Into efunekayo ityala lika-ORBITA lithetha ntoni kuwe
NgoNovemba ka-2017, iziphumo zetyala lekliniki ekhethekileyo zabikwa kwiLancet , ngokukhawuleza ukuphonsa ihlabathi lezinto eziphilayo. Ityala lika-ORBITA lijongene nemingeni emashumi amathathu e-cardiology dogma ngokubhekiselele ekusebenzeni kwe- angina esomeleleyo eneentente . I-Stents, ityala le-ORBITA liphelile, alibonelelanga ukuphuculwa kweeklinikhi ekungeneni kwe-angina xa kuthelekiswa nenkqubo ye-sham.
Ingaba ngaba ngaba iinzuzo ze-cardiologists zithatyathwe kwiintente zonke eli xesha zibangelwa nto ngaphandle kwefuthe le-placebo? Iingcali zenziwe kwimigca yokulwa ngobusuku. Elinye iqela livakalise ukuba ityala le-ORBITA kufuneka liphelise umgangatho wokuba u-angina ozinzile. Iqela lesibini leengcali zatsho ukuba isilingo se-ORBITA, ngelixa esithakazelisayo, sasinokuphosakela, kwaye akufanele sitshintshe umgangatho weclini.
Oku kuhlanganiselwa imfazwe kubonakala ngathi ayiyi kusombululwa iminyaka emininzi. Oku, kunjalo, indlela inzululwazi yeklinikhi eqhubela phambili ngayo. Umbuzo kuthi: Nguwuphi umntu ojongene no-angina ozinzile namhlanje (ngelixa iingcali ziphikisana) kufuneka zenze ntoni ngoku?
Ukuba sibuyela emva kwaye sijonge iinjongo ezikhoyo kwi-data ekhoyo, kuya kuba nzima ukuba ufikelele kwindlela yokunyanga i-angina esomeleleyo enengqiqo, kwaye ihambelana nobungqina bezilingo zamachiza (kuquka i-ORBITA) nje ikhoyo namhlanje.
Iimpawu zeStable Angina
Amagqabantshintshi anama-wire-shaped struts awandiswa ngaphakathi kwintsimbi evinjiweyo ngexesha lenkqubo ye-angioplasty. Nge- angioplasty , ibhaluni ihlonyelwe kwisayithi ye- atherosclerotic plaque ukukhupha ukukhutshwa. I-stent yenziwa ngokufanayo ukuze kugcinwe i-artery.
I-Angioplasty kunye ne-stenting idla ngokugqithiselwa ngabagqirha ngokuthi "ukungenelela kwe-coronary", okanye i-PCI.
I-PCI yaphuhliswa njengengeniso engaphantsi kwe-artery coronary bypass grafting , inkqubo yokuhlinzwa yintliziyo evulekile. Ekubeni i-PCI yaphuhliswa, inani lezigulane ezinezifo zengqungquthela eziphathekayo eziphathwe ngophenyo lwe-parpass liye lahla kakhulu.
Kukho amaxesha apho ukusebenzisa i-PCI kubaluleke kakhulu. I-PCI ngokukhawuleza iphucula kakhulu imiphumo yabantu abajongene ne -acon coronary syndrome (ACS) -yoluhlu lweengxaki ezisongela ubomi obangelwa ukukhutshwa ngokukhawuleza komzobo we-coronary. Ezi zintathu ze-clinic syndromes ezibangelwa yi-ACS zibandakanya i- angina engaqinisekanga , i- ST-segment elevation myocardial infarction (STEMI) , kunye ne-ST-segment-up myocardial infarction (NSTEMI) . Kwizinto ezininzi zezi syndromes, i-PCI ekhawulezayo isungulwe, ngamanyathelo athile ekliniki, njengonyango olukhethiweyo.
Kwiminyaka emininzi, ukunyamezela kwakunjalo unyango olukhethiweyo kubantu abaninzi ababenokuthi bangama-angina-angina abomelelekileyo obangelwa ukukhutshwa okungapheliyo, okuzinzileyo, okukhethiweyo kwi-artery coronary. Ukuba i-PCI ikhululile i-angina kula bantu yayibonakala kubo bonke, yaye bekucingelwa ukuba baya kuba neengozi enciphise yokuhlaselwa kwentliziyo.
Emva koko, ngasekupheleni kweminyaka yama-2000, uvavanyo lweCOURAGE lubonise ukuba i-PCI ayizange iyanciphise ngokukhawuleza umngcipheko wokuhlaselwa kwentliziyo okanye ukufa kubantu abane-angina ezinzile, xa kuthelekiswa neyeza lonyango elinonya . Ukususela ngelo xesha, izikhokelo zeklinikhi zincome i-cardiologists ukuba isebenzise i-PCI ngokuzimelela ukukhupha iimpawu ze-angina, kwaye kuphela kubantu abangazange baphathwe ngempumelelo ngamachiza.
Nangona kunzima ukubhala ngokuchanekileyo, kubonakala ngathi abaninzi bezinto ze-cardiologists (nangona oko kukho izikhokelo zithetha nangona ubungqina bezilingo zeclini), baye baqhubeka besetyenziselwa ukugqithisa njenge-first line ye-anti-angina, kwaye kungekhona njengonyango lwe-line abantu abahlulekayo ngeziyobisi.
Benza oku, baya kuthixelela, kuba akukho nto itshaya i-stent yokukhupha i-angina.
Enyanisweni, phantse wonke umntu ukholelwa ukuba i-stents yindlela ephumelelayo yokukhupha i-angina, kwanabo bacebisa i-cardiologists ukuba bazame unyango lokuqala lonyango. Kuye yaba yinto eyinqobo: Naphezu kwayo yonke ingxaki, ukunyamezela kuyindlela ethembekileyo kwaye isebenzayo yokuphatha i-angina ezinzile.
Kodwa ngoku, ityala le-ORBITA liye lala le mfundiso ingxakini.
Yintoni eyenziwa yi-ORBITA Study
Abaphandi be-ORBITA bavavanya i-hypothesis ephazamisayo. Bambuza: Kuthiwani ukuba u-angina uncedo olunezigulane emva kokuba i-stent ayikho ngenxa yokuvulwa komthamo kodwa ingumphumo we-placebo? Ukuvavanya le ngcamango, baqhathanisa ukugqithisa okwenziweyo kwinkqubo yokuphosa.
Babhalise abantu abangama-200 abane-angina esomeleleyo kwaye ubuncinci obunqandekileyo kwi-coronary artery (ngaphezulu kwe-70 ekhulwini ivalwe). Emva kweeveki ezintandathu zeveki zokuphucula unyango, kwaye emva kokuvavanya okubanzi kwindlela yokuhlola ukulinganisa ubungakanani be-angina kunye namandla abo okusebenzisa, izifundo zazingenakulinganiswa ukuba zifumane i-stent, okanye inkqubo ye-sham stent. Kwinkqubo ye-sham, izifundo zifumene inkqubo yonke ye-PCI, kubandakanywa ukufaka ucingo kwi-blocking, ngaphandle kokuba akukho-angioplasty okanye i-stent eyenziwe. Emva kwenkqubo, zombini amaqela athola unyango olukhuselekileyo olusetyenziswayo emva kwe-PCI .
Emva kweiveki ezintandathu, zonke izifundo zihlolwe kwakhona ukulinganisa ubungakanani be-angina kunye nokusebenzisa amandla. Abaphandi bafumanise ukuba, ngelixa abo bafumene i-stents babonakala bephuculwe ngakumbi kunabo babenomsebenzi wenkohlakalo, umahluko phakathi kwamaqela amabini wawungasondelanga ukuba luphawu oluthile.
Ngoko ke, baqukumbele, ukugqithisa akunakulinganiswa ngokugqithiseleyo kunendlela yokwenza umlomo wokuphatha abantu abane-angina.
Ukuphendula kwi-ORBITA Study
Umhleli weLancet ohambisane nokupapashwa kwetyala le-ORBITA lathi le ngxelo "iyaba nefuthe kakhulu," kwaye yacela ukuba izikhokelo zonyango zihlaziyeke ukuze "zitshise" ukusetyenziswa kwe-PCI kwizigulane ezinezinyathelo ezinqinileyo.
Iingcali ze-cardiologists (abo benza i-PCI), ngokusebenzisa intlangano yabo (uMbutho we-Cardiovascular Angiography ne-Interventions, SCAI), wakhupha ngokukhawuleza i-critique enkulu ye-ORBITA. I-SCAI ibonise, phakathi kwezinye izinto, ukuba izigulane ezibhalisweyo zinezinga elingaphantsi kwe-angina (oko kukuthi, abaninzi abafanele babe ngabaviwa kwi-PCI kwindawo yokuqala); Isiphumo esiphambili solu vavanyo (ixesha lokusebenzisa) liyaziwayo ngokuzimela kwaye lixhomekeke ekuchazeni okukhulu; isifundo sincinci kwaye sifutshane; kwaye enye imilinganiselo enyanisekileyo yecychemia eyenziwa kwilingo (umlinganiselo obizwa ngokuba "ngongoma ophezulu wokupasa ugxininiso lwamanqaku") wabonisa ukuphucuka okukhulu kunye ne-PCI. Ngoko ke, bagqiba, iziphumo ze-ORBITA, ngelixa zinomdla, akufanele zisetyenziswe ukutshintsha isenzo sonyango.
Ngoko, njengokuba ubona, imida yokulwa, kwaye kufuneka silungiselele iminyaka emininzi yemfazwe.
Yintoni esifanele siyenze ngayo yonke le nto?
Isilingo se-ORBITA sinombuzo ngokuqinisekileyo ukuba i-PCI ephumelelayo njani ekuphatheni iimpawu ze-angina esomeleleyo. I-Cardiologists ayifanele ithathe, njengokuba yenzile, ukuba ukukhupha izibhengezo eziphezulu kwi-coronary artery kuya kwenza ukuba impawu zenzeke ngokukhawuleza.
Nangona kunjalo, i-cardiologist yangenelelo iphakamisa iingxaki ezininzi ezisemthethweni kunye nesifundo se-ORBITA. Lowo kufuneka asithintele njengengxaki enkulu yile: Izigulane ezingalindelekanga kwili vavanyo zinama-angina aphantsi aphantsi, kwaye phantsi kwezikhokelo zamanje abaninzi banakungabikho abaviwa be-PCI kwindawo yokuqala. Ngamanye amazwi, akufanele silindele ukuba ukugaya kunokuba nomthelela omkhulu kwizigulane. Inyaniso yokuba ayinayo imiphumo eningi kufuneka ukuba yayiqaliwe ukususela ekuqaleni.
Ngelo xesha, ukungenelela kungabikho ukuthatha induduzo enkulu ekuhlaselweni kwabo kwetyala. I-ORBITA isifundo ngokwenene ibonisa ukuba, kwiqela elikhulu lezigulane ezihlala zifumana i-PCI kwihlabathi langempela (oko kukuthi, abantu abaneenqobo "ezibalulekileyo" ezinempawu ezincinci ukuba zilinganise), ukunyaniseka akwenzi nto efanelekileyo.
Ngoko ke, nangona i-ORBITA ingacaciswanga ukutshintsha izikhokelo ezisesikweni ngoku, ngokuqinisekileyo iyalungelelanisa ukutshintshwa kweendlela zokwelapha ezikhoyo ngoku.
Ukuba Unamandla Angina namhlanje
Izitshintshi ziye zaguqula unyango lwe-coronary artery disease. Kubantu abanomnye we-coronary syndromes, i-PCI ibangele ekunciphiseni okukhulu ekufeni nasekufeni. Kwaye abaninzi abantu abanesifo esinzima, esinokukhubazeka angina (iqela elingakhange livivinywe kwi-trial ye-ORIBTA), i-PCI ibangele ukuphucula okukhulu kwiimpawu.
Nangona kunjalo, i-stents kufuneka igwenywe xa kunokwenzeka. Ukongeza komngcipheko ochaphazelekayo ekusebenzeni kwenkqubo ye-PCI ngokwayo, ubukho be-stent bubangela ingxaki yokulawula ixesha elide, kubini ugqirha kunye nesigulane, isisombululo sakhe esisigxina asihlali ngokucacileyo. Ngaloo nto, ngaba ikhuselekile ukuyeka izidakamizwa ezinamandla ezinxamnye ne-PCI? (Ngokuqinisekileyo, izigulane eziliqela kwilingo le-ORIBTA lalinomsebenzi wenkohlakalo liye lahlaselwa iipasiti ezinkulu ngexesha lokulandelelana.) Funda kabanzi malunga neengxaki eziqhubekayo kunye neentente .
Ukuba unesimo esilungileyo namhlanje, i-cardiologist yakho ayifanele ibe nomdla ngokuyenza i-PCI. Ukuqhaqhazela akuyi kuphelisa ngokupheleleyo ingxaki yakho yezokwelapha (nangona iphumelela ngokuphatha i-angina yakho); Kunoko, ukunyamezela kuya kuthungela enye ingxaki yokulawula engapheliyo kwenye.
Esikhundleni sokungena ngqo kwi-PCI, kwiimeko ezininzi i-cardiologist kufuneka ikhuthaze isilingo esinobudlova, esilumkileyo sonyango lwe-anti-anginal, kwaye umntu onokumelana ne-angina kufanele awamkele ingcamango yokuqala unyango. Bobabini amaqela kufuneka abe nesigulane, kuba ukufumana unyango olufanelekileyo lonyango lingathabatha iiveki okanye iinyanga.
Ukuba i-angina ephawulekayo ihlala ingxaki nangemva kokuvavanya kwenyango lwonyango, yilapho kuqikelelwe ingqwalasela enzulu kwi-stent. Funda ngakumbi malunga nokuba ufuna ngempela i-stent .
ILizwi
Ityala le-ORBITA lidala ingxubusho enkulu kwihlabathi le-cardiology ngokuphathelele unyango lwe-angina.
Nangona kunjalo, ukuba unayo i-angina enesigxina, iziphumo zolu vavanyo akufanele zixakeke kakhulu unyango lwakho, nje ngokuba wena nogqirha wakho bathatha inqaku lokujonga ubungqina.
Nangona ilingo le-ORBITA lingabonakali ukuba litshintshile indlela u-angina ozinzile kufuneka uphathwe ngayo, lucacisa utshintsho kwindlela esoloko iphathwe ngayo yi-cardiologists yangempela.
> Imithombo:
> Al-Lamee R, Thompson D, Dehbi HM, et al. Ukungenelela kweCononary Percutaneous In-Stable Angina (Orbita): I-Trib-Blind, i-Trimmed Trial Trial. Lancet 2017; INGXELO: 10.1016 / S0140-6736 (17) 32714-9. Abstract
> I-Brown DL, i-Redberg RF. I-Nail Yokugqibela Kwi-Coffin I-Pci Kwi-Stable Angina? Lancet 2017; INGXELO: 10.1016 / S01406736 (17) 32757-5. Hlela
> Umbutho weeNtsholongwane zengqondo kunye neNgeniso. I-SCAI ihlola amandla kunye nobuthathaka be-Sham PCI Trial. Novemba 2, 2017. https://medicalxpress.com/news/2017-11-scai-strengths-weaknesses-sham-pci.html