CAJ | 학술논문

目的探讨无创产前诊断对RhD阴性孕妇胎儿RhD基因型诊断的敏感度和特异度及该方法在临床上施行的可行性.方法检索PubMed、Embase、Web of Science数据库中的文献,按照诊断试验的纳入和排除标准筛选文献,提取纳入文献的特征信息.应用MetaDisc1.4软件对符合条件的研究结果进行荟萃分析.结果共纳入55篇文献,胎儿17 138例,研究间具有异质性,采用随机效应模型,汇总敏感度、特异度和ROC曲线下的面积分别为98.5％、97.3％和0.994.对纳入的文献进行亚组分析和敏感度分析.样本量＜100的25篇文献敏感度(94.6％)低于样本量100～300的19篇文献(98.5％)和样本量＞ 100的11篇文献(99.0％),差异有统计学意义(x2=36.800、106.062,P＜0.05),样本量100～ 300的研究组和样本量＞300的研究组敏感度(98.5％、99.0％)差异无统计学意义(x2 =3.068,P＞0.05).结论无创产前诊断胎儿RhD基因型的敏感度和特异度较高,可用于Rh阴性孕妇胎儿的Rh基因型的产前诊断,预防新生儿溶血症的发生.
목적 탐토무창산전진단대RhD음성잉부태인RhD기인형진단적민감도화특이도급해방법재림상상시행적가행성.방법 검색PubMed、Embase、Web of Science수거고중적문헌,안조진단시험적납입화배제표준사선문헌,제취납입문헌적특정신식.응용MetaDisc1.4연건대부합조건적연구결과진행회췌분석.결과 공납입55편문헌,태인17 138례,연구간구유이질성,채용수궤효응모형,회총민감도、특이도화ROC곡선하적면적분별위98.5％、97.3％화0.994.대납입적문헌진행아조분석화민감도분석.양본량＜100적25편문헌민감도(94.6％)저우양본량100～300적19편문헌(98.5％)화양본량＞ 100적11편문헌(99.0％),차이유통계학의의(x2=36.800、106.062,P＜0.05),양본량100～ 300적연구조화양본량＞300적연구조민감도(98.5％、99.0％)차이무통계학의의(x2 =3.068,P＞0.05).결론 무창산전진단태인RhD기인형적민감도화특이도교고,가용우Rh음성잉부태인적Rh기인형적산전진단,예방신생인용혈증적발생.
Objective To explore the sensitivity,specificity and clinical validity of fetal Rh genotyping from maternal blood.Methods A comprehensive literature search of PubMed,Embase and Web of Science was performed for describing fetal RhD determination from maternal blood.The inclusion criteria were established based on the validity criteria for diagnostic research.And the eligible entries were collected and analyzed with MetaDisc4.0.Results This meta-analysis included 55 studies with a total of 17 138 samples.The random-effect model was used for analysis because of heterogeneity.The pooled sensitivity and specificity were 98.5％ and 97.3％ respectively.The SROC curve was plotted and the area under the curve (AUC) calculated (AUC =0.994).The subgroup and sensitivity analyses were performed.The sensitivity of 25 studies with samples ＜ 100 (94.6％) was significantly lower than those of 19 studies with samples 100-300 (98.5％) and 11 studies with samples ＞300 (99.0％) (x2 =36.800,106.062,P＜0.05).The sensitivity of 19 studies with samples 100-300 (98.5％) was not different from that of 11 studies with samples ＞ 300 (99.0％) (x2 =3.068,P ＞ 0.05).Conclusions Noninvasive prenatal diagnosis of fetal RhD status from maternal blood represents a significant achievement in the application of research with high sensitivity and specificity.It may be applied for screening testing of all RhD-negative pregnant women.