Umhla we-19 kuCanzibe luSuku lweHlabathi lwe-IBD, ezinikele ekuphakamiseni ulwazi loluntu ngesifo samathumbu esidumbileyo (IBD) kunye nokunyamekela izigulana ze-IBD. I-IBD ibandakanya ikakhulu i-ulcerative colitis (UC) kunye nesifo sikaCrohn (CD). Yimeko yamathumbu edumbileyo engapheliyo, ephinda ibuyele esiqhelweni eyonakalisa kakhulu umgangatho wobomi bezigulana. Ngeli xesha, siyavuya ukwabelana ngophando lwamva nje olwenziwe yi-Union Hospital, iTongji Medical College, iHuazhong University of Science and Technology, esebenziseIkhithi yoVavanyo lweCalprotectin(Uvavanyo lweFluorescence Immunochromatography, FICA)kwaye iIsihlalutyi se-Immunoassay esiqhubekayo se-WIZ-A202yenziwe sithi, inika iireferensi ezibalulekileyo zolawulo lwezifo zezigulane ze-UC.
Imvelaphi yoPhando: Ukufuna iZibonakaliso ezingcono zokubeka esweni ezingangenisi ntsholongwane kwi-UC
I-Colonoscopy "ngumgangatho ogqwesileyo" wokuvavanya umsebenzi wesifo se-endoscopic kwi-UC, kodwa ayingeni kwaye ayinyamezelwa kakuhle zizigulana, nto leyo eyenza kube nzima ukujonga rhoqo. Iimpawu ze-serum ezifana ne-Iprotheyini esebenzayo ye-C (CRP) kwaye izinga lokutyibilika kwe-erythrocyte (ESR) alinazo iinkcukacha ezithile kwaye alihambelani kakuhle nokuvuvukala kwamathumbu.
I-calprotectin yendle (FC), uphawu lokuvuvukala oluhambelana namathumbu oluvela kwi-neutrophils, lube sisixhobo esibalulekileyo esingangenisi ntsholongwane kulawulo lwe-IBD. Nangona kunjalo, imingcele ye-FC yahluka kakhulu kwiindlela ezahlukeneyo zokufumanisa ngenxa yokungabikho kwamaxabiso amiselweyo okusika. Uvavanyo lwe-Fluorescence immunochromatography (FICA) yindlela yokufumanisa ekhawulezayo nelula, kodwa amaxabiso ayo afanelekileyo okusika afuna ukuqinisekiswa okungakumbi.
Iinjongo zoPhando kunye neendlela
1) Iinjongo zoPhando: Olu phononongo lujolise ekuvavanyeni ulwalamano phakathi kwe-FC efunyenwe yi-FICA kunye nomsebenzi wesifo se-clinical/endoscopic kwi-UC, kunye nokuchonga amaxabiso afanelekileyo okuqikelela umsebenzi wesifo.
2）Abemi boPhando: Izigulana ezili-110 ezifunyaniswe zine-UC ezazilaliswe esibhedlele kwiSibhedlele i-Union, kwiKholeji yezoNyango yaseTongji, kwiYunivesithi yeSayensi neTekhnoloji yaseHuazhong phakathi kukaJanuwari 2021 noJuni 2022.
3） Indlela yokuFumanisa: I-FC ilinganiswe kusetyenziswaIsihlalutyi se-Immunoassay esiqhubekayo se-WIZ-A202 kunye nokuhambelanaIkhithi ye-FICA yeCalprotectinkuthi
4）Iikhrayitheriya zoVavanyo: Umsebenzi weklinikhi uhlolwe ngokwe-partial Mayo score (pMS); umsebenzi we-endoscopic uhlolwe yi-Ulcerative Colitis Endoscopic Index of Severity (UCEIS) kunye ne-Mayo Endoscopic Score (MES).
Iziphumo zoPhando oluPhambili
1. Amanqanaba e-FC anxulumene kakhulu nomsebenzi wesifo.
Amanqanaba e-FC abonise ulwalamano oluhle kakhulu ne-pMS (r=0.609), i-UCEIS (r=0.751), kunye ne-MES (r=0.635) (zonke i-P<0.001), kunye nolwalamano olungcono kuneI-CRPkunye ne-ESR. Ulwalamano phakathi kwe-FC kunye nomsebenzi we-endoscopic belunamandla kakhulu.
2. Amaxabiso okuphela afanelekileyo amiselwe.
| Ithagethi yokuqikelela | Ukusika okufanelekileyo (μg/g) | Uvelwano | Ukuchaneka |
|---|---|---|---|
| Umsebenzi weklinikhi (pMS ≥ 3) | ≥57.38 | 78.02% | 100% |
| Umsebenzi we-Endoscopic (UCEIS ≥ 1 / MES ≥ 1) | ≥53.30 | 71.57–73.74% | 100% |
3. I-FC ibonise ukusebenza okugqwesileyo ekukhetheni i-UC esebenzayo.
Uhlalutyo lwe-ROC curve lubonise ukuba i-AUC ye-FC yokuqikelela umsebenzi weklinikhi yayiyi-0.9456, kwaye yokuqikelela umsebenzi we-endoscopic yayiyi-0.9075 (UCEIS) kunye ne-0.9118 (MES), zonke zingcono kakhulu kune-CRP kunye ne-ESR.
4. Ukukhululwa kwezonyango akulingani nokukhululwa kwe-endoscopic.
Phakathi kwezigulane ezili-11 ezifumene uxolelo lweklinikhi (pMS < 3) kodwa zisene-endoscopic activity, ezili-10 (90.91%) zazinamanqanaba e-FC angaphantsi kwama-53.30 μg/g. Oku kuthetha ukuba nangona amanqanaba e-FC eqhelekileyo, ezinye izigulane zisenokungafumani ukuphiliswa kwe-endoscopic, kwaye i-colonoscopy ayinakutshintshwa ngokupheleleyo.
Izigqibo zoPhando
- Ukufunyanwa kwe-FC okusekwe kwi-FICA kukubonisa kakuhle umsebenzi weklinikhi kunye nowe-endoscopic kwi-UC.
- Kucetyiswa ukuba kuncitshiswe i-57.38 μg/g ukuze kuvavanywe umsebenzi weklinikhi.
- Kucetyiswa ukuba kuncitshiswe i-53.30 μg/g ukuze kuvavanywe umsebenzi we-endoscopic (umlinganiselo ophantsi unceda ukuphucula uvakalelo).
- I-FC inokunciphisa ngempumelelo iikholonoskopi ezingeyomfuneko kwaye iphucule ukusetyenziswa kwezixhobo zonyango.
Ukuqhubela phambili ukuxilongwa ngokuchanekileyo kunye nonyango lwe-IBD-Baysen esebenzayo
I-Xiamen Baysen Medical yaphuhliswa ngokuzimeleyoIkhithi yoVavanyo lweCalprotectin (Uvavanyo lwe-Fluorescence Immunochromatography) kunyeIsihlalutyi se-Immunoassay esiqhubekayo se-WIZ-A202zibonelela ngezi zibonelelo zilandelayo:
Ikhithi yoVavanyo lweCalprotectin (Uvavanyo lweFluorescence Immunochromatography)
Indawo: Uvavanyo lweKlinikhi loBuninzi
I-FICA isebenzisa indlela yesandwich ye-double-antibody ukufumanisa i-FC, ibonisa ulwalamano oluhle ne-ELISA, kwaye inokuvavanya ngempumelelo umsebenzi we-IBD.
Iingenelo zeMveliso:
- Ngokukhawuleza nangokulula:Iziphumo ziyafumaneka kwimizuzu eli-15 kuphela
- Ukusebenza okululaAkukho zixhobo zinzima zifunekayo; zifanelekile kumaziko ezonyango kuwo onke amanqanaba
- Iziphumo ezithembekileyo:Unxibelelwano oluhle nomsebenzi weklinikhi kunye nomsebenzi we-endoscopic
- Iimfuno zeSampuli ezicacileyoInkqubo yokuvavanya isampuli esemgangathweni iqinisekisa umgangatho wovavanyo
Izicelo:Ukuhlolwa kwezigulane zangaphandle, ukubekwa esweni kwezigulane ezilaliswayo, ukulandelwa konyango, kunye nentsebenziswano yophando
Iingenelo zeMveliso:
- Ukuhambelana kohlobo olupheleleyo lweSampuli: Uyakwazi ukuvavanya iisampuli zegazi, umchamo, kunye nendle
- Ukuhambelana okuhle: Ivumela indlela yegolide ye-colloidal, indlela ye-latex, kunye ne-fluorescence immunoassay
- Ikhuselekile ngokwebhayoloji:Ukuqokelelwa kwamakhadi enkunkuma ngokuzenzekelayo ukuze kulahlwe lula kwaye kukhuselekile
- Ukuthatha isampuli rhoqo:Ixhotyiswe ngegumbi lokufunxa elineendawo ezininzi, elivumela ukulayisha nokuvavanya isampuli ngaphandle kokuphazamiseka
- Ukuqatshelwa koBulumko: Zichonga ngokuzenzekelayo izinto zovavanyo kunye nendlela yokusebenza
- Ukusebenzisana kwedatha:Ixhasa unxibelelwano ne-LIS yesibhedlele (iNkqubo yoLwazi lweLebhu)
Olu phononongo luqinisekisa ixabiso elibalulekileyo leklinikhi lokufunyanwa kwe-FICA-based FC kulawulo lwe-UC, lubonelela ngesixhobo esinamandla sokujonga izigulane ze-IBD ngendlela engenabungozi.
Kwihlabathi liphela, ukwanda kwe-IBD kuyanda rhoqo. Ukuxilongwa kwangoko, unyango oluqhelekileyo, kunye nokubekwa esweni ngokwesayensi zibalulekile ekuphuculeni iziphumo zesigulana. Njenge-biomarker engangenisi, elula, kwaye echanekileyo kakhulu, i-calprotectin yendle iguqula imodeli yolawulo lwesifo se-IBD.
Thina Baysen/Wizbiotech sisazimisele kuphando nasekuphuculeni iimveliso zokuxilonga ezinxulumene ne-IBD, sibonelela oogqirha kunye nezigulane ngezisombululo zovavanyo ezichanekileyo nezilula, kwaye sisebenzisana ukukhusela impilo yamathumbu.
Ixesha leposi: Meyi-19-2026