Mauskopf J A, Backhouse M E, Jones D, Wold D E, Mammel M C, Mullett M, Guthrie R, Long W A
Burroughs Wellcome Co., Wellcome Research Labs, Research Triangle Park, North Carolina.
J Pediatr. 1995 Jan;126(1):94-101. doi: 10.1016/s0022-3476(95)70509-0.
To determine the impact of the use of synthetic surfactant on hospital resource use and charges, we analyzed the economic data from a multicenter, randomized, placebo-controlled clinical trial of synthetic surfactant in infants with neonatal respiratory distress syndrome and birth weights between 700 and 1350 gm. Two 5 ml/kg doses of a synthetic surfactant (Exosurf Neonatal) or air placebo were administered to 419 infants who were receiving mechanical ventilation and had an arterial/alveolar oxygen tension ratio < 0.22. In addition to the clinical endpoints for safety and efficacy, data were collected on length of hospital stay, days in the neonatal intensive care unit, days of mechanical ventilation, days of oxygen supplementation, and hospital charges until the infant reached 1 year adjusted age. Growth and development of infants who received synthetic surfactant therapy in the study and survived to 1 year adjusted age were equivalent to those of the survivors in the air placebo group. For 1-year survivors, synthetic surfactant reduced the average length of stay at the different levels of care needed during the hospitalization such as neonatal intensive care unit days, days of mechanical ventilation, and days of oxygen supplementation. For nonsurvivors, synthetic surfactant increased the average length of stay, especially at more intense levels of care. Total hospital charges for the initial hospitalization and through 1 year adjusted age for a hypothetic cohort of 100 infants treated with synthetic surfactant were, on average, the same as those for a comparable cohort of infants in the air placebo group. These results indicate that rescue therapy with synthetic surfactant in infants with respiratory distress syndrome and birth weights from 700 to 1350 gm can result in significantly improved survival without significant increases in hospital charges.
为确定使用合成表面活性剂对医院资源利用和费用的影响，我们分析了一项多中心、随机、安慰剂对照临床试验的经济数据，该试验针对出生体重在700至1350克之间的新生儿呼吸窘迫综合征婴儿使用合成表面活性剂。向419名接受机械通气且动脉/肺泡氧分压比<0.22的婴儿给予两剂5毫升/千克的合成表面活性剂（Exosurf Neonatal）或空气安慰剂。除了安全性和有效性的临床终点外，还收集了住院时间、新生儿重症监护病房天数、机械通气天数、吸氧天数以及直至婴儿达到1岁校正年龄时的医院费用等数据。在研究中接受合成表面活性剂治疗并存活至1岁校正年龄的婴儿的生长发育与空气安慰剂组的存活者相当。对于1岁的存活者，合成表面活性剂缩短了住院期间不同护理水平所需的平均住院时间，如新生儿重症监护病房天数、机械通气天数和吸氧天数。对于非存活者，合成表面活性剂增加了平均住院时间，尤其是在护理强度更高的水平。对于一组假设的100名接受合成表面活性剂治疗的婴儿，从初始住院到1岁校正年龄的总医院费用平均与空气安慰剂组中类似婴儿队列的费用相同。这些结果表明，对出生体重700至1350克的呼吸窘迫综合征婴儿进行合成表面活性剂抢救治疗可显著提高存活率，且不会显著增加医院费用。
