IRDS Surfaktantravi. M-L Ilmoja, T Metsvaht Mai 2015
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1 IRDS Surfaktantravi M-L Ilmoja, T Metsvaht Mai 2015
2 Epidemioloogia Oluline haigestumuse ja suremuse põhjus Esinemissagedus ja raskus rasedusnädalat: 50% rasedusnädalat: <30% Esinemissagedus gr: 42% gr: 71% gr: 54% gr: 36% gr: 22%
3 Kopsude areng
4 Kopsude venitatavus
5 Terve kops
6 Hüaliinmembraanid
7 Kliinilised tunnused Tahhüpnoe Ninatiibade puhevus Oigamine Abilihaste haaratus Tsüanoos
8 TTN MAS Pneumoonia Südamerike Õhulekke sündroomid Hüpoglükeemia Metaboolsed häired Aneemia, polütsüteemia Kopsude väärareng Dif. diagnostika
9
10 Surfaktandi koostis Fosfolipiidid 80-85% dipalmitoüülfosfatidüülkoliin DPPC 50% Küllastamata fosfolipiidid Kolesterool 8-10% Valgud 10-12% Hüdrofiilsed SP-A, SP-D Hüdrofoobsed SP-B, SP-C (CB Daniels et al. News Physiol Sci 18: , 2003; AV Andreeva et al. Am J Physiol Lung Cell Mol Physiol 293: L259 L271, 2007; TP Stevens. Chest 2007;131:1577)
11 Surfaktandi toime Laplace i seadus Pindpinevus (lung mechanics) Pindpinevus Kopsumahu stabiliseerumine madala transpulmonaalserõhu juures atelektaas Kopsuturse Väikeste hingamisteede avatus (Enhorning 1993) Gaasivahetus Gaasivahetuse pindala Intrapulmonaalne šunt TM 2006
12 Bronchoalveolar Lesions in Airways of Preterm Surfactant Deficient Rabbits are Prevented by Surfactant Treatment Robertson, 1984
13 SP-B mõju surfaktandi toimele ventileeritud enneaegsetel küülikutel Rider et al., Am Rev. Resp. Dis., 1993
14 S füsioloogia 2 Kaitse (host defence) Antibakteriaalne/ viirusvastane aktiivsus Spetsiifiline immuunsus SP-A, SP-D Makrofaagide fnmuutus (Van Iwaarden 1991, McFadden 1994) Mukotsiliaarnetransport (Kakuta 1991) Antioksüdant Surfactant protein A (SP-A) and SP-D potentially bind several receptors, including SP-R210, Tolllike receptor 2 (TLR2), TLR4, signal-inhibitory regulatory protein-(sirp-) and CD91 calreticulin. SP-A binds SIRP-and inhibits production of inflammatory mediators. By contrast, when SP-A is bound to a pathogen or cellular debris, its collagen-like region is bound to CD91 calreticulin and induces inflammatory-mediator production. NF-B, nuclear factor-b; PKC, protein kinase C; SHP1, SRC homology 2 (SH2)-domain-containing protein tyrosine phosphatase 1. TM 2006
15 Skontsentratsioon inimese alveoolides surfaktant (mg/kg) Alveolaar vedelik (ml/kg) Surfaktandi kontsentratsioon (mg/ml) täiskasvanu mg/ml Ajaline vastsündinu Ca100 suur kõrge Enneaegne vastsündinu 0-10 suur madal Aitäh! A. Jobe
16 Surfaktant ja RDS 18. saj II pool esmased RDS kirjeldused Inglismaal, Saksamaal, Prantsusmaal 1929.a. K von Neergaard alveoolide pindpinevus Radford, Macklin, Pattle, Clements surfaktandi koostis, süntees, füsioloogiline roll 1959.a. ME Avery & J Mead S defitsiit vastsündinu IRDS põhjusena TM 2006 (S Parmigiani et al. Acta Biomed Ateneo Parmense 2003; 74:69-75; Historical Archives Advisory Committee. Pediatrics2001; 107: )
17 Pco 2 and Surfaktandi hulk enneaegsetel lammastel 2 tv CPAP-ravil hingamispuudulikkus pco 2 Mulrooney, et al., AJRCCM, 2005
18 Surfaktant ja IRDS 1980.a. Fujiwara looduslik surfaktant parandab dramaatiliselt IRDS-ga vastsündinute kopsufunktsiooni 1990.a. rutiinkasutuses, FDA heakskiit >400 kliinilise uuringu >34 RCT aastast 2000! TM 2006 (TP Stevens et al. Chest 2007;131:1577-)
19 S vs kontroll: IRDS elulemus Surma risk 40% Pneumotooraksi risk 30-65% IVH risk (GK Suresh et al. J Perinatol 2005; 25:S40-S44) TM 2006 (JKH Sinn et al. J Paediatr Child Health 2002; 38: ; TP Stevens et al. Chest 2007;131: )
20 Surfaktant-preparaadid Nimetus/loom, kellelt saadakse/ tootja Looduslikud: eraldatakse purustatud kopsukoe lipiidosast või alveolaarlavaaži vedelikust (TP Stevens et al. CHEST 2007; 131: )
21 Naturaalsed S Veise: Surfaktant TA (Surfacten) Survanta (Beractant) Alveofact CLSE Infasurf Sea: Curosurf (Poractant α) Eelis Sisaldab SP-B ja SP-C Inaktivatsioon puudus Haiguste ülekande risk Soovimatud koostisosad Immunoloogilised tagajärjed? TM 2006 (I Frerking et al. Int Care Med 2001; 27: )
22 Sünteetilised S Lipiid-S: Exosurf, ALEC (Pumactant) Eelis Haiguste oht Immunoloogiline äratõuge Täpne koostis odav Puudus Inaktivatsioon Puuduvad pindaktiivsed valgud Vähene/aeglane mõju gaasivahetusele Lipiid+valk: SP-B fragment KL 4 (Surfaxin) rsp-c Venticute Sisaldab apoproteiine Täpne koostis Inaktivatsioon TM 2006 (I Frerking et al. Int Care Med 2001; 27: )???
23 Surfaktant: kuidas ja kui palju? Efekt oksügenisatsioonile oluliselt parem 25 vs mg/kg, pco 2 pole vahet Bronhoskoopiliselja intratrahheaalsel manustamisel pole vahet efektis oksügenistasioonile, esimene aeglasem (24,5 vs 11,6 min) Jaotuvus sõltub mahust (J Lewis et al. AmJ RespirCritCareMed1999;159: )
24 Looduslik vs sünteetiline valkudeta S Meta-analüüs 10 RCT: looduslik S parem Surevus RR 0,87; 95% CI 0,75-0,99 Pneumotooraks RR 0,63; 95% CI 0,52-0,76 Pole erinevust IVH, BPD, PDA, sepsis TM 2006 (RF Soll et al. The Cochrane Library 2003; 3)
25 Naturaalne vs sünteetiline peptiidiga S: STAR trial N=252 Lucinactant Poractant GA r.n. Sk g S 30 min sünnist % surevus 28p surevus 36n PMA elus BPD-ta 28p elus BPD-ta 36n PMA TM 2006 (SK Sinha et al. Pediatrics 2005; 115: )
26 Profülaktiline vs ravi S Profülaktilise S eelised Kiire S reservi ja tsirkulatsiooni taastamine Enne kui gaasivahetus on häirunud väldib põetikukaskaadi käivitumise/ võimendumise valgurikka vedeliku kogunemise alveoolide valendikus Hilise S eelised Välditud üleravimine Invasiivsusest tulenevad riskid Infektsiooni ülekanne??? (TP Stevens et al. Chest 2007;131: )
27 IRDS profülaktika vs ravi (8 RCT; >2500 vs) Profülaktiline S 30 min jooksul sünnist vs välja kujunenud RDS ravi Surm RR 0,61; 95% CI 0,48-0,77 NNT 7! Surm v BPD RR 0,87; 95% CI 0,77-0,97 Pneumotooraks RR 0,62; 95% CI 0,42-0,89 PIE RR 0,54; 95% CI 0,36-0,82 IVH III-IV RR 0,19; 95% CI 0,07-0,54 TM 2006 (RF Soll. The Cochrane Library2003; 3)
28 Miks ikkagi ravi? Kellele profülaktika? 80% EA >28 r.n. ei vaja KKV 80% EA <27 r.n. vajab KKV Tehniline teostus enne esimest hingetõmmet?? Hõlmatakse vähem haigeid Asjatu invasiivsus Neuroloogiline tulemus?? Majanduslik kaalutlus Varane ravi sama efektiivne TM 2006 (TP Stevens et al. Chest 2007;131: )
29 IRDS varane vs hiline ravi Surevus RR 0,87; 95% CI 0,77-0,99 Pneumotooraks RR 0,70; 95% CI 0,59-0,82 PIE RR 0,63; 95% CI 0,43-0,93 CLD 36 r.n. RR 0,70; 95% CI 0,55-0,88 TM 2006 (RF Soll. Biol Neonate 2005; 88: )
30
31 RDS esinemissagedus VLBW vastsündinutel uuring uuritavad % RDS % surfaktantravi Danish Experience 27±2 weeks - 30% NICHD g 63% 62% NICHD weeks 95% 76% COIN Trial 950g average - 38% (CPAP arm) NICHD Support Trial weeks - 67% (CPAP arm) Vermont-Oxford CPAP Trial weeks - 15% (CPAP arm)
32 Ohud/ tüsistused Hingamisteede obstruktsioon (mööduv) Barotrauma ja kopsuverejooksu risk Kiiresti suureneb venitatavus Aju perfusiooni muutused RVM ümberjaotumine Intubatsiooniga seotud tüsistused
33 Euroopa juhis soovitused Vastsündinutele, kellel onrds või kõrge risk selle tekkeks tuleb manustada surfaktanti(a). Profülaktika enamasti GA< 26nädala; samuti kui vajalik intubatsioon (A). Varane ravi, kui tekid RDS kliinik (suurenev hapnikravi vajadus etc) (A). Poractant alfa200 mg/kg on raske kuni mõõduka RDS korral parem kui 100 mg/kg (poractant või beractant)(b). Kui seisund on stabiilne, kaaluda varast ekstubatsiooni CPAP-le (B). 2-ne ja 3-s doos on näidustatud kui püsib lisahapniku ja/ või juhitava hingamise vajadus (A).
34 INSURE (Intubate-SURfactant-Extubateto CPAP) Pikaajalist intubatsiooni on võimalik vältida Cochrane meta-analüüs 6 RCT KKV (RR % CI; ) pneumotooraks(rr % CI; ) BPD (RR % CI; ) Mida varasem interventsioon, seda edukam!
35 Kas oleks võimalik intubatsiooni vältida? Intraamniootiline manustamine Inhalatsioon Intratrahheaalse kateetriga Kõrimask Neelu (enne esimest hingetõmmet)?? Cochrane Database Syst Rev Mar 16;(3):CD
36 Surfaktandi manustamine neelu Surfaktant pea sünnil, edasi CPAP 23 vs GA nädalat (teostatavus?) 2/15 vaginaalselt sündinud vs vajasid KKV 5/8 keiserlõike teel sündinud lapsest vajasid KKV, 2 said surfaktantravi Kõrimask 8 vastsündinut (Itaalia) Kattwinkel 2004 Trevisanuto 2005
37 Surfaktandiintraamniootiline manustamine 6 vastsündinut Itaalia 1997 Emadele aminofülliin; 2 RDS ta, 4 kerge-mõõdukas RDS 45 vastsündinut Hiina 2004 Võrreldes 30 kontrollgrupi vs-ga vähem RDS (biokeemilisi muutusi) Risk ei kaalu üles võimalikku kasu? Cosmi EV, La Torre R, Piazze JJ, et al. Intraamniotic surfactant for prevention of neonatal respiratory distress syndrome (IRDS): rationale and personal experience. Eur J Obstet Gynecol Reprod Biol 1997; 71: Zhang JP, Wang YL, Wang YH, et al. Prophylaxis of neonatal respiratory distress syndrome by intra-amniotic administration of pulmonary surfactant. Chin Med J (Engl) 2004; 117: A bdel-latif ME, Osborn DA, Challis D. Intra-amniotic surfactant for women at risk of preterm birth for preventing respiratory distress in newborns. Cochrane Database of Systematic Reviews 2010,Issue1.Art.No.:CD
38 S aerosool J Sun et al. Critical Care 2009, 13:R31
39 Surfactandi aerosool Lipiide raske aerosooliks teha Loomkatses mõõdetav kopsufn muutus väga suurte annustega 2000 pilootuuring 34 vs CPAP-ravil 480 mg Curosurfi Pole muutust oksügenistasioonis; suurem uuring pole näidustatud Berggren E, Acta Paediatrica 2000
40 Minimaalselt invasiivne surfaktant-ravi(mist) Surfaktant manustatakse omahingamisel CPAP foonil Pilootuuringud Saksamaal ja Austraalias Saksamaa: 319 vs võrreldud 1222 ajaloolise kontrolliga KKV vajadus 72 tv 29% vs 53%; p < BPD 36 nädalat PMA 10% vs 17.5%; p = Mitmekeskuseline RCT ilmumas
41 S muud näidustused Vastsündinu muu kopsukahjustus: Pneumoonia Mekooniumi aspiratsiooni sündroom (MAS) SP (SP-B) defitsiit Bronhioliit ARDS/ALI TM 2006
42 MAS: in vitro Mekooniumi toime surfaktandile: Inhibeerib annusest sõltuvalt pindaktiivsust, toime ületatav S suurte kontsentratsioonidega SP-A, SP-B (D Moses et al. Am J Obstet Gynecol 1991; 164: ) (GM Cleary et al. Pediatrics 1997; 100: ) TM 2006
43 MAS: kliinilised uuringud Surfaktant ECMO vajadus Metaanalüüs (n=208) RR 0,64 (95% CI 0,46-0,91) Oksügenisatsioon Uuringud tehtud enne inoravi ajastut! PPHN (Õhktüsistused ) Ravi kestvus TM 2006 (A Lotze et al. J Pediatr 1998; 132:40-47; RD Findlay et al. Pediatrics 1996; 97:48-52; RF Soll et al. Cochrane Database Syst Rev 2000; 2)
44 MAS ja S tulemus Ei muuda Surevus Õhktüsistused (pneumotooraks, - mediastiinum, PIE) KKV kestus O2 ravi CLD IVH ECMO vajadus Haiglaravi kestus Shahed et al. Cochrane reviews 2007
45 S lavaaž ja MAS 2 RCT, n=87+ 8 NRSs, n=178 S lavaažvähendab ECMO vajadust ja/või surevust RR 0.34, 95% CI 0.11, 0.99 NRStulemused kooskõlas RCT-ga Conclusions:Lung lavage with diluted surfactant appeared to improve the clinical outcome in infants with MAS. Given that less than 100 infants were included in the two RCTs, the findings of this study may still be regarded as insufficient evidence. HJ Choi et al. Neonatology2012;101:
46 Pneumoonia: invitroja loomkatsed Bakterite kasv (GBS, E coli jt) Oksügenisatsioon Plasmavalgud inhibeerivad S TM 2006
47 Pneumoonia: kliinilised uuringud Parandab oksügenisatsiooni TM 2006 (E Herting et al. Pediatrics 2000; 106: )
48 CDH: loomkatsed Hüaliinmembraanid BAL valgusisaldus S süntees Kopsude compliance Profülaktiline S(enne I hingetõmmet)? Oksügenisatsioon Kopsumaht, compliance PVR, v-p šunt TM 2006 (NN Finer. Paed Res Rev 2004; 5(Suppl A):S289-S297)
49 S ja ARDS S toimed Pindpinevus (lung mechanics) Pindpinevus Kopsumahu stabiliseerumine madala transpulmonaalse rõhu juures atelektaas Kopsuturse Väikeste hingamisteede avatus (Enhorning 1993) Gaasivahetus Gaasivahetuse pindala Intrapulmonaalne šunt S funktsiooni kaotus ja ARDS Venitatavuse Ventilatsiooni-perfusiooni mismatch Alveoolide ja väikeste hingamisteede kollaps Kopsuturse Host-defence Põletikureaktsioon Fibroblastide proliferatsioon TM 2006 W Seeger et al. Clin Invest 1993; 71:177-90
50 S ja ARDS: lapsed n=314 M Duffett et al. Critical Care 2007, 11:R66 (doi: /cc5944)
51 S ja ARDS: lapsed, elulemus Wilson 2005: varane ravi! Surevus 36% kontroll vs 19% S grupis M Duffett et al. Critical Care 2007, 11:R66 (doi: /cc5944)
52 S ja ARDS: lapsed, KKV ja intensiivravi kestvus M Duffett et al. Critical Care 2007, 11:R66 (doi: /cc5944)
53 S ja ARDS: lapsed, kõrvaltoimed M Duffett et al. Critical Care 2007, 11:R66 (doi: /cc5944)
54 S ja ARDS: lapsed, kokkuvõte Surfaktant vähendab ägeda hingamispuudulikkusega laste surevust Lühendab juhitava hingamise kestust On suhteliselt ohutu tõsiseid kõrvaltoimeid ei kirjeldatud Vajalik on suur III faasi uuring (M Duffett et al. Critical Care 2007, 11:R66 (doi: /cc5944); _s6/articles/04_article.html)
55 S ja ARDS: täiskasvanud III faasi kliinilised uuringud Exosurf aerosool ca 5 mg/kg/die kuni 5 päeva Pole mõju gaasivahetusele ega surevusele 2 x Venticute 50 mg/kg kuni 4 doosi 24 tj Edasine ravi sarnane 46% pneumoonia v aspiratsioonisündroom (R Schmidt et al. Respiratory Research 2007, 8:55 doi: / ; A Anzueto et al. NEJM 1996; 334: ; RG Spragg et al. NEJM 2004; 351: )
56 S ja ARDS: täiskasvanud (RG Spragg. NEJM 2004; 351:884-92)
57 S ja A R D S (RG Spragg. NEJM 2004; 351:884-92)
58
59 Miks S ei tööta? Preparaadi koostis? Annus ja manustamisviis? Jaotumine? Roll patofüsioloogias?
60 the duration of treatment in theventicute trials was not long enough to ascertain an enduring effect of surfactant treatment on gas exchange multiple surfactant dosing with persistent improvement in gas exchange mayultimately improve outcome in ARDS. (R Schmidt et al. Respiratory Research 2007, 8:55 doi: / )
61 S ja ARDS: täiskasvanud RCT N=418, ALI/ ARDS Surfaktant HL 10 (sea surfaktant): 90-95% fosfolipiidid 1-2% hüdrofoobsed valgud (SP-B, SP-C) teised lipiidid Doos: 200 mg/kg (max 600 mg/kg) Ajastus: 0h +/-12h +/-36h J Kesecioglu et al. AJRCCM 2009; 180:
62 S ja ARDS: täiskasvanud Katkestas ennetähtaegselt (planeeritud 1000 pt) Tõsiseid kõrvalnähte n=116(55.2%) kontroll vs 157 (76.6%) HL 10 grupis; p <0,001 hüpokseemia : kontroll 53/210 (25,2%) vs HL /208(51.9%) hüpotensioon : kontroll 36/210 (17,1%) vs HL10 70/208(34.1%) care only J Kesecioglu et al. AJRCCM 2009; 180:
63 Halva raviefekti põhjused (2) Manustamise hetkeks olemasolev kopsukahjustus Muud organkahjustused MOF Hingamispuudulikkuse põhjuseks pole S defitsiit Mehhanism, mis hoiab alal S fn kaotust
64
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