目的 系統(tǒng)評價大劑量西地那非治療新生兒持續(xù)肺動脈高壓（PPHN）的療效和安全性，為臨床合理用藥提供參考。方法 通過檢索Cochrane Library、PubMed、Embase、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、維普中文期刊全文數(shù)據(jù)庫（VIP）和萬方數(shù)據(jù)庫，收集大劑量西地那非（>1 mg/kg）對比常規(guī)劑量西地那非（1 mg/kg）治療PPHN的隨機(jī)對照試驗(yàn)（RCTs），檢索時間從建庫到2019年12月。提取相關(guān)資料并評價研究的方法學(xué)質(zhì)量，使用RevMan 5.3軟件進(jìn)行Meta-分析。結(jié)果 共納入13項RCTs，共計772例患者。Meta-分析結(jié)果顯示：試驗(yàn)組的肺動脈下降［MD=-4.21，95%CI（-5.72～-2.69）］、血氧飽和度增加［MD=2.79，95%CI（1.53～4.06）］、氧分壓增加［MD=3.43，95%CI（2.19～4.67）］、二氧化碳分壓下降［MD=-4.53，95%CI（-7.62～-1.44）］顯著優(yōu)于對照組（P<0.01），不良反應(yīng)發(fā)生率與對照組比較無顯著差異［OR=1.55，95%CI（0.61～3.95），P>0.05）］。結(jié)論 大劑量西地那非（>1 mg/kg）在治療PPHN方面與常規(guī)劑量西地那非相比，臨床療效更優(yōu)，安全性相當(dāng)。

Objective To systematically evaluate the efficacy and safety of high-dose sildenafil in the treatment of persistent pulmonary hypertension in newborns (PPHN), and to provide a reference for the rational drug use. Methods Retrieved from the Cochrane Library, PubMed, Embase, CBM, CNKI, VIP and Wanfang Database from the inception to December 2019, randomized controlled trials (RCTs) about of high-dose sildenafil (> 1 mg/kg) compared with conventional-dose sildenafil (1 mg/kg) in the treatment of PPHN was collected. After the data extraction and evaluation of methodological quality of RCTs, meta-analysis was conducted by using RevMan 5.3 software. Results A total of 13 RCTs were included, involving 772 patients. The results of Metaanalysis showed that pulmonary arteries decreased[MD=-4.21, 95%CI (-5.72~-2.69)], blood oxygen saturation increased[MD=2.79, 95%CI (1.53~4.06)], partial oxygen pressure increased[MD=3.43, 95%CI (2.19~4.67)], the partial pressure of carbon dioxide decreases[MD=-4.53, 95%CI (-7.62~-1.44)] of high-dose sildenafil group were significantly superior to those of conventional-dose sildenafil group, with statistical significance (P<0.01). And the rate of ADR[OR=1.55, 95%CI (0.61~3.95)] of high-dose sildenafil group was no difference of that in conventional-dose sildenafil group. Conclusion High-dose sildenafil (> 1 mg/kg) has better clinical efficacy and similar safety compared with conventional-dose of sildenafil in the treatment of PPHN.

R974;R985