Collaborative quality improvement to promote evidence based surfactant for preterm infants: a cluster randomised trial
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7473.1004 (Published 28 October 2004) Cite this as: BMJ 2004;329:1004
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A letter from Russia
Preparations of pulmonary surfactant (Sf) are broadly used for treatment of infant respiratory distress syndrome (RDS). Exogenous surfactant has proven to be less effective in acute lung injury/ARDS beyond the infancy i.e. when there is no primary deficiency of Sf [1]. Some publications from Russia have reported on successful use of Sf preparations for treatment of ARDS in children and adults [2] including ARDS developing after surgical operations [3,4]; for viral and bacterial pneumonia in children and the newborn [5,6], bronchopneumonia complicated by atelectasis [7] and for pulmonary tuberculosis, significantly accelerating dissolution of infiltrates and closing of caverns [8-10]. The data on the decrease of mortality in adults with ARDS after the Sf-therapy [2] are, in general, not confirmed in the international literature [13-18], although improved survival has been reported for ARDS due to pneumonia and aspiration [19]. Improvement of lung histopathology and ultrastructure in rats with bleomycin- and radiation-induced pulmonary fibrosis after Sf instillation was reported in [20-23]; but the illustrations, showing singular cells with unspecific changes, appear to be non-representative. Although perspectives of Sf-therapy of ARDS have been discussed [24-27], recent reviews concluded that its use for ARDS is not recommended at least as a routine therapy for adults [15,28,29].
Sf-BL (from bovine lungs) and Sf-HL (from human amniotic fluid) have been permitted for clinical use in Russia; methods of their manufacturing are simplified in comparison with foreign analogues [10,22,30,31]. These preparations have a relatively high concentration of proteins [10,31], possibly due to contaminations from plasma. At the same time, it has been reported that Sf-BL is 30-50 times more active than Sf preparations manufactured in other countries [4], whereas Sf-HL is "no less potent than foreign analogues." [5] The following statements were made (verbatim from Russian): "Analysis of the protein spectrum by electrophoresis... detected groups of proteins with molecular weight 18 kDa and 5-8 kDa. These hydrophilic proteins are specific for natural pulmonary Sf. Other proteins were not found." [10,31] However, molecular weights of Sf-associated proteins quite different from the above figures were reported by other researchers [32]. In any case, it is unclear, how the high level of purification is achieved, if the manufacturing methods don't include chromatography or other subtle methods of protein separation [10,30,31]. High protein concentration, including that of potentially antigenic plasma proteins, is regarded as a contraindication for clinical use of Sf preparations [33]. Furthermore, it appears probable that instillations of protein can supply material for building of hyaline membranes, having unfavorable effect because more protein will eventually have to be organized, resulting in more fibrosis. Moreover, complications can be caused alone by bronchoscopy, performed for the Sf-therapy, especially if it is performed by not perfectly trained personnel. A concluding point is that some data published in the Russian-language professional literature about effectiveness of Sf preparations in pulmonary diseases especially in adults are generally not confirmed in the international literature, while action mechanisms are not readily comprehensible. Probably, further animal experiments are needed to explore the perspectives of Sf supplementation in different pathological pulmonary conditions beyond infancy [1]. At the same time, unfounded experimentation should be avoided, especially if there is no adequate equipment or possibility to objectively evaluate the data.
References
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2. Granov AM, Rozenberg OA, Tsybul'kin EK, et al. Critical state medicine. Surfactant therapy of adult respiratory distress syndrome (results of multicenter studies). Vestn Ross Akad Med Nauk 2001;(5):34-8.
3. Bautin A, Khubulava G, Kozlov I, et al. Surfactant therapy for patients with ARDS after cardiac surgery. J Liposome Res 2006;16(3):265-72.
4. Erokhin VV, Zhilin IuN, Naumov VN, et al. Treatment method for patients with acute lung injury syndrome after extensive surgery. Patent of Russian Federation No. 2195958. 2003 Jan. (cited 2012 Jan 12). Available from: http://ru-patent.info/21/95-99/2195958.html
5. Tsybul'kin EK, Rozenberg OA, Seĭliev AA, et al. Our experience in the use of a Russian preparation of pulmonary surfactant in the treatment of acute respiratory distress syndrome and severe pneumonia in children. Anesteziol Reanimatol 1999;(2):61-5.
6. Rozenberg OA, Riumina II, Dementieva GM, et al. Treatment method of postnatal pneumonias in newborns. Patent of Russian Federation No. 2149015. 2000 May. (cited 2012 Jan 12). Available from: http://ru-patent.info/21/45-49/2149015.html
7. Gomozova SP, Rozenberg OA, Vladimirova AG, et al. Treatment method for acute bronchopneumonias complicated by atelectasis. Patent of Russian Federation No. 2149014. 2000 May. (cited 2012 Jan 12). Available from: http://ru-patent.info/21/45-49/2149014.html
8. Lovacheva OV, Erokhin VV, Chernichenko NV, et al. Results of use of surfactant in complex therapy of patients with destructive pulmonary tuberculosis. Probl Tuberk Bolezn Legk 2006;(10):12-7.
9. Erokhin VV, Lovacheva OV, Lepekha LN, et al. Treatment method of pulmonary tuberculosis. Patent of Russian Federation No. 2195313. 2002 Dec. (cited 2012 Jan 12). Available from: http://ru-patent.info/21/95-99/2195313.html
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15. Davidson WJ, Dorscheid D, Spragg R, et al. Exogenous pulmonary surfactant for the treatment of adult patients with acute respiratory distress syndrome: results of a meta-analysis. Crit Care 2006;10(2):R41.
16. Jain R, DalNogare A. Pharmacological therapy for acute respiratory distress syndrome. Mayo Clin Proc 2006;81(2):205-12.
17. Kesecioglu J, Haitsma JJ. Surfactant therapy in adults with acute lung injury/acute respiratory distress syndrome. Curr Opin Crit Care 2006;12(1):55-60.
18. Bernard GR. Innovative therapy. In: Russel JA, Walley KR, Eds. Acute respiratory distress syndrome. Cambridge University Press 1999; pp. 233-50.
19. Taut FJ, Rippin G, Schenk P, et al. A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute). Chest 2008;134(4):724-32.
20. Volchkov VA, Dubrovskaya VF, Klestova OV, et al. Therapeutic efficiency of early and late administration of surfactant-BL during bleomycin-induced damage to rat lungs. Bull Exp Biol Med 2006;141(6):682-4.
21. Loshakova LV, Kirillov IuA, Lebedeva ES, et al. The structural changes in the lungs and the phospholipids of the pulmonary surfactant in experimental bleomycin-induced pneumosclerosis in rats. Biull Eksp Biol Med 1991;112(11):534-6.
22. Rozenberg OA, Danilov LN, Volchkov VA, et al. Pharmacological properties and therapeutic efficacy of the domestic preparations of lung surfactants. Biull Eksp Biol Med 1998;126(10):455-8.
23. Kirillov IuA. Morphogenesis of experimental fibrosing alveolitis and modern technologies of its correction. Doctoral dissertation. Moscow I.M. Sechenov Medical Academy 2005.
24. Gadek JE. Consensus on surfactant and inhaled nitric oxide for ARDS. J Aerosol Med 1996;9(1):155-62.
25. Walmrath D, Günther A, Ghofrani HA, et al. Bronchoscopic surfactant administration in patients with severe adult respiratory distress syndrome and sepsis. Am J Respir Crit Care Med 1996;154(1):57-62.
26. Lewis JF, Jobe AH. Surfactant and the adult respiratory distress syndrome. Am Rev Respir Dis 1993;147(1):218-33.
27. Prabhakaran P. Acute respiratory distress syndrome. Indian Pediatr 2010;47(10):861-8.
28. Stevens TP, Sinkin RA. Surfactant replacement therapy. Chest 2007;131(5):1577-82.
29. Shah S. Exogenous surfactant: intubated present, nebulized future? World J Pediatr 2011;7(1):11-5.
30. Rozenberg OA, Shaldzhian AA, Seĭliev AA, et al. Surfactant manufacturing method. Patent of Russian Federation No. 2066197. 1996 Sept. (cited 2012 Jan 12). Available from: http://ru-patent.info/20/65-69/2066197.html
31. Rozenberg OA, Shaldzhian AA, Seĭliev AA, et al. Surfactant manufacturing method. Patent of Russian Federation No. 2066198. 1996 Sept. (cited 2012 Jan 12). Available from: http://ru-patent.info/20/65-69/2066198.html
32. Katyal SL, Estes LW, Lombardi B. Method for the isolation of surfactant from homogenates and lavages of lung of adult, newborn, and fetal rats. Lab Invest 1977;36(6):585-92.
33. Fujiwara T, Robertson B. Pharmacology of exogenous surfactant. In: Robertson B, van Golde LMG, Batenburg JJ, Eds. Pulmonary surfactant. From molecular biology to clinical practice. Amsterdam: Elsevier 1992; pp. 561-92.
Competing interests: No competing interests
Re: Collaborative quality improvement to promote evidence based surfactant for preterm infants: a cluster randomised trial
After our last rapid response [1], 2 articles have been published on this topic [2,3]. It should be added that excessive instrumentation e.g. endoscopy might be associated with enhanced risk of some blood-borne infections e.g. viral hepatitis [4-7]. Sf must be delivered into the alveoli. For such purpose, bronchoscopic instillation can be theoretically of advantage. However, it remains questionable whether exogenous Sf is efficient in conditions without a primary Sf deficiency, especially in adults; more details are in [1-3]. Further experimental studies are needed to confirm efficacy and safety of Sf preparations for conditions without primary Sf deficiency. Large animals such as calves can be used to assess bronchoscopy for that purpose [8]. For example, radiolabeled Sf can be administered to large animals by means of bronchoscopy and other techniques before sacrificing, with subsequent estimation of its amount that has reached alveoli e.g. using autoradiography. Especially in edematous and inflammatory conditions, when alveoli and respiratory ways contain exudations, relative quantity of Sf reaching alveoli would be lower than in healthy animals and can in fact be negligible. In any case, animal experiments should be planned only in conditions of integrity and the presence of adequate equipment.
References
1. Jargin SV. Surfactant preparations beyond infancy: primum non nocere. BMJ Rapid Response 22 January 2012 http://www.bmj.com/rapid-response/2012/01/21/re-collaborative-quality-im...
2. Jargin SV. Surfactant preparations for tuberculosis and other diseases beyond infancy: a letter from Russia. Tuberculosis (Edinb) 2012;92:280-2.
3. Jargin SV. Surfactant therapy of pulmonary conditions excluding those with primary surfactant deficiency and bronchoscopy as delivery method: an overview of Russian patents and publications. Recent Pat Drug Deliv Formul. 2013;7(2):134-7.
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6. Shakhbazian IE, Garkusha MB, Sklianskaia OA, Ali NIu, Daurova NV, Chumakov AM, et al. Campylobacter pylori gastroduodenitis in children with juvenile rheumatoid arthritis. Revmatologiia (Mosk) 1991;(3):23-8.
7. Sklianskaia OA, Garkusha MB, Ufimtseva AG, Daurova NV, Chumakov AM, Sekamova SM, et al. Chronic gastroduodenitis in children and Campylobacter pylori. Arkh Patol 1990;52(10):49-53.
8. Potgieter LN, McCracken MD, Hopkins FM, Walker RD, Guy JS. Use of fiberoptic bronchoscopy in experimental production of bovine respiratory tract disease. Am J Vet Res 1984;45(5):1015-9.
Competing interests: No competing interests