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預(yù)防性HPV疫苗預(yù)防宮頸癌有效性和安全性Meta分析

發(fā)布時(shí)間:2018-05-29 01:54

  本文選題:HPV疫苗 + 宮頸癌; 參考:《中華腫瘤防治雜志》2015年09期


【摘要】:目的系統(tǒng)評(píng)價(jià)預(yù)防性HPV疫苗預(yù)防宮頸癌的有效性與安全性。方法計(jì)算機(jī)全面檢索Cochrane Library、PubMed、EMbase、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)、相關(guān)期刊論文(CNKI)以及萬(wàn)方數(shù)據(jù)庫(kù),并輔以手工檢索,檢索時(shí)間從建庫(kù)至2014-08,查找關(guān)于預(yù)防性HPV疫苗預(yù)防宮頸癌的隨機(jī)對(duì)照研究(randomized control trials,RCT)。由2名評(píng)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(píng)價(jià)后,采用RevMan 5.2軟件進(jìn)行Meta分析。結(jié)果最終共納入22篇RCT,包括14項(xiàng)原始研究,8項(xiàng)隨訪研究。Meta分析結(jié)果顯示,與對(duì)照組相比,預(yù)防性HPV疫苗對(duì)HPV16和HPV18相關(guān)的宮頸上皮內(nèi)瘤樣變(cervical intraepithelial neoplasia,CIN)Ⅱ+感染的相對(duì)危險(xiǎn)度(RR)及其95%可信區(qū)間(95%CI),在按照預(yù)案規(guī)定(PP)人群分析分別為0.03(0.01~0.07)和0.05(0.02~0.13),在意向性分析(ITT)人群分別為0.51(0.41~0.63)和0.15(0.10~0.22)。HPV疫苗對(duì)HPV16和HPV18相關(guān)的≥6個(gè)月持續(xù)性感染的RR及其95%CI,在PP人群分析分別為0.06(0.04~0.08)和0.19(0.12~0.32),在ITT人群分析分別為0.14(0.10~0.21)和0.07(0.02~0.26),HPV疫苗對(duì)CINⅠ+感染也有相似的有效性。同時(shí),HPV疫苗對(duì)于高風(fēng)險(xiǎn)HPV所引起的CINⅡ+、HPV持續(xù)性感染和CINⅠ+也有交叉保護(hù)效果,其差異有統(tǒng)計(jì)學(xué)意義。預(yù)防性HPV疫苗的主要不良反應(yīng)較輕微,嚴(yán)重不良反應(yīng)和死亡率在疫苗組和對(duì)照組保持均衡。結(jié)論預(yù)防性HPV疫苗對(duì)預(yù)防宮頸癌前病變及HPV持續(xù)性感染顯示了高效的保護(hù)效應(yīng)和交叉保護(hù)效果,是安全有效的。然而現(xiàn)有報(bào)道尚不能提供預(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(zhǎng)隨訪時(shí)間以進(jìn)一步驗(yàn)證。
[Abstract]:Objective to evaluate the efficacy and safety of prophylactic HPV vaccine in the prevention of cervical cancer. Methods Cochrane Library PubMeden EMbase, Chinese Biomedical Literature Database, Chinese Journal Full-text Database and Wanfang database were searched by computer, supplemented by manual retrieval. The search time was from the construction of the library to 2014-08, and the randomized control trialsof randomized controlled study on the prevention of cervical cancer with prophylactic HPV vaccine was found. 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 RevMan 5.2 software. Results A total of 22 RCTs were included, including 14 original studies and 8 follow-up studies. Meta-analysis showed that, compared with the control group, The relative risk of HPV16 and HPV18 associated cervical intraepithelial neoplasia cin 鈪,

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