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Abstract
RIASSUNTO
Introduzione: La stomatite da farmaci chemioterapici è un importante effetto collaterale del trattamento. I protocolli per la cura del cavo orale, si basano su due livelli di intervento: senza e con uso di medicamenti . La letteratura descrive numerosi interventi di profilassi e terapia ma ad oggi non esiste ancora un intervento considerato gold standard. Obiettivo: Valutare l'efficacia del Gelclair® nella prevenzione e trattamento di pazienti sottoposti a trapianto di cellule staminali emopoietiche. Materiale metodi: 57 pazienti (28 gruppo di controllo e 29 gruppo sperimentale ) hanno utilizzato i colluttori 3 volte al giorno, la valutazione è stata effettuata con i seguenti strumenti: scala di valutazione della stomatite (WHO), scala VAS per dolore e Likert per gradimento. I pazienti sono stati osservati mediamente per 17 giorni. Risultati: 38/57 pazienti osservati (61%) hanno manifestato stomatiti .Non è stata rilevata differenza tra i due gruppi in termine di grado di stomatite p= 0.75 in tutto il periodo di osservazione. Il dolore è stato registrato in 31 soggetti su 57 (54%). Non si sono registrate differenze tra i due gruppi per quanto riguarda il valore medio di dolore riferito prima dell'utilizzo dei colluttori per tutti i giorni di osservazione p=0,06, gli utenti del gruppo sperimentale hanno dimostrato una riduzione del grado di dolore dopo l'utilizzo del collutorio p=0,04. Conclusioni: Gelclair® non influenza i tempi di insorgenza e l'andamento della stomatite. E' in grado di ridurre il dolore, sono necessari però ulteriori studi multicentrici per confermare la reale utilití di utilizzo nei pazienti sottoposti a Trapianto.
Parole chiave: Stomatite, trapianto di cellule staminali emopoietiche, infermieristica
Abstract
Introduction: Chemotherapy-induced stomatitis is a major side effect of the treatment. Numerous approaches are described in the literature for the prevention and treatment of this complication. Objective: the aim was assess the effectiveness of Gelclair® in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis, stomatitis-pain and the severity of stomatitis Interventions/Methods: Fifty-seven patients (28 control group and 29 experimental group) used a mouthwash 3 times a day and were evaluated by means of a specially-tailored form containing the following assessment items:stomatitis evaluation scale (WHO), VAS for pain and Likert-Scale for agreement. Results: 61% of patients presented with stomatitis. No difference was observed between the two groups with regard to stomatitis grade throughout the observation period. Painful symptoms were observed in 54% subjects. No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p=0.06. Results showed a pain-relieving effect in the experimental group after using the mouthwash p=0.04. Conclusions: Although Gelclair® had no influence on the onset and severity of stomatitis in transplanted patients, a significant benefit was observed in terms of pain control. Our study suggest the possibility to implementation the use of Gelclair® in clinical practice. However, further multicenter trials are needed to provide stronger evidence on the real usefulness of this product.
Key words: stomatitis; Bone marrow transplantation; nursing
Dettagli dell'articolo
Riferimenti
- Bearman SI, Appelbaum FR, Buckner CD et al. (1988). Regimen-related toxicity in patients undergoing bone marrow transplantation. Journal of Clinical Oncology, 6, 1562-1568.
- Barber C, Powell R, Hewett J. (2007). Comparing pain control to eat and drink with standard therapy vs. Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy- induced oral mucositis. Supportive Care Cancer,15(4),427-40.
- Blijlevens NM, Donnelly JP, De Pauw BE. (2000). Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplantation, 25(12),1269-78.
- Buchsel PC. (2003).Gelclair oral gel. Clinical Journal of Oncolology Nursing,7(1),109-10.
- Cawley MM, Benson LM. (2005). Current trends in managing oral mucositis (Review). Clinical Journal of Oncology Nursing,9,584-592.
- Cheng KK.(2007). Oral mucositis, dysfunction, and distress in patients undergoing cancer therapy. Journal Clinical Nursing,Nov,16(11),2114-21.
- Copelan EA. (2006).Hematopoietic Stem-Cell transplantation. New England Journal of Medicine, 354,1813-26.
- Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. (1978).Studies with pain rating scales. Annals of Rheumatic Disease Aug,37(4),378-81.
- Gabriel DA, Shea T, Olajida O, et al. (2003).The effect of oral mucositis on morbidity and mortality in bone marrow transplant (Review). Seminars in Oncology, 30,76-83.
- Harris DJ, Eilesr J, Harriman A, et al. (2008). Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clinical Journal of Oncology Nursing, 12(1), 141-52.
- Hita-iglesias P, Torres-lagares D, Gutiérrez-Pérez JL. (2006).Evaluation of the clinical behaviour of a polyvinylpyrrolidone and sodium hyalonurate gel (Gelclair) in patients subjected to surgical treatment with CO2 laser. International Journal of Oral and Maxillofacial Surgery,35,514-517.
- Innocenti M, Moscatelli G, Lopez S. (2002). Efficacy of Gelclair in reducing pain in palliative care patient with oral lesion- preliminary findings from an open pilot study. Journal of Pain Symptom Managemen,24,456-457.
- Lalla RV, Sonis ST,Peterson DE. (2008).Management of oral mucositis in patients who have cancer. Dental Clinics of North America,52(1),61-77.
- McGowan D.(2009). Chemotherapy-induced oral dysfunction: a literature review. British Journal Nursing, Jan 7,17(22),1422-6.
- McGuire DB, Altomonte V, Peterson DE, et al. (1993).Patterns of mucositis and pain in patients receiving preparative chemotherapy and bone marrow transplantation. Oncology Nursing Forum, 20, 1493-1502.
- Moore D, Roach J, Deveney P, et al.( 2009).Good oral hygiene practice. Australian Nursing Journal,16(11), 46 – 7.
- Pederson DE, Cariello A. (2004).Mucosal damage: a major risk factor for severe complications after cytotoxic therapy. Seminars in Oncology,31,35-44.
- Pico JL, Avila-Garavito A, Naccachie P. (1998). Mucositis: its occurrence, consequences, and treatment in the oncology setting. The Oncologist, 3, 446-451.
- Rapoport AP, Watelet LF, Linder T et al. (1999). Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants. Journal of Clinical Oncology,17,2446-53.
- Rubenstein EB, Peterson DE, Schubert M, et al. (2004).Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer, 1, 100(9), 2026-46.
- Smith T. (2001).Gelclair: managing the symptoms of oral mucositis. Hospital Medicine,62(10),623-6.
- Sonis S, Clark J. (1991).Prevention and management of oral mucositis induced by antineoplastic therapy. Oncology.; 5: 11-18.
- Sonis ST. (1998).Mucositis as a biological process: a new hypothesis for the development of chemotherapy induced stomatotoxicity, Oral Oncology 34, 39-43.
- Sonis ST, Oster G, Fuchs H, et al. (2001).Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. Journal Clinical Oncology,19,2201-205.
- Sonis ST. (2004).A biological approach to mucositis. Journal Support Oncology,2(1),21-32.
- Sonis ST. (2004).Oral mucositis in cancer Therapy (Review). Journal Support Oncology,2, 3-8.
- Sonis ST, Elting LS, Keefe D, et al. (2004). Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer, 1,100(9),1995-2025.
- Vokurka S, Skardova J, Hruskova R, Kabatova-Maxova K, Svoboda T, Bystricka E, Steinerova K, Koza V. (2011). The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Medical Science Monitor, Oct,17(10),CR572-6.
- Woo SB, Sonis ST, Monopoli MM, et al. (1993). A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients. Cancer, 72, 1612-1617.
- Worthington HV, Clarkson JE, Eden OB. (2006). Interventions for preventing oral mucositis for patients receiving cancer treatment. Cochrane Database Syst Rev,19,(2).
Riferimenti
Bearman SI, Appelbaum FR, Buckner CD et al. (1988). Regimen-related toxicity in patients undergoing bone marrow transplantation. Journal of Clinical Oncology, 6, 1562-1568.
Barber C, Powell R, Hewett J. (2007). Comparing pain control to eat and drink with standard therapy vs. Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy- induced oral mucositis. Supportive Care Cancer,15(4),427-40.
Blijlevens NM, Donnelly JP, De Pauw BE. (2000). Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplantation, 25(12),1269-78.
Buchsel PC. (2003).Gelclair oral gel. Clinical Journal of Oncolology Nursing,7(1),109-10.
Cawley MM, Benson LM. (2005). Current trends in managing oral mucositis (Review). Clinical Journal of Oncology Nursing,9,584-592.
Cheng KK.(2007). Oral mucositis, dysfunction, and distress in patients undergoing cancer therapy. Journal Clinical Nursing,Nov,16(11),2114-21.
Copelan EA. (2006).Hematopoietic Stem-Cell transplantation. New England Journal of Medicine, 354,1813-26.
Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. (1978).Studies with pain rating scales. Annals of Rheumatic Disease Aug,37(4),378-81.
Gabriel DA, Shea T, Olajida O, et al. (2003).The effect of oral mucositis on morbidity and mortality in bone marrow transplant (Review). Seminars in Oncology, 30,76-83.
Harris DJ, Eilesr J, Harriman A, et al. (2008). Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clinical Journal of Oncology Nursing, 12(1), 141-52.
Hita-iglesias P, Torres-lagares D, Gutiérrez-Pérez JL. (2006).Evaluation of the clinical behaviour of a polyvinylpyrrolidone and sodium hyalonurate gel (Gelclair) in patients subjected to surgical treatment with CO2 laser. International Journal of Oral and Maxillofacial Surgery,35,514-517.
Innocenti M, Moscatelli G, Lopez S. (2002). Efficacy of Gelclair in reducing pain in palliative care patient with oral lesion- preliminary findings from an open pilot study. Journal of Pain Symptom Managemen,24,456-457.
Lalla RV, Sonis ST,Peterson DE. (2008).Management of oral mucositis in patients who have cancer. Dental Clinics of North America,52(1),61-77.
McGowan D.(2009). Chemotherapy-induced oral dysfunction: a literature review. British Journal Nursing, Jan 7,17(22),1422-6.
McGuire DB, Altomonte V, Peterson DE, et al. (1993).Patterns of mucositis and pain in patients receiving preparative chemotherapy and bone marrow transplantation. Oncology Nursing Forum, 20, 1493-1502.
Moore D, Roach J, Deveney P, et al.( 2009).Good oral hygiene practice. Australian Nursing Journal,16(11), 46 – 7.
Pederson DE, Cariello A. (2004).Mucosal damage: a major risk factor for severe complications after cytotoxic therapy. Seminars in Oncology,31,35-44.
Pico JL, Avila-Garavito A, Naccachie P. (1998). Mucositis: its occurrence, consequences, and treatment in the oncology setting. The Oncologist, 3, 446-451.
Rapoport AP, Watelet LF, Linder T et al. (1999). Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants. Journal of Clinical Oncology,17,2446-53.
Rubenstein EB, Peterson DE, Schubert M, et al. (2004).Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer, 1, 100(9), 2026-46.
Smith T. (2001).Gelclair: managing the symptoms of oral mucositis. Hospital Medicine,62(10),623-6.
Sonis S, Clark J. (1991).Prevention and management of oral mucositis induced by antineoplastic therapy. Oncology.; 5: 11-18.
Sonis ST. (1998).Mucositis as a biological process: a new hypothesis for the development of chemotherapy induced stomatotoxicity, Oral Oncology 34, 39-43.
Sonis ST, Oster G, Fuchs H, et al. (2001).Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. Journal Clinical Oncology,19,2201-205.
Sonis ST. (2004).A biological approach to mucositis. Journal Support Oncology,2(1),21-32.
Sonis ST. (2004).Oral mucositis in cancer Therapy (Review). Journal Support Oncology,2, 3-8.
Sonis ST, Elting LS, Keefe D, et al. (2004). Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer, 1,100(9),1995-2025.
Vokurka S, Skardova J, Hruskova R, Kabatova-Maxova K, Svoboda T, Bystricka E, Steinerova K, Koza V. (2011). The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Medical Science Monitor, Oct,17(10),CR572-6.
Woo SB, Sonis ST, Monopoli MM, et al. (1993). A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients. Cancer, 72, 1612-1617.
Worthington HV, Clarkson JE, Eden OB. (2006). Interventions for preventing oral mucositis for patients receiving cancer treatment. Cochrane Database Syst Rev,19,(2).