SF-36 QUESTIONNAIRE AS THE INSTRUMENT OF THE LIFE QUALITY ASSESSMENT IN PATIENTS WITH DIABETES MELLITUS TYPE 2

Today diabetes mellitus (DM) significantly reduces the parameters of the life quality of patients. Therefore, the life quality assessment is current and promising direction of medicine, which allows to determine a reasonable method of treatment. The aim of this study was the use of SF-36 questionnaire for determining the quality of life of patients with T2DM when applying different schemes of pharmacotherapy. The research objectives are: 1) carrying out retrospective analysis of medical histories and treatment sheets of T2DM patients in hospital environment; 2) carrying out frequency analysis of the treatment regimens used; 3) analysis of patients included in the study; 4) carrying out the survey by a nonspecific SF-36 questionnaire; 5) determination of the quality of life in T2DM patients. The research object is the quality of life in T2DM patients in hospital environment. The research methods were retrospective, frequency analysis, life quality assessment by a nonspecific SF-36 questionnaire. The pharmacoeconomic research included 2 groups of patients: the first group (25 patients) received the combination of metformin+gliclazide (43.1% of cases), the second one (56 patients) received the combination of metformin + glimepiride (16%). Patients did not significantly differ from all of the parameters analyzed, and it enabled to compare their quality of life. The life quality parameters were assessed by a nonspecific SF-36 questionnaire. When studying the life quality in patients with the metformin + gliclazide scheme the average physical health component was 24.64±0.63 and the average mental health component was 25.24±0.78; in patients with the metformin + glimepiride scheme the average physical health component was 23.89±1.1 and the average mental health component was 24.37±0.55. These results indicate that the quality of life in patients is fairly low and does not depend on the pharmacotherapeutic scheme used, obviously it is due to the severity of the T2DM course and the presence of complications. The quality of life in patients according to the physical and mental components has fairly low indicators irrespective of the pharmacotherapeutic scheme used.

At present diabetes mellitus (DM) acquires the status of non-infectious epidemic that affects all society. DM complications reduce the parameters of the life quality of patients significantly and constitute the greatest danger [5].Taking into account that the last World Health Organization programme activities are directed to improvement of the life quality of patients by improving the quality of diagnosis and treatment of chronic diseases [4] the need to study the quality of life in clinical practice, in particular in endocrinology, becomes clear. Today the life quality assessment is a promising direction of medicine which allows to determine a reasonable method of treatment [1].
The aim of this study is the use of SF-36 questionnaire for determining the quality of life of patients with T2DM when applying different schemes of pharmacotherapy.
The research objectives are: 1) carrying out retrospective analysis of medical histories and treatment sheets of T2DM patients in hospital environment; 2) carrying out frequency analysis of the treatment regimens used; 3) analysis of the patients included in the study according to certain parameters (age, gender, body mass index (BMI), fasting plasma glucose (FPG) on admission, duration of disease of T2DM) in the context of drug regimens; 4) carrying out survey of T2DM patients in hospital environment by a nonspecific SF-36 questionnaire; 5) determination of the quality of life in patients with the most commonly used treatment regimens.
The research object is the quality of life in T2DM patients in hospital environment.
The research methods are: 1. retrospective analysis; 2. frequency analysis; 3. the life quality assessment by a nonspecific SF-36 questionnaire.

Materials and Methods
To select the most frequently used drug regimens the frequency analysis of all (599) medical histories and treatment sheets of T2DM patients included in this study was conducted. Selection of treatment regimens was carried out by endocrinologists. Аll patients treated in 2011-2012 in the Vinnytsia Regional Clinical Endocrinology Clinic (VRCEC) were included in the study.
As a result of frequency analysis it was found that the following schemes of pharmacotherapy were the most frequently used: metformin+glimepiride in 43.1% of cases, gliclazide+metformin -in 16% of cases, metformin monotherapy -in 15.5% of cases. Treatment was applied for all patients according to the state standard for management of T2DM patients [8], including monotherapy and combination therapy. The above pharmacotherapy schemes were used for 445 patients. Other 144 patients received various pharmacotherapeutic schemes at a frequency from 0.2% to 8% (Figure).
The pharmacoeconomic research included 81 patients on the combined pharmacotherapy: the first group (25 patients) received the combination of metformin + gliclazide, the second one (56 patients) received the combination of metformin + glimepiride.
Patients of the first and second groups received different pharmacotherapy and did not significantly differ by all of the parameters analyzed, and it enabled to compare their quality of life in the context of the treatment schemes selected (Tab. 1).
There were 41 mеn and 40 women among the respondents, the average age was 57.9±0.87 years (from 35 to 76 years old). All patients had complications of T2DM. For example, in the 1 st group retinopathy was observed in 66.7% of patients, angiopathy -in 98%, neuropathy -in 97%, nephropathy -in 19%, cardio-vascular complications -in 83%. In group 2 of patients retinopathy was found in 45%, neuropathy -in 91% angiopathy -in 88.8%, nephropathy -in 17.4%, cardiovascular complications -in 91.5%. All patients received treatment according to standard management of patients with T2DM [2].
Parameters of the life quality of patients were assessed by a nonspecific SF-36 questionnaire recommended by Ware J.E., Kosinski M., Keller S.D. Statistical analysis of information was carried out by means of the instructions prepared by Evidens company that deals with clinical and pharmacological investigations [3,7]. A nonspecific SF-36 questionnaire was adapted for the study groups of patients with different chronic diseases [6,8].
Questions of the questionnaire were grouped into eight scales. The scales were grouped into two indicators "physical health component" and "mental health component". The physical health component scale includes the following items: physical functioning, rolephysical functioning, body pain, general health. As for the mental component of health it includes the following items: vitality, social functioning, role-emotional, mental health. Indicators of each scale vary between 0
When assessing the general state it has been found that 68% of patients (55 patients) suggest to be "more prone to disease than others"; 83% of patients (67 patients) consider "their health is not worse than in most of their friends"; 98% of patients (79 patients) are "waiting for health deterioration" and 98% of patients (79 patients) consider the statements about their "excellent health" to be "incorrect" (Tab. 2).
Thus, the study has shown that physical functioning is "greatly limited" in 61% of patients (49 patients); role functioning "causes the difficulties" in 82% of patients (66 patients); "very strong" and "strong" pain is felt by 56% of patients (45 patients); in 65% (53 patients) pain "prevents the regular work"; 41% of patients (33 patients) have reported that their health is "poor"; 98% of patients (79 patients) expect "health deterioration" and consider the statement about their "excellent health" to be "incorrect".
When assessing the mental health component the vitality, social functioning, role-emotional and mental health were studied. In the study of vitality it has been found that 70% of patients (57 patients) "are rarely vigorous", 73% of patients (59) "rarely feel full of strength and energy", 88% of patients (71 patient) "always feel exhausted" and 89% of patients (72 patients) "always feel tired" (Tab. 3).
The study of social functioning has shown that in 27% of patients (22 patients) "their physical and emotional state is very serious obstacle to spend time with the family"; in 29% of patients (24 patients) it hin-  ders "very much"; in 34% of patients (28 patients) it interferes "moderately"; in 9% of patients (7 patients) it "bothers a little"; in 1% of patients (1 patient) -"it doesn't bother at all". The physical and emotional health prevents from active communication with people "all the time" in 38% of patients (31 patients), "most of the time" -47% of patients (38 patients), "sometimes" -12% of patients (10 patients), "rarely" -3% of patients (2 patients), "never" -0% of patients (0 patients).
The study of role-emotional functioning has shown that "there are difficulties in usual daily activities" in 86% of patients (70 patients), "there are no difficulties" -in 14% of patients (11 patients).
Hence, it has been found that 70% of patients (57 patients) "are seldom vigorous"; "the physical and emotional health interfers to spend time with the family very much" in 56% of cases (45 patients) and "actively communicate with people most of the time" in 85% of patients (69 patients); role functioning "causes difficulties in usual daily activities" in 86% of patients (68 patients); 79% (64 patients) are "very nervous all the time"; 67% (54 patients) "feel depressed all the time".
In the study of the quality of life in patients with pharmacotherapeutic scheme 1 the average physical health component was 24.64±0.63 and the average mental health component was 25.24±0.78; in patients with pharmacotherapeutic scheme 2 the average physical health component was 23.89±1.1 and the average mental health component was 24.37±0.55.
Thus, these results indicate that the quality of life in patients is fairly low and does not depend on the pharmacotherapeutic scheme used, obviously it is due to the severity of the T2DM course and the presence of complications. CONCLUSIONS 1. It has been found in frequency analysis that among the patients included in research the following schemes of pharmacotherapy are used the most frequently: metformin + glimepiride in 43.1% of cases and gliclazide + metformin in 16% of cases.
2. When comparing groups of patients received different pharmacotherapy it has been found that patients do not significantly differ from all of the parameters analyzed.
3. The survey conducted among 81 patients by SF-36 questionnaire has revealed the low indicators of the life quality of patients according to the physical and mental components irrespective of the pharmacotherapeutic scheme used.