本文選題：西地那非 + 肺動(dòng)脈高壓��； 參考：《廣西醫(yī)科大學(xué)》2012年碩士論文

【摘要】：目的評(píng)價(jià)西地那非治療兒童肺動(dòng)脈高壓(PH)的療效及其安全性。 方法計(jì)算機(jī)檢索Cochrane圖書館的臨床對(duì)照試驗(yàn)中心注冊(cè)庫、EMBASE、PubMed、CNKI、VIP、萬方數(shù)字化期刊群。檢索時(shí)間均從建庫至2011年5月。輔以手工檢索相關(guān)會(huì)議論文集,獲得西地那非治療兒童PH的隨機(jī)對(duì)照試驗(yàn)(RCT)。采用Cochrane評(píng)價(jià)手冊(cè)5.0推薦的方法對(duì)納入研究的方法學(xué)質(zhì)量進(jìn)行評(píng)估。合并分析采用Review Manager5.0軟件進(jìn)行,對(duì)無法進(jìn)行合并分析的結(jié)果進(jìn)行描述性分析。 結(jié)果共納入11個(gè)研究,共582例患兒。3篇正確描述了隨機(jī)序列的產(chǎn)生,4篇正確描述了分配隱藏,6篇描述使用了盲法及盲法的具體實(shí)施方法,7篇正確描述了退出或失訪情況。Meta分析結(jié)果顯示：采用西地那非治療后,患兒病死率有所下降[RR=0.18,95%CI(0.07,0.48)]；肺動(dòng)脈收縮壓及平均肺動(dòng)脈壓明顯下降[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患兒OI值[MD=-12.53,95%CI(-18.60,-6.47)],改善患兒動(dòng)脈血氧分壓[MD=12.39,95%CI(6.00,18.77)],并且基本不影響體循環(huán)血壓[MD=0.01,95%CI(-6.64,6.67)]。6個(gè)研究報(bào)道了研究過程中不良發(fā)應(yīng)的發(fā)生情況,研究期間無藥物相關(guān)死亡,各研究均報(bào)道患兒對(duì)西地那非有較好的耐受性。不良反應(yīng)主要為：短暫陰莖勃起、暫時(shí)性鼻阻塞、胃腸道出血、胃腸道反應(yīng)等。 結(jié)論西地那非能有效降低PH患兒死亡風(fēng)險(xiǎn),有效降低患兒升高的肺動(dòng)脈壓；并且能改善患兒氧合能力,改善患兒動(dòng)脈血氧分壓。短期運(yùn)用西地那非安全性及耐受性均較好。但是對(duì)于西地那非確切療效及遠(yuǎn)期安全性的評(píng)價(jià)仍有待大樣本,高質(zhì)量及長(zhǎng)期隨訪的RCT進(jìn)一步證實(shí)。
[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 鹵0.48)], pulmonary arterial systolic pressure and mean pulmonary artery pressure decreased significantly [MD-10.92 鹵95CI (-15.84 鹵-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 鹵-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.
【學(xué)位授予單位】：廣西醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類號(hào)】：R725.4

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