Amanqaku aphambili kwiMvumelwano yeeNgcali malunga nokuBekwa kweliso kwiiKliniki zeHeparin Drugs: Isitshixo soNyango oluKhuselekileyo lweAnticoagulant


Umbhali: Succeeder   

UXINGO LWENKONZO YOKUXINANA
ISICELO SEZIXAKI ZOKUHLAZIYA

Ukubeka esweni ngokufanelekileyo amayeza e-heparin yisayensi kunye nobugcisa, kwaye kunxulumene ngokuthe ngqo nempumelelo okanye ukungaphumeleli konyango lokunciphisa ukugabha kwegazi.

Amayeza e-Heparin asetyenziswa kakhulu njenge-anticoagulants ukuthintela nokunyanga izifo ze-thromboembolic kwaye asetyenziswa kakhulu kwiinkalo ezininzi zonyango.

Nangona kunjalo, indlela yokusebenzisa ngokuchanekileyo nokubeka esweni ngokufanelekileyo la mayeza ukuqinisekisa ukhuseleko nokusebenza kakuhle konyango ibisoloko iyinto ephambili koogqirha.

Ikhutshwe kutshanje "Imvumelwano yeengcali malunga nokubekwa esweni kwezonyango kweziyobisi zeHeparin"uxoxe ngokupheleleyo ngeempawu, idosi, ukubeka esweni kunye nezinye iinkalo zamayeza e-heparin, ngakumbi ucacise iindlela zokusetyenziswa kweklinikhi zezalathisi zelebhu ezifana nomsebenzi wokulwa ne-Xa."

Eli nqaku liza kushwankathela amanqaku aphambili ale mvumelwano ukunceda abasebenzi bezonyango ukuba bayisebenzise ngcono.

SF-8300

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-9200

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-8200

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

1-Ukukhethwa kwezalathisi zokubeka esweni ilabhoratri

Isivumelwano sigxininisa ukuba izinto eziqhelekileyo ekufuneka zijongwe ngaphambi nangexesha lokusetyenziswa kwamayeza e-heparin ziquka kodwa azipheleli nje kwi-hemodynamics, ukusebenza kwezintso, i-hemoglobin, inani leeplatelet kunye negazi elingaqhelekanga elisesitulweni.

Amanqaku ama-2 aphambili okujonga amayeza ahlukeneyo e-heparin

(1) I-heparin engaqhekekanga (UFH)

Umthamo wonyango we-UFH kufuneka ujongwe kwaye umthamo uhlengahlengiswe ngokwemisebenzi ye-anticoagulant.

Ukubeka iliso kwi-ACT kusetyenziswa xa kusetyenziswe idosi ephezulu (njengaxa kusenziwa i-PCI kunye nokujikeleza kwegazi ngaphandle komzimba [CPB]).

Kwezinye iimeko (ezifana nonyango lwe-ACS okanye i-VTE), i-APTT elungisiweyo yomsebenzi we-anti-Xa okanye we-anti-Xa inokukhethwa.

(2) I-heparin enobunzima obuphantsi bemolekyuli (LMWH)

Ngokweempawu ze-pharmacokinetic ze-LMWH, akufuneki ukuba kujongwe rhoqo umsebenzi we-anti-Xa.

Nangona kunjalo, izigulane ezinobunzima bomzimba obuphezulu okanye obuphantsi, ukukhulelwa, okanye ukungasebenzi kakuhle kwezintso kufuneka ziphononongwe ngokhuseleko okanye zilungiswe idosi ngokusekelwe kumsebenzi wokulwa noXa.

(3) Ukuhlolwa kwe-sodium yeFondaparinux

Izigulane ezisebenzisa idosi zokuthintela okanye zonyango ze-fondaparinux sodium azidingi ukubekwa esweni rhoqo kwemisebenzi yokulwa ne-Xa, kodwa ukubekwa esweni kwemisebenzi yokulwa ne-Xa kuyacetyiswa kwizigulane ezityebileyo ezinengxaki yezintso.

 

SF-8100

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-8050

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-400

Isihlalutyi seCoagulation esizenzekelayo esincinci

3- Ukuxhathisa i-Heparin kunye nonyango lwe-HIT

Xa kukho ukurhanelwa kokungabikho kwe-antithrombin (AT) okanye ukuxhathisa i-heparin, kuyacetyiswa ukuba kuvavanywe amanqanaba omsebenzi we-AT ukuze kukhutshwe ukungabikho kwe-AT kwaye kukhokelwe unyango olufunekayo lokutshintsha.

Kucetyiswa ukusebenzisa uvavanyo lwe-chromogenic substrate olusekelwe kwi-IIa (equlethe i-bovine thrombin) okanye i-Xa kumsebenzi we-AT.

Kwizigulane ezirhanelwa ngokwezonyango ukuba zine-heparin-induced thrombocytopenia (HIT), uvavanyo lwe-HIT antibody alukhuthazwa kwizigulane ezijongene ne-UFH ezinethuba eliphantsi le-HIT (≤3 points) ngokusekelwe kumanqaku e-4T.

Kwizigulane ezinethuba eliphakathi ukuya kweliphezulu le-HIT (amanqaku ama-4-8), uvavanyo lwe-HIT antibody luyacetyiswa.

Kucetyiswa umda ophezulu xa kuvavanywa i-antibody exutyiweyo, ngelixa umda ophantsi ucetyiswa xa kuvavanywa i-antibody ethile ye-IgG.

4- Ulawulo loMngcipheko woKopha kunye noNyango oluGuqukileyo

Kwimeko yokopha kakhulu okunxulumene ne-heparin, amayeza okunciphisa ukudumba kwegazi kufuneka apheliswe ngoko nangoko, kwaye ukuzinza kwe-hemostasis kunye ne-hemodynamic kufuneka kugcinwe ngokukhawuleza.

Iprotamine iyacetyiswa njengonyango lokuqala lokunciphisa i-heparin.

Idosi yeprotamine kufuneka ibalwe ngokusekelwe kubude bokusetyenziswa kwe-heparin.

Nangona kungekho ndlela zithile zokubeka esweni i-protamine, uvavanyo lweklinikhi lwempembelelo yokuguqula i-protamine lunokwenziwa ngokujonga imeko yokopha kwesigulana kunye notshintsho kwi-APTT.

Akukho chiza lithile le-fondaparinux sodium; iziphumo zayo ze-anticoagulant zinokuguqulwa kusetyenziswa i-FFP, i-PCC, i-rFVIIa, kwanokutshintshwa kwe-plasma.

Le mvumelwano ibonelela ngeenkqubo zokubeka esweni ezineenkcukacha kunye namaxabiso ekujoliswe kuwo, okusinceda senze izigqibo ezichanekileyo ngakumbi kwindlela yokusebenza kweklinikhi.

Unyango lwe-anticoagulant lukrele elintlangothi-mbini: ukusetyenziswa ngokufanelekileyo kunokuthintela nokunyanga iingxaki ze-thrombotic, kodwa ukusetyenziswa okungafanelekanga kunokunyusa umngcipheko wokopha.

Siyathemba ukuba ukutolika le mvumelwano kuya kukunceda usebenze ngakumbi kwizonyango kwaye ubonelele ngonyango olukhuselekileyo nolusebenzayo lwe-anticoagulant kwizigulana zakho.

SF-8300

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-9200

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

SF-8200

I-Analyzer ye-Coagulation ezenzekelayo ngokupheleleyo

I-Beijing Succeeder Technology Inc. (ikhowudi yesitokhwe: 688338) ibisoloko ibandakanyeka kakhulu kwicandelo lokuxilongwa kwe-coagulation ukususela ekusekweni kwayo ngo-2003, kwaye izimisele ukuba yinkokeli kweli candelo. Ikomkhulu layo liseBeijing, le nkampani ineqela elinamandla le-R&D, lemveliso kunye nelokuthengisa, eligxile ekuveliseni izinto ezintsha kunye nokusetyenziswa kwetekhnoloji yokuxilonga i-thrombosis kunye ne-hemostasis.

Ngenxa yamandla ayo abalaseleyo obuchwephesha, iSucceeder iphumelele amalungelo obunikazi angama-45 agunyazisiweyo, kuquka amalungelo obunikazi okuvelisa izinto ezintsha ali-14, amalungelo obunikazi ohlobo lwe-utility model ali-16 kunye namalungelo obunikazi oyilo ali-15.

Le nkampani ikwanazo nezatifikethi zobhaliso lwemveliso yezixhobo zonyango zeKlasi yesiBini ezingama-32, izatifikethi zokufaka iifayile zeKlasi yoku-1 ezi-3, kunye nesatifikethi se-EU CE kwiimveliso ezili-14, kwaye iphumelele isatifikethi senkqubo yolawulo lomgangatho se-ISO 13485 ukuqinisekisa ukugqwesa nokuzinza komgangatho wemveliso.

I-Succeeder ayisiyo nje kuphela inkampani ephambili yeBeijing Biomedicine Industry Leapfrog Development Project (G20), kodwa ikwaphumelele ekufikeleleni kwiBhodi yoVuselelo lweSayensi neTekhnoloji ngo-2020, ifikelela kuphuhliso oluphezulu lwenkampani.

Okwangoku, inkampani yakhe inethiwekhi yokuthengisa kuzwelonke egubungela amakhulu eearhente kunye neeofisi.

Iimveliso zayo zithengiswa kakuhle kwiindawo ezininzi zelizwe.

Ikwakhulisa iimarike zaphesheya kwaye iphucula rhoqo ukukhuphisana kwayo namazwe ngamazwe.