PROCENA EFIKASNOSTI KORTIKOSTEROIDNE TERAPIJE KOD LUMBALNOG RADIKULARNOG BOLA

Abstract

Značaj istraživanja tretmana lumbalnog bola proizilazi iz činjenice da ovaj sindrom predstavlja vodeći uzrok godina proživljenih sa invaliditetom na globalnom nivou. Nedovoljna efikasnost aktuelno dostupnih tretmana dovodi do potrebe za konstatnim naporima u pronalaženju modaliteta lečenja koji bi doprineo boljem kvalitetu života osoba pogođenih ovim stanjem. Ciljevi aktuelnog istraživanja su uključivali utvrđivanje efikasnosti lečenja lumbalnog radikularnog bola korišćenjem standardne konzervativne terapije (bez kortikosteroida), zatim korišćenjem kombinacije standardne konzervativne i kortikosteroidne terapije, kao i poređenje efikasnosti ove dve vrste tretmana. Disertacija je konstruisana kao opservaciono prospektivno istraživanje efikasnosti dva modaliteta lečenja pacijenata sa dijagnozom lumbalnog radikularnog bola u okviru Klinike za neurologiju Kliničkog centra Vojvodine u Novom Sadu u periodu od 2015. do 2022. godine. Ispitivanje je odobreno od strane Etičkog odbora Kliničkog centra Vojvodine. U istraživanje je uključeno 152 bolesnika sa dijagnozom lumbalnog radikularnog bola koji su zadovoljili uključujuće kriterijume. Na početku istraživanja tj. pre administriranja terapije, zatim nakon sedam dana od administriranja terapije, nakon tri i nakon šest meseci od administriranja terapije sprovođeno je ispitivanje korišćenjem skala kliničke procene Osvestri indeks onesposobljenosti (Oswestry disability index) i Numerička skala procene bola (Numerical rating scale) i prikupljani su odgovarajući sociodemografski i medicinski podaci. Ispitivanje odnosa nezavisnih varijabli je rađeno neparametarskim Man-Vitnijevim (Mann-Whithey) testom koji je zamena za t-test kada nemamo normalnu raspodelu. Ispitivanje odnosa zavisnih obeležja je rađeno neparametarskim Vilkoksonovim (Wilcohon) testom. Testirane su hipoteze o jednakosti verovatnoća dve populacije. Za obradu podataka korišćen je licencirani softver “Statistica V 14.0”. Uzorak čine 152 ispitanika sa dominantnim učešćem osoba ženskog pola (64%). Prosečna starost ispitanika je 54 godina. Utvrđeno je da su ispitanici koji su u istraživanju koristili kombinaciju konzervativne i kortikosteroidne terapije statistički značajno kraće bili bolnički lečeni sa nivom značajnosti p<0.005. Rezultati istraživanja ukazuju da ne postoji statistički značajna razlika u inicijalnom intenzitetu bola i stepenu onesposobljenosti mereno skalama kliničke procene u odnosu na pol, zaposlenost i komorbiditete pre započinjanja medikamentoznog tretmana. Rezultati istraživanja ukazuju da inicijalno ne postoje statistički značajne razlike u nivou bola i stepenu onesposobljneosti između muškaraca i žena, zaposlenih i nezaposlenih, pušača i nepušača, pacijenata sa hipertenzijom i bez hipertenzije, pacijenata sa hroničnom lezijom sa aktuelizacijom i sa akutnom, te pacijenata sa levostranim i desnostranim neurološkim nalazom. Ono što je značajno jeste da je dokazano da su oba ispitivana terapijska protokola dovela do statistički značajne redukcije akutnog bola i stepena onesposobljenosti nakon 7 dana od primenjene medikamentozne terapije, bez obzira na protokol lečenja. Statistički značajne razlike nakon 7 dana od primene medikamentozne terapije pokazuju da su registrovani nivo bola i stepen onesposobljnosti pri primeni terapije koja je uključivala kortikosteroide statistički značajno niži od onih registrovanih pri primeni konvencionalne terapije NSAIL. U trećoj ispitivanoj vremenskoj tačci tj. nakon 3 meseca od osnovne posete statistički značajno manji nivo bola i onesposobljenosti se pojavljuje u grupi tretiranoj kortikosteroidnom terapijom i kod postojanja faktora rizika (pušenje). Nakon 6 meseci od osnovne posete registrovani nivo bola i onesposobljenosit pri primeni protokola koji je uključivao kortikosteroidnu terapiju je statistički značajno niži od onih registrovanih pri primeni konvencionalne terapije. Intenzitet bola u sva tri ispitivana vremenska perioda bio je niži u grupi u kojoj je korišćena kortikosteroidna terapija, ali da se izraženost tih razlika s protokom vremena smanjuje. Aktuelno istraživanje pokazuje da sistemski korišćeni kortikosteroidi mogu biti efikasni u tretmanu lumbalnog radikularnog bola. Potrebna su dalja istraživanja primene sistemske kortikosteroidne terapije u redukciji intenziteta lumbalnog radikularnog bola kako bi se odredila optimalna doza i trajanje ovakvog tretmana. Pored samog praćenja intenziteta bola potrebno je razjasniti efekte primene sistemskih kortikosteroida na kvalitet života, dugoročne ishode i neželjene efekte.

The importance of research into the treatment of low back pain stems from the fact that this syndrome is the leading cause of years lived with disability globally. The insufficient effectiveness of currently available treatments leads to the need for constant efforts in finding treatment modalities that would contribute to a better quality of life for people affected by this condition. The goals of the current research included determining the effectiveness of treating lumbar radicular pain using standard conservative therapy (without corticosteroids), then using a combination of standard conservative and corticosteroid therapy, as well as comparing the effectiveness of these two types of treatment. The dissertation was constructed as an observational prospective study of the effectiveness of two treatment modalities for patients diagnosed with lumbar radicular pain within the Neurology Clinic of the Clinical Center of Vojvodina in Novi Sad in the period from 2015 to 2022. The study was approved by the Ethics Committee of the Clinical Center of Vojvodina. 152 patients diagnosed with lumbar radicular pain who met the inclusion criteria were included in the study. At the beginning of the research, ie. before the administration of the therapy, then after seven days after the administration of the therapy, after three and after six months from the administration of the therapy, an examination was conducted using the Oswestry disability index and the Numerical rating scale, and appropriate sociodemographic and medical data were collected. The examination of the relationship of independent variables was done with the non-parametric Mann-Whitney test, which is a substitute for the t-test when we do not have a normal distribution. The examination of the relationship of dependent characteristics was done with the non-parametric Wilcoxon test. Hypotheses about the equality of probabilities of two populations were tested. The licensed software "Statistica V 14.0" was used for data processing. The sample consists of 152 respondents with the dominant participation of women (64%). The average age of the respondent is 54 years. It was found that the subjects who used a combination of conservative and corticosteroid therapy were treated in a hospital for a statistically significantly shorter time with a significance level of p<0.005. The research results indicate that there is no statistically significant difference in the initial intensity of pain and the degree of disability measured by clinical assessment scales in relation to gender, employment and comorbidities before the start of medical treatment. The research results indicate that initially there are no statistically significant differences in the level of pain and degree of disability between men and women, employed and unemployed, smokers and non-smokers, patients with hypertension and without hypertension, patients with chronic lesion with actualization and with acute, and patients with left- and right-sided neurological findings. What is significant is that it was proven that both investigated therapeutic protocols led to a statistically significant reduction in acute pain and the degree of disability after 7 days of the applied drug therapy, regardless of the treatment protocol. Statistically significant differences after 7 days from the application of drug therapy show that the registered level of pain and the degree of disability during the application of therapy that included corticosteroids are statistically significantly lower than those registered during the application of conventional NSAID therapy. In the third investigated time point, i.e. after 3 months from the baseline visit, a statistically significantly lower level of pain and disability appears in the group treated with corticosteroid therapy and in the presence of risk factors (smoking). After 6 months from the baseline visit, the registered level of pain and disability when applying the protocol that included corticosteroid therapy was statistically significantly lower than those registered when applying conventional therapy. The intensity of pain in all three investigated time periods was lower in the group in which corticosteroid therapy was used, but the expression of these differences decreases with the passage of time. Current research shows that systemic corticosteroids can be effective in the treatment of lumbar radicular pain. Further research on the application of systemic corticosteroid therapy in reducing the intensity of lumbar radicular pain is needed in order to determine the optimal dose and duration of such treatment. In addition to monitoring the intensity of pain, it is necessary to clarify the effects of the use of systemic corticosteroids on the quality of life, long-term outcomes and side effects.