Randomizirovannoe dvoynoe slepoe platsebo-kontroliruemoe issledovanie PANTHEON: primenenie N-atsetiltsisteina v doze 600 mg 2 raza v den' dlya preduprezhdeniya obostreniy khronicheskoy obstruktivnoy bolezni legkikh

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  • Authors: Zheng J.1, Wen F.2, Bai C.3, Wan H.4, Kang J.5, Chen P.6, Yao W.7, Ma L.8, Li X.9, Raiteri L.10, Sardina M.10, Gao Y.1, Wang B.11, Zhong N.1
  • Affiliations:
    1. State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respi- ratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
    2. West China Hospital, Sichuan University, Chengdu, China
    3. Zhongshan Hospital, Fudan University, Shanghai, China
    4. Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
    5. First Affiliated Hospital of China Medical University, Shenyang, China
    6. Shenyang PLA General Hospital, Shenyang, China
    7. Peking University Third Hospital, Beijing, China
    8. Henan Provincial People's Hospital, Zhengzhou, China
    9. Hainan Zambon Pharmaceutical, Beijing, China
    10. Innovation & Medical Sciences Department, Zambon, Bresso, Milan, Italy
    11. MedKey Med-Tec Development, Shanghai, China
  • Issue: Vol 16, No 3 (2014)
  • Pages: 74-81
  • Section: Articles
  • URL: https://journal-vniispk.ru/2075-1753/article/view/94075
  • ID: 94075

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Abstract

Опубликовано: журнал «The Lancet Respiratory Medicine», март 2014; 2 (3): 187-194. Финансирование: Hainan Zambon Pharmaceutical. Целью исследования стали оценка способности долгосрочной высокодозной терапия N-ацетилцистеином снижать число обострений ХОБЛ и изучение зависимости данного эффекта от использования сопутствующей терапии ИГКС.В исследовании PANTHEON принимали участие только китайские пациенты. Можно прогнозировать, что хороший клинический эффект возможно получить и у пациентов с ХОБЛ I стадии, и данное положение должно стать предметом будущих исследований. Необходимо также проведение фармакоэкономического анализа предлагаемой терапии.

About the authors

Jin-Ping Zheng

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respi- ratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

Fu-Qiang Wen

West China Hospital, Sichuan University, Chengdu, China

Chun-Xue Bai

Zhongshan Hospital, Fudan University, Shanghai, China

Huan-Ying Wan

Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Jian Kang

First Affiliated Hospital of China Medical University, Shenyang, China

Ping Chen

Shenyang PLA General Hospital, Shenyang, China

Wan-Zhen Yao

Peking University Third Hospital, Beijing, China

Li-jun Ma

Henan Provincial People's Hospital, Zhengzhou, China

Xia Li

Hainan Zambon Pharmaceutical, Beijing, China

Luca Raiteri

Innovation & Medical Sciences Department, Zambon, Bresso, Milan, Italy

Marco Sardina

Innovation & Medical Sciences Department, Zambon, Bresso, Milan, Italy

Yi Gao

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respi- ratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

Bai-Song Wang

MedKey Med-Tec Development, Shanghai, China

Nan-Shan Zhong

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respi- ratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

References

  1. Vestbo J, Hurd S.S, Agustf A.G et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013; 187: 347-65.
  2. Donaldson G.C, Seemungal T.A, Bhowmik A, Wedzicha J.A. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57: 847-52.
  3. Spencer S, Calverley P.M, Burge P.S, Jones P.W. Impact of preventing exacerbations on deterioration of health status in COPD. Eur Respir J 2004; 23: 698-702.
  4. Wouters E.F. The burden of COPD in The Netherlands: results from the confronting COPD survey. Respir Med 2003; 97 (Suppl. C): S51-59.
  5. Blackwell T.S, Blackwell T.R, Holden E.P et al. In vivo antioxidant treatment suppresses nuclear factor - kappa B activation and neutrophilic lung inflammation. J Immunol 1996; 157: 1630-377.
  6. van Overveld F.J, Demkow U, Gorecka D et al. New developments in the treatment of COPD: comparing the effects of inhaled corticosteroids and N-acetylcysteine. J Physiol Pharmacol 2005; 56 (Suppl. 4): 135-42.
  7. Dekhuijzen P.N.R. Antioxidant properties of N-acetylcysteine: their relevance in relation to chronic obstructive pulmonary disease. Eur Respir J 2004; 23: 629-36.
  8. Ueno T, Yamada M, Igarashi Y, Ogawa T. N-acetylcysteine protects osteoblastic function from oxidative stress. J Biomed Mater Res A 2011; 99: 523-31.
  9. Sadowska A.M, Manuel-Y-Keenoy B, De Backer W.A. Antioxidant and antiinflammatory efficacy of NAC in the treatment of COPD: discordant in vitro and in vivo dose - effects: a review. Pulm Pharmacol Ther 2007; 20: 9-22.
  10. Grandjean E.M, Berthet P, Ruffmann R, Leuenberger P. Efficacy of oral long - term N-acetylcysteine in chronic bronchopulmonary disease: a meta - analysis of published double - blind, placebo - controlled clinical trials. Clin Ther 2000; 22: 209-21.
  11. Gerrits C.M, Herings R.M, Leufkens H.G, Lammers J.W. N-acetylcysteine reduces the risk of re - hospitalisation among patients with chronic obstructive pulmonary disease. Eur Respir J 2003; 21: 795-98.
  12. Decramer M, Rutten - van Mölken M, Dekhuijzen P.N et al. Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomised on N-acetylcysteine Cost-Utility Study, BRONCUS): a randomised placebo - controlled trial. Lancet 2005; 365: 1552-60.
  13. Schermer T, Chavannes N, Dekhuijzen R et al. Fluticasone and N-acetylcysteine in primary care patients with COPD or chronic bronchitis. Respir Med 2009; 103: 542-51.
  14. Zuin R, Palamidese A, Negrin R et al. High dose N-acetylcysteine in patients with exacerbations of chronic obstructive pulmonary disease. Clin DrugInvestig 2005; 25: 401-8.
  15. Zheng J.P, Wen F.Q, Bai C.X et al. High - dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON study. COPD 2013; 10: 164-71.
  16. Anthonisen N.R, Manfreda J, Warren C.P.W et al. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987; 106: 196-204.
  17. Burge S, Wedzicha J.A. COPD exacerbations: definitions and classifications. Eur Respir J 2003; 21 (Suppl. 41): 46-53.
  18. Zheng J.P, Kang J, Huang S.G et al. Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): a randomised placebo - controlled study. Lancet 2008; 371: 2013-18.
  19. Calverley P.M, Anderson J.A, Celli B et al. TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356: 775-89.
  20. Tashkin D.P, Celli B, Senn S et al, for the UPLIFT study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
  21. Zhou Y, Wang X, Zeng X et al. Positive benefits of theophylline in a randomised, double - blind, parallel - group, placebo controlled study of low - dose, slow - release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11: 603-10.
  22. Tse H.N, Raiteri L, Wong K.Y et al. High - dose N-acetylcysteine in stable chronic obstructive pulmonary disease: the 1-year, double - blind, randomised, placebo - controlled HIACE study. Chest 2013; 144: 106-18.
  23. Jenkins C.R, Jones P.W, Calverley P.M et al. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo - controlled TORCH study. Respir Res 2009; 10: 59.
  24. Decramer M, Celli B, Kesten S et al, for the UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009; 374: 1171-78.
  25. Zheng J.P, Zhong N.S, Jiang M, Zeng G.Q. Carbocisteine for acute exacerbations of COPD - authors' reply. Lancet 2008; 372: 1631-32.
  26. Hurst J.R, Vestbo J, Anzueto A et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010; 363: 1128-38.
  27. Zheng J.P, Yang L, Wu Y.M et al. The efficacy and safety of combination salmeterol (50 µg)/fluticasone propionate (500 µg) inhalation twice daily via Accuhaler in Chinese patients with COPD. Chest 2007; 132:1756-63.
  28. Zhong N, Wang C, Yao W et al. Prevalence of chronic obstructive pulmonary disease in China: a large population - based survey. Am J Respir Crit Care Med 2007; 176: 753-60.
  29. Calverley P, Pauwels R, Vestbo J et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361: 449-56.
  30. Thomsen M, Nordestgaard B.G, Vestbo J et al. Characteristics and outcomes of chronic obstructive pulmonary disease in never smokers in Denmark: a prospective population study. Lancet Respir Med 2013; 1: 543-50.
  31. Zhong N, Zheng J, Wen F et al. Efficacy and safety of budesonide/ formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin 2012; 28: 257-65.
  32. Stav D, Raz M. Effect of N-acetylcysteine on air trapping in COPD: a randomised placebo - controlled study. Chest 2009; 136: 381-86.
  33. Mata M, Sarrion I, Armengot M et al. Respiratory syncytial virus inhibits ciliagenesis in differentiated normal human bronchial epithelial cells: effectiveness of N-acetylcysteine. PLoS One 2012; 7: e48037.

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