牛/猪肺表面活性物质治疗早产儿呼吸窘迫综合征的快速卫生技术评估

Rapid health technology assessment of bovine pulmonary surfactant versus porcine ones in the treatment of preterm neonates with respiratory distress syndrome

目的比较牛肺表面活性物质(PS)和猪PS治疗早产儿呼吸窘迫综合征(RDS)的有效性、安全性和经济性。方法计算机检索PubMed、Embase、Cochrane Library、中国知网、SinoMed、万方数据、国内外卫生技术评估(HTA)机构官方网站及相关数据库,收集牛PS与猪PS对比治疗早产儿RDS的HTA报告、系统评价/Meta分析和药物经济学研究,检索时限均为建库起至2022年2月。资料提取和质量评价后,对纳入研究的结果进行描述性分析。结果共纳入1篇HTA报告、6篇系统评价/Meta分析、6篇药物经济学研究。牛PS在新生儿重症监护病房住院时间和肺外指标发生率方面与猪PS相当;PS再治疗率、血气指标、总有效率、动脉导管未闭发生率方面,猪PS较牛PS更有优势;两者在死亡率和支气管肺发育不良、漏气综合征、肺出血发生率方面的结果存在争议。经济性方面,两组患儿的平均住院费用、每剂给药成本的差异均无统计学意义(P>0.05);与猪PS比较,牛PS的平均每剂浪费成本更高(P<0.001),治疗24 h平均费用更低(P<0.05);平均药品费用的结果存在争议。结论牛PS治疗早产儿RDS的有效性、安全性和经济性与猪PS相当或劣于猪PS,但其劣势尚不确定是否具有显著的临床意义。

OBJECTIVE To compare the effectiveness,safety and economy of bovine pulmonary surfactant(PS)and porcine PS in the treatment of preterm neonates with respiratory distress syndrome(RDS).METHODS Retrieved from PubMed,Embase,Cochrane Library,CNKI,SinoMed,Wanfang and health technology assessment(HTA)organization websites and relevant database,HTA report,systematic review/meta-analysis and pharmacoeconomic study about bovine PS versus porcine PS in the treatment of preterm neonates with RDS were included from the inception to Feb 2022.Data extraction and quality evaluation were carried out for the included literature,and then research results were summarized and analyzed descriptively.RESULTS A total of 1 HTA report,6 systematic reviews/meta-analyses,and 6 pharmacoeconomic studies were included.There appeared to be no significant differences between bovine PS and porcine PS in terms of time staying in neonatal intensive care unit and extra-pulmonary outcomes.In terms of PS re-treatment,blood gas index,total effective rate and the incidence of patent ductus arteriosus,porcine PS was superior to bovine PS.Results from other indicators,such as mortality,the incidence of bronchopulmonary dysplasia,air leakage syndrome,pulmonary hemorrhage,were still controversial.In terms of economy,there was no statistical difference in average hospital charges and administration cost per dose between two groups(P>0.05);compared with porcine PS,mean wastage cost per dose of bovine PS was higher(P<0.001),and 24 h treatment cost of bovine PS was lower(P<0.05);the results of average medication cost were controversial.CONCLUSIONS The effectiveness,safety and economy of bovine PS are found to be similar or inferior to porcine PS.It is not certain whether the inferiority has clinical significance.