Wielofunkcyjne krople nawilżające w postaci mikroemulsji, przeznaczonej do stosowania w umiarkowanym oraz ciężkim ZSO, opracowane w oparciu o etiologię choroby: randomizowane, poczwórnie zaślepione badanie kliniczne z grupą kontrolną leczoną aktywnie Komentarz
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Opublikowane:
mar 14, 2022
Słowa kluczowe:
sacha inchi (Plukenetia volubilis), wieloskładnikowa mikroemulsja sacha inchi (SIME), zespół suchego oka
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Abstrakt
Sacha inchi (Plukenetia volubilis) to roślina oleista pochodząca z tropikalnych lasów deszczowych w Ameryce Południowej. Nasiona rośliny stanowią potencjalne źródło makro- i mikroelementów, kwasu α-linolenowego i fitochemikaliów.
Jednoośrodkowe, prospektywne, zaślepione badanie kliniczne zostało opracowane w celu określenia skuteczności i bezpieczeństwa wieloskładnikowej mikroemulsji sacha inchi (SIME) w leczeniu pacjentów z zespołem suchego oka.
Autorzy jednoznacznie wykazali bezpieczeństwo wyrobu medycznego oraz wysoką skuteczność mikroemulsji SIME w odtworzeniu fizjologicznej funkcji ochronnej filmu łzowego i przywracaniu homeostazy powierzchni oka.
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Nowińska A. Wielofunkcyjne krople nawilżające w postaci mikroemulsji, przeznaczonej do stosowania w umiarkowanym oraz ciężkim ZSO, opracowane w oparciu o etiologię choroby: randomizowane, poczwórnie zaślepione badanie kliniczne z grupą kontrolną leczoną aktywnie. Ophthatherapy [Internet]. 14 marzec 2022 [cytowane 3 lipiec 2024];9(1):46-2. Dostępne na: https://journalsmededu.pl/index.php/ophthatherapy/article/view/1771
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Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa – Użycie niekomercyjne – Bez utworów zależnych 4.0 Międzynarodowe.
Copyright: © Medical Education sp. z o.o. License allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
Bibliografia
1. Craig JP, Nichols KK, Akpek EK et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017; 15: 276-83. http://doi.org/10.1016/J.JTOS.2017.05.008.
2. Lemp MA, Baudouin C, Baum J et al. The definition and classification of dry eye disease: report of the Definition and ClassificationSubcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007; 5: 75-92. http://doi.org/10.1016/S1542-0124(12)70081-2.
3. Stapleton F, Alves M, Bunya VY et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017; 15: 334-65. http://doi.org/10.1016/J.JTOS.2017.05.003.
4. Zhang X, Wang L, Zheng Y et al. Prevalence of dry eye disease in the elderly: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020; 99: e22234.
5. Song P, Xia W, Wang M et al. Variations of dry eye disease prevalence by age, sex and geographic characteristics in China: a systematic review and meta-analysis. J Glob Health. 2018; 8. http://doi.org/10.7189/JOGH.08.020503.
6. Nelson JD, Shimazaki J, Benitez-del-Castillo JM et al. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011; 52: 1930-7. http://doi.org/10.1167/IOVS.10-6997B.
7. Matossian C, McDonald M, Donaldson KE et al. Dry Eye Disease: Consideration for Women’s Health. J Women’s Heal. 2019; 28: 502. http://doi.org/10.1089/JWH.2018.7041.
8. Laihia J, Järvinen R, Wylęgała E et al. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020; 98: 244-54. http://doi.org/10.1111/AOS.14252.
9. Bron AJ, de Paiva CS, Chauhan SK et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017; 15: 438-510. http://doi.org/10.1016/J.JTOS.2017.05.011.
10. Bron AJ, de Paiva CS, Chauhan SK et al. Corrigendum to “TFOS DEWS II pathophysiology report” (The Ocular Surface (2017) 15(3) (438- 510), (S1542012417301349), (10.1016/j.jtos.2017.05.011)). Ocul Surf. 2019; 17: 842.
11. Wolffsohn JS, Arita R, Chalmers R et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017; 15: 539-74.
12. Shin J, Rho CR, Hyon JY et al. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021; 37: 4-11. http://doi.org/10.1089/JOP.2020.0104.
13. Cagini C, Torroni G, Mariniello M et al. Trehalose/sodium hyaluronate eye drops in post-cataract ocular surface disorders. Int Ophthalmol. 2021; 41: 3065-71.
14. Haji-Ali-Nili N, Khoshzaban F, Karimi M et al. Effect of a Natural Eye Drop, Made of Plantago Ovata Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial. Iran J Pharm Res IJPR. 2019; 18: 1602-11. http://doi.org/10.22037/IJPR.2019.1100717.
15. Labetoulle M, Chiambaretta F, Shirlaw A et al. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017; 31: 1409-16. http://doi.org/10.1038/EYE.2017.73.
16. Jun JH, Bang SP, Park HS et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol. 2022; 66: 58-67. http://doi.org/10.1007/S10384-021-00885-X.
17. Cagini C, Di Lascio G, Torroni G et al. Dry eye and inflammation of the ocular surface after cataract surgery: effectiveness of a tear film substitute based on trehalose/hyaluronic acid vs hyaluronic acid to resolve signs and symptoms. J Cataract Refract Surg. 2021; 47: 1430-5.
18. Brar S, Vanga HR, Ganesh S. Comparison of efficacy of trehalose-based eye drops versus topical 0.1% Hyaluronic Acid for management of clinically significant dry eye using non-invasive investigational modalities. Int Ophthalmol. 2021; 41: 3349-59.
19. Shiraishi A, Sakane Y. Assessment of dry eye symptoms: Current trends and issues of dry eye questionnaires in Japan. Invest Ophthalmol Vis Sci. 2018; 59(14): DES23-DES28. http://doi.org/10.1167/iovs.18-24570.
20. Ousler GW, Hagberg KW, Schindelar M et al. The Ocular Protection Index. Cornea. 2008; 27: 509-13. http://doi.org/10.1097/ICO.0B013E31816583F6.
21. Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003; 22: 640-50. http://doi.org/10.1097/00003226-200310000-00008.
22. Baudouin C. [A new approach for better comprehension of diseases of the ocular surface]. J Fr Ophtalmol. 2007; 30: 239-46. http://doi.org/10.1016/S0181-5512(07)89584-2.
23. Chirinos R, Pedreschi R, Domínguez G et al. Comparison of the physico-chemical and phytochemical characteristics of the oil of two Plukenetia species. Food Chem. 2015; 173: 1203–6. http://doi.org/10.1016/J.FOODCHEM.2014.10.120.
24. Wang S, Zhu F, Kakuda Y. Sacha inchi (Plukenetia volubilis L.): Nutritional composition, biological activity, and uses. Food Chem. 2018; 265: 316-28. http://doi.org/10.1016/J.FOODCHEM.2018.05.055.
25. Simmons PA, Carlisle-Wilcox C, Chen R et al. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015; 37: 858-68. http://doi.org/10.1016/J.CLINTHERA.2015.01.001.
26. opis odsyła Kojima T, Nagata T, Kudo H et al. The Effects of High Molecular Weight Hyaluronic Acid Eye Drop Application in Environmental Dry Eye Stress Model Mice. Int J Mol Sci. 2020; 21. http://doi.org/10.3390/IJMS21103516cza.
27. Čejková J, Čejka Č, Luyckx J. Trehalose treatment accelerates the healing of UVB-irradiated corneas. Comparative immunohistochemical studies on corneal cryostat sections and corneal impression cytology. Histol Histopathol. 2012; 27: 1029-40. http://doi.org/10.14670/HH-27.1029.
28. Čejková J, Ardan T, Čejka Č et al. Favorable effects of trehalose on the development of UVB-mediated antioxidant/pro-oxidant imbalance in the corneal epithelium, proinflammatory cytokine and matrix metalloproteinase induction, and heat shock protein 70 expression. Graefe’s Arch Clin Exp Ophthalmol. 2011; 249: 1185-94.
29. Cejka C, Kubinova S, Čejková J. Trehalose in ophthalmology. Histol Histopathol. 2019; 34: 611-8.
30. Panigrahi T, Shivakumar S, Shetty R et al. Trehalose augments autophagy to mitigate stress induced inflammation in human corneal cells. Ocul Surf. 2019; 17: 699-713. http://doi.org/10.1016/J.JTOS.2019.08.004.
2. Lemp MA, Baudouin C, Baum J et al. The definition and classification of dry eye disease: report of the Definition and ClassificationSubcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007; 5: 75-92. http://doi.org/10.1016/S1542-0124(12)70081-2.
3. Stapleton F, Alves M, Bunya VY et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017; 15: 334-65. http://doi.org/10.1016/J.JTOS.2017.05.003.
4. Zhang X, Wang L, Zheng Y et al. Prevalence of dry eye disease in the elderly: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020; 99: e22234.
5. Song P, Xia W, Wang M et al. Variations of dry eye disease prevalence by age, sex and geographic characteristics in China: a systematic review and meta-analysis. J Glob Health. 2018; 8. http://doi.org/10.7189/JOGH.08.020503.
6. Nelson JD, Shimazaki J, Benitez-del-Castillo JM et al. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011; 52: 1930-7. http://doi.org/10.1167/IOVS.10-6997B.
7. Matossian C, McDonald M, Donaldson KE et al. Dry Eye Disease: Consideration for Women’s Health. J Women’s Heal. 2019; 28: 502. http://doi.org/10.1089/JWH.2018.7041.
8. Laihia J, Järvinen R, Wylęgała E et al. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020; 98: 244-54. http://doi.org/10.1111/AOS.14252.
9. Bron AJ, de Paiva CS, Chauhan SK et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017; 15: 438-510. http://doi.org/10.1016/J.JTOS.2017.05.011.
10. Bron AJ, de Paiva CS, Chauhan SK et al. Corrigendum to “TFOS DEWS II pathophysiology report” (The Ocular Surface (2017) 15(3) (438- 510), (S1542012417301349), (10.1016/j.jtos.2017.05.011)). Ocul Surf. 2019; 17: 842.
11. Wolffsohn JS, Arita R, Chalmers R et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017; 15: 539-74.
12. Shin J, Rho CR, Hyon JY et al. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021; 37: 4-11. http://doi.org/10.1089/JOP.2020.0104.
13. Cagini C, Torroni G, Mariniello M et al. Trehalose/sodium hyaluronate eye drops in post-cataract ocular surface disorders. Int Ophthalmol. 2021; 41: 3065-71.
14. Haji-Ali-Nili N, Khoshzaban F, Karimi M et al. Effect of a Natural Eye Drop, Made of Plantago Ovata Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial. Iran J Pharm Res IJPR. 2019; 18: 1602-11. http://doi.org/10.22037/IJPR.2019.1100717.
15. Labetoulle M, Chiambaretta F, Shirlaw A et al. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017; 31: 1409-16. http://doi.org/10.1038/EYE.2017.73.
16. Jun JH, Bang SP, Park HS et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol. 2022; 66: 58-67. http://doi.org/10.1007/S10384-021-00885-X.
17. Cagini C, Di Lascio G, Torroni G et al. Dry eye and inflammation of the ocular surface after cataract surgery: effectiveness of a tear film substitute based on trehalose/hyaluronic acid vs hyaluronic acid to resolve signs and symptoms. J Cataract Refract Surg. 2021; 47: 1430-5.
18. Brar S, Vanga HR, Ganesh S. Comparison of efficacy of trehalose-based eye drops versus topical 0.1% Hyaluronic Acid for management of clinically significant dry eye using non-invasive investigational modalities. Int Ophthalmol. 2021; 41: 3349-59.
19. Shiraishi A, Sakane Y. Assessment of dry eye symptoms: Current trends and issues of dry eye questionnaires in Japan. Invest Ophthalmol Vis Sci. 2018; 59(14): DES23-DES28. http://doi.org/10.1167/iovs.18-24570.
20. Ousler GW, Hagberg KW, Schindelar M et al. The Ocular Protection Index. Cornea. 2008; 27: 509-13. http://doi.org/10.1097/ICO.0B013E31816583F6.
21. Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003; 22: 640-50. http://doi.org/10.1097/00003226-200310000-00008.
22. Baudouin C. [A new approach for better comprehension of diseases of the ocular surface]. J Fr Ophtalmol. 2007; 30: 239-46. http://doi.org/10.1016/S0181-5512(07)89584-2.
23. Chirinos R, Pedreschi R, Domínguez G et al. Comparison of the physico-chemical and phytochemical characteristics of the oil of two Plukenetia species. Food Chem. 2015; 173: 1203–6. http://doi.org/10.1016/J.FOODCHEM.2014.10.120.
24. Wang S, Zhu F, Kakuda Y. Sacha inchi (Plukenetia volubilis L.): Nutritional composition, biological activity, and uses. Food Chem. 2018; 265: 316-28. http://doi.org/10.1016/J.FOODCHEM.2018.05.055.
25. Simmons PA, Carlisle-Wilcox C, Chen R et al. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015; 37: 858-68. http://doi.org/10.1016/J.CLINTHERA.2015.01.001.
26. opis odsyła Kojima T, Nagata T, Kudo H et al. The Effects of High Molecular Weight Hyaluronic Acid Eye Drop Application in Environmental Dry Eye Stress Model Mice. Int J Mol Sci. 2020; 21. http://doi.org/10.3390/IJMS21103516cza.
27. Čejková J, Čejka Č, Luyckx J. Trehalose treatment accelerates the healing of UVB-irradiated corneas. Comparative immunohistochemical studies on corneal cryostat sections and corneal impression cytology. Histol Histopathol. 2012; 27: 1029-40. http://doi.org/10.14670/HH-27.1029.
28. Čejková J, Ardan T, Čejka Č et al. Favorable effects of trehalose on the development of UVB-mediated antioxidant/pro-oxidant imbalance in the corneal epithelium, proinflammatory cytokine and matrix metalloproteinase induction, and heat shock protein 70 expression. Graefe’s Arch Clin Exp Ophthalmol. 2011; 249: 1185-94.
29. Cejka C, Kubinova S, Čejková J. Trehalose in ophthalmology. Histol Histopathol. 2019; 34: 611-8.
30. Panigrahi T, Shivakumar S, Shetty R et al. Trehalose augments autophagy to mitigate stress induced inflammation in human corneal cells. Ocul Surf. 2019; 17: 699-713. http://doi.org/10.1016/J.JTOS.2019.08.004.