Inhaled combination of 7% hypertonic saline and 0.1% hyaluronic acid in therapy of patients with cystic fibrosis: results of a Russian observational study
https://doi.org/10.18093/0869-0189-2018-28-4-436-444
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Abstract
This was an observational prospective cohort study of safety and efficacy of mucolytic therapy with inhaled combination of 7% hypertonic saline (HS) and 0.1% hyaluronic acid (HA) in patients with cystic fibrosis (CF). The treatment duration was 4 weeks, the follow-up of patients was continued up to 8 weeks. Methods. The study involved 74 CF patients aged > 12 years. A comparative analysis of respiratory function, patients’ satisfaction with therapy, and efficacy and safety of 4-wk treatment was performed in groups of patients treated with 7% HS (n = 33) or HA (n = 41). Changes in patients’ status (n = 41) were assessed after 8 weeks. Results. The forced expiratory volume for 1 sec (FEV1) increased by 5.8% (p = 0.037) after 4-wk therapy with HA and additionally increased by 5.5% (p = 0.020) in 8 weeks after starting the treatment; the total growth in FEV1 during the study was 11.3% (p < 0.001). FEV1 did not improve in the HS group. Nasal and ear congestion, mucus in the throat or in the chest (62.9% vs 83.9%; p = 0.0014), appearance or worsening of cough (68.8% vs 93.8%; p < 0.0001), sore throat (43.8% vs 68.8%; p = 0.0006); unpleasant taste (29.4% vs 43.8%; p = 0.0398), and balance disorder (12.5% vs 3.1%; p = 0.0317) significantly differed between the groups. Conclusion. HA was better tolerated compared to HS in CF patients. One-month therapy with HA could decrease frequency and severity of sore throat, cough and nasal congestion in CF patients. Prolonged treatment with HA for 2 months was associated with improved tolerability of the drug and significant increase in FEV1.
About the Authors
E. L. AmelinaRussian Federation
Candidate of Medicine, Head of Laboratory of Cystic Fibrosis, Federal Pulmonology Research Institute
tel.: (926) 205-03-91
Orekhovyy bul'var 28, Moscow, 115682, Russia
ul. Odinnadtsataya Parkovaya 32, Moscow, 105077, Russia
E. I. Kondrat’yeva
Russian Federation
Doctor of Medicine, Professor, Head of Research and Clinical Division of Cystic Fibrosis, Federal Medical Genetic Academic Center, Head of Department of Cystic Fibrosis, Moscow Regional State Referral Center for Children
tel.:(916) 255-33-85
ul. Moskvorech'e 1, Moscow, 1115478, Russia
S. A. Krasovskiy
Russian Federation
Candidate of Medicine, Senior Researcher, Laboratory of Cystic Fibrosis, Federal Pulmonology Research Institute, Federal Medical and Biological Agency of Russia; a pulmonologist at the 2nd Pulmonology Department, D.D.Pletnev City Teaching Hospital, Moscow Healthcare Department; Senior Researcher at Research and Clinical Division of Cystic Fibrosis, Federal Medical Genetic Academic Center, Russian Academy of Medical Science
tel.:(495) 965-23-24
Orekhovyy bul'var 28, Moscow, 115682, Russia
ul. Odinnadtsataya Parkovaya 32, Moscow, 105077, Russia
ul. Moskvorech'e 1, Moscow, 1115478, Russia
I. K. Asherova
Russian Federation
Doctor of Medicine, Head of Pulmonology Division
tel.: (4852) 74-66-34
pr. Lenina 12/76, Yaroslavl’, 150003, Russia
A. V. Orlov
Russian Federation
Candidate of Medicine, Head of Department of Infectious Diseases, Center for Cystic Fibrosis
tel.: (812) 295-69-92
ul. Zemledel’cheskaya 2, Saint-Petersburg, 194156, Russia
T. A. Stepanenko
Russian Federation
Candidate of Medicine, Head of Department of Pulmonology No.2
tel.: (812) 338-94-86
Uchebnyy per. 5, Saint-Petersburg, 194354, Russia
O. I. Simonova
Russian Federation
Doctor of Medicine, Professor, Head of Department of Cystic Fibrosis, Federal Academic Centre of Children's Health, Healthcare Ministry of Russia; Head of Service for Cystic Fibrosis, Medical and Genetic Department, Morozov State Pediatric Teaching Hospital; Moscow Healthcare Department
tel.: (499) 134-14-77
Lomonosovskiy pr. 2, build.1, Moscow, 119991, Russia
4-y Dobryninskiy per. 1/9, Moscow, 119049, Russia
E. V. Boytsova
Russian Federation
Doctor of Medicine, Professor, Leading Researcher, Division of Therapeutic Pulmonology
tel.: (911) 739-00-22
ul. Rentgena 12, Saint-Petersburg, 197022, Russia
V. D. Sherman
Russian Federation
Candidate of Medicine, Senior Researcher, Research and Clinical Division of Cystic Fibrosis, Federal Medical Genetic Academic Center; a pediatrician, Moscow Regional State Referral Center for Children
tel.: (495) 111-85-80
ul. Moskvorech'e 1, Moscow, 1115478, Russia
ul. Kominterna 24A, build.1, Mytishchi of Moscow Region, 1141007, Russia
Yu. V. Gorinova
Russian Federation
Candidate of Medicine, a pediatrician, Department of Cystic Fibrosis, Federal Academic Centre of Children's Health, Healthcare Ministry of Russia; a pediatrician, Medical and Genetic Department, Morozov State Pediatric Teaching Hospital; Moscow Healthcare Department
tel.: (499) 134-14-77
Lomonosovskiy pr. 2, build.1, Moscow, 119991, Russia
4-y Dobryninskiy per. 1/9, Moscow, 119049, Russia
M. A. Mukhina
Russian Federation
a pediatrician, Medical and Genetic Department
tel.: (495) 959-87-74
4-y Dobryninskiy per. 1/9, Moscow, 119049, Russia
N. V. Meshchenkova
Russian Federation
Senior Medical Advisor
tel.: (495) 967-12-12
Vyatskaya 27, build. 13, Moscow, 127015, Russia
References
1. Elkins M.R., Robinson M., Rose B. et al. A controlled trial of long-term Inhaled hypertonic saline in patients with cystic fibrosis. N. Engl. J. Med. 2006; 354 (3): 229-240. https://doi.org/10.1056/NEJMoa043900.
2. Smyth A.R., Bell S.C., Bojcin S. et al. European cystic fibrosis society standards of care: best practice guidelines. J. Cyst. Fibros. 2014. 13 (Suppl. 1): S23-S42. https://doi.org/10.1016/j.jcf.2014.03.010.
3. Krasovskiy S.A., Chernyak A.V., Voronkova A.Yu., eds. The Register of Patients with Cystic Fibrosis in Russian Federation, 2016. Moscow: Medpraktika-M; 2018 (in Russian).
4. Turino G.M., Cantor J.O. Hyaluronan in respiratory injury and repair. Am. J. Respir. Crit. Care Med. 2003; 167 (9): 1169-1175. https://doi.org/10.1164/rccm.200205-449PP.
5. Cantor J.O., Turino J.M. Can exogenously administered hyaluronan improve respiratory function in patients with pulmonary emphysema? Chest. 2004; 125 (1): 288-292. https://doi.org/10.1378/chest.125.1.288.
6. Cantor J.O., Shteyngart B., Cerreta J.M. et al. The effect of hyaluronan on elastic fiber injury in vitro and elastase-induced airspace enlargement in vivo. Proc. Soc. Exp. Biol. Med. 2000; 225 (1): 65-71. https://doi.org/10.1111/j.1525-1373.2000.22508.x.
7. Akatsuka M., Yamamoto Y., Tobetto K. et al. Suppressive effects of hyaluronic acid on elastase release from rat peritoneal leucocytes. J. Pharm. Pharmacol. 1993; 45 (2): 110-114. https://doi.org/10.1111/j.2042-7158.1993.tb03693.x.
8. Zahm J.M., Miliot M., Bresin A. et al. The effect of hyaluronan on airway mucus transport and airway epithelial barrier integrity: potential application to the cytoprotection of airway tissue. Matrix. Biol. 2011; 30 (7-8): 389-395. https://doi.org/10.1016/j.matbio.2011.07.003.
9. Buonpensiero P., De Gregorio F., Sepe A. et al. Hyaluronic acid improves “pleasantness” and tolerability of nebulized hypertonic saline in a cohort of patients with cystic fibrosis. Adv. Ther. 2010; 27 (11): 870-878. https://doi.org/10.1007/s12325-010-0076-8.
10. Ros M., Casciaro R., Lucca F. et al. Hyaluronic acid improves the tolerability of hypertonic saline in the chronic treatment of cystic fibrosis patients: a multicenter, randomized, controlled clinical trial. J. Aerosol. Med. Pulm. Drug Deliv. 2014; 27 (2): 133-137. https://doi.org/10.1089/jamp.2012.1034.
11. Máiz Carro L., Lamas Ferreiro A., Ruiz de Valbuena Maiz M. et al. [Tolerance of two inhaled hypertonic saline solutions in patients with cystic fibrosis]. Med. Clin. (Barc). 2012; 138 (2): 57-59. https://doi.org/10.1016/j.medcli.2011.02.022 (in Spanish).
12. Furnari M.L., Termini L., Traverso G. et al. Nebulized hypertonic saline containing hyaluronic acid improves tolerability in patients with cystic fibrosis and lung disease compared with nebulized hypertonic saline alone: a prospective, randomized, double-blind, controlled study. Ther. Adv. Respir. Dis. 2012; 6 (6): 315-322. https://doi.org/10.1177/1753465812458984.
Review
For citations:
Amelina E.L., Kondrat’yeva E.I., Krasovskiy S.A., Asherova I.K., Orlov A.V., Stepanenko T.A., Simonova O.I., Boytsova E.V., Sherman V.D., Gorinova Yu.V., Mukhina M.A., Meshchenkova N.V. Inhaled combination of 7% hypertonic saline and 0.1% hyaluronic acid in therapy of patients with cystic fibrosis: results of a Russian observational study. PULMONOLOGIYA. 2018;28(4):436-444. (In Russ.) https://doi.org/10.18093/0869-0189-2018-28-4-436-444
ISSN 2541-9617 (Online)