Conservative Treatment of Patients with Chronic Venous Insufficiency in Varicose Disease of the Lower Extremities in Outpatient Settings

The dissertation is devoted to improving the effectiveness of outpatient treatment of chronic venous insufficiency (CVI) in patients with varicose disease of the lower extremities (VDLE) by means of contemporary conservative therapy. The work aims to fill the gap in knowledge regarding the age-related features of CVI course, the dynamics of blood coagulation parameters, and the quality of life of patients receiving treatment outside the hospital. Particular attention is paid to a comparative analysis of the effect of conventional topical therapy, Detralex monotherapy, and the combination of Detralex with Cardiomagnyl on the edematous and pain syndromes, hemostasis parameters (fibrinogen, PTI), as well as on the quality of life of patients in different age groups.

The practical significance of the study consists in substantiating a differentiated approach to the conservative management of patients with early stages of CVI (C2-C5, 2-3 degree according to the Russian consensus) in polyclinic settings using venotonics and antiplatelet agents. The obtained results have been introduced into the clinical practice of the Municipal Polyclinic No. 10 in Tyumen, the multidisciplinary clinic of the Tyumen State Medical Academy, and into the educational process of the Department of Hospital Surgery.

The relevance of the problem is determined by the high prevalence of chronic venous insufficiency (CVI) arising from venous pathology, as a rule, against the background of varicose disease of the lower extremities (VDLE). It occurs in 45-63% of people of working age (Khanevich M.D. et al., 2003; Labropoulos N., 2004; Petukhov V.I., 2006).

A considerable number of works devoted to this problem consider it predominantly from the standpoint of complicated ulcerative lesions of the skin of the lower extremities, as well as inpatient and surgical treatment (Belyaev M.V. et al., 2007).

The most radical method for eliminating phlebohypertension is considered to be surgical intervention. At the same time, according to the literature (Kiriyenko A.I., Bogachev V.M., 2007), surgical intervention is indicated in only 10-15% of patients; it is contraindicated in elderly and senile individuals with severe concomitant diseases and in cases of deep vein valve incompetence. In addition, the recurrence rate in the postoperative period is rather high, reaching 40% (Zolotukhin I.A. et al., 2007). In this regard, conservative treatment acquires great importance, as it is practically the main therapeutic means that improves the patient's quality of life (Stoyko Yu.M. et al., 2001).

Only isolated works have studied the issues concerning the correction of phlehemodynamics and the reduction of the severity of CVI manifestations in outpatient settings (Ivanov E.V., 2006), taking into account the age of the patients (Nizamov F.Kh. et al., 1999). And only a very small number of studies provide data on changes in the blood coagulation system, its age-related dynamics during treatment, and the use of antiplatelet drugs to reduce the manifestations of CVI.

Given the fact that surgical intervention is indicated in only 10-20% of patients, there is a need to develop tactics for conservative management using topical and systemic agents for such patients in outpatient settings (Nizamov F.Kh. et al., 2003).

The assessments of the quality of life of patients with VDLE complicated by CVI reported in the literature are generally performed after surgical and inpatient treatment and in complicated forms of the disease. At the same time, the overwhelming majority of patients undergo treatment in polyclinic settings. The number of works covering the quality of life of patients with venous pathology receiving conservative treatment is also insignificant.

Despite the large number of studies devoted to chronic venous insufficiency (CVI), many aspects of the problem still remain insufficiently studied. The proposed algorithms for choosing a treatment method take into account either various options of surgical intervention, or are devoted to the analysis of severe forms with skin lesions of the lower extremities in the form of trophic venous ulcers. There are no methods of a differentiated approach to the treatment of milder degrees of this pathology in outpatient settings. At the same time, adequate outpatient care for the population has been designated as one of the priority tasks of the National Project "Health".

The problems of CVI are discussed annually at conferences and symposia with the participation of leading domestic and foreign scientists, where, predominantly, the issues of inpatient and surgical treatment are considered (Burleva E.P. et al., 2003; Bogachev V.Yu. et al., 2004; Belyaev M.V. et al., 2007).

Chronic venous insufficiency is not an independent nosological entity, but a symptom complex (syndrome) that arises in a number of diseases, is their consequence, and is characterized by stagnation or distortion of blood flow in the system of the vena cava, primarily of the lower extremities (Saveliev V.S. et al., 2001; Khanevich M.D. et al., 2003). In recent years, the question of the significance of aggregation of formed blood elements and their adhesion to the vascular wall with the development of the process called platelet-leukocyte-endothelial aggression has been actively discussed (Petukhov V.I., 2006; Magomedov M.S., 2008). Varicose and post-thrombotic diseases are the most common causes of CVI development, while angiodysplasias (Klippel-Trenaunay syndrome, F. Parkes Weber-Rubashov disease) account for no more than 1% (Servelle M., 1985).

In Russia, up to 35% of the working-age population of large cities and more than 50% of pensioners suffer from CVI (Khanevich M.D. et al., 2003). There are isolated works devoted to the study of the influence of age and disease duration on the course of CVI (Kabirov A.V. et al., 2007).

At the same time, the absolute majority of such patients should be treated in outpatient settings; however, they practically do not receive such treatment. According to the consolidated data of V.I. Petukhov (2006), the number of untreated patients with manifestations of CVI on the background of varicose disease reaches 56.9%, and another 29.3% receive only episodic treatment.

Chronic venous insufficiency leads to a sharp decrease in the quality of life (Franks P.J., Moffatt C.J., 2001; Intcertov M.A., 2005; Ivanov E.V., 2006; Menyaylenko O.Yu., 2008). In the few works devoted to the study of quality of life in CVI patients, its changes after various types of surgical treatment were considered (Chukin S.A., 2004; Intcertov M.A., 2005). At the same time, the question of the quality of life of CVI patients receiving treatment in outpatient settings remains open.

The pathogenesis of chronic venous insufficiency is very complex and includes, along with other factors, disorders of hemocoagulation and fibrinolysis (Dormandy A., 1997). Some hemostasis parameters can serve as markers of CVI severity and assist in predicting the correction of phlehemodynamic disorders (Blomgren L. et al., 2001). At the same time, there are very few studies concerning the dynamic assessment of changes in hemostasis parameters in CVI patients.

For a long time it was believed that CVI treatment should be surgical; it mainly consists in eliminating vertical and horizontal reflux through perforating and communicating veins (Krishtopov A.P. et al., 2006). However, practice shows that even a brilliantly performed operation does not guarantee a complete cure of CVI, nor does it always prevent further progression of the disease. This indicates the need for an integrated approach to CVI treatment using modern venotonics in combination with modern anticoagulants and antiplatelet agents. In addition, there is a significant number of patients who categorically refuse to undergo any kind of surgery (Petukhov V.I., 2003). The literature contains indications of the expediency of the widespread use of non-surgical methods of treatment: first, the desired result can often be achieved by non-surgical means; second, prevention of further disease progression is impossible without the help of conservative agents (Kiriyenko A.I. et al., 2003).

As pointed out by C.J. Moffat and P.J. Franks (2004), to date there is no unified tactics for the treatment of CVI that has developed on the basis of peripheral vein diseases in the early stages of the disease, especially in polyclinic settings, taking into account the age-related features of the disease course. In the domestic literature there are practically no works devoted to the assessment of the quality of life of patients with early stages of CVI, without ulcerative complications from the skin and receiving treatment in outpatient settings. In a small number of works, mainly of a thesis-like character, fragmentary data are given on changes in blood coagulation parameters in the age aspect and their dynamics during treatment. There are no pathogenetically substantiated methods of CVI treatment that could be used in outpatient-polyclinic settings. The foregoing statements formed the basis of the present work.

The aim of the study is to improve the results of outpatient treatment of patients with chronic venous insufficiency in varicose disease of the lower extremities by means of modern topical and systemic conservative treatment.

Research objectives

1. To carry out a comparative analysis of the dynamics of changes in blood coagulation system parameters, edematous and pain syndromes in patients of different age periods with early (C2-C5, 2-3 degree according to the Russian consensus) stages of chronic venous insufficiency.

2. To compare the dynamics of fibrin content and PTI under different variants of conservative treatment of chronic venous insufficiency in outpatient settings.

3. Based on the dynamics of edematous and pain syndromes, to substantiate the criteria for the use of the combination of Detralex and Cardiomagnyl for the correction of phlehemodynamics in the treatment of chronic venous insufficiency in varicose disease of the lower extremities in patients of various ages.

4. To study the quality of life of patients of different age periods with chronic venous insufficiency in varicose disease of the lower extremities.

Scientific novelty of the work.

For the first time, the dynamics of fibrinogen content and PTI in peripheral blood, changes in edematous and pain syndromes in different age periods before, during and after a course of traditional topical and modern systemic treatment with venotonics in combination with antiplatelet agents have been demonstrated. The possibility of correcting phlehemodynamics in patients with CVI of 2-3 degree on the basis of varicose disease by the combination of Detralex and Cardiomagnyl has been proved, which is especially indicated in elderly and senile age. For the first time, the quality of life of patients with uncomplicated forms of CVI in varicose disease who received systemic and topical treatment in outpatient settings, as well as the characteristics of different age groups, has been studied.

Practical and theoretical significance.

The obtained results expand and supplement the information on the pathogenesis of chronic venous insufficiency of 2-3 degree that has developed in varicose disease. The necessity of determining the content of fibrinogen and PTI and the dynamics of their changes related to age and during treatment for assessing the achievement of CVI compensation has been substantiated. A differentiated approach to CVI treatment, taking into account the age-related features of the blood coagulation system in polyclinic settings, makes it possible to obtain a longer remission, reduce the periods of disability and significantly improve the patients' quality of life.

Main propositions submitted for defense:

1. The use of treatment with the combination of Detralex and Cardiomagnyl leads to a decrease in blood coagulation system parameters and provides the possibility of achieving regression and significantly reduces the edematous and pain symptoms, especially in senile and elderly age.

2. Treatment of patients with chronic venous insufficiency in varicose disease of the lower extremities with the combination of Detralex and Cardiomagnyl leads to a twofold improvement in the quality of life.

Approval of the research results.

The results of this work were reported and discussed at the All-Russian Scientific and Practical Conference "Current Issues of Phlebology" (Barnaul, 2007), the Scientific and Practical Interregional Conference dedicated to the 40th anniversary of the Department of Hospital Surgery of the Tyumen State Medical Academy (Tyumen, 2007), and at the Scientific and Practical Conference "Current Problems of Endoscopic Surgery" (Tyumen, 2008).

Publications on the topic of the dissertation. On the topic of the dissertation, 7 printed works have been published, of which 4 are in peer-reviewed central journals.

Implementation of the results.

The results of the study have been implemented in the practice of the Municipal Polyclinic No. 10 in Tyumen, the multidisciplinary clinic of the Tyumen State Medical Academy, and are used in the teaching work of the Department of Hospital Surgery of the Tyumen State Medical Academy.