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Abstract：
BACKGROUND: Prophylactic paracetamol for extremely low gestation age neonates (ELGAN, <27 weeks\' gestation) with symptomatic patent ductus arteriosus (sPDA) in high-income countries (HIC) reduces medical and surgical interventions. Its effectiveness in low-to-middle-income countries (LMIC) remains uncertain. This study assesses prophylactic paracetamol\'s impact on sPDA interventions in ELGANs in an LMIC.
METHODS: This is a retrospective cohort study that compared a historical cohort of ELGANs that were treated with oral ibuprofen or intravenous paracetamol after diagnosis of sPDA (n = 104) with infants (n = 76) treated with prophylactic paracetamol (20 mg/kg loading, 7.5 mg/kg qid for 4 days), in a tertiary neonatal intensive care unit (NICU) in Vietnam. Oral ibuprofen or intravenous therapeutic paracetamol were administered if prophylactic paracetamol failed to close sPDA. Surgical ligation was conducted if targeted medical intervention failed, or the infant deteriorated from conditions attributable to sPDA.
RESULTS: In the historical cohort, 57 (55%) infants died within 7 days of life compared to 18 (24%) from the prophylactic cohort (p < 0.01). Of the survivors, 21 (45%) of the historical and 23 (39.7%) of the prophylactic cohort required surgical ligation (p = 0.6). Duration of hospitalization for survivors was lower in the prophylactic cohort (mean 74 vs. 97 days, p = 0.01). In the prophylactic cohort, 24 (41%) infants did not need further treatment while 34 (59%) required further treatment including ibuprofen and/or paracetamol 28 (48%) and surgical ligation 22 (38%).
CONCLUSIONS: Prophylactic paracetamol for ELGAN in LMIC does not reduce the need for surgical ligation, sPDA rates, and other PDA-related morbidities in infants who survive beyond 7 days of age. It may reduce the risk of death and the duration of hospitalization but further study into the reasons behind this need to be determined with larger studies.
METHODS: This is a retrospective cohort study that compared a historical cohort of ELGANs that were treated with oral ibuprofen or intravenous paracetamol after diagnosis of sPDA (n = 104) with infants (n = 76) treated with prophylactic paracetamol (20 mg/kg loading, 7.5 mg/kg qid for 4 days), in a tertiary neonatal intensive care unit (NICU) in Vietnam. Oral ibuprofen or intravenous therapeutic paracetamol were administered if prophylactic paracetamol failed to close sPDA. Surgical ligation was conducted if targeted medical intervention failed, or the infant deteriorated from conditions attributable to sPDA.
RESULTS: In the historical cohort, 57 (55%) infants died within 7 days of life compared to 18 (24%) from the prophylactic cohort (p < 0.01). Of the survivors, 21 (45%) of the historical and 23 (39.7%) of the prophylactic cohort required surgical ligation (p = 0.6). Duration of hospitalization for survivors was lower in the prophylactic cohort (mean 74 vs. 97 days, p = 0.01). In the prophylactic cohort, 24 (41%) infants did not need further treatment while 34 (59%) required further treatment including ibuprofen and/or paracetamol 28 (48%) and surgical ligation 22 (38%).
CONCLUSIONS: Prophylactic paracetamol for ELGAN in LMIC does not reduce the need for surgical ligation, sPDA rates, and other PDA-related morbidities in infants who survive beyond 7 days of age. It may reduce the risk of death and the duration of hospitalization but further study into the reasons behind this need to be determined with larger studies.
摘要：
背景：极低胎龄新生儿的预防性扑热息痛（ELGAN，在高收入国家（HIC），<27周妊娠）有症状的动脉导管未闭（sPDA）可减少医疗和手术干预。其在中低收入国家（LMIC）的有效性仍然不确定。本研究评估了预防性扑热息痛对LMIC中ELGANssPDA干预的影响。
方法：这是一项回顾性队列研究，比较了在诊断为sPDA（n=104）后口服布洛芬或静脉注射扑热息痛治疗的ELGANs与婴儿（n=76）预防性扑热息痛（20mg/kg负荷，7.5mg/kgqid，持续4天），在越南的三级新生儿重症监护病房（NICU）。如果预防性扑热息痛未能关闭sPDA，则口服布洛芬或静脉内治疗性扑热息痛。如果有针对性的医疗干预失败，则进行手术结扎，或婴儿因sPDA引起的病情恶化。
结果：在历史队列中，57（55％）婴儿在生命的7天内死亡，而预防队列中有18（24％）婴儿死亡（p<0.01）。在幸存者中，21（45％）的历史和23（39.7％）的预防队列需要手术结扎（p=0.6）。预防性队列中幸存者的住院时间较低（平均74vs.97天,p=0.01)。在预防队列中，24例（41％）婴儿不需要进一步治疗，而34例（59％）需要进一步治疗，包括布洛芬和/或扑热息痛28例（48％）和手术结扎22例（38％）。
结论：LMIC中的ELGAN的预防性扑热息痛不会减少手术结扎的需要，sPDA费率,以及其他与PDA相关的7日龄以上婴儿的发病率。它可能会降低死亡风险和住院时间，但需要通过更大规模的研究来进一步研究这背后的原因。
方法：这是一项回顾性队列研究，比较了在诊断为sPDA（n=104）后口服布洛芬或静脉注射扑热息痛治疗的ELGANs与婴儿（n=76）预防性扑热息痛（20mg/kg负荷，7.5mg/kgqid，持续4天），在越南的三级新生儿重症监护病房（NICU）。如果预防性扑热息痛未能关闭sPDA，则口服布洛芬或静脉内治疗性扑热息痛。如果有针对性的医疗干预失败，则进行手术结扎，或婴儿因sPDA引起的病情恶化。
结果：在历史队列中，57（55％）婴儿在生命的7天内死亡，而预防队列中有18（24％）婴儿死亡（p<0.01）。在幸存者中，21（45％）的历史和23（39.7％）的预防队列需要手术结扎（p=0.6）。预防性队列中幸存者的住院时间较低（平均74vs.97天,p=0.01)。在预防队列中，24例（41％）婴儿不需要进一步治疗，而34例（59％）需要进一步治疗，包括布洛芬和/或扑热息痛28例（48％）和手术结扎22例（38％）。
结论：LMIC中的ELGAN的预防性扑热息痛不会减少手术结扎的需要，sPDA费率,以及其他与PDA相关的7日龄以上婴儿的发病率。它可能会降低死亡风险和住院时间，但需要通过更大规模的研究来进一步研究这背后的原因。
