Precioso Alexander R, Sakae Paula P O, Mascaretti Renata S, Kubrusly Flávia S, Gebara Vera C B Cainelli, Iourtov Dmitri, Rebello Celso M, Vaz Flávio A C, Raw Isaías
Pediatrics Department, São Paulo University Medical School, São Paulo, SP, Brazil.
Clinics (Sao Paulo). 2006 Apr;61(2):153-60. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.
To study the immunogenicity and the stability of the porcine pulmonary surfactant preparation produced by the Instituto Butantan.
Immunogenicity assay: Sixteen New-Zealand-White rabbits (1000 g body weight) were divided into 4 study groups. Each group was assigned to receive either a) Butantan surfactant, b) Survanta (Abbott Laboratories), c) Curosurf (Farmalab Chiesi), or d) no surfactant. The surfactants were administered intratracheally, and the animals were collected immediately before and 60 and 180 days after surfactant administration. Sera were assayed for the presence of antisurfactant antibodies by enzyme-linked immunosorbent assay (ELISA). Stability assay: The Butantan surfactant used in this assay had been stored for one year in the refrigerator (4 to 8 degrees C) and its stability was evaluated in distinct assay conditions using a premature rabbit model.
Immunogenicity assay: None of the surfactants analyzed triggered antibody immune responses against their components in any of the animals. Stability assay: The results of this study demonstrate that Butantan surfactant was as effective as Curosurf when both were submitted to the adverse circumstance of short- and long-term storage at room temperature. A similar level of efficacy for the Butantan surfactant, as compared to Curosurf was demonstrated by the pulmonary dynamic compliance, ventilatory pressure, and pressure-volume curve results.
The results of our study demonstrate that Butantan surfactant may be a suitable alternative for surfactant replacement therapy.
研究布坦坦研究所生产的猪肺表面活性物质制剂的免疫原性和稳定性。
免疫原性测定：将16只新西兰白兔（体重1000克）分为4个研究组。每组分别接受以下处理：a）布坦坦表面活性物质，b）珂立苏（雅培实验室），c）固尔苏（基耶西制药），或d）不接受表面活性物质。通过气管内给药表面活性物质，在给药前以及给药后60天和180天立即收集动物。通过酶联免疫吸附测定（ELISA）检测血清中抗表面活性物质抗体的存在。稳定性测定：本测定中使用的布坦坦表面活性物质已在冰箱（4至8摄氏度）中储存一年，并且使用早产兔模型在不同的测定条件下评估其稳定性。
免疫原性测定：所分析的任何一种表面活性物质均未在任何动物中引发针对其成分的抗体免疫反应。稳定性测定：本研究结果表明，当布坦坦表面活性物质和固尔苏都在室温下经历短期和长期储存的不利情况时，二者效果相当。肺动态顺应性、通气压力和压力-容积曲线结果表明，布坦坦表面活性物质与固尔苏的疗效水平相似。
我们的研究结果表明，布坦坦表面活性物质可能是表面活性物质替代疗法的合适替代品。
