人类乳头状病毒检测诊断宫颈癌前病变的价值:随机对照研究的系统评价

Diagnostic Accuracy of Human Papillomavirus Test for Cervical Neoplasia:A Systematic Review of Randomized Controlled Trials

目的系统评价人类乳头状病毒检测对宫颈癌前病变的诊断价值。方法计算机检索CBM、CNKI、MEDLINE、PubMed、EMbase(均从建库至2010年6月),Cochrane临床对照试验中心注册库(2010年第2期),并手工检索相关杂志和纳入研究的参考文献。由两位评价员按照纳入与排除标准独立选择文献、提取资料和评价质量后,采用MetaDisc1.4软件进行Meta分析,并用RevMan5.0软件绘制森林图和SROC曲线。结果共纳入7个随机对照研究,合计171604例受试者。Meta分析结果显示:与传统的宫颈细胞学检查比较,人类乳头状病毒(HPV)检测能明显提高对宫颈癌前病变诊断的敏感性,其中HPV联合宫颈细胞学筛查诊断宫颈上皮内瘤变2级及以上病变时,与传统的宫颈细胞学检查比较差异有统计学意义(P<0.00001);但HPV检测却明显降低了对其诊断的特异性;只检测HPV,同时检测HPV和宫颈细胞学和先检测HPV。再以细胞学分流的方法诊断宫颈上皮内瘤变,与传统宫颈细胞学检查比较,除了第三种方法诊断宫颈上皮内瘤变1级及以上病变无统计学差异外(P=0.41),其余两种方法与之比较均有明显的统计学差异(P<0.01)。结论现有循证医学证据显示,与传统的宫颈细胞学筛查相比,HPV检测联合宫颈细胞学筛查可以明显提高诊断宫颈上皮内瘤变2级及以上病变的敏感性,但HPV检测并不能提高诊断宫颈癌前病变的特异性;应用HPV检测筛查宫颈癌前病变有待进一步研究。

Objective To evaluate the diagnostic accuracy of human papillomavirus test for cervical neoplasia.Methods The Cochrane Library（Issue 2,2010）,Cochrane Central Register of Controlled Trials（Issue 2,2010）,and the following databases as CBMdisc,CNKI,MEDLINE,PubMed,and EMbase were all searched from their establishment to June 2010 to get all the randomized control trials（RCTs）,and the relevant magazines and the references of the included studies were also searched.The screening,data extraction and quality assessment were conducted in accordance with the inclusion and exclusion criteria by two reviewers independently.The software Metadisc 1.4 was used to perform meta-analyses,and the forest plots and SROC curves were drewn with the RevMan 5.0 software.Results A total of 7 RCTs involving 171 604 subjects were included.The meta-analyses showed,the sensitivity of the HPV test for detecting cervical neoplasia（CIN） was higher than that of the conventional cytology test;the difference in sensitivity for detecting CIN in or above second grade was only found between the test of HPV combined with cervical cytology and the test of conventional cytology（P0.00001）,but the HPV test obviously lowered its diagnostic specificity.Among the following three tests for diagnosing CIN,such as,the single test of HPV,the combined test of HPV and cervical cytology,and the test of HPV followed by cytology shunting,the statistic differences compared with the conventional cytology test were found（P0.01） except the last test（P=0.41） which had no difference in diagnosing CIN in or above the first grade.Conclusion The current evidence indicates that,compared with the conventional cytology test,the HPV combined with the cytology test can improve the sensitivity for diagnosing CIN in or above the second grade,but the HPV test cannot improve the specificity for cervical neoplasia.The application of human papillomavirus test for detecting cervical neoplasia needs to be further studied.