西地那非治疗新生儿持续性肺动脉高压的Meta-分析

 目的 系统评价西地那非治疗新生儿持续性肺动脉高压(PPHN)的有效性和安全性,为临床治疗提供参考依据。方法 计算机检索PubMed、The Cochrane Library、Ovid-Embase、中国期刊全文数据库(CJFD)、万方数据库和中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM),收集西地那非治疗新生儿PPHN的随机对照试验(RCTs),严格根据纳入排除标准,对纳入文献进行内在偏倚风险评估、资料提取、运用RevMan5.3软件进行数据合并。结果 最终纳入9个RCTs。Meta-分析结果显示:与基础治疗相比,加用西地那非能降低病死率RR=0.16,95％CI(0.06,0.41), P＜0.01],降低肺动脉压MD=13.69,95％CI(3.98,23.40), P＜0.01],升高氧分压MD=6.51,95％CI(5.13,7.89), P＜0.01],降低二氧化碳分压MD=16.04,95％CI(11.33,20.74), P＜0.01],且差异均有统计学意义;但在升高血氧饱和度MD=14.34,95％CI(-3.72,32.40),P＞0.01],降低氧合指数MD=21.43,95％CI(-3.98,46.84), P=0.01]方面,两组差异无统计学意义。结论 西地那非在降低PPHN患儿的病死率和肺动脉压,升高氧分压和降低二氧化碳分压方面具有一定优势,局限于纳入研究数量和随访时间,在缩短其住院时间和机械通气时间等方面尚不明确,且缺乏长期安全性评估结果。

Meta analysis of sildenafil in the treatment of persistent pulmonary hypertension in newborns

Objective To evaluate the efficacy and safety of sildenafil in the treatment of persistent pulmonary hypertension in newborns, and to provide evidence-based reference for clinical treatment. Methods Databases including PubMed, the Cochrane Library, Ovid-EMbase, CJFD, Wanfang Data, CBM and VIP were searched to collect RCTs about PPHN treated with sildenafil in newborns. Meta-analysis was performed by using RevMan 5.3 software after data extraction and quality evaluation according to the clinical inclusion and exclusion criteria. Results A total of 9 RCTs were included. The results of meta-analysis showed that, compared with basic therapy, sildenafil could significantly reduce the mortalityRR=0.16,95％CI(0.06,0.41),P＜0.01]and pulmonary arterial pressureMD=13.69,95％CI(3.98,23.40), P＜0.01],increase oxygen partial pressure MD=6.51,95％CI(5.13,7.89), P＜0.01],and reduce carbon dioxide partial pressureMD=16.04,95％CI(11.33,20.74), P＜0.01].The difference was statistically significant,but there was no statistically significant difference in the increase of oxygen saturationMD=14.34,95％CI(-3.72,32.40),P＞0.01] or in the decrease of oxygenation indexesMD=21.43,95％CI(-3.98,46.84),P=0.01]. Conclusions Current evidence suggests that sildenafil can improve the mortality and pulmonary arterial pressure during the treatment of PPHN, and is effective for increasing oxygen partial pressure and decreasing carbon dioxide partial pressure.Because of the limited amount of inclusion and follow-up time of research, the mechanism by which the length of hospital stay and the duaration of mechanical ventilation are shortened is not clear. Moreover, long-term safety evaluation results are lacking.