西地那非治疗儿童肺动脉高压疗效及安全性的系统评价

发布时间：2018-06-23 20:18

本文选题：西地那非 + 肺动脉高压　；参考：《广西医科大学》2012年硕士论文

【摘要】：目的评价西地那非治疗儿童肺动脉高压(PH)的疗效及其安全性。方法计算机检索Cochrane图书馆的临床对照试验中心注册库、EMBASE、PubMed、CNKI、VIP、万方数字化期刊群。检索时间均从建库至2011年5月。辅以手工检索相关会议论文集,获得西地那非治疗儿童PH的随机对照试验(RCT)。采用Cochrane评价手册5.0推荐的方法对纳入研究的方法学质量进行评估。合并分析采用Review Manager5.0软件进行,对无法进行合并分析的结果进行描述性分析。结果共纳入11个研究,共582例患儿。3篇正确描述了随机序列的产生,4篇正确描述了分配隐藏,6篇描述使用了盲法及盲法的具体实施方法,7篇正确描述了退出或失访情况。Meta分析结果显示：采用西地那非治疗后,患儿病死率有所下降[RR=0.18,95%CI(0.07,0.48)]；肺动脉收缩压及平均肺动脉压明显下降[MD=-10.92,95%CI(-15.84,-6.01)；MD=-9.11,95%CI(-11.29,-6.92)]。另外,西地那非有助于降低PH患儿OI值[MD=-12.53,95%CI(-18.60,-6.47)],改善患儿动脉血氧分压[MD=12.39,95%CI(6.00,18.77)],并且基本不影响体循环血压[MD=0.01,95%CI(-6.64,6.67)]。6个研究报道了研究过程中不良发应的发生情况,研究期间无药物相关死亡,各研究均报道患儿对西地那非有较好的耐受性。不良反应主要为：短暂阴茎勃起、暂时性鼻阻塞、胃肠道出血、胃肠道反应等。结论西地那非能有效降低PH患儿死亡风险,有效降低患儿升高的肺动脉压；并且能改善患儿氧合能力,改善患儿动脉血氧分压。短期运用西地那非安全性及耐受性均较好。但是对于西地那非确切疗效及远期安全性的评价仍有待大样本,高质量及长期随访的RCT进一步证实。
[Abstract]:Objective to evaluate the efficacy and safety of sildenafil in the treatment of pulmonary hypertension (PH) in children. Methods the library of Cochrane Clinical controlled trial Center was searched by computer for EMBASE PubMED CNKII VIPs and Wanfang Digital Journal Group. The retrieval time is from the construction of the database to May 2011. A randomized controlled trial (RCT) of sildenafil for treatment of children with PH was obtained by manual retrieval of related proceedings. Methods recommended by Cochrane Review Manual 5.0 were used to assess the quality of methodology included in the study. The merging analysis is carried out by Review Manager 5.0 software, and the results that can not be combined analysis are analyzed in a descriptive way. The results were included in 11 studies, A total of 582 children with 3 articles correctly described the generation of random sequences, 4 correctly described the distribution, concealment, 6 descriptions of the use of blind method and the implementation of blind method 7 correctly described the situation of withdrawal or loss of interviews. Meta-analysis results show : after treatment with sildenafil, The mortality of children decreased [RRV 0.18 95 CI (0.07 卤0.48)], pulmonary arterial systolic pressure and mean pulmonary artery pressure decreased significantly [MD-10.92 卤95CI (-15.84 卤-6.01) CI -9.11 1 95 CI (-11.29 -6.92)]. In addition, sildenafil can decrease the OI value of children with PH [MD-12.53-95 CI (-18.60 卤-6.47)], improve the partial pressure of oxygen in children's arteries [MD-12.39 ~ 95CI (6.00 ~ 18.77)], and have no effect on systemic blood pressure [MD0.0195CI (-6.64c6.67)]. All studies reported better tolerance to sildenafil in children. The main adverse reactions were: temporary penile erection, temporary nasal obstruction, gastrointestinal bleeding, gastrointestinal reaction and so on. Conclusion sildenafil can effectively reduce the risk of death and increase pulmonary artery pressure in children with PH, and can improve oxygenation ability and oxygen partial pressure of arterial blood in children. Short-term use of sildenafil is safe and well tolerated. However, the evaluation of the efficacy and long-term safety of sildenafil still needs to be confirmed by high quality and long term follow-up RCT.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R725.4

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