中华临床医师杂志（电子版）
中華臨床醫師雜誌（電子版）
중화림상의사잡지（전자판）
CHINESE JOURNAL OF CLINICIANS(ELECTRONIC VERSION)
2013年
9期
3743-3748
,共6页
黎嘉敏%何永成%曾劲峰%卢亮%李彤
黎嘉敏%何永成%曾勁峰%盧亮%李彤
려가민%하영성%증경봉%로량%리동
血液透析%肝炎抗体,丙型%肝炎病毒属%HCV-RNA
血液透析%肝炎抗體,丙型%肝炎病毒屬%HCV-RNA
혈액투석%간염항체,병형%간염병독속%HCV-RNA
Hemodialysis%Hepatitis C antibodies%Hepacivirus%HCV-RNA
目的研究维持性血液透析患者丙型肝炎病毒（ HCV）感染的血清学诊断方法，探讨抗-HCV联合HCV-RNA检测在维持性血液透析患者HCV感染早期诊断中的意义，以期获得维持性血液透析患者HCV感染早期诊断的可靠方法。方法选择深圳市第二人民医院血液透析中心183例维持性血液透析患者为研究对象，分别使用国产和进口HCV抗体试剂盒检测抗-HCV，使用TMA法定性检测HCV-RNA，荧光定量PCR法定量检测HCV-RNA，比较不同产品及诊断方法对HCV的检出率，评价ALT变化与HCV-RNA载量的关系，评价抗-HCV S/CO值与HCV-RNA载量的关系。结果国产和进口试剂检测抗-HCV的检出率均为7.1％（ P＝1.000）；TMA法定性检测HCV-RNA的检出率为8.7％，免疫荧光定量PCR法的检出率为5.5％，但两者之间差异有统计学意义（χ2＝87.537，P＝0.000）；HCV-RNA定性检测比检测抗-HCV的检出率高，两者的差异有统计学意义（χ2＝81.531，P＝0.000）；联合抗-HCV和HCV-RNA定性检测结果HCV阳性共19例，检出率为10.4％，与单独检测抗-HCV比较差异有统计学意义（ P＝0.031），但与单独定性检测HCV-RNA比较差异无统计学意义（P＝0.250）。 HCV-RNA的载量和ALT的变化无相关性（r＝0.189，P＝0.536）；抗-HCV初筛的S/CO值与HCV-RNA载量无相关性（ r＝0.174， P＝0.569）。结论 HCV-RNA定性检测较抗-HCV检测能缩短维持性血液透析患者HCV感染检出的窗口期，有利于早期诊断。 HCV-RNA定性检测能较临床现行的HCV-RNA免疫荧光定量检测显著提高HCV感染的检出率。联合抗-HCV和TMA法定性检测HCV-RNA既能缩短HCV感染的“窗口期”，也能显著提高HCV感染的检出率，可避免漏检处于血清转换期或慢性病毒携带或既往感染的“隐性”患者，值得临床推广应用。 ALT的变化和HCV载量无明显相关性，在血液透析患者中辅助早期诊断HCV感染的作用较小。
目的研究維持性血液透析患者丙型肝炎病毒（ HCV）感染的血清學診斷方法，探討抗-HCV聯閤HCV-RNA檢測在維持性血液透析患者HCV感染早期診斷中的意義，以期穫得維持性血液透析患者HCV感染早期診斷的可靠方法。方法選擇深圳市第二人民醫院血液透析中心183例維持性血液透析患者為研究對象，分彆使用國產和進口HCV抗體試劑盒檢測抗-HCV，使用TMA法定性檢測HCV-RNA，熒光定量PCR法定量檢測HCV-RNA，比較不同產品及診斷方法對HCV的檢齣率，評價ALT變化與HCV-RNA載量的關繫，評價抗-HCV S/CO值與HCV-RNA載量的關繫。結果國產和進口試劑檢測抗-HCV的檢齣率均為7.1％（ P＝1.000）；TMA法定性檢測HCV-RNA的檢齣率為8.7％，免疫熒光定量PCR法的檢齣率為5.5％，但兩者之間差異有統計學意義（χ2＝87.537，P＝0.000）；HCV-RNA定性檢測比檢測抗-HCV的檢齣率高，兩者的差異有統計學意義（χ2＝81.531，P＝0.000）；聯閤抗-HCV和HCV-RNA定性檢測結果HCV暘性共19例，檢齣率為10.4％，與單獨檢測抗-HCV比較差異有統計學意義（ P＝0.031），但與單獨定性檢測HCV-RNA比較差異無統計學意義（P＝0.250）。 HCV-RNA的載量和ALT的變化無相關性（r＝0.189，P＝0.536）；抗-HCV初篩的S/CO值與HCV-RNA載量無相關性（ r＝0.174， P＝0.569）。結論 HCV-RNA定性檢測較抗-HCV檢測能縮短維持性血液透析患者HCV感染檢齣的窗口期，有利于早期診斷。 HCV-RNA定性檢測能較臨床現行的HCV-RNA免疫熒光定量檢測顯著提高HCV感染的檢齣率。聯閤抗-HCV和TMA法定性檢測HCV-RNA既能縮短HCV感染的“窗口期”，也能顯著提高HCV感染的檢齣率，可避免漏檢處于血清轉換期或慢性病毒攜帶或既往感染的“隱性”患者，值得臨床推廣應用。 ALT的變化和HCV載量無明顯相關性，在血液透析患者中輔助早期診斷HCV感染的作用較小。
목적연구유지성혈액투석환자병형간염병독（ HCV）감염적혈청학진단방법，탐토항-HCV연합HCV-RNA검측재유지성혈액투석환자HCV감염조기진단중적의의，이기획득유지성혈액투석환자HCV감염조기진단적가고방법。방법선택심수시제이인민의원혈액투석중심183례유지성혈액투석환자위연구대상，분별사용국산화진구HCV항체시제합검측항-HCV，사용TMA법정성검측HCV-RNA，형광정량PCR법정량검측HCV-RNA，비교불동산품급진단방법대HCV적검출솔，평개ALT변화여HCV-RNA재량적관계，평개항-HCV S/CO치여HCV-RNA재량적관계。결과국산화진구시제검측항-HCV적검출솔균위7.1％（ P＝1.000）；TMA법정성검측HCV-RNA적검출솔위8.7％，면역형광정량PCR법적검출솔위5.5％，단량자지간차이유통계학의의（χ2＝87.537，P＝0.000）；HCV-RNA정성검측비검측항-HCV적검출솔고，량자적차이유통계학의의（χ2＝81.531，P＝0.000）；연합항-HCV화HCV-RNA정성검측결과HCV양성공19례，검출솔위10.4％，여단독검측항-HCV비교차이유통계학의의（ P＝0.031），단여단독정성검측HCV-RNA비교차이무통계학의의（P＝0.250）。 HCV-RNA적재량화ALT적변화무상관성（r＝0.189，P＝0.536）；항-HCV초사적S/CO치여HCV-RNA재량무상관성（ r＝0.174， P＝0.569）。결론 HCV-RNA정성검측교항-HCV검측능축단유지성혈액투석환자HCV감염검출적창구기，유리우조기진단。 HCV-RNA정성검측능교림상현행적HCV-RNA면역형광정량검측현저제고HCV감염적검출솔。연합항-HCV화TMA법정성검측HCV-RNA기능축단HCV감염적“창구기”，야능현저제고HCV감염적검출솔，가피면루검처우혈청전환기혹만성병독휴대혹기왕감염적“은성”환자，치득림상추엄응용。 ALT적변화화HCV재량무명현상관성，재혈액투석환자중보조조기진단HCV감염적작용교소。
Objective By comparing the serological diagnosis methods of HCV infection ,to discussing the significance of anti-HCV combined with HCV-RNA qualitative detection by TMA in early diagnosis of HCV infection in maintenance hemodialysis patients , exploring the reliable method to diagnosis HCV infection in maintenance hemodialysis patients .Methods 183 maintenance hemodialysis patients were choosed as the research object ,using domestic and imported HCV 3.0 ELISA test system to detect HCV antibody respectively;HCV-RNA was detected by using TMA and fluorescence quantitative PCR method respectively;compare their positive rates of various diagnosis methods for detection of HCV , evaluation the relationship of ALT and HCV viral load , in addition, to evaluate the relationship of anti-HCV S/CO value and HCV viral load .Results The positive rate of anti-HCV both using domestic and imported diagnostic kits was 7.1%,there was no statistically significant difference between both of them (P=1.000).The positive rate of HCV-RNA was 8.7% by TMA,while 5.5% by fluorescence quantitative PCR , there was statistically significant difference between both of them (χ2 =87.537 ,P=0.000 ) .The rate of HCV-RNA qualitative detection was higher than anti-HCV detection , there was statistically significant (χ2 =81.531 , P =0.000 ) .The positive rate was 10.4% by an-HCV and/or HCV-RNA qualitatively , compared with the detection of anti-HCV alone(P=0.031),there was statistically significant difference ,but with the qualitative detection of HCV-RNA alone,there was no statistically significant difference (P=0.250).No correlation was found between the change of ALT and HCV viral load(r=0.189,P=0.536).Similarly,S/CO ratio of anti-HCV had nothing to do with HCV viral load(r =0.174,P =0.569).Conclusions Compared with detection of anti-HCV,qualitative detection of HCV-RNA can shorten the window period after HCV infection ,it would be diagnosis earlier with this method in the hemodialysis patients .Qualitative detection of HCV-RNA can increase the detection rate of HCV infection than immune fluorescence quantitative detection .Combined detection of anti-HCV and HCV-RNA qualitively can not only shorten the window period ,also significantly improve the detection rate .It can avoid missing detection such “hidden”patients,who was in serum transition or chronic virus carrying or previous infection , it′s worthy of clinical popularization and application .No obvious relevance between the change of ALT and HCV viral load ,so ALT affected littlely in assisting diagnosis of HCV infection .
