-demand tadalafil therapy was effective in patients with diabetes mellitus. We note that the effect on lower urinary tract symptoms (LUTS) in these patients was greater with 5 mg tadalafil daily, although this is not the purpose of this article. Interestingly, tadalafil also improved ejaculatory function in patients with diabetes [11]. There are indications that tadalafil reduced fat-to-muscle ratio and waist circumference in men; Presumably, this occurs due to improved insulin secretion, an increase in the number of androgen receptors and inhibition of testosterone aromatization. In addition, an improvement in endothelial function has been confirmed using the Endo-Pat2000 device [12]. Molecular cellular study by E. Maneschi et al. demonstrated that tadalafil influenced the differentiation of preadipocytes and promoted a healthy phenotype by enhancing the expression of genes characteristic of brown adipose tissue, improving mitochondrial structure and normalizing insulin sensitivity in animal models [13].

In addition, metabolic syndrome may be associated with hypogonadism. A significant decrease in testosterone levels in the blood serum can weaken libido, and this turns out to be an additional pathogenetic factor in the development of ED in metabolic syndrome. There is a hypothesis according to which a regular rhythm of sexual activity helps to normalize the level of endogenous testosterone. In a study by L. Ozcan et al. Long-term use of tadalafil increased testosterone levels in patients with ED and metabolic syndrome without hormone replacement therapy [14]. L. Maresca et al. showed that taking tadalafil and regular exercise enhanced each other's effect in patients with ED and metabolic syndrome [15].

Tadalafil in patients with chronic prostatitis or benign prostatic hyperplasia

In 2007, SJ Grimsley et al. suggested that PDE-5 may mediate relaxation of the smooth muscle of the prostate ducts, facilitating the outflow of their contents, including those that initially entered the acini due to urethral-prostatic reflux [16]. M. Kurita et al. found that PDE-5 inhibitors, in particular tadalafil, relieve chronic pelvic pain [17]. Clinically, these results were confirmed in the work of Y. Nishino et al., who examined patients with benign prostatic hyperplasia (BPH), combined with chronic pelvic pain syndrome [18]. However, the above-described effects of taking tadalafil have not yet been widely confirmed and require further study [19]. P.V. Glybochko et al. demonstrated that PDE-5 increases blood flow not only in the arteries of the penis, but also in the prostate gland [20]. This direction is considered particularly promising, since chronic prostatitis can indirectly cause the development of various sexual dysfunctions [21].

We will not touch upon the issue of daily use of tadalafil for LUTS associated with BPH, as we believe that this issue deserves a separate comprehensive discussion. However, it is known that some men with prostate adenoma can obtain a positive clinical effect from taking PDE-5 on demand [22]. In particular, this applies to patients at high risk of progression of BPH who are prescribed 5-alpha reductase inhibitors (finasteride and dutasteride). These are drugs that can reduce the volume of the prostate gland with long-term use and reduce the risk of developing acute urinary retention in older men. The mechanism of action of these drugs is to inhibit the conversion of testosterone to the active metabolite dihydrotestosterone. It is the influence on testosterone metabolism that is often explained by the characteristic adverse events associated with taking finasteride and dutasteride - the appearance of persistent ED, decreased libido and impaired ejaculation. Several studies have confirmed that tadalafil, taken on demand at a dose of 20 mg, is effective against ED in patients taking dutasteride [23, 24].

Data on the effect on erection of another class of drugs actively used for BPH, namely selective alpha-1a blockers (tamsulosin and silodosin), are contradictory. There is a controversial opinion that they have little positive effect on erectile function. In any case, there is no convincing data on the negative effects of tamsulosin and silodosin on erectile function. Consequently, the question arises about their compatibility with IPDE-5, since both classes of drugs, to one degree or another, affect the tone of the vascular walls. Studies have confirmed the safety and good tolerability of combination therapy for LUTS with tamsulosin and tadalafil, which did not increase the risk of orthostatic collapse [25, 26]. The safety and effectiveness of the combination of tadalafil with silodosin has also been proven [27].

Tadalafil for neurogenic erectile dysfunction

Neurogenic ED is the most difficult form of ED to treat conservatively. The reason is that PDE-5, included in the 1st line of therapy, causes relaxation of the smooth muscles of the cavernous bodies as a result of the accumulation of cyclic guanosine monophosphate, formed due to the action of nitric oxide (NO). If the release of nitric oxide from the nitrergic synapses of parasympathetic nerve fibers does not occur, then IPDE-5 essentially has no point of application and is obviously ineffective. Therefore, for severe types of neurogenic ED, intracavernous injections remain the only effective method of conservative treatment [1]. Nevertheless, with at least partial preservation of the innervation of the penis, IPDE-5 have a certain effectiveness, which can be explained by their ability to biochemically amplify a weak NO signal and activate endothelial NO synthase. Thus, sildenafil, tadalafil and vardenafil are effective in some patients with traumatic spinal cord injury [28], the use of other PDE-5 inhibitors in this category of patients has not been studied.

The pathogenesis of ED and concomitant sexual disorders in multiple sclerosis is very complex [29]. The effectiveness of tadalafil in multiple sclerosis has been demonstrated in several studies. G. Lombardi et al. reported good results with on-demand tadalafil 10 mg in men with ED and multiple sclerosis [30]. 1 patient developed headache during therapy, 1 patient developed tachycardia; These are expected side effects that also occur in people without neurological diseases.

Not a single case of autonomic dysregulation was reliably recorded. In a study by D. Francomano et al. The effect of tadalafil not only on erection, but also on the severity of LUTS, which often occurs in patients with multiple sclerosis, has been confirmed [31]. This study also found a change in the ratio of serum testosterone to estradiol levels with tadalafil.

The use of IPDE-5 may be effective in patients with ED due to Parkinson's disease. In patients with other pathologies of the central nervous system, the use of IPDE-5 is limited due to a possible decrease in libido, the development of endocrine disorders with damage to the hypothalamic-pituitary region, and the potential effect of drugs on the neurological status [32].

The use of tadalafil to regulate reproductive function

One of the debatable questions is how justified is the prescription of IPDE-5 to men with ED who are trying to conceive a child. On the one hand, erection is the most important component of the copulatory cycle, and without it natural conception is almost impossible. On the other hand, some experts express an opinion about the potential testicular and spermatological toxicity of IPDE-5.

Non-specific PDE inhibitors such as caffeine, pentoxifylline and theophylline are known to stimulate sperm motility in vitro. Moreover, pentoxifylline is widely used for this purpose as part of assisted reproductive technologies. The effect of these compounds on male fertility in vivo has not been proven [33].

In a study by Y. Yang et al. The effect of tadalafil on sperm motility and acrosome reaction was assessed [34]. Neither in vitro nor in vivo, tadalafil suppressed gamete motility or increased the incidence of premature acrosome activation. However, this study assessed only the immediate period after the introduction of tadalafil into the medium or after its oral administration, and therefore its results do not allow us to exclude late cumulative toxicity.

Attempts have been made to prove the positive effect of IPDE-5 on spermatogenesis. Thus, in a study by A. Corvasce et al. After 12 weeks of taking tadalafil, spermogram parameters in patients with psychogenic ED significantly improved [35], including an increase in ejaculate volume. This fact indicates that the positive effect on sperm parameters could be caused primarily by the normalization of ejaculation. As is known, phosphodiesterase type 5 is expressed in all muscle tissues of the male reproductive tract, which means that influencing the level of this enzyme makes it possible to pharmacologically regulate ejaculatory function [33].

Conclusion

The effectiveness of tadalafil depends on the etiology of ED, the presence of concomitant diseases and the nature of the therapy. Tadalafil can be used in men with diabetes and metabolic syndrome, as it has been shown to be effective in these groups of patients with ED. Tadalafil combines well with typical medications used for BPH. Tadalafil is effective in some cases for neurogenic ED, although with some limitations; Its most promising use is in spinal cord injury and multiple sclerosis. Convincing data indicating a negative effect of tadalafil on fertility has not been published, although it is also premature to draw a conclusion about its positive effect on spermatogenesis and sperm motility.

Undoubtedly, tadalafil at a dosage of 5 mg for daily use has the greatest potential among all the PDE-5 inhibitors on the market, which made penile rehabilitation after treatment for prostate cancer and single-component therapy for ED and LUTS possible. However, taking tadalafil on demand is acceptable and convenient for many men suffering from ED.

The appearance on the Russian market of a generic tadalafil – “Dynamico Long”, produced on the basis of an Israeli substance2 in compliance with modern requirements and quality standards3, may make this treatment option more accessible4 compared to the use of the original tadalafil. It is important that such treatment has a positive effect not only on erectile, but also on orgasmic and ejaculatory functions, and the long duration of the drug helps maintain spontaneity of sexual life and increases a man’s self-confidence [36, 37].

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The article was published in the journal “Andrology and Genital Surgery” issue No. 4 2021, pp. 15-20

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Andrology and genital surgery 2021 No. 4

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What are the management tactics for the development of endometrial hyperplasia?

Many people are concerned about the development of endometrial hyperplasia while taking tamoxifen, as well as the possibility of developing endometrial cancer.

The risk of developing endometrial cancer increases in the group of postmenopausal women. For other patients, this risk does not differ from the general population.

With the development of endometrial hyperplasia, discontinuation of tamoxifen is not required. In the absence of clinical manifestations of hyperplasia - bloody discharge from the genital tract, menorrhagia - separate diagnostic curettage is not necessary.

To determine the tactics of examination and treatment, you need to contact a gynecologist. After a survey, examination and carrying out the necessary instrumental research methods, the gynecologist decides to conduct a separate diagnostic curettage or dynamic observation.

Self-medication and its negative consequences

Non-traditional treatment methods at home are especially dangerous. Under no circumstances should you self-medicate. Acupuncture and manual therapy, cryo- and hirudotherapy, urine and aromatherapy - all this not only does not help, but in some cases worsens the state of health.

Only a competent and comprehensive approach will help achieve positive treatment results. Activities for intensive cleansing of the body are also prohibited. In order not to worsen the situation, you need to contact a specialized clinic.

What drugs can or cannot be taken during tamoxifen therapy?

Since the drug is taken for a very long period of time, you need to know which drugs should be taken with great caution and which are contraindicated.

Carefully:

• coumarin anticoagulant drugs - increased risk of bleeding;
• drugs that reduce calcium excretion - hypercalcemia may develop;
• selective serotonin reuptake inhibitors (antidepressants) - reducing the effectiveness of tamoxifen.

A more complete list of interactions between tamoxifen and other medications can be found in the relevant sections of the instructions for the drug on the websites rls.ru, vidal.ru and similar ones.

How can you enhance the antitumor effect of hormone therapy and achieve more lasting results?

According to research, indole-3-carbinol enhances the effect of tamoxifen against tumor cells, promoting their death, and also prevents the appearance of new cells with increased proliferative activity. This compound is the main active ingredient of Promisan, which is recommended for the correction of metabolic disorders in patients with cancer and for the prevention of the development of breast, ovarian and endometrial cancer.

Very often, patients have a question: is it possible to take Promisan during tamoxifen therapy?

If you look at the list of interactions between tamoxifen and other medications, then there are no contraindications for taking Promisan during tamoxifen therapy.

Indole-3-carbinol and epigallocatechin-3-gallate, which form the basis of Promisan, demonstrate antiproliferative effects on estrogen-dependent organs and tissues and, therefore, may represent a potential combination with hormones in the treatment of estrogen-sensitive breast cancer.

Conclusion

Oncology doctors carry out a complete diagnosis of the patient. Not only the type and location of cancer is determined, but also its prevalence. Specialists prescribe the optimal treatment method, taking into account the type of cancer and the individual characteristics of the patient’s body. Diagnosis and treatment are carried out using modern equipment. Oncology doctors provide highly qualified consultations that allow them to find answers to many questions of people diagnosed with cancer.