PROTIMIKROBNA ZDRAVILA V
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1 PROTIMIKROBNA ZDRAVILA V NOSEČNOSTI Petra Bogovič Klinika za infekcijske bolezni in vročinska stanja UKC Ljubljana 9. junij, 2017
2 Uvod Uporaba zdravil v nosečnosti koristi in tveganja za nosečnico in plod Skoraj vsa zdravila prehajajo iz materinega krvnega obtoka skozi posteljico v krvni obtok ploda (za večino učinkovin njihov neškodljiv/škodljiv vpliv na plod ni dokazan) Raziskave na živalih, retrospektivne raziskave»primer-kontrola«, poročila o primerih, podatki iz registrov Med 213 novimi učinkovinami (FDA, ) le za 5 % humani podatki glede varnosti uporabe v nosečnosti Mazer-Amirshahi M et al. Am J Obstet Gynecol 2014 Nezdravljena bolezen lahko škodljivo vpliva na plod (spremenjena presnova, okužba ploda)
3 Teratogeni (toksičen) učinek zdravil Prirojene razvojne nenormalnosti (2 5 % otrok) - Nepojasnjen vzrok (65 70 %) - Genetski dejavniki, kromosomske nepravilnosti (20 %) - Zdravila (2 3 %) ~ 30 zdravil/skupin zdravil so verjetni/dokazani teratogeni - Narava učinkovine (lastnosti in mehanizem delovanja) Freyer AM. Drug-prescribing challenges during pregnancy. Obstet Gynaecol Reproduct Med 2008
4 Teratogeni (toksičen) učinek zdravil Prirojene razvojne nenormalnosti (2 5 % otrok) - Nepojasnjen vzrok (65 70 %) - Genetski dejavniki, kromosomske nepravilnosti (20 %) - Zdravila (2 3 %) ~ 30 zdravil/skupin zdravil so verjetni/dokazani teratogeni - Narava učinkovine (lastnosti in mehanizem delovanja) - Odmerek - Trajanje izpostavljenosti - Razvojna stopnja zarodka/ploda - Genotip zarodka - Součinkovanje z drugimi snovmi (alkohol, kajenje ) Freyer AM. Drug-prescribing challenges during pregnancy. Obstet Gynaecol Reproduct Med 2008
5 FDA razvrstitev učinkovin glede varnosti uporabe med nosečnostjo SKUPINA A DEFINICIJA Kontrolirane raziskave pri nosečnicah niso pokazale povečane nevarnosti za razvoj nenormalnosti pri plodu. B Raziskave na živalih niso dokazale škodljivosti za plod, vendar kontrolirane raziskave na nosečnicah niso bile opravljene ALI raziskave na živalih so dokazale škodljivost za plod, vendar kontrolirane raziskave na nosečnicah škodljivosti za plod niso potrdile. C Raziskave na živalih so dokazale škodljivost za plod, kontrolirane raziskave na nosečnicah niso bile D Kontrolirane ali opazovalne raziskave na nosečnicah so potrdile škodljivost za plod, vendar lahko opravljene ALI Raziskave na živalih in kontrolirane raziskave na nosečnicah niso bile opravljene. korist pretehta potencialno nevarnost. X Kontrolirane ali opazovalne raziskave na živalih ali nosečnicah so potrdile škodljivost za plod. Uporaba učinkovin je prepovedana pri ženskah, ki so ali lahko postanejo noseče. Dostopno na :
6 Fiziološke spremembe v nosečnosti - Pojavijo se zgodaj po zanositvi, najbolj izražene so v 3. trimesečju - Vplivajo na vse faze farmakokinetičnih procesov Absorpcijo, porazdelitev, presnovo in izločanje Spremenijo se: - motiliteta GIT, bruhanje nepredvidljiva biološka uporabnost, tmax celokupna voda (znotraj- in zunajžilna) Vd hidrofilnih substanc maščobnih zalog Vd in upočasnjeno izločanje lipofilnih substanc pretok čez ledvice in GF (za ~50 %) očistek konc. albuminov konc. prostih substanc - aktivnost jetrnih encimov konc. aktivnih/neaktivnih produktov Prenizki odmerki, toksičnost
7 Fiziološke spremembe v nosečnosti klinična praksa? Prilagajanje odmerka? Prilagajanje odmernega intervala? Objektivnih podatkov je zelo malo (merjenje koncentracij opazovanih učinkovin) - Manj kot 2% vseh farmakokinetičnih raziskav (ZDA) vključuje nosečnice McCormack SA et al. Front Pediatr 2014
8 Fiziološke spremembe v nosečnosti klinična praksa? Prilagajanje odmerka? Prilagajanje odmernega intervala? Objektivnih podatkov je zelo malo (merjenje koncentracij opazovanih učinkovin) - Manj kot 2% vseh farmakokinetičnih raziskav (ZDA) vključuje nosečnice - Pariente G et al. Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review. PloS Med MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science (do ) študij, 121 različnih zdravil
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10 SLIKA Drug prescribing challenges during pregnancy Freyer AM. Obstet Gynaecol Reprod Med. 2008; 20: 241-7
11 ZDA, , n= % nosečnic prejelo 1/več zdravil 54 % - vitamini/minerali 64 % - ostala zdravila 1,7 različnih zdravil/nosečnico, 2,7 Rp/nosečnico 1. trimesečje 39 % 2. trimesečje 34,4 % 3. trimesečje 37,9 %
12 Slovenija Nacionalni perinatalni informacijski sistem 83 % žensk med nosečnostjo vzame vsaj 1 zdravilo - Antibiotiki: 15 % - Tokolitiki: 4 5 % - Zdravila za zniževanje krvnega tlaka: 2 3 % - Antiemetiki, antacidi, antihistaminiki, pomirjevala: <1 % - Pripravki z železom in vitamini: 40 %
13 Antibiotiki Najpogosteje predpisana protimikrobna zdravila v nosečnosti - Brezsimptomna bakteriurija - Okužba sečil - Okužba dihal (zgornjih! in spodnjih) Večina antibiotikov uvrščenih v skupini B in C FDA Topična uporaba antibiotikov je praviloma varna skozi kožo absorbira le malo učinkovine
14 SKUPINA PROTIBAKTERIJSKE UČINKOVINE A / B fenoksimetilpenicilin, benzilpenicilin, ampicilin, sulbaktam, amoksicilin, klavulanska kislina, piperacilin, tazobaktam, kloksacilin, cefazolin, cefuroksim, cefotaksim, ceftriakson, ceftazidim, cefaklor, cefepim, aztreonam, etambutol, linkomicin, ertapenem, meropenem, eritromicin, azitromicin, klindamicin,, metronidazol* C imipenem, cilastatin, klaritromicin, rifampicin, izoniazid, pirazinamid, ciprofloksacin, norfloksacin, moksifloksacin, levofloksacilin, linezolid, trimetoprim, sulfametoksazol, vankomicin, gentamicin D amikacin, netilmicin, streptomicin, tobramicin, doksiciklin Dostopno na :
15 SKUPINA A B PROTIBAKTERIJSKE UČINKOVINE / fenoksimetilpenicilin, benzilpenicilin, ampicilin, sulbaktam, amoksicilin, PENICILINI (naravni/polsintetični, tudi kombinacija z zaviralci βlaktamaz), klavulanska kislina, piperacilin, tazobaktam, klindamicin; kloksacilin, cefazolin, cefuroksim, CEFALOSPORINI, MONOBAKTAMI, cefotaksim, ceftriakson, ceftazidim, MAKROLIDI cefaklor, cefepim,(ne aztreonam, etambutol, KARBAPENEMI (ne imipenem), klaritromicin); linkomicin, ertapenem, meropenem, eritromicin, azitromicin, klindamicin, metronidazol (1. trimesečje X) vankomicin po., metronidazol* C imipenem, cilastatin, klaritromicin, rifampicin, izoniazid, pirazinamid, ciprofloksacin, norfloksacin, moksifloksacin, levofloksacilin, linezolid, trimetoprim, sulfametoksazol, vankomicin, gentamicin D amikacin, netilmicin, streptomicin, tobramicin, doksiciklin Dostopno na :
16 SKUPINA A B PROTIBAKTERIJSKE UČINKOVINE / fenoksimetilpenicilin, benzilpenicilin, ampicilin, sulbaktam, amoksicilin, PENICILINI (naravni/polsintetični, tudi kombinacija z zaviralci βlaktamaz), klavulanska kislina, piperacilin, tazobaktam, klindamicin; kloksacilin, cefazolin, cefuroksim, CEFALOSPORINI, MONOBAKTAMI, cefotaksim, ceftriakson, ceftazidim, MAKROLIDI cefaklor, cefepim,(ne aztreonam, etambutol, KARBAPENEMI (ne imipenem), klaritromicin); linkomicin, ertapenem, meropenem, eritromicin, azitromicin, klindamicin, vankomicin po., metronidazol (1. trimesečje X) vankomicin po., metronidazol* C imipenem, cilastatin, klaritromicin, rifampicin, pirazinamid, FLUOROKINOLONI, SULFONAMIDI INizoniazid, TRIMETOPRIM, ciprofloksacin, norfloksacin, moksifloksacin, levofloksacilin, linezolid, vankomicin, linezolid, gentamicin, kloramfenikol trimetoprim, sulfametoksazol, vankomicin iv., gentamicin imipemem, klaritromicin D amikacin, netilmicin, streptomicin, tobramicin, doksiciklin Dostopno na :
17 SKUPINA A B PROTIBAKTERIJSKE UČINKOVINE / fenoksimetilpenicilin, benzilpenicilin, ampicilin, sulbaktam, amoksicilin, PENICILINI (naravni/polsintetični, tudi kombinacija z zaviralci βlaktamaz), klavulanska kislina, piperacilin, tazobaktam, klindamicin; kloksacilin, cefazolin, cefuroksim, CEFALOSPORINI, MONOBAKTAMI, cefotaksim, ceftriakson, ceftazidim, MAKROLIDI cefaklor, cefepim,(ne aztreonam, etambutol, KARBAPENEMI (ne imipenem), klaritromicin); linkomicin, ertapenem, meropenem, eritromicin, azitromicin, klindamicin, vankomicin po., metronidazol (1. trimesečje X) vankomicin po., metronidazol* C imipenem, cilastatin, klaritromicin, rifampicin, pirazinamid, FLUOROKINOLONI, SULFONAMIDI INizoniazid, TRIMETOPRIM, ciprofloksacin, norfloksacin, moksifloksacin, levofloksacilin, linezolid, vankomicin, linezolid, gentamicin, kloramfenikol trimetoprim, sulfametoksazol, vankomicin iv., gentamicin imipemem, klaritromicin D AMINOGLIKOZIDI (izjema gentamicin), amikacin, netilmicin, streptomicin, tobramicin,tetraciklini doksiciklin Dostopno na :
18 Metronidazol - Raziskave na živalih (glodavci) mutageno in karcinogeno delovanje - Možna povezava - atrofija optičnega živca, razcepljeno nebo, nepravilnosti rok, mentalna retardacija - Večina zbranih podatkov v nosečnosti tega ne potrjuje - Dolgoročni postnatalni učinek z možnostjo mutagenega in karcinogenega delovanja pri uporabi v nosečnosti ni bil opredeljen - EMA (European Medicines Agency) - SmPC - kontraindiciran v 1. trimesečju, previdnost pri uporabi v 2. in 3. trimesečju
19 Klaritromicin - Raziskave na živalih srčno žilne nepravilnosti, razcepljeno nebo, več splavov pri uporabi v prvem tromesečju - Večje tveganje za spontani splav pri uporabi v 1. trimesečju Andersen JT et al. Clarithromycin in early pregnancy and the risk of miscarriage and malformation: a register based nationwide cohort study. PLoS One nosečnosti - tveganje za spontani splav (HR1,56) - Pogostost malformacij primerljiva
20 Muanda FT et al. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ Tveganje za spontani splav Azitromicin (OR 1,65) Klaritromicin (OR 2,35) Eritromicin (OR 0,70) Tetraciklini (OR 2,59) Kinoloni (OR 2,72) Ciprofloksacin (OR 2,45) Norfloksacin (OR 4,81) Levofloksacin (OR 3,28) Sulfonamidi (OR 2,01) Metronidazol (OR 1.7) Nitrofurantoin (OR 0,70) Podobni rezultati, ko primerjalna skupina nosečnice izpostavljene penicilinom in cefalosporinom
21 Sulfonamidi niso teratogeni Izpodrivanje bilirubina iz vezavnih mest na plazemskih albuminih - huda zlatenica, kernikterus (pozna nosečnost) Pri plodu s pomankanjem Glu-6-P-DH primeri hude hemolitične anemije (pozna nosečnost) V kombinaciji s trimetoprimom (1. trimesečje) - povečana verjetnost za kardiovaskularne okvare (antagonist folne kisline)
22 Nitrofurantoin (urinarni antiseptik) Tveganje za prirojene malformacije nasprotujoče ugotovitve raziskav - Crider KS et al. Arch pediatr Adolesc Med 2009; Ailes EC et al. Birth Defects Res A Clin Mol Teratol Kazemier BM. Lancet Infect Dis 2015 Posamezni opisi hemolitične anemije pri novorojenčkih s pomankanjem encima Glu-6-P-DH (pozna nosečnost)
23 Fluorokinoloni - Okvara sklepnega hrustanca pri poizkusih na živali Aminoglikozidi - Okvare sluha in ravnotežja - Pri sočasni uporabi s cefalosporini se lahko poveča nefrotoksičnost Tetraciklini - Trajna obarvanost zob in hipoplazija sklenine, upočasnjena rast kosti
24 Protiglivne učinkovine
25 FDA razvrstitev protiglivnih učinkovin
26 FDA razvrstitev protiglivnih učinkovin FDA spremenil uvrstitev flukonazola iz skupine C v D Od odmerka odvisna toksičnost ( 300 mg) Enkratni odmerek 150 mg vaginalna kandidoza (C) Mølgaard-Nielsen D et al. Use of Oral Fluconazole during Pregnancy and the Risk of Birth Defects. N Engl J Med 2013; 369: 830-9
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29 Walsh TJ et al. Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America. Clin Infect Dis 2008; 46: Nosečnice kot posebna skupina niso izpostavljene Za večino invazivnih oblik bolezni - Primarna terapija: vorikonazol (D) - embriotoksičen in teratogen pri poskusih na živalih (glodavci, zajci) - opis uspešnega zdravljenja pri nosečnicah (2. in 3. trimesečje) Shoai Tehrani M et al. Exposure to voriconazole in second and third trimesters of pregnancy: a case report. Antimicrob Agents Chemother Alternativa: L-AMB (B), ABLC (B), kaspofungin (C), mikafungin (C), posakonazol (C), itrakonazol (C)
30 Povrhnje glivne okužbe (koža, sluznice, nohti) Vulvovaginalna kandidoza v nosečnosti pogostejša (20 %) - Topična uporaba antimikotikov je praviloma varna (vključno z azoli) - Kadar je indicirano sistemsko zdravljenje (onihomikoza, micetom) zdravljenje odložimo na čas po porodu
31 Protivirusne učinkovine Toksičnost je odvisna od stopnje selektivnega delovanja na virusne encime Večina protivirusnih zdravil je razvrščenih v skupino C V skupino B so uvrščeni: aciklovir, valaciklovir, nekatera zdravila za zdravljenje okužbe s HIV in hepatitisa B
32 Oseltamivir (skupina C) Težji potek gripe v nosečnosti, lahko neugoden vpliv na potek nosečnosti CDC priporočila: -»Available risk-benefit data indicate that pregnant women with suspected or confirmed influenza should receive prompt antiviral therapy during any trimester of pregnancy«-»oral oseltamivir is currently preferred. The duration of antiviral treatment is 5 days «
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34 Učinkovine z delovanjem na parazite - Varnost uporabe v nosečnosti za večino zelo slabo poznana (malo raziskav-nerazviti svet) - Ni jasnih/enotnih priporočil za uporabo v nosečnosti SKUPINA DEFINICIJA A / B prazikvantel, progvanil, permetrin (topično), metronidazol C albendazol, mebendazol, atovakon, progvanil, klorokin, kinidin, meflokin, primakin, pentamidin, ivermektin, pirimetamin D / X kinin, metronidazol - 1. trimesečje Dostopno na :
35 Okužbe s paraziti 1. Zdravljenje odložimo na čas po porodu (drugo polovico nosečnosti) - Okužbe s človeško glisto in podančicami (albendazol, mebendazol) - Ameboza, okužbe z Giardio lamblio, Trihomonas vaginalis (metronidazol) 2. Zdravimo takoj - Malarija! (večina antimalarikov je razvrščenih v skupino C) - Akutna okužba s Toxoplazmo gondi (spiramicin) - Okužbe s trakuljo (prazikvantel) WHO od leta 1994 priporoča zdravljenje vseh nosečnic okuženih s trakuljo
36 Zaključek Uporaba zdravil v nosečnosti postavlja na tehtnico tveganje za mater (in plod) ob nezdravljeni bolezni in teratogenost učinkovin (prirojene okvare ploda) 1. Zdravilo v nosečnosti predpišemo le, kadar zanj obstaja indikacija 2. V kolikor to dopušča indikacija, uvedbo zdravljenja preložimo na čas po prvem tromesečju nosečnosti 3. Izberemo najbolj varno zdravilo 4. Monoterapija ima prednost pred kombinacijo več zdravil 5. Uporabimo najnižji še učinkovit odmerek zdravila
Kako zdravniki predpisujemo antibiotike. doc.dr.bojana Beović, dr. med. Klinika za infekcijske bolezni in vročinska stanja, KC Ljubljana
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