人乳頭瘤病毒疫苗預(yù)防宮頸癌及其相關(guān)感染有效性及安全性的Meta分析
發(fā)布時(shí)間:2018-06-06 23:27
本文選題:乳頭狀瘤病毒疫苗 + 宮頸腫瘤; 參考:《中國全科醫(yī)學(xué)》2015年12期
【摘要】:目的系統(tǒng)評價(jià)人乳頭瘤病毒(HPV)疫苗預(yù)防宮頸癌及HPV相關(guān)感染的有效性與安全性。方法計(jì)算機(jī)檢索Pub Med、EMBase、Cochrane Library、OVID、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、中國知網(wǎng)、萬方數(shù)據(jù)庫,并輔以手工檢索相關(guān)雜志和納入研究的參考文獻(xiàn),查找關(guān)于HPV疫苗預(yù)防宮頸癌及HPV相關(guān)感染的隨機(jī)對照研究(RCT),檢索時(shí)限從建庫至2014年7月。由2名評價(jià)員按照納入和排除標(biāo)準(zhǔn)獨(dú)立進(jìn)行文獻(xiàn)篩選、資料提取和質(zhì)量評價(jià)后,采用Rev Man 5.2軟件進(jìn)行Meta分析。結(jié)果最終納入23篇RCT。Meta分析結(jié)果顯示,疫苗組宮頸上皮內(nèi)瘤樣病變(CIN)Ⅱ+發(fā)生率、6個(gè)月HPV持續(xù)性感染發(fā)生率、12個(gè)月HPV持續(xù)性感染發(fā)生率、陰道內(nèi)皮瘤樣變(VIN)Ⅱ+/外陰內(nèi)皮瘤樣變(Va IN)Ⅱ+發(fā)生率、外生殖器疣發(fā)生率、高危型HPV(HR-HPV)相關(guān)感染與疾病發(fā)生率均低于對照組(P0.05)。按照預(yù)案規(guī)定(PP)人群及意向性分析(ITT)人群,疫苗組CINⅡ+發(fā)生率、6個(gè)月HPV持續(xù)性感染發(fā)生率、12個(gè)月HPV持續(xù)性感染發(fā)生率、VINⅡ+/Va INⅡ+發(fā)生率、外生殖器疣發(fā)生率、HR-HPV相關(guān)感染與疾病發(fā)生率均低于對照組(P0.05)。疫苗組注射部位相關(guān)不良反應(yīng)發(fā)生率高于對照組(P0.05);疫苗組與對照組系統(tǒng)不良反應(yīng)發(fā)生率、嚴(yán)重不良反應(yīng)發(fā)生率、病死率比較,差異無統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論 HPV疫苗對預(yù)防宮頸癌前病變、HPV持續(xù)性感染、HPV相關(guān)外生殖器病變顯示了高效的保護(hù)效應(yīng)和交叉保護(hù)效果,因此是安全、有效的。然而現(xiàn)有報(bào)道尚未證明HPV疫苗預(yù)防宮頸癌的遠(yuǎn)期療效,不能提供HPV疫苗預(yù)防宮頸癌的直接證據(jù),有待開展更多高質(zhì)量RCT并延長隨訪時(shí)間以進(jìn)一步驗(yàn)證。
[Abstract]:Objective to evaluate the efficacy and safety of human papillomavirus (HPV) vaccine in the prevention of cervical cancer and HPV related infections. Methods Pub Medsite was searched by computer, the Chinese Biomedical Literature Database (CBM), the Chinese knowledge Network, the Wanfang Database, and the related journals and references were retrieved by hand. A randomized controlled study on the prevention of cervical cancer and HPV associated infections with HPV vaccine was conducted. The search time was from the establishment of the library to July 2014. According to the criteria of inclusion and exclusion, two evaluators independently carried out literature screening, data extraction and quality evaluation, and Meta analysis was carried out with Rev Man 5.2 software. Results the results of 23 RCT.Meta analysis showed that the incidence of cervical intraepithelial neoplasia (cin) 鈪,
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