LOPL pacientų su sveikata susijusios gyvenimo kokybės reikšmė Raimundas Sakalauskas Pulmonologijos ir imunologijos klinika Kauno medicinos universitetas

LOPL gydymo tikslai Palengvinti simptomus Pagerinti fizinio krūvio toleravimą Apsaugoti nuo paūmėjimų ir juos gydyti Apsaugoti nuo komplikacijų ir jas gydyti Pagerinti gyvenimo kokybę Sulėtinti ligos progresavimą Užkirsti kelią mirštamumui Padeda pacientams pasiekti geresnę kasdieninių simptomų kontrolę ir išvengti gąsdinančių paūmėjimų Suteikia pacientams kiek įmanoma geresnę gyvenimo kokybę Management of COPD The GOLD guidelines recommend several goals for the effective management of COPD. These goals aim to enable patients to achieve daily control of symptoms and to avoid exacerbations, allowing them to enjoy a good quality of life and to reduce the risk of future exacerbations. Pharmacological treatments can control symptoms, improve exercise tolerance and reduce exacerbations, thus leading to improvements in health status. These goals should be reached with minimal side effects from treatment. The best pharmacological treatment is one that achieves most of these COPD management goals with the least side effects. Frequently, as the disease progresses, more than one treatment approach is often required to achieve these goals. Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006. Available from http://www.goldcopd.com/ Sumažina mirties riziką Adaptuota iš Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006. Available from http://www.goldcopd.com/ 2

Ko tikisi LOPL pacientai iš gydymo? Greitas simptomų palengvinimas 55 Kuo ilgesni tarpai tarp paūmėjimų 40 Kuo mažiau nepageidaujamų reakcijų 36 Lengviau atlikti namų ruošos darbus 27 Mažesni gydymo kaštai 27 COPD patients require effective therapies that offer rapid symptom relief Due to the growing interest in patient-centred healthcare the perception of exacerbations of chronic obstructive pulmonary disease (PERCEIVE) study, conducted by Miravitlles et al., investigated patients’ perceptions of their COPD, their exacerbations and expectations after treatment. Data were collected by telephone interview from 1100 patients from the European Union and the USA. The most frequent symptom reported was shortness of breath (78%). The most frequent complaint was that due to their COPD: ‘‘they could not complete the activities they like to do’’ (54%); 17% (187) of individuals were afraid that their COPD would cripple, or eventually kill them. After presenting a list of six items regarding expectations about treatment, 55% of patients stated that quicker symptom relief was the most desired requirement of treatment, followed by longer period between flare-ups (40%) and fewer side effects (36%) and better ability to cope with daily chores (27%). Miravitlles M, et al. Respir Med 2007;101:453–460. Mažesnės dozės 23 10 20 30 40 50 60 Pacientai (%) Interviu rezultatai iš į ES šalių ir JAV ( 1100 respondentų) Miravitlles M, et al. Respir Med 2007;101:453–460. 3

Suvokiamas sunkumas (%) Subjektyvus dusulio intensyvumo įvertinimas priklausomai nuo LOPL sunkumo (pagal dusulio stiprumą, MRC skalė) n = 216 n = 727 n = 898 n = 517 n = 639 n = 210 100 80 Lengva LOPL Vid.sunkumo LOPL Sunki LOPL 60 Suvokiamas sunkumas (%) 40 Although the self-reporting of moderate and severe disease increases with the degree of breathlessness, many COPD patients underestimate the severity of their disease. Of those patients scoring 3, 4, or 5 on the MRC dyspnea scale, 75.2%, 60.3%, and 35.8% of these patients, respectively, rated their disease as either mild or moderate. 20 1 2 3 4 5 MRC skalė Rennard et al. Eur Respir J 2002; 20:799-805

Ankstyvas sergančiųjų LOPL fizinio aktyvumo apribojimas LOPL pacientai daug mažiau aktyvūs palyginti su to paties amžiaus sveikais žmonėmis Šis aktyvumo apribojimas ryškus visose GOLD stadijose 100 80 60 Ėjimo laikas (min.) 40 20 Patients with COPD are notably less active compared with healthy individuals. The study by Pitta and colleagues evaluated walking time using an accelerometer in healthy normal subjects and subjects with COPD. The investigators observed that even in patients with mild and moderate COPD, the amount of time spent walking each day is approximately half that of healthy individuals. In many patients, the unpleasant experience of dyspnea during exertion causes them to alter their participation in routine physical activities. For example, a person may choose to take an elevator rather than climb a single flight of stairs. This reduced activity, in turn, perpetuates a cycle of reduced aerobic activity that leads to deconditioning, reduced exercise tolerance, and further increases in dyspnea. Sveiki GOLD I ir II FEV1 65% GOLD III FEV1 38% GOLD IV FEV1 25% Pitta F. et al. Am J Respir Crit Care Med 2005; 171:972-977

aktyvumo pokyčiai (min.) Fizinio aktyvumo pokyčiai kasdieniame gyvenime: vyresnio amžiaus LOPL pacientai vs vyresnio amžiaus sveiki žmonės 80 * * 60 40 20 aktyvumo pokyčiai (min.) LOPL pacientų fizinio -20 Ėjimas (min) Stovėjimas (min) Sėdėjimas (min) Gulėjimas (min) -40 * -60 The physical activities of daily life of COPD patients differ significantly from healthy age-matched controls. Pitta and colleagues measured activity in COPD patients using accelerometers (devices that measure movement). They demonstrated that COPD patients are less active than their healthy counterparts, spending less time walking (37 minutes) and standing (104 minutes) each day than healthy-age matched controls. Additionally COPD patients spent 68 minutes longer sitting and 58 minutes longer lying each day compared with the control group. This study objectively demonstrates how COPD limits participation in daily activities. -80 -100 * * p < 0,05 -120 Pitta F. et al. Am J Respir Crit Care Med 2005; 171:972-977

LOPL sergančių pacientų veiklos apribojimas (2500 pacientų apklausa) Miego sutrikimai Prausimasis/maudymasis Lovos klojimas Namų ruošos darbai Pasivaikščiojimas Darbas sode Lipimas laiptais 52 55 Reikšmingumas 59 65 68 75 COPD has a tremendous impact on the daily activity of those that suffer from it. Dyspnea, a major symptom of COPD, renders patients incapable of conducting simple life tasks to which we are all normally accustomed. Limitation of activity can be divided into those that are essential to normal daily life (ie, washing, dressing, climbing stairs) and those that restrict social functioning and recreation (ie, gardening, socializing with friends). According to the British Lung Foundation survey over 50% of COPD patients have difficulty washing/bathing and 79% have difficulty climbing stairs. Reference: Jones PW. Chapter 31: Health Status. In: Calverley PMA, MacNee W, Pride NB (eds). Chronic Obstructive Pulmonary Disease, 2nd edition. London: Arnold; pp.479-489. 79 25 50 75 100 Taip (proc.) n = 2500 Jones PW. Chapter 31: Health Status. In: Calverley PMA, MacNee W, Pride NB (eds). Chronic Obstructive Pulmonary Disease, 2nd edition. London: Arnold; pp.479-489.

LOPL paūmėjimų dažnis ir sunkumas Vidutinio sunkumo – sunki LOPL Lengva LOPL (ISOLDE tyrimas) Vidutinio sunkumo – sunki LOPL (Kopenhagos miesto plaučių tyrimas) 30 30 25 25 20 20 Pacientai % Pacientai % 15 15 10 10 COPD is often associated with exacerbations which are acute onset worsening of symptoms, above those experienced normally, and require additional therapy. At least one exacerbation a year is experienced by 50% of the patients with mild COPD. As COPD becomes more severe – that is, as lung function (FEV1) progressively declines, exacerbations become more frequent. Approximately 60% of COPD patients experiencing this severity of disease experience from 1 to 4 exacerbations a year. Decreased lung function can determine susceptibility to the frequency and severity of exacerbations. 5 5 0-1 1-2 2-3 3-4 4-6 6-8 >8 0-1 1-2 2-3 3-4 4-6 6-8 >8 Paūmėjimų dažnis / metus Paūmėjimų dažnis / metus Jones PW et al. Eur Respir J. 2003; 21:68-73

Simptomų palengvėjimo laikas po LOPL paūmėjimo 70 Dusulys 60 50 sustiprėjusiu dusuliu (proc.) Paūmėjimai su 40 30 Negrįžimas į pradinę būklę 35 dieną : 20% 91 dieną : 4,6% 20 Several studies have shown that some of the symptoms of exacerbations may persist for a number of weeks. As an example, in this study performed with the East London Group, dyspnea had not returned to baseline values in 20% of patients after 35 days following the onset of the exacerbation. Exacerbations take a major toll on COPD patients. They are debilitating and must be prevented. Once an exacerbation occurs, it should be treated (see GOLD guidelines) to minimize the severity and the duration so that patients can hopefully return to their own pre-exacerbation lifestyle, which is not always possible. 10 -15 -10 -5 5 10 15 20 25 30 35 Dienos Prospektyvinis tyrimas: 504 vidutinio sunkumo ir sunkūs paūmėjimai (101 pacientas) Seemungal et al. AJRCCM 2000; 161:1608-1613

Su sveikata susijusi gyvenimo kokybė: pasiskirstymas pagal LOPL sunkumą 84 72 Bloga 60 p < 0,01: 0 - III / IV I - III / IV II - III / IV 48 SGRQ bendrasis balas 36 24 A clear correlation exists between the severity of COPD, according to the Global Initiative for Obstructive Lung Disease (GOLD) stage (older classifications), and health status, assessed using the St George’s Respiratory Questionnaire (SGRQ) total score. Clinically significant differences (>4 points) were observed between each stage of the disease, with the exception of stage 0 (patients at risk for COPD) to stage I (patients with mild COPD). Quality of life becomes worse as COPD becomes more severe. Of note, the study characterized patients according to earlier criteria for staging of COPD severity. Stages I, IIa, IIb, III correspond to present stages II, III, and IV. 12 Gera I II III IV GOLD stadijos Antonelli-Incalzi R. et al. Eur Respir J 2003; 22:444-449

greičiau nusiprausti ir apsirengti ir nesustodami užlipti laiptais Kliniškai reikšmingas sveikatos būklės pagerėjimas reiškia, kad pacientai gali: greičiau nusiprausti ir apsirengti ir nesustodami užlipti laiptais eiti apsipirkti ar priimti svečius Benefits of a clinically important improvement in St George’s Respiratory Questionnaire (SGRQ) score Analysis of health status data through “back calculating” changes in the health status score has enabled clinical scenarios to be developed that illustrate the type of changes that may occur following effective treatment. The threshold for a clinically significant change is 4 points of the SGRQ score. A 4-point change in SGRQ score corresponds to, for example, a patient who returns a few weeks after the prescription of a new treatment to report that he or she no longer takes so long to wash or dress, can now walk up stairs without stopping, and is now able to leave the house for shopping or entertainment. A 4-unit improvement in the SGRQ score would only occur if the patient reported all three improvements. Jones PW. Eur Respir J 2002;19:398–404. Jones PW. Eur Respir J 2002;19:398–404.

Pagrindiniai klausimai gydymo poveikio LOPL simptomams įvertinti PAGRINDINIAI KLAUSIMAI, LEIDŽIANTYS ĮVERTINTI GYDYMO EFEKTYVUMĄ Ar jaučiate skirtumą paskyrus šį gydymą? Ar lengviau kvėpuojate? Ar galite atlikti veiksmus, kurių iki šiol negalėjote, arba tuos pačius veiksmus atliekate greičiau? Ar mažiau dūstate užsiimdami kasdienine veikla? Ar pagerėjo Jūsų miegas? Kasdieninėje praktikoje neįmanoma visų LOPL sergančių pacientų būklės įvertinti pagal SGRQ. Tad, kaip nustatyti gydymo poveikį LOPL pacientams kasdieninėje praktikoje? Šie 5 klausimai yra tinkamas ir paprastas įrankis. “Jei pacientas pastebi pagerėjimą, tai yra kliniškai reikšminga” Jones PW, et al. Thorax 2001;17:368–373.

Gydant sergančius LOPL Symbicort pasiekiamas žymus gyvenimo kokybės pagerėjimas Budezonidas Formoterolis –1 –2 –3 Vidut. SGRQ pokytis (balais) –3.0 * –4 † –4.1 ** –5 –6 ***p<0.001, **p<0.01, *p<0.05 vs placebo FIGURE 13- GROUPED VERSION –7 p=0.001 Symbicort vs Budesonide –8 –7.5 *** p=0.014 Symbicort vs Formoterol † pacientui kliniškai reikšmingas pokytis Calverley PM and all. Am. J. R. Cr. M. 2003.

LOPL pakopinis gydymas Lengva Vidutinio sunkumo Sunki Labai sunki Vengti rizikos veiksnių; vakcinacija nuo gripo Pridėti trumpai veikiančius bronchodilatatorius pagal poreikį Skirti nuolatinį gydymą vienu ar keliais ilgai veikiančiais bronchodilatatoriais Taikyti reabilitaciją Pridėti inhaliuojamuosius gliukokortikosteroidus, jei kartojasi paūmėjimai Taikyti ilgalaikę O2 terapiją, jei yra LKN Svarstyti chirurginio gydymo galimybę