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文章摘要
xingyingying.Bosentan Combined with Phosphodiesterase Inhibitors in the Treatment of Pulmonary Hypertension in Children with Congenital Heart Disease:A Systematic Review[J].中国药物评价,2019,36(3):223-229
波生坦联合磷酸二酯酶抑制剂治疗儿童先天性心脏病术后肺动脉高压的系统评价
Bosentan Combined with Phosphodiesterase Inhibitors in the Treatment of Pulmonary Hypertension in Children with Congenital Heart Disease:A Systematic Review
投稿时间:2019-05-12  修订日期:2019-05-12
DOI:
中文关键词: 波生坦  磷酸二酯酶抑制剂  先天性心脏病  肺动脉高压  联合用药  Meta 分析
英文关键词: Bosentan  Phosphodiesterase inhibitor  Congenital heart disease  Pulmonary hypertension  Combination therapy  Meta-analysis
基金项目:教育部青年基金项目(19C10316005)
作者单位E-mail
邢影影 中国药科大学国际医药商学院 18236536157@163.com 
周俊婷 中国药科大学  
李勇 中国药科大学 lsyg168@163.com 
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中文摘要:
      目的:系统评价波生坦联合磷酸二酯酶抑制剂治疗儿童先天性心脏病术后肺动脉高压的疗效与安全性。方法:计算机检索 PubMed、EMbase、The Cochrane Library、CBM、WanFang Data和CNKI数据库,搜集国内外有关波生坦联合磷酸二酯酶抑制剂治疗儿童先天性心脏病术后肺动脉高压的随机对照试验(RCT),检索时限均为建库至2019年3月1 日。由2位研究员按纳入与排除标准独立筛选文献、提取资料并评价纳入研究的偏倚风险;采用RevMan 5.3软件进行Meta分析。结果:最终纳入6个RCT,共458例患者。Meta分析结果显示:对比单药磷酸二酯酶抑制剂,波生坦联合磷酸二酯酶抑制剂总有效率更高[OR=4.05,95%CI(1.84,8.95),P=0.000 5],降低了先天性心脏病术后肺动脉高压患儿的NYHAFC评分[MD=-0.21,95%CI(-0.30,-0.12),P<0.000 01]、Brog评分[MD=-0.30,95%CI(-0.37,-0.23),P<0.000 01]、肺动脉收缩压[MD=-9.65,95%CI(-12.39,-6.90),P<0.000 01]和平均肺动脉压力[MD=-7.94,95%CI(-12.15,-3.73),P=0.000 2];提高了先天性心脏病术后肺动脉高压患儿的血氧饱和度SPO2[MD=4.19,95%CI(3.24,5.14,P<0.000 01]、肺循环血流量/体循环血流量比值Qp/Qs[MD=0.16,95%CI(0.06,0.25,P=0.000 8]以及延长了先天性心脏病术后肺动脉高压患儿的6MWD[MD=39.16,95%CI(14.83,63.49),P=0.002];然而在不良反应发生率[OR=0.60,95%CI(0.30,1.16),P=0.13]方面,两组差异无统计学意义。结论:对比单药磷酸二酯酶抑制剂,波生坦联合磷酸二酯酶抑制剂疗效更显著,能提高先天性心脏病术后肺动脉高压患儿的总有效率,改善先天性心脏病术后肺动脉高压患儿的呼吸功能、心脏功能和运动能力,同时降低了肺动脉压力,但在不良反应发生率方面效果尚不明确。受纳入研究数量和质量的限制,上述结论尚需进一步研究来验证,以期为临床医学提供循证依据。
英文摘要:
      Objective:To evaluate the efficacy and safety of bosentan combined with phosphodiesterase inhibitor in the treatment of postoperative pulmonary hypertension in children with congenital heart disease. Methods:Computers were searched for PubMed, EMbase, The Cochrane Library, CBM, WanFang Data and CNKI databases to collect randomized controlled trials (RCT) of bosentan combined with phosphodiesterase inhibitors in the treatment of postoperative pulmonary hypertension in children with congenital heart disease. The search time limit is built until March 1, 2019. Two investigators independently screened the literature according to inclusion and exclusion criteria, extracted the data and evaluated the risk of bias in the included studies. Meta-analysis was performed using RevMan 5.3 software. Results:A total of 458 patients were included in the six RCTs. Meta-analysis showed that the total effective rate of bosentan combined with phosphodiesterase inhibitor was higher than that of single-drug phosphodiesterase inhibitor [OR=4.05, 95% CI (1.84, 8.95), P=0.000 5], lowering NYHAFC scores in children with pulmonary hypertension after congenital heart disease [MD=-0.21, 95% CI (-0.30, -0.12), P<0.000 01], Brog score [MD=-0.30, 95% CI (-0.37), -0.23), P<0.000 01], pulmonary systolic pressure [MD=-9.65, 95% CI (-12.39,-6.90), P< 0.000 01] and mean pulmonary artery pressure [MD=-7.94, 95% CI (-12.15), -3.73), P=0.000 2]; increased oxygen saturation SpO2 in children with pulmonary hypertension after congenital heart disease [MD=4.19, 95% CI (3.24, 5.14, P<0.000 01), pulmonary circulation blood flow / Systemic blood flow ratio Qp/Qs [MD=0.16, 95% CI (0.06, 0.25, P=0.000 8) and prolonged 6MWD in children with pulmonary hypertension after congenital heart disease [MD=39.16, 95% CI (14.83, 63.49), P=0.002]. However, in the incidence of adverse reactions [OR=0.60, 95% CI (0.30, 1.16), P=0.13], the difference between the two groups was not statistically significant. Conclusion:Compared with single-drug phosphodiesterase inhibitors,bosentan combined with phosphodiesterase inhibitors are more effective, can improve the total effective rate of children with pulmonary hypertension after congenital heart disease, and improve the pulmonary artery after congenital heart disease. Respiratory function, cardiac function and exercise capacity of high-pressure children, while reducing pulmonary artery pressure, but the effect on the incidence of adverse reactions is not clear. Due to the limitations of the number and quality of the included studies, the above conclusions need further research to verify, in the hope Provide evidence-based evidence for clinical medicine.
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