口服波生坦治疗在先天性心脏病Fontan术后患者中的安全性和有效性分析  

Safety and Efficacy of Oral Bosentan in Patients with Congenital Heart Disease after Fontan Operation

作　　者：魏婷婷 卢婷[2] 袁浩泳 吴忠仕[2] 黄灿[2] WEI Ting-ting;LU Ting;YUAN Hao-yong;WU Zhong-shi;HUANG Can(Department of Pediatrics, Hunan Maternal and Child Health Hospital, Changsha 410000, Hunan, China;Department of Cardiovascular Surgery, the Second Xiangya Hospital of Central South University, Changsha 410011, Hunan, China)

机构地区：[1]湖南省妇幼保健院儿科,湖南长沙410000 [2]中南大学湘雅二医院心血管外科,湖南长沙410011

出　　处：《中国现代手术学杂志》2020年第4期241-245,共5页Chinese Journal of Modern Operative Surgery

基　　金：湖南省出生缺陷协同防治科技重大专项(2019SK1010)。

摘　　要：目的采用系统综述及Meta分析方法评价口服波生坦(Bosentan)治疗在先天性心脏病Fontan术后患者中的安全性及有效性。方法系统性检索2018年12月以前,Pubme、EMBASE以及循证医学数据库关于先天性心脏病Fontan术后患者接受口服波生坦治疗的研究文章。用Review Manager version 5.0(Cochrane Collaboration)和加权均数差分析所获取的数据并评价波生坦治疗的安全性及有效性。结果来源于5篇文献的83例接受Fontan手术的患者被纳入本项研究。所有患者均接受最短16周的波生坦治疗,并表现出对该治疗的良好耐受,没有出现肝酶水平的显著升高(3倍于正常水平)。波生坦治疗前后,患者的6 min步行距离,峰值摄氧量以及SF-36生活质量评分均没有显著差异。结论口服波生坦治疗对于Fontan术后患者是安全的,能够获得良好耐受。由于治疗前后无显著差异,以及本研究的局限性,口服波生坦治疗在Fontan术后患者中的有效性尚需进一步研究。Objective To evaluate the efficiency and safety of oral Bosentan in patients with Fontan circulation by systematic review and Meta-analysis.Methods Databases including Pubmed,EMBASE,and the Cochrane Library were searched for relevant research studies published any time before December 2018 on patients with Fontan circulation treated with oral Bosentan.Review Manager version 5.0(Cochrane Collaboration)and weighted mean differences were used to analyze the data and evaluate the efficiency and safety of Bosentan treatment.Result Five studies including 83 patients with Fontan circulation were enrolled in our study.After at least 16 weeks of Bosentan therapy,the patients tolerated the treatment well without significant increased liver enzyme levels(i.e.,more than three times of the normal level).There was no significant difference in the values of the 6-minute walking distance,peak oxygen uptake,and SF-Item Short Form Survey before and after Bosentan therapy.Conclusions Oral Bosentan is safe and well tolerated in patients with Fontan circulation.Because there were no significant changes before and after Bosentan therapy and our Meta-analysis has limitations,the efficiency of oral Bosentan therapy needs to been confirmed in future studies.

关 键 词：先天性心脏病 波生坦 FONTAN手术 

分 类 号：R654.2[医药卫生—外科学]