猪肺磷脂注射液和氨溴索治疗新生儿呼吸窘迫综合征疗效对比的Meta分析

Effects comparison of Poractant Alfa Injection and ambroxol hydrochloride in treating neonatal respiratory distress syndrome:a Meta analysis

目的系统评价猪肺磷脂注射液和氨溴索治疗新生儿呼吸窘迫综合征(NRDS)的临床疗效及安全性。方法计算机检索国内外比较猪肺磷脂注射液和氨溴索治疗NRDS的临床疗效及安全性的随机对照试验(RCT)文献。根据改良后的JADAD量表进行文献质量评价,采用Rev Man 5.3.1软件进行分析。结果共纳入24个RCT。Meta分析结果显示,相较于氨溴索治疗NRDS,猪肺磷脂注射液更能明显升高pH值(MD=-0.02,95%CI:-0.03^-0.01,P<0.01)、PaO_2值(MD=-2.92,95%CI:-4.59^-1.26,P<0.01)、PaO_2/FiO_2值(MD=-7.62,95%CI:-10.87^-4.37,P<0.01),降低PaCO_2值(MD=0.95,95%CI:0.12~1.77,P=0.02)、FiO_2值(MD=0.03,95%CI:0.01~0.05,P<0.01)、近期并发症(RR=1.67,95%CI:1.31~2.12,P<0.01)和远期并发症发生率(RR=2.85,95%CI:1.14~7.07,P=0.02),减少平均住院时间(MD=3.03,95%CI:0.94~5.11,P<0.01)及病死率(RR=1.96,95%CI:1.15~3.34,P=0.01)。两组患者持续气道正压通气(CPAP)时间、给氧时间、临床症状转归时间、NRDS发病率、治疗总有效率差异无统计学意义(P>0.05)。结论猪肺磷脂注射液治疗NRDS临床疗效优于氨溴索,但鉴于该Meta分析纳入文献数量有限且质量中等,结论尚需规范的大规模、多中心RCT论证。

Objective To systematically assess the clinical effect and safety of Poractant Alfa Injection and ambroxol hydrochloride in treating neonatal respiratory distress syndrome（NRDS）.Methods The home and abroad randomized controlled trials（RCTs）on the comparison of clinical effect and safety of Poractant Alfa Injection and ambroxol hydrochloride in treating NRDS were retrieved by computer.The literature quality was evaluated by the modified JADAD scale.Rev Man5.3.1 software was used for conducting the meta analysis.Results Twenty-four RCT were included.The meta analysis results showed that compared with ambroxol hydrochloride,Poractant Alfa Injection for treating NRDS could more significantly increase the PH value（MD=-0.02,95%CI：-0.03--0.01,P〈0.01）,increased the PaO2 value（MD=-2.92,95%CI：-4.59--1.26,P〈0.01）,decreased the PaCO2 value（MD=0.95,95%CI：0.12-1.77,P=0.02）,reduced the FiO2 value（MD=0.03,95%CI：0.01-0.05,P〈0.01）,enhanced the Pa O2/FiO2 ratio（MD=-7.62,95%CI：-10.87--4.37,P〈0.01）,reduced the short term complications（RR=1.67,95%CI：1.31-2.12,P〈0.01）and long-term complications（RR=2.85,95%CI：1.14-7.07,P=0.02）,shortened the hospitalization days（RR=3.03,95%CI：0.94-5.11,P〈0.01）as well as decreased the mortality rate（RR=1.96,95%CI：1.15-3.34,P=0.01）.However,there were no statistical differences in the durations of continuous positive airway pressure（CPAP）mechanical ventilation,oxygen inhalation time,time of clinical symptom outcome,incidence rate of NRDS and total effective rate of treatment between the two groups.Conclusion Currently published evidences show that Poractant Alfa Injection is superior to ambroxol hydrochloride in treating NRDS,however,due to limited number of included RCD and medium quality,the conclusion needs large scale and multicenter RCT verification.