거대세포 바이러스 특이항원 자극 인터페론-감마효소결합면역흡착점적법/ 효소결합면역흡착측정법의안전성과 유효성에 대한 체계적 문헌 고찰
Safety and Effectiveness of Cytomegalovirus Specific Antigen Induced Interferon-Gamma ELISPOT/ELISA: A Systematic Review
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배경: 거대세포바이러스 특이항원 자극 인터페론-감마 효소결합면역흡착점적법/ 효소결합면역흡착측정법은면역저하환자에서 CMV 감염/질환의위험예측검사로서안전성및유효성을체계적문헌고찰방법을통하여확인하고자하였다. 방법: 문헌 검색은 MEDLINE, EMBASE 및 Cochrane library를 포함한 전자 데이터베이스를 통해수행되었으며, 884편이검색되었다. 최종적으로선택된문헌은 25편(코호트연구 15편, 단면연구10편)으로 연구대상이 고형장기 이식환자, 조혈모세포 이식환자, 혈액투석 환자이었다. 두 명의연구자는독립적으로자료추출및문헌의질평가를수행하였다. 결과: 선택된 대부분의 연구는 고형장기 이식환자를 대상으로 한 연구였다. 동 검사는 체외에서이루어지는 검사로 안전하다. 유효성은 대부분이 예후 관련 결과 발생의 위험도는 검사결과 활성군 대비 비활성군에서 CMV 사건발생(CMV 감염, CMV 질환 등) 위험비 또는 오즈비가 유의하게 높았고, 카플란-마이어 생존분석 결과에서도 CMV 사건 발생률이 유의하게 높았다. 그러나,CMV 세포면역반응에대한임계치가다양하였고, 예측정확도의범위가넓게보고되었다. 결론: 거대세포바이러스 특이항원 자극 인터페론 감마 효소결합면역흡착점적법/ 효소결합면역흡착측정법은고형장기이식환자에서는 CMV 감염/질환의위험을층화하여예방적/선제적치료의 방침을 결정할 수 있는 잠재성이 있는 검사이나, 임계치 확립과 검사의 표준화를 위하여 추가적인문헌적근거가필요하다.
Abstract
Background: This study evaluated the safety and effectiveness of the cytomegalovirus(CMV) Specific Antigen Induced Interferon-Gamma ELISPOT (enzyme-linked immunosorbentspot)/ELISA (enzyme-linked immunosorbent assay) procedure in predicting the risk of CMVinfection/disease in immunocompromised patients through a systematic literature review. Methods: The searched electronic databases included MEDLINE, EMBASE and the CochraneLibrary. A total of 884 non-duplicate citations were retrieved and a total of 25 studies (15cohort studies, 10 cross-sectional studies) were included in this review. Study subjects wereselected among patients with solid organ, hematopoietic stem cell transplantation, or thosewho were on hemodialysis. Data extraction and literature quality assessment were carried outindependently by two researchers. Results: Most of the studies were conducted on patients with solid organ transplants. As it isconducted outside the body, CMV Specific Antigen Induced Interferon-Gamma ELISPOT/ELISAassay was safe. Regarding its effectiveness, most studies on risk analysis based on prognosis related outcomes reported that the inactive group showed a significantly higher hazard ratioor odds ratio than the active group. Results of Kaplan-Meier survival analysis also showedthat the inactive group had a significantly higher incidence of CMV event (CMV infection,CMV disease, other events) than the active group. However, various thresholds for CMV cellimmune response were reported, as was a broad range of predictive diagnostic accuracies. Conclusion: CMV Specific Antigen Induced Interferon-Gamma ELISPOT/ELISA assay haspotential to stratify the risk of CMV infection/disease among solid organ transplant patients andto determine a policy for a prophylaxis/preemptive. However, additional literature evidence isneeded to establish thresholds for CMV cell immune response and standardized tests.
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