Upotreba selektivnog inhibitora ponovnog preuzimanja serotonina tokom rane trudnoće i kongenitalnih malformacija: sistematski pregled i meta-analiza kohortnih studija više od 9 miliona porođaja.
BMC medicine
Sažetak istraživanja
Pozadina U 2005. godini, FDA je upozorila da izloženost paroksetinu, selektivnom inhibitoru ponovnog preuzimanja serotonina (SSRI), tokom prvog trimestra trudnoće može povećati rizik od srčanih malformacija. Od tada, povezanost između majčinske upotrebe SSRI tokom trudnoće i kongenitalnih malformacija kod novorođenčadi je predmet mnogih diskusija i kontroverzi.
Cilj ove studije je da se sistematski preispita povezanost između upotrebe SSRI-a u ranoj trudnoći i rizika od urođenih malformacija, sa posebnom pažnjom na potencijalnu konfuziju po indikacijama.
Metode Protokol studije je registrovan kod PROSPERO (CRD42018088358). Kohortne studije o kongenitalnim malformacijama kod dojenčadi rođenih od majki koje su bile izložene SSRI u prvom tromjesečju identificirane su putem PubMed, Embase, Web of Science i Cochrane Library baza podataka do 17. januara 2018. Modeli nasumičnih efekata korišteni su za izračunavanje zbirnih relativnih rizika (RR).
Rezultati Identifikovano je dvadeset i devet kohortnih studija koje uključuju 9.085.954 rođenih. Sve u svemu, upotreba SSRI bila je povezana sa povećanim rizikom od ukupnih velikih kongenitalnih anomalija (MCAs, RR 1,11, 95% CI 1,03 do 1,19) i kongenitalnih srčanih mana (CHD, RR 1,24, 95% CI 1,11 do 1,37). Nije uočen značajno povećan rizik kada je ograničen na žene sa psihijatrijskom dijagnozom (MCAs, RR 1,04, 95% CI 0,95 do 1,13; CHD, RR 1,06, 95% CI 0,90 do 1,26). Slične značajne asocijacije uočene su i pri izloženosti majke citalopramu (MCAs, RR 1,20, 95% CI 1,09 do 1,31; CHD, RR 1,24, 95% CI 1,02 do 1,51), fluoksetinu (MCAs, RR 1,7 do 1,7. 1,28; CHD, 1,30, 95% CI 1,12 do 1,53) i paroksetin (MCAs, RR 1,18, 95% CI 1,05 do 1,32; CHD, RR 1,17, 95% CI 0,97 do 1) sa psihičkim analizama nisu ograničene na žene. statistički značajno. Sertralin je bio povezan sa defektima septuma (RR 2,69, 95% CI 1,76 do 4,10), defektima atrijalnog septuma (RR 2,07, 95% CI 1,26 do 3,39) i defektima respiratornog sistema (RR 2,65, 95% CI 1,32).
Zaključci Dokazi ukazuju na generalno mali rizik od kongenitalnih malformacija i osporavaju značajan teratogeni efekat SSRI. Preporučuje se oprez pri donošenju odluka o tome da li nastaviti ili prekinuti terapiju SSRI tokom trudnoće.
Prikaži originalni naslov i sažetak na engleskom
Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births.
Background In 2005, the FDA cautioned that exposure to paroxetine, a selective serotonin reuptake inhibitor (SSRI), during the first trimester of pregnancy may increase the risk of cardiac malformations. Since then, the association between maternal use of SSRIs during pregnancy and congenital malformations in infants has been the subject of much discussion and controversy. The aim of this study is to systematically review the associations between SSRIs use during early pregnancy and the risk of congenital malformations, with particular attention to the potential confounding by indication.
Methods The study protocol was registered with PROSPERO (CRD42018088358). Cohort studies on congenital malformations in infants born to mothers with first-trimester exposure to SSRIs were identified via PubMed, Embase, Web of Science, and the Cochrane Library databases through 17 January 2018. Random-effects models were used to calculate summary relative risks (RRs).
Results Twenty-nine cohort studies including 9,085,954 births were identified. Overall, use of SSRIs was associated with an increased risk of overall major congenital anomalies (MCAs, RR 1.11, 95% CI 1.03 to 1.19) and congenital heart defects (CHD, RR 1.24, 95% CI 1.11 to 1.37). No significantly increased risk was observed when restricted to women with a psychiatric diagnosis (MCAs, RR 1.04, 95% CI 0.95 to 1.13; CHD, RR 1.06, 95% CI 0.90 to 1.26). Similar significant associations were observed using maternal citalopram exposure (MCAs, RR 1.20, 95% CI 1.09 to 1.31; CHD, RR 1.24, 95% CI 1.02 to 1.51), fluoxetine (MCAs, RR 1.17, 95% CI 1.07 to 1.28; CHD, 1.30, 95% CI 1.12 to 1.53), and paroxetine (MCAs, RR 1.18, 95% CI 1.05 to 1.32; CHD, RR 1.17, 95% CI 0.97 to 1.41) and analyses restricted to using women with a psychiatric diagnosis were not statistically significant. Sertraline was associated with septal defects (RR 2.69, 95% CI 1.76 to 4.10), atrial septal defects (RR 2.07, 95% CI 1.26 to 3.39), and respiratory system defects (RR 2.65, 95% CI 1.32 to 5.32).
Conclusions The evidence suggests a generally small risk of congenital malformations and argues against a substantial teratogenic effect of SSRIs. Caution is advisable in making decisions about whether to continue or stop treatment with SSRIs during pregnancy.
Izvorni podaci
- DOI
- 10.1186/s12916-018-1193-5
- PMID
- 30415641
- PMCID
- PMC6231277
- Provjereno
- 2026-07-26
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